Inhixa

Package leaflet: Information for the user

Inhixa 2,000 IU (20 mg)/0.2 ml solution for injection, 4,000 IU (40 mg)/0.4 ml solution for injection, 6,000 IU (60 mg)/0.6 ml solution for injection, 8,000 IU (80 mg)/0.8 ml solution for injection, 10,000 IU (100 mg)/1 ml solution for injection

enoxaparin sodium
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Inhixa is and what it is used for
2. What you need to know before using Inhixa
3. How to use Inhixa
4. Possible side effects
5. How to store Inhixa
6. Contents of the pack and other information

1. What Inhixa is and what it is used for

Inhixa contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Inhixa works in two ways:

1. It prevents the growth of existing blood clots. This helps the body to break them down and prevents them from causing harm.
2. It prevents the formation of blood clots.
   Inhixa can be used for:

• Treating existing blood clots
• Preventing the formation of blood clots in the following situations:
  • before and after surgery
  • in case of an acute illness requiring reduced mobility
  • to prevent further blood clots if you have had a blood clot due to cancer
  • in unstable angina (a condition in which insufficient blood reaches the heart)
  • after a heart attack
• Preventing the formation of blood clots in the tubing of dialysis machines (used by people with severe kidney problems).

2. What you need to know before using Inhixa

Do not use Inhixa

• If you are allergic to enoxaparin sodium or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you are allergic to heparin or to other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
• If you have previously had a reaction to heparin that caused a severe drop in the number of blood cells involved in clotting (platelets) (this reaction is called heparin-induced thrombocytopenia), within the last 100 days, or if you have antibodies against enoxaparin in your blood.
• If you are actively bleeding or have a condition with a high risk of bleeding (such as a stomach ulcer, recent brain or eye surgery), including recent hemorrhagic stroke.
• If you are using Inhixa to treat blood clots and you are scheduled to receive spinal or epidural anaesthesia or a lumbar puncture within 24 hours.

Warnings and precautions
Inhixa must not be used interchangeably with other medicines belonging to the
group of low molecular weight heparins. These medicines are not identical and
do not have the same activity or usage instructions.
Consult your doctor or pharmacist before using Inhixa if:

• you have ever had a reaction to heparin that caused a significant drop in platelet count
• you need to undergo spinal or epidural anaesthesia or lumbar puncture (see Surgery and anaesthesia): observe the recommended time interval between Inhixa use and this procedure
• you have had a heart valve implanted
• you suffer from endocarditis (an infection of the inner lining of the heart)
• you have previously had a stomach ulcer
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or diabetes-related eye blood vessel problems (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if over 75
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (levels can be checked with a blood test)
• you are currently taking medicines that may affect bleeding (see next section - Other medicines and Inhixa).

You may need to have a blood test before starting this medicine and regularly during treatment to monitor your platelet count and blood potassium levels.
Children and adolescents
The safety and efficacy of Inhixa have not been established in children or adolescents.
Other medicines and Inhixa
Inform your doctor, pharmacist or nurse if you are taking or might take any other medicines.

• Warfarin – another anticoagulant medicine used to thin the blood
• Acetylsalicylic acid (also known as aspirin or ASA), clopidogrel or other medicines used to prevent clot formation (see also section 3, “Switching anticoagulant medicines”)
• Injectable dextran – used as a blood substitute
• Ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory agents used to treat pain and swelling in arthritis and other conditions
• Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
• Medicines that increase potassium levels in the blood, such as potassium salts, diuretics and certain medicines for heart conditions.

Surgery and anaesthesia
If you are scheduled for a spinal puncture or surgery requiring epidural or spinal anaesthesia, inform your doctor that you are using Inhixa. See “Do not use Inhixa”. Also inform your doctor if you have any spinal problems or have had previous spinal surgery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
If you are pregnant and have a mechanical heart valve, you may be at increased risk of developing blood clots. Your doctor will discuss this with you.
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine.
Driving and using machines
Inhixa does not affect the ability to drive or operate machinery.
Traceability
It is important to record the batch number of Inhixa. Therefore, each time you start a new pack of Inhixa, write down the date and the batch number (shown on the packaging after Batch) and keep this information in a safe place.
Inhixa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Inhixa

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Administration of the medicine

• Inhixa is normally administered by a doctor or nurse, as it must be given by injection.
• When you are discharged from hospital, you may need to continue using Inhixa and administer it yourself (see instructions below on how to do this).
• Inhixa is usually administered by subcutaneous injection (under the skin).
• Inhixa may be administered by intravenous injection (into a vein) after certain types of heart attack or surgery.
• Inhixa may be added to the tube draining blood from the body (arterial line) at the beginning of a dialysis session. Do not inject Inhixa into a muscle.

How much medicine will be given to you

• Your doctor will decide how much Inhixa you should receive. The dose depends on why it is being used.
• If you have kidney problems, you may receive a lower dose of Inhixa.

1. Treatment of blood clots present in the blood
   • The usual dose is 150 IU (1.5 mg) per kilogram of body weight per day or 100 IU (1 mg) per kilogram of body weight twice daily.
   • Your doctor will decide how long you should receive Inhixa.
2. Prevention of blood clots in the following situations:
   • Surgery or periods of reduced mobility due to illness
   • The dose depends on how likely you are to develop a clot. You will receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of Inhixa per day.
   • If surgery is planned, the first injection is usually given 2 hours or 12 hours before the operation.
   • If you have reduced mobility due to illness, 4,000 IU (40 mg) of Inhixa per day is usually administered.
   • Your doctor will decide how long you should receive Inhixa.
   • After a heart attack Inhixa can be used for two different types of heart attack, called STEMI (ST-segment elevation myocardial infarction) or non-STEMI (NSTEMI). The amount of Inhixa given depends on your age and the type of heart attack.

NSTEMI-type heart attack:

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually ask you to take acetylsalicylic acid (aspirin) as well.
• Your doctor will decide how long you should receive Inhixa.

STEMI-type heart attack if you are under 75 years of age:

• An initial dose of 3,000 IU (30 mg) of Inhixa administered as an intravenous injection.
• At the same time, you will also receive Inhixa as a subcutaneous injection (under the skin). The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually ask you to take acetylsalicylic acid (aspirin) as well.
• Your doctor will decide how long you should receive Inhixa.

STEMI-type heart attack if you are 75 years of age or older:

• The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum dose of Inhixa administered for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should receive Inhixa.

For patients undergoing a procedure called percutaneous coronary intervention (PCI):
Depending on when Inhixa was last administered, your doctor may decide to
administer an additional dose of Inhixa before a PCI. The medicine will be injected into a vein.

3. Prevention of blood clots in the tubing of a dialysis machine
   • The usual dose is 100 IU (1 mg) per kilogram of body weight.
   • Inhixa is added to the tube draining blood from the body (arterial line) at the beginning of the dialysis session. This amount is usually sufficient for a 4-hour session. However, your doctor may administer an additional dose of 50–100 IU (0.5–1 mg) per kilogram of body weight if necessary.

