Inhixa 6,000 IU (60 mg)/0.6 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Inhixa 2,000 IU (20 mg)/0.2 ml solution for injection

Inhixa 4,000 IU (40 mg)/0.4 ml solution for injection

Inhixa 6,000 IU (60 mg)/0.6 ml solution for injection

Inhixa 8,000 IU (80 mg)/0.8 ml solution for injection

Inhixa 10,000 IU (100 mg)/1 ml solution for injection

Enoxaparin sodium

Read the entire leaflet carefully before you start 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, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse 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. By preventing existing blood clots from becoming larger. This helps your body break them down and prevents further harm.
2. By inhibiting the formation of new blood clots.

Inhixa can be used to:

• treat existing blood clots

• prevent the formation of blood clots in the following situations:

  • before and after surgical procedures
  • when you have an acute illness and are experiencing a period of reduced mobility
  • if you have developed blood clots due to cancer, to prevent the formation of new clots
  • when you have unstable angina (a condition in which insufficient blood reaches the heart)
  • after a heart attack

• prevent the formation of blood clots in the tubing of dialysis equipment (used in 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 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 known as heparin-induced thrombocytopenia – within the last 100 days, or if you have antibodies against enoxaparin in your blood.
• If you are experiencing severe bleeding or have conditions at high risk of bleeding (such as stomach ulcer, recent eye or brain surgery), including recent hemorrhagic stroke.
• If you are using Inhixa to treat blood clots and are scheduled to receive spinal anaesthesia, epidural anaesthesia, or lumbar puncture within 24 hours.

Warnings and precautions

Inhixa must not be interchanged with other medicines belonging to the group of low molecular weight heparins. This is because they are not exactly the same and do not have identical activity or usage instructions.

Talk to your doctor or pharmacist before using Inhixa if:

• you have ever had a reaction to heparin that caused a severe drop in platelet count
• you are scheduled to receive spinal/lumbar anaesthesia or lumbar puncture (see “Surgery and anaesthesia”): a time interval must be observed between Inhixa administration and the procedure
• you have had a heart valve implanted
• you have endocarditis (an infection of the inner lining of the heart)
• you have a history of gastric ulcer
• you have recently had a stroke (cerebrovascular accident)
• you have high blood pressure
• you have diabetes or diabetes-related blood vessel problems in the eyes (known as diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), particularly if over 75 years
• you have kidney problems
• you have liver problems
• you have very low body weight or are overweight
• you have high levels of potassium in your blood (which may be detected by a blood test)
• you are currently taking medicines that affect bleeding (see below – Use of Inhixa with other medicines)

You may need to have blood tests before starting and during treatment with this medicine to monitor the levels of blood cells involved in clotting (platelets) and potassium levels in your blood.

Children and adolescents

The safety and efficacy of Inhixa have not been established in children or adolescents.

Use of Inhixa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Warfarin – another anticoagulant medicine used to reduce blood clotting
• Acetylsalicylic acid (also known as aspirin or ASA), clopidogrel, or other medicines used to prevent blood clots (see also section 3, “Switching anticoagulant treatment”)
• Dextran injection – used as a blood plasma substitute
• Ibuprofen, diclofenac, ketorolac, and other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation in arthritis and other conditions
• Prednisolone, dexamethasone, and other medicines used to treat asthma, rheumatoid arthritis, and other diseases
• Medicines that increase potassium levels in blood, such as potassium salts, diuretics (water tablets), and some medicines used to treat heart conditions.

Surgery and anaesthesia

If you are scheduled for a lumbar puncture or surgery requiring spinal or epidural anaesthesia, inform your doctor that you are using Inhixa. See “Use of Inhixa with other medicines”. Also, inform your doctor if you have any spinal problems or have previously undergone spinal surgery.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant and have a mechanical heart valve implanted, you may have an 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 your ability to drive or operate machinery.

Traceability

It is important to keep a record of the batch number of your Inhixa. Therefore, each time you receive a new pack of Inhixa, write down the date and the batch number (shown on the pack after "Batch") and keep this information in a safe place.

Inhixa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free".

3. How to use Inhixa

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use of the medicine

• Normally your doctor or nurse will administer Inhixa to you. This is because it must be given by injection.
• When you return home, you may need to continue using Inhixa and may have to self-administer it (see instructions on how to do so).
• Inhixa is generally administered by injection under the skin (subcutaneous route).
• Inhixa may be administered by injection into your veins (intravenous route) after certain types of heart attacks and surgical procedures.
• Inhixa can be added to the tube draining from the body (arterial line) at the beginning of a dialysis session.

Do not administer Inhixa into muscle (intramuscular route).

What dose you will be given

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

1. Treatment of blood clot formation:

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

1. Prevention of blood clot formation in the following situations:
   • Surgery or periods of limited mobility due to illness
     • The dose depends on your risk of developing a clot. You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Inhixa per day.
     • If you are undergoing surgery, the first injection is usually given 2 or 12 hours before the operation.
     • If you have reduced mobility due to illness, you will usually be given 4,000 IU (40 mg) of Inhixa per day.
     • Your doctor will decide how long you will receive Inhixa.

• After having had a heart attack

Inhixa may be used in two different types of heart attacks, known as STEMI (ST-segment elevation myocardial infarction) or non-STEMI. The dose of Inhixa you receive will depend on your age and the type of heart attack you have had.

STEMI heart attack:

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

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

• You will receive an initial intravenous injection of 3,000 IU (30 mg) of Inhixa.
• At the same time, you will receive a subcutaneous injection of Inhixa. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also advise you to take acetylsalicylic acid (aspirin).
• Your doctor will decide how long you will 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 in the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you will receive Inhixa.

For patients undergoing percutaneous coronary intervention (PCI):

Depending on when your last dose of Inhixa was administered, your doctor may decide to give you an additional dose of Inhixa before a PCI procedure. This would be given by intravenous injection.

1. Prevention of blood clot formation in dialysis tubing
   • The usual dose is 100 IU (1 mg) per kilogram of body weight.
   • Inhixa is