How to self-administer an Inhixa injection using a pre-filled syringe without a needle safety device
If you are able to self-administer this medicine, your doctor or nurse will
show you how to do it. Do not attempt to give the injection yourself if you have not been trained. If you are unsure what to do, consult your doctor or nurse immediately.
Before self-administering an Inhixa injection

• Check the expiry date of the medicine. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the liquid inside is clear. If not, use another syringe.
• Do not use this medicine if you notice any changes in its appearance.
• Make sure you know how much medicine you are about to inject.
• Check whether the previous injection caused redness, skin discoloration, swelling, oozing, or if it is still painful. If so, contact your doctor or nurse.
• Decide where to inject the medicine. Change the injection site each time, alternating between the right and left side of the abdomen (stomach). This medicine must be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away from these areas).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa
1) Wash your hands and the injection site with soap and water. Dry them thoroughly.
2) Sit or lie down in a comfortable position so that you are relaxed. Make sure you can see the area where you will inject. A reclining chair, adjustable bed, or lying on a bed with pillows is ideal.
3) Choose an area on the right or left side of your abdomen. This area should be at least 5 cm away from the navel and towards the hips.
Remember: Do not inject within 5 cm of the navel or near existing scars or bruises.
Change the injection site between the left and right sides of the abdomen, depending on where you injected last time.
4) Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and remove the pre-filled syringe.
5) Carefully remove the needle cap from the syringe. Discard the cap. The syringe is pre-filled and ready to use.

Do not press the plunger before administering the injection. Once the cap is removed, avoid letting the needle touch anything to ensure it remains clean (sterile).
6) Hold the syringe in your writing hand (like a pencil) and with the other hand gently pinch the clean area of the abdomen between your thumb and index finger to create a skin fold.
Make sure to keep the skin pinched throughout the entire injection.
7) Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the full length of the needle into the skin fold.

8) Press the plunger with your thumb. This will inject the medicine into the fatty tissue of the abdomen. Make sure to keep the skin pinched throughout the injection.
9) Remove the needle by pulling it straight out.

To minimize the risk of bruising, do not rub the site where you just injected.
10) Dispose of the used syringe in a sharps container. Close the container tightly and place it out of reach of children.
When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions. Do not
put it in household waste.

How to self-administer an Inhixa injection using a pre-filled syringe with a needle safety device
The pre-filled syringe may be equipped with a needle safety device to protect against accidental needle sticks. If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself if you have not been trained. If you are unsure what to do, consult your doctor or nurse immediately.
Before self-administering an Inhixa injection

• Check the expiry date of the medicine. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the liquid inside is clear. If not, use another syringe.
• Do not use this medicine if you notice any changes in its appearance.
• Make sure you know how much medicine you are about to inject.
• Check whether the previous injection caused redness, skin discoloration, swelling, oozing, or if it is still painful. If so, contact your doctor or nurse.
• Decide where to inject the medicine. Change the injection site each time, alternating between the right and left side of the abdomen (stomach). This medicine must be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away from these areas).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa
1) Wash your hands and the injection site with soap and water. Dry them thoroughly.
2) Sit or lie down in a comfortable position so that you are relaxed. Make sure you can see the area where you will inject. A reclining chair, adjustable bed, or lying on a bed with pillows is ideal.
3) Choose an area on the right or left side of your abdomen. This area should be at least 5 cm away from the navel and towards the hips.
Remember: Do not inject within 5 cm of the navel or near existing scars or bruises.
Change the injection site between the left and right sides of the abdomen, depending on where you injected last time.
4) Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and remove the pre-filled syringe.
5) Carefully remove the needle cap from the syringe. Discard the cap. The syringe is pre-filled and ready to use.

Do not press the plunger before administering the injection. Once the cap is removed, avoid letting the needle touch anything to ensure it remains clean (sterile).
6) Hold the syringe in your writing hand (like a pencil) and with the other hand gently pinch the clean area of the abdomen between your thumb and index finger to create a skin fold.
Make sure to keep the skin pinched throughout the entire injection.
7) Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the full length of the needle into the skin fold.

8) Press the plunger with your thumb. This will inject the medicine into the fatty tissue of the abdomen. Make sure to keep the skin pinched throughout the injection.
9) Remove the needle by pulling it straight out. Do not release pressure on the plunger!

To minimize the risk of bruising, do not rub the site where you just injected.
10) Firmly press the plunger. The needle safety shield, shaped like a plastic cylinder, will automatically move over the needle, completely covering it.

11) Dispose of the used syringe in a sharps container. Close the container tightly and place it out of reach of children.
When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions. Do not
put it in household waste.

How to self-administer an Inhixa injection using a pre-filled syringe with UltraSafe Passive needle safety device
The pre-filled syringe is equipped with an UltraSafe Passive needle safety device to protect against accidental needle sticks. If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself if you have not been trained. If you are unsure what to do, consult your doctor or nurse immediately.
Before self-administering an Inhixa injection

• Check the expiry date of the medicine. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the liquid inside is clear. If not, use another syringe.
• Do not use this medicine if you notice any changes in its appearance.
• Make sure you know how much medicine you are about to inject.
• Check whether the previous injection caused redness, skin discoloration, swelling, oozing, or if it is still painful. If so, contact your doctor or nurse.
• Decide where to inject the medicine. Change the injection site each time, alternating between the right and left side of the abdomen (stomach). This medicine must be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away from these areas).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa
1) Wash your hands and the injection site with soap and water. Dry them thoroughly.
2) Sit or lie down in a comfortable position so that you are relaxed. Make sure you can see the area where you will inject. A reclining chair, adjustable bed, or lying on a bed with pillows is ideal.
3) Choose an area on the right or left side of your abdomen. This area should be at least 5 cm away from the navel and towards the hips.
Remember: Do not inject within 5 cm of the navel or near existing scars or bruises.
Change the injection site between the left and right sides of the abdomen, depending on where you injected last time.
4) Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and remove the pre-filled syringe.
5) Carefully remove the needle cap from the syringe. Discard the cap. The syringe is pre-filled and ready to use.

Do not press the plunger before administering the injection. Once the cap is removed, avoid letting the needle touch anything to ensure it remains clean (sterile).
6) Hold the syringe in your writing hand (like a pencil) and with the other hand gently pinch the clean area of the abdomen between your thumb and index finger to create a skin fold.
Make sure to keep the skin pinched throughout the entire injection.
7) Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the full length of the needle into the skin fold.

8) Press the plunger with your thumb. This will inject the medicine into the fatty tissue of the abdomen. Make sure to keep the skin pinched throughout the injection.
9) Remove the needle by pulling it straight out. Do not release pressure on the plunger!

To minimize the risk of bruising, do not rub the site where you just injected.
10) Release the plunger and the syringe will move forward until the safety mechanism covers the needle and locks into place.

11) Dispose of the used syringe in a sharps container. Close the container tightly and place it out of reach of children.
When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions. Do not
put it in household waste.

How to self-administer an Inhixa injection using a pre-filled syringe with a manually activated needle safety device
The pre-filled syringe may be equipped with a manually activated needle safety device to protect against accidental needle sticks. If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself if you have not been trained. If you are unsure what to do, consult your doctor or nurse immediately.
Before self-administering an Inhixa injection

• Check the expiry date of the medicine. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the liquid inside is clear. If not, use another syringe.
• Do not use this medicine if you notice any changes in its appearance.
• Make sure you know how much medicine you are about to inject.
• Check whether the previous injection caused redness, skin discoloration, swelling, oozing, or if it is still painful. If so, contact your doctor or nurse.
• Decide where to inject the medicine. Change the injection site each time, alternating between the right and left side of the abdomen (stomach). This medicine must be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away from these areas).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa
1) Wash your hands and the injection site with soap and water. Dry them thoroughly.
2) Sit or lie down in a comfortable position so that you are relaxed. Make sure you can see the area where you will inject. A reclining chair, adjustable bed, or lying on a bed with pillows is ideal.
3) Choose an area on the right or left side of your abdomen. This area should be at least 5 cm away from the navel and towards the hips.
Remember: Do not inject within 5 cm of the navel or near existing scars or bruises.
Change the injection site between the left and right sides of the abdomen, depending on where you injected last time.
4) Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and remove the pre-filled syringe.
5) Carefully remove the needle cap from the syringe. Discard the cap. The sy游戏副本

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Like other anticoagulant medicines (medicines to reduce blood clotting), Inhixa can cause bleeding, which may potentially be life-threatening. In some cases, bleeding may not be obvious.
If you experience any bleeding events that do not stop on their own, or if you develop signs of excessive bleeding (extreme weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately.
Your doctor may decide to monitor you closely or switch your medication.
Stop using Inhixa and contact your doctor or nurse immediately if you develop any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
Stop using enoxaparin and consult a doctor immediately if you notice any of the following symptoms:

• A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis).

You must inform your doctor immediately

• If you experience signs of a blood vessel blockage caused by a clot, such as:
• cramps, redness, warmth, or swelling in one of the legs – signs of deep vein thrombosis
• shortness of breath, chest pain, fainting, or coughing up blood – signs of pulmonary embolism
• If you develop a painful skin rash with dark red spots under the skin that do not fade when pressed. Your doctor may ask you to have a blood test to check your platelet count.

General list of possible side effects:
Very common (may affect more than 1 in 10 people)

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Bruising more easily than usual. This may be due to a blood disorder with low platelet count.
• Pink spots on the skin. These are more likely to appear in the area where Inhixa was injected.
• Skin rash (urticaria).
• Itchy, red skin.
• Bruising or pain at the injection site.
• Decrease in red blood cells.
• High number of platelets in the blood.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache. This could be a sign of bleeding in the brain.
• Stomach pain and swelling. You may have bleeding in the stomach.
• Large, irregular red skin patches with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and darker urine. These could be signs of liver problems.

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction. Signs of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Increased potassium levels in the blood. More likely in people with kidney problems or diabetes. Your doctor may monitor this with a blood test.
• Increased number of white blood cells called eosinophils in the blood. Your doctor may monitor this with a blood test.
• Hair loss.
• Osteoporosis (a condition that makes bones more fragile) after prolonged use.
• Tingling, numbness, and muscle weakness (particularly in the lower part of the body) if you undergo spinal puncture or receive spinal anaesthesia.
• Loss of bladder or bowel control (inability to control when to go to the bathroom).
• Hard mass or nodule at the injection site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Inhixa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Store below 25°C. Do not freeze.
After dilution, the solution must be used within 8 hours.
Do not use this medicine if you notice any visible change in the appearance of the solution.
Pre-filled syringes are for single use only. Dispose of all unused medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Inhixa contains

• The active substance is enoxaparin sodium. Each ml contains 10,000 IU (100 mg) of enoxaparin sodium. Each 0.2 ml pre-filled syringe contains 2,000 IU (20 mg) of enoxaparin sodium. Each 0.4 ml pre-filled syringe contains 4,000 IU (40 mg) of enoxaparin sodium. Each 0.6 ml pre-filled syringe contains 6,000 IU (60 mg) of enoxaparin sodium. Each 0.8 ml pre-filled syringe contains 8,000 IU (80 mg) of enoxaparin sodium. Each 1 ml pre-filled syringe contains 10,000 IU (100 mg) of enoxaparin sodium.
• The other component is water for injections.

Description of the appearance of Inhixa and contents of the pack
Inhixa 2,000 IU (20 mg)/0.2 ml is a 0.2 ml solution in:

• a clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a blue polypropylene plunger. In addition, the syringes may be equipped with a needle protection device; or a manual needle protection device; or
• a clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a white polycarbonate plunger, equipped with the UltraSafe Passive needle protection device.

Packs containing:

• 1, 2, 6, 10, 20 and 50 pre-filled syringes
• 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle protection device
• 6, 10 and 20 pre-filled syringes with manual needle protection device
• 2 and 6 pre-filled syringes with UltraSafe Passive needle protection device

Inhixa 4,000 IU (40 mg)/0.4 ml is a 0.4 ml solution in:

• a clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a yellow polypropylene plunger. In addition, the syringes may be equipped with a needle protection device; or a manual needle protection device; or
• a clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a white polycarbonate plunger, equipped with the UltraSafe Passive needle protection device.

Packs containing:

• 2, 5, 6, 10, 20, 30 and 50 pre-filled syringes
• 2, 5, 6, 10, 20, 30, 50 and 90 pre-filled syringes with needle protection device
• 2, 6, 10, 20 and 50 pre-filled syringes with manual needle protection device
• 2 and 6 pre-filled syringes with UltraSafe Passive needle protection device

Inhixa 6,000 IU (60 mg)/0.6 ml is a 0.6 ml solution in:

• a graduated, clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and an orange polypropylene plunger. In addition, the syringes may be equipped with a needle protection device; or a manual needle protection device; or
• a graduated, clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a white polycarbonate plunger, equipped with the UltraSafe Passive needle protection device.

Packs containing:

• 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes
• 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes with needle protection device
• 6, 10, 12, 20, 24 and 50 pre-filled syringes with manual needle protection device
• 2 and 10 pre-filled syringes with UltraSafe Passive needle protection device

Inhixa 8,000 IU (80 mg)/0.8 ml is a 0.8 ml solution in:

• a graduated, clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a red polypropylene plunger. In addition, the syringes may be equipped with a needle protection device; or a manual needle protection device; or
• a graduated, clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a white polycarbonate plunger, equipped with the UltraSafe Passive needle protection device.

Packs containing:

• 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes
• 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes with needle protection device
• 6, 10, 12, 20, 24 and 50 pre-filled syringes with manual needle protection device
• 2 and 10 pre-filled syringes with UltraSafe Passive needle protection device

Inhixa 10,000 IU (100 mg)/1 ml is a 1 ml solution in:

• a graduated, clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a black polypropylene plunger. In addition, the syringes may be equipped with a needle protection device; or a manual needle protection device; or
• a graduated, clear, colourless, neutral Type I glass syringe with fixed needle and needle cover closed with a chlorobutyl rubber stopper and a white polycarbonate plunger, equipped with the UltraSafe Passive needle protection device.

Packs containing:

• 2, 6, 10, 12, 20, 24, 30, 50 and 90 pre-filled syringes
• 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes with needle protection device
• 6, 10, 12, 20, 24 and 50 pre-filled syringes with manual needle protection device
• 2 and 10 pre-filled syringes with UltraSafe Passive needle protection device

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Techdow Pharma Netherlands B.V.
Strawinskylaan 1143, Toren C-11
1077XX Amsterdam
The Netherlands

Manufacturer
SciencePharma spółka z ograniczoną odpowiedzialnością
Chełmska 30/34
00-725 Warsaw
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+31 (0)76 531 5388 +37125892152

България Luxembourg/Luxemburg
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +49 (0)30 220 13 6906

Česká republika Magyarország
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+420255790502 +3618001930

Danmark Malta
Techdow Pharma Netherlands B.V. Mint Health Ltd.
+4578774377 +356 2755 9990

Deutschland Nederland
Mitvertrieb: Techdow Pharma Germany GmbH Techdow Pharma Netherlands B.V.
Potsdamer Platz 1, 10785 Berlin +31208081112
+49 (0)30 98 321 31 00

Eesti Norge
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+37125892152 +4721569855

Ελλάδα Österreich
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +43720230772

España Polska
TECHDOW PHARMA SPAIN, S.L. Techdow Pharma Netherlands B.V.
Tel: +34 91 123 21 16 +49 (0)30 220 13 6906

France Portugal
Viatris Santé Laboratórios Atral, S.A.
+33 4 37 25 75 00 +351308801067

Hrvatska România
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+385 17776255 +49 (0)30 220 13 6906

Ireland Slovenija
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+31208081112 +49 (0)30 220 13 6906

Ísland Slovenská republika
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +421233331071

Italia Suomi/Finland
Techdow Pharma Italy S.R.L. Techdow Pharma Netherlands B.V.
Tel: +39 0256569157 +358942733040

Κύπρος Sverige
MA Pharmaceuticals Trading Ltd Techdow Pharma Netherlands B.V.
+357 25 587112 +46184445720

Latvija United Kingdom (Northern Ireland)
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+37125892152 +44 28 9279 2030

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Package leaflet: Information for the user

Inhixa 12,000 IU (120 mg)/0.8 ml solution for injection, 15,000 IU (150 mg)/1 ml solution for injection

enoxaparin sodium
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Inhixa is and what it is used for
2. What you need to know before using Inhixa
3. How to use Inhixa
4. Possible side effects
5. How to store Inhixa
6. Contents of the pack and other information

1. What Inhixa is and what it is used for

Inhixa contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Inhixa works in two ways:
3) It prevents the growth of existing blood clots. This helps the body to break them down and prevents them from causing harm.
4) It prevents the formation of blood clots.
Inhixa can be used for:

• Treating blood clots that are already present
• Preventing the formation of blood clots in the following situations:
  o before and after surgery
  o in case of an acute illness involving a period of reduced mobility
  o to prevent the formation of further clots if you have had a blood clot due to cancer
  o in unstable angina (a condition in which insufficient blood reaches the heart) or after a heart attack
• Preventing the formation of blood clots in the tubing of a dialysis machine (used by people with severe kidney problems).

2. What you need to know before using Inhixa

Do not use Inhixa

• If you are allergic to enoxaparin sodium or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you are allergic to heparin or to other low molecular weight heparins, such as nadroparin, tinzaparin or dalteparine.
• If you have previously had a reaction to heparin that caused a severe decrease in the number of blood cells involved in clotting (platelets) (this reaction is called heparin-induced thrombocytopenia), within the last 100 days, or if you have antibodies against enoxaparin in your blood.
• If you are actively bleeding or have a disease with a high risk of bleeding (such as a stomach ulcer, recent brain or eye surgery), including recent hemorrhagic stroke.
• If you are using Inhixa to treat blood clots and you will undergo spinal or epidural anaesthesia or a lumbar puncture within 24 hours.

Warnings and precautions
Inhixa must not be used interchangeably with other medicines belonging to the
group of low molecular weight heparins. These medicines are not identical and do not
have the same activity or usage instructions.
Consult your doctor or pharmacist before using Inhixa if:

• you have previously had a reaction to heparin that caused a significant decrease in platelet count
• you need to undergo spinal or epidural anaesthesia or lumbar puncture (see Surgery and anaesthesia): observe the recommended time interval between Inhixa use and this procedure
• you have had a heart valve implanted
• you suffer from endocarditis (an infection of the inner lining of the heart)
• you suffer from a stomach ulcer
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or diabetes-related eye vessel problems (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if over 75 years
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (levels can be checked with a blood test)
• you are currently taking medicines that may affect bleeding (see the next section - Other medicines and Inhixa).

You may need to have a blood test before starting this medicine and regularly during treatment to monitor your platelet count and blood potassium levels.
Use in children and adolescents
The safety and efficacy of Inhixa have not been established in children or adolescents.
Other medicines and Inhixa
Inform your doctor or pharmacist if you are taking or might take any other medicines.

• Warfarin – other anticoagulant medicines used to thin the blood
• Acetylsalicylic acid (also known as Aspirin or ASA), clopidogrel, or other medicines used to prevent clot formation (see also section 3, “Changing anticoagulant medicines”)
• Injectable dextran – used as a blood substitute
• Ibuprofen, diclofenac, ketorolac, or other medicines known as non-steroidal anti-inflammatory agents used to treat pain and swelling in arthritis and other conditions
• Prednisolone, dexamethasone, or other medicines used to treat asthma, rheumatoid arthritis, and other conditions
• Medicines that increase potassium levels in the blood, such as potassium salts, diuretics, and certain heart medications.

Surgery and anaesthesia
If you are scheduled for a spinal puncture or surgery requiring epidural or spinal anaesthesia, inform your doctor that you are using Inhixa. See “Do not use Inhixa”. Also inform your doctor if you have any spinal problems or have had previous spinal surgery.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
If you are pregnant and have a mechanical heart valve, you may be at increased risk of developing blood clots. Your doctor will discuss this with you.
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine.
Driving and using machines
Inhixa does not affect the ability to drive or operate machinery.
Traceability
It is important to record the batch number of Inhixa. Therefore, each time you start a new pack of Inhixa, write down the date and the batch number (shown on the packaging after Batch) and keep this information in a safe place.
Inhixa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Inhixa

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Administration of the medicine

• Inhixa is normally administered by a doctor or nurse, as it must be given by injection.
• When you are discharged, you may need to continue using Inhixa and administer it yourself (see instructions below on how to do so).
• Inhixa is usually administered by subcutaneous injection (under the skin).
• Inhixa may be administered by intravenous injection (into a vein) after certain types of heart attack or surgical procedures.
• Inhixa may be added to the arterial line (the tube carrying blood out of the body) at the beginning of a dialysis session. Do not inject Inhixa into a muscle.

How much medicine will be administered to you

• Your doctor will decide how much Inhixa you should receive. The dose depends on the reason it is being used.
• If you have kidney problems, you may receive a lower dose of Inhixa.

1. Treatment of blood clots present in the bloodstream

• The usual dose is 150 IU (1.5 mg) per kilogram of body weight per day or 100 IU (1 mg) per kilogram of body weight twice daily.
• Your doctor will decide how long you should continue receiving Inhixa.

2. Prevention of blood clot formation in the following situations:

• Surgery or periods of reduced mobility due to illness

• The dose depends on how likely you are to develop a clot. You will receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of Inhixa per day.

• If surgery is planned, the first injection is usually given 2 hours or 12 hours before the operation.

• If you have reduced mobility due to illness, you will usually receive 4,000 IU (40 mg) of Inhixa per day.

• Your doctor will decide how long you should continue receiving Inhixa.

• After a heart attack
  Inhixa can be used for two different types of heart attack, called STEMI (ST-segment elevation myocardial infarction) or non-STEMI (NSTEMI). The amount of Inhixa administered depends on your age and the type of heart attack you have had.

NSTEMI-type heart attack:

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually ask you to take acetylsalicylic acid (aspirin) as well.
• Your doctor will decide how long you should continue receiving Inhixa.

STEMI-type heart attack if you are under 75 years of age:

• An initial dose of 3,000 IU (30 mg) of Inhixa administered as an intravenous injection.
• At the same time, you will also receive Inhixa as a subcutaneous (under the skin) injection. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually ask you to take acetylsalicylic acid (aspirin) as well.
• Your doctor will decide how long you should continue receiving Inhixa.

STEMI-type heart attack if you are 75 years of age or older:

• The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum dose of Inhixa for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should continue receiving Inhixa.

For patients undergoing a procedure called percutaneous coronary intervention (PCI):
Depending on when Inhixa was last administered, your doctor may decide to
administer an additional dose of Inhixa before a PCI. The medicine will be injected into a vein.

3. Prevention of blood clot formation in the dialysis machine tubing

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Inhixa is added to the arterial line (the tube carrying blood out of the body) at the beginning of the dialysis session. This amount is usually sufficient for a 4-hour session. However, your doctor may administer an additional dose of 50–100 IU (0.5–1 mg) per kilogram of body weight if necessary.

How to self-administer an Inhixa injection using a pre-filled syringe without a needle safety device
If you are able to self-administer this medicine, your doctor or nurse will show you
how to do it. Do not attempt to give the injection yourself unless you have been trained. If you are unsure what to do, consult your doctor or nurse immediately.
Before self-injecting Inhixa

• Check the medicine's expiry date. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the liquid inside is clear. If not, use another syringe.
• Do not use this medicine if you notice any changes in its appearance.
• Make sure you know how much medicine you are about to inject.
• Check whether the previous injection caused redness, skin discoloration, swelling, leakage, or is still painful. If so, contact your doctor or nurse.
• Decide where to inject the medicine. Change the injection site each time, alternating between the right and left side of the abdomen (stomach). This medicine must be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away from these areas).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa
1) Wash your hands and the injection site with soap and water. Dry them thoroughly.
2) Sit or lie down in a comfortable position so you are relaxed. Make sure you can see the injection site. A reclining chair, recliner, or lying on a bed with pillows is ideal.
3) Choose an injection site on the right or left side of the abdomen. The site must be at least 5 cm away from the navel and toward the sides.
Remember: Do not inject within 5 cm of the navel or near existing scars or bruises.
Change the injection site between the left and right sides of the abdomen, depending on where you injected last time.
4) Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and remove the pre-filled syringe.
5) Carefully remove the needle cap from the syringe. Discard the cap. The syringe is pre-filled and ready to use.

Do not press the plunger before injecting. Once the cap is removed, avoid letting the needle touch anything to ensure it remains clean (sterile).
6) Hold the syringe in your writing hand (like a pencil) and with your other hand, gently pinch the cleaned area of the abdomen between your index finger and thumb to create a skin fold.
Make sure to keep the skin pinched throughout the entire injection.
7) Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the full length of the needle into the skin fold.

8) Press the plunger with your thumb to inject the medicine into the fatty tissue of the abdomen. Ensure you keep the skin pinched during the entire injection.
9) Remove the needle by pulling it straight out.

To minimize the risk of bruising, do not rub the injection site after injecting.
10) Dispose of the used syringe in a sharps container. Close the container tightly and keep it out of children's reach.
When the container is full, dispose of it according to your doctor's or pharmacist's instructions. Do not
throw it in household waste.

How to self-administer an Inhixa injection using a pre-filled syringe with a needle safety device
The pre-filled syringe may be equipped with a needle safety device to prevent accidental needle sticks. If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself unless you have been trained. If you are unsure what to do, consult your doctor or nurse immediately.
Before self-injecting Inhixa

• Check the medicine's expiry date. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the liquid inside is clear. If not, use another syringe.
• Do not use this medicine if you notice any changes in its appearance.
• Make sure you know how much medicine you are about to inject.
• Check whether the previous injection caused redness, skin discoloration, swelling, leakage, or is still painful. If so, contact your doctor or nurse.
• Decide where to inject the medicine. Change the injection site each time, alternating between the right and left side of the abdomen (stomach). This medicine must be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away from these areas).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa
1) Wash your hands and the injection site with soap and water. Dry them thoroughly.
2) Sit or lie down in a comfortable position so you are relaxed. Make sure you can see the injection site. A reclining chair, recliner, or lying on a bed with pillows is ideal.
3) Choose an injection site on the right or left side of the abdomen. The site must be at least 5 cm away from the navel and toward the sides.
Remember: Do not inject within 5 cm of the navel or near existing scars or bruises.
Change the injection site between the left and right sides of the abdomen, depending on where you injected last time.
4) Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and remove the pre-filled syringe.
5) Carefully remove the needle cap from the syringe. Discard the cap. The syringe is pre-filled and ready to use.

Do not press the plunger before injecting. Once the cap is removed, avoid letting the needle touch anything to ensure it remains clean (sterile).
6) Hold the syringe in your writing hand (like a pencil) and with your other hand, gently pinch the cleaned area of the abdomen between your index finger and thumb to create a skin fold.
Make sure to keep the skin pinched throughout the entire injection.
7) Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the full length of the needle into the skin fold.

8) Press the plunger with your thumb to inject the medicine into the fatty tissue of the abdomen. Ensure you keep the skin pinched during the entire injection.
9) Remove the needle by pulling it straight out. Do not release pressure on the plunger!

To minimize the risk of bruising, do not rub the injection site after injecting.
10) Firmly press the plunger. The needle safety shield, shaped like a plastic cylinder, will automatically move forward and completely cover the needle.

11) Dispose of the used syringe in a sharps container. Close the container tightly and keep it out of children's reach.
When the container is full, dispose of it according to your doctor's or pharmacist's instructions. Do not
throw it in household waste.

Switching anticoagulant therapy

• Switching from Inhixa to anticoagulants called vitamin K antagonists (e.g., warfarin)
  Your doctor will ask you to have a blood test called INR and will tell you when to stop Inhixa based on the results.
• Switching from anticoagulants called vitamin K antagonists (e.g., warfarin) to Inhixa
  Stop treatment with vitamin K anticoagulants. Your doctor will ask you to have a blood test called INR and will tell you when to start Inhixa based on the results.
• Switching from Inhixa to direct oral anticoagulants (e.g., apixaban, dabigatran, edoxaban, rivaroxaban)
  Stop treatment with Inhixa. Start taking the direct oral anticoagulant 0–2 hours before the time of your next scheduled Inhixa injection, then continue as usual.
• Switching from direct oral anticoagulants to Inhixa
  Stop treatment with the direct oral anticoagulant. Start treatment with Inhixa only 12 hours after the last dose of the direct oral anticoagulant.

If you use more Inhixa than you should
If you think you have used too much or too little Inhixa, inform your doctor, nurse, or
pharmacist immediately, even if you do not have any symptoms. If a child accidentally injects or swallows Inhixa, take them immediately to the emergency room.
If you forget to use Inhixa
If you forget to take a dose, take it as soon as you remember. Do not take a double dose on the same day to make up for the missed dose. Keeping a diary may help you avoid missing doses.
If you stop using Inhixa
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.
It is important that you continue your Inhixa injections until your doctor decides to stop them. If you stop them, a blood clot may form, which could be very dangerous.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other anticoagulant medicines (medicines to reduce blood clotting), Inhixa can cause bleeding, which may potentially be life-threatening. In some cases, bleeding may not be obvious.
If you experience any bleeding events of any kind that do not stop on their own, or if you experience signs of excessive bleeding (extreme weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately.
Your doctor may decide to monitor you closely or to switch your medication.
Stop using Inhixa and contact your doctor or nurse immediately if you develop any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
Stop using enoxaparin and consult your doctor immediately if you notice any of the following symptoms:

• A widespread red, scaly rash with lumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption).

You must inform your doctor immediately

• If you experience signs of a blood vessel blockage caused by a clot, such as:
• cramps, redness, warmth or swelling in one of the legs – signs of deep vein thrombosis
• shortness of breath, chest pain, fainting or coughing up blood – signs of pulmonary embolism
• If you develop a painful rash with dark red spots under the skin that do not fade when pressed. Your doctor may ask you to have a blood test to check your platelet count.

General list of possible side effects
Very common (may affect more than 1 in 10 people)

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Bruising more easily than usual. This may be due to a blood disorder with low platelet count.
• Pink spots on the skin. These are more likely to appear in the area where Inhixa was injected.
• Skin rash (urticaria).
• Itchy, red skin.
• Bruising or pain at the injection site.
• Decrease in certain blood cells (red blood cells).
• High number of platelets in the blood.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache. This could be a sign of bleeding in the brain.
• Pain and swelling in the stomach. You may have bleeding in the stomach.
• Large, irregularly shaped red skin patches with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and darker urine. These could be signs of a liver problem.

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction. Signs of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• Increased potassium in the blood. More likely in people with kidney problems or diabetes. Your doctor may monitor this with a blood test.
• Increased number of white blood cells called eosinophils in the blood. Your doctor may monitor this with a blood test.
• Hair loss.
• Osteoporosis (a condition that makes bones more fragile) after prolonged use.
• Tingling, numbness, and muscle weakness (particularly in the lower part of the body) if you undergo a spinal puncture or receive spinal anaesthesia.
• Loss of bladder or bowel control (inability to control when to go to the toilet).
• Hard mass or nodule at the injection site.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Inhixa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton.
The expiry date refers to the last day of that month.
Store below 25°C. Do not freeze.
After dilution, the solution must be used within 8 hours.
Do not use this medicine if you notice any visible changes in the appearance of the solution.
Pre-filled syringes are for single use only. Dispose of all unused medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Inhixa contains

• The active substance is enoxaparin sodium. Each ml contains 15,000 IU (150 mg) of enoxaparin sodium. Each 0.8 ml pre-filled syringe contains 12,000 IU (120 mg) of enoxaparin sodium. Each 1 ml pre-filled syringe contains 15,000 IU (150 mg) of enoxaparin sodium.
• The other component is water for injections.

Description of the appearance of Inhixa and contents of the pack
Inhixa 12,000 IU (120 mg)/0.8 ml is a 0.8 ml solution in:

• a clear, colourless Type I neutral glass syringe, with a fixed needle and a needle cap sealed with a chlorobutyl rubber stopper and a purple polypropylene plunger. In addition, the syringes may be equipped with a needle protection device.

Packs of:

• 2, 10 and 30 pre-filled syringes
• 10 and 30 pre-filled syringes with needle protection device

Inhixa 15,000 IU (150 mg)/1 ml is a 1 ml solution in:

• a clear, colourless Type I neutral glass syringe, with a fixed needle and a needle cap sealed with a chlorobutyl rubber stopper and a dark blue polypropylene plunger. In addition, the syringes may be equipped with a needle protection device.

Packs of:

• 2, 10 and 30 pre-filled syringes
• 10 and 30 pre-filled syringes with needle protection device

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Techdow Pharma Netherlands B.V.
Strawinskylaan 1143, Tower C-11
1077 XX Amsterdam
The Netherlands

Manufacturer
SciencePharma spółka z ograniczoną odpowiedzialnością
Chełmska 30/34
00-725 Warsaw
Poland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+31 (0)76 531 5388 +37125892152

България Luxembourg/Luxemburg
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +49 (0)30 220 13 6906

Česká republika Magyarország
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+420255790502 +3618001930

Danmark Malta
Techdow Pharma Netherlands B.V. Mint Health Ltd.
+4578774377 +356 2755 9990

Deutschland Nederland
Co-marketing: Techdow Pharma Germany GmbH Techdow Pharma Netherlands B.V.
Potsdamer Platz 1, 10785 Berlin +31208081112
+49 (0)30 98 321 31 00

Eesti Norge
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+37125892152 +4721569855

Ελλάδα Österreich
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +43720230772

España Polska
TECHDOW PHARMA SPAIN, S.L. Techdow Pharma Netherlands B.V.
Tel: +34 91 123 21 16 +49 (0)30 220 13 6906

France Portugal
Viatris Santé Laboratórios Atral, S.A.
+33 4 37 25 75 00 +351308801067

Hrvatska România
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+385 17776255 +49 (0)30 220 13 6906

Ireland Slovenija
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+31208081112 +49 (0)30 220 13 6906

Ísland Slovenská republika
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +421233331071

Italia Suomi/Finland
Techdow Pharma Italy S.R.L. Techdow Pharma Netherlands B.V.
Tel: +39 0256569157 +358942733040

Κύπρος Sverige
MA Pharmaceuticals Trading Ltd Techdow Pharma Netherlands B.V.
+357 25 587112 +46184445720

Latvija United Kingdom (Northern Ireland)
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+37125892152 +44 28 9279 2030

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Package leaflet: Information for the user

Inhixa 30,000 IU (300 mg)/3 ml solution for injection in multi-dose container, 50,000 IU (500 mg)/5 ml solution for injection in multi-dose container, 100,000 IU (1000 mg)/10 ml solution for injection in multi-dose container

enoxaparin sodium
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Inhixa is and what it is used for
2. What you need to know before using Inhixa
3. How to use Inhixa
4. Possible side effects
5. How to store Inhixa
6. Contents of the pack and other information

1. What Inhixa is and what it is used for

Inhixa contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Inhixa works in two ways:

1. It prevents the growth of existing blood clots. This helps the body to break them down and prevents them from causing harm.
2. It prevents the formation of blood clots.
   Inhixa can be used for:

• Treating existing blood clots
• Preventing the formation of blood clots in the following situations:
  • before and after surgery
  • in case of an acute illness involving a period of reduced mobility
  • to prevent the formation of further clots if you have had a blood clot due to cancer
  • in unstable angina (a condition in which insufficient blood reaches the heart) or after a heart attack
• Preventing the formation of blood clots in the tubes of the dialysis machine (used by people with severe kidney problems).

2. What you need to know before using Inhixa

Do not use Inhixa

• if you are allergic to sodium enoxaparin or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or
  tongue
• if you are allergic to heparin or to other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin
• if you have previously had a reaction to heparin that caused a severe drop in the number of blood cells involved in clotting (platelets) (this reaction is called heparin-induced thrombocytopenia), within the last 100 days, or if you have antibodies against enoxaparin in your blood
• if you are currently bleeding heavily or have a disease with a high risk of bleeding (such as a stomach ulcer, recent brain or eye surgery), including recent hemorrhagic stroke
• if you are using Inhixa to treat blood clots and you will undergo spinal or epidural anaesthesia or a lumbar puncture within 24 hours
• if the patient is a premature newborn or a newborn up to 1 month of age due to the risk of severe toxicity, including possible breathing abnormalities ("gasping syndrome").

Warnings and precautions
Inhixa must not be used interchangeably with other medicines belonging to the group of
low molecular weight heparins. These medicines are not identical and do not have the same activity or the same instructions for use.
Consult your doctor or pharmacist before using Inhixa if:

• you have ever had a reaction to heparin that caused a significant drop in platelet count
• you need to undergo spinal or epidural anaesthesia or lumbar puncture (see "Surgical procedures and anaesthesia"): observe the recommended time interval between using Inhixa and this procedure
• you have had a heart valve implanted
• you suffer from endocarditis (an infection of the inner lining of the heart)
• you suffer from a stomach ulcer
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or diabetes-related eye blood vessel problems (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if over 75 years
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (levels can be checked with a blood test)
• you are currently taking medicines that may affect bleeding (see section below "Other medicines and Inhixa").

You may need to have a blood test before starting this medicine and regularly during treatment to monitor the levels of blood cells involved in clotting (platelets) and the level of potassium in your blood.
Children and adolescents
The safety and efficacy of Inhixa have not been established in children or adolescents.
Other medicines and Inhixa
Inform your doctor or pharmacist if you are taking or might take any other medicines.

• Warfarin – other anticoagulant medicines used to thin the blood
• Acetylsalicylic acid (also known as aspirin or ASA), clopidogrel or other medicines used to prevent clot formation (see also section 3, "Switching anticoagulant medicines")
• Injectable dextran – used as a blood substitute
• Ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory agents used to treat pain and swelling in arthritis and other conditions
• Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
• Medicines that increase potassium levels in the blood such as potassium salts, diuretics and certain medicines for heart problems.

Surgical procedures and anaesthesia
If you are scheduled for a spinal puncture or surgery requiring epidural or spinal anaesthesia, inform your doctor that you are using Inhixa. See “Do not use Inhixa”. Also inform your doctor if you have any spinal problems or have had previous spinal surgery.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant and have a mechanical heart valve, you may be at increased risk of developing blood clots. Your doctor will discuss this with you.
If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.
Driving and using machines
Inhixa does not affect the ability to drive or operate machinery.
Traceability
It is important to record the batch number of Inhixa. Therefore, each time you start a new pack of Inhixa, write down the date and the batch number (shown on the packaging after "Batch") and keep this information in a safe place.
Inhixa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, within the recommended dosage range, i.e. essentially “sodium-free”.
Inhixa contains benzyl alcohol
Inhixa contains benzyl alcohol (45 mg / 3 ml; 75 mg/5 ml; 150 mg/10 ml). Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems (also known as "gasping syndrome") in young children.
Do not administer to newborns (up to 4 weeks of age) unless advised by your doctor. Do not use for more than one week in young children (under 3 years of age) unless advised by your doctor or pharmacist.
Consult your doctor or pharmacist if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and may cause adverse effects (known as "metabolic acidosis").

3. How to use Inhixa

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Administration of the medicine

• Inhixa is normally administered by a doctor or nurse, as it must be given by injection.
• When you are discharged, you may need to continue using Inhixa and administer it yourself.
• Inhixa is usually administered by subcutaneous injection (under the skin).
• Inhixa may be administered by intravenous injection (into a vein) after certain types of heart attack or surgical procedures.
• Inhixa may be added to the arterial line (the tube carrying blood out of the body) at the beginning of a dialysis session. Do not inject Inhixa into a muscle.

How much medicine will be administered to you

• Your doctor will decide how much Inhixa you should receive. The dose depends on why it is being used.
• If you have kidney problems, you may receive a lower dose of Inhixa.

1. Treatment of blood clots

• The usual dose is 150 IU (1.5 mg) per kilogram of body weight per day or 100 IU (1 mg) per kilogram of body weight twice daily.
• Your doctor will decide how long you should receive Inhixa.

2. Prevention of blood clots in the following situations:

• Surgery or periods of reduced mobility due to illness

• The dose depends on how likely you are to develop a clot. You will receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of Inhixa per day.

• If surgery is planned, the first injection is usually given 2 hours or 12 hours before the operation.

• In cases of reduced mobility due to illness, 4,000 IU (40 mg) of Inhixa per day is usually administered.

• Your doctor will decide how long you should receive Inhixa.

• After a heart attack
  Inhixa may be used for two different types of heart attack, known as STEMI (ST-segment elevation myocardial infarction) or non-STEMI (NSTEMI). The amount of Inhixa administered depends on your age and the type of heart attack you have had.

NSTEMI heart attack:

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually ask you to also take acetylsalicylic acid (aspirin).
• Your doctor will decide how long you should receive Inhixa.

STEMI heart attack if you are under 75 years of age:

• An initial dose of 3,000 IU (30 mg) of Inhixa administered by intravenous injection.
• At the same time, you will receive Inhixa by subcutaneous injection (under the skin). The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually ask you to also take acetylsalicylic acid (aspirin).
• Your doctor will decide how long you should receive Inhixa.

STEMI heart attack if you are 75 years of age or older:

• The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum dose of Inhixa administered for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should receive Inhixa.

For patients undergoing a procedure called percutaneous coronary intervention (PCI):
Depending on when Inhixa was last administered, your doctor may decide to
administer an additional dose of Inhixa before a PCI. The medicine will be injected into a vein.

3. Prevention of blood clots in dialysis machine tubing

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Inhixa is added to the arterial line (the tube carrying blood out of the body) at the beginning of the dialysis session. This amount is usually sufficient for a 4-hour session. However, your doctor may administer an additional dose of 50–100 IU (0.5–1 mg) per kilogram of body weight if necessary.

Switching anticoagulant treatments
Switching from Inhixa to anticoagulants known as vitamin K antagonists (e.g. warfarin)
Your doctor will ask you to have a blood test called INR and will tell you when to stop
treatment with Inhixa based on the results.
Switching from anticoagulants known as vitamin K antagonists (e.g. warfarin) to Inhixa
Stop treatment with vitamin K anticoagulants. Your doctor will ask you to have a blood
test called INR and will tell you when to start treatment with Inhixa based on the results.
Switching from Inhixa to direct oral anticoagulants (e.g. apixaban, dabigatran,
edoxaban, rivaroxaban)
Stop treatment with Inhixa. Start taking the direct oral anticoagulant 0–2 hours before
the time when the next Inhixa injection would have been given, then continue as usual.
Switching from direct oral anticoagulants to Inhixa
Stop treatment with the direct oral anticoagulant. Start treatment with Inhixa only 12 hours
after the last dose of the direct oral anticoagulant.

If you use more Inhixa than you should
If you think you have used too much or too little Inhixa, inform your doctor, nurse, or
pharmacist immediately, even if you do not have any symptoms. If a child accidentally injects or ingests
Inhixa, take them immediately to the emergency department.

If you forget to use Inhixa
If you forget to take a dose, take it as soon as you remember. Do not take a double dose on the
same day to make up for a missed dose. Keeping a diary can help you avoid missing doses.

If you stop using Inhixa
If you have any other questions about using this medicine, consult your doctor, pharmacist, or
nurse.
It is important that you continue your Inhixa injections until your doctor decides to stop them.
If you stop them, a blood clot may form, which could be very dangerous.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other anticoagulant medicines (medicines to reduce blood clotting), Inhixa can cause bleeding, which may potentially be life-threatening. In some cases, bleeding may not be obvious.
If you experience any bleeding events of any kind that do not stop on their own, or if you develop signs of excessive bleeding (severe weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), contact your doctor immediately.
Your doctor may decide to monitor you closely or to switch your medication.
Stop using Inhixa and contact your doctor or nurse immediately if you develop any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
Stop using enoxaparin and contact your doctor immediately if you notice any of the following symptoms:

• A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized pustular exanthema).

You must contact your doctor immediately

• if you experience signs of a blood vessel blockage caused by a clot, such as:
• cramps, redness, warmth, or swelling in one of your legs – signs of deep vein thrombosis
• shortness of breath, chest pain, fainting, or coughing up blood – signs of pulmonary embolism
• if you develop a painful rash with dark red spots under the skin that do not fade when pressed. Your doctor may ask you to have a blood test to check your platelet count.

General list of possible side effects:
Very common (may affect more than 1 in 10 people)

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Bruising more easily than usual. This may be due to a blood disorder with low platelet count.
• Pink spots on the skin. These are more likely to appear at the site where Inhixa was injected.
• Skin rash (urticaria).
• Itchy, red skin.
• Bruising or pain at the injection site.
• Decrease in the number of certain blood cells (red blood cells).
• High number of platelets in the blood.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache. This could be a sign of bleeding in the brain.
• Pain and swelling in the stomach. You may have bleeding in the stomach.
• Large, irregular red skin patches with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and darker urine. These could be signs of a liver problem.

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction. Signs of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Increased potassium levels in the blood. More likely in people with kidney problems or diabetes. Your doctor may monitor this with a blood test.
• Increased number of white blood cells called eosinophils in the blood. Your doctor may monitor this with a blood test.
• Hair loss.
• Osteoporosis (a condition that makes bones more fragile) after prolonged use.
• Tingling, numbness, and muscle weakness (particularly in the lower part of the body) if you undergo a spinal puncture or receive spinal anaesthesia.
• Loss of bladder or bowel control (inability to control when to go to the bathroom).
• Hard mass or nodule at the injection site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Inhixa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton.
The expiry date refers to the last day of that month.
Store below 25°C. Do not freeze.

After first opening:
Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
From a microbiological point of view, once opened, the medicine can be stored for up to 28 days below 25°C. Any other in-use storage times and conditions are the responsibility of the user.

After dilution with sodium chloride solution 9 mg/ml (0.9%) for infusion or 5% glucose injectable solution:
Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
From a microbiological standpoint, unless the dilution method excludes the risk of microbial contamination, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Do not use this medicine if you notice any visible changes in the appearance of the solution.
Dispose of all unused medicine.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Inhixa contains

• The active substance is enoxaparin sodium. Each ml contains 10,000 IU (100 mg) of enoxaparin sodium. A vial (3.0 ml) contains 30,000 IU (300 mg) of enoxaparin sodium. A vial (5.0 ml) contains 50,000 IU (500 mg) of enoxaparin sodium. A vial (10.0 ml) contains 100,000 IU (1,000 mg) of enoxaparin sodium.
• The other components are benzyl alcohol (see section 2) and water for injections.

Description of the appearance of Inhixa and contents of the pack
3 ml of solution in:

• Type I clear, colourless glass vial, sealed with a rubber stopper and white aluminium-plastic cap, packed in a cardboard box.

Pack sizes:

• 1 vial

5 ml of solution in:

• Type I clear, colourless glass vial, sealed with a rubber stopper and white aluminium-plastic cap, packed in a cardboard box.

Pack sizes:

• 5 vials

10 ml of solution in:

• Type I clear, colourless glass vial, sealed with a rubber stopper and white aluminium-plastic cap, packed in a cardboard box.

Pack sizes:

• 1 vial
• 5 vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Techdow Pharma Netherlands B.V.
Strawinskylaan 1143, Toren C-11
1077XX Amsterdam
The Netherlands

Manufacturer
SciencePharma spółka z ograniczoną odpowiedzialnością
Chełmska 30/34
00-725 Warsaw
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+31 (0)76 531 5388 +37125892152

България Luxembourg/Luxemburg
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +49 (0)30 220 13 6906

Česká republika Magyarország
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+420255790502 +3618001930

Danmark Malta
Techdow Pharma Netherlands B.V. Mint Health Ltd.
+4578774377 +356 2755 9990

Deutschland Nederland
Co-marketing: Techdow Pharma Germany GmbH Techdow Pharma Netherlands B.V.
Potsdamer Platz 1, 10785 Berlin +31208081112
+49 (0)30 98 321 31 00

Eesti Norge
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+37125892152 +4721569855

Ελλάδα Österreich
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +43720230772

España Polska
TECHDOW PHARMA SPAIN, S.L. Techdow Pharma Netherlands B.V.
Tel: +34 91 123 21 16 +49 (0)30 220 13 6906

France Portugal
Viatris Santé Laboratórios Atral, S.A.
+33 4 37 25 75 00 +351308801067

Hrvatska România
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+385 17776255 +49 (0)30 220 13 6906

Ireland Slovenija
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+31208081112 +49 (0)30 220 13 6906

Ísland Slovenská republika
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+49 (0)30 220 13 6906 +421233331071

Italia Suomi/Finland
Techdow Pharma Italy S.R.L. Techdow Pharma Netherlands B.V.
Tel: +39 0256569157 +358942733040

Κύπρος Sverige
MA Pharmaceuticals Trading Ltd Techdow Pharma Netherlands B.V.
+357 25 587112 +46184445720

Latvija United Kingdom (Northern Ireland)
Techdow Pharma Netherlands B.V. Techdow Pharma Netherlands B.V.
+37125892152 +44 28 9279 2030

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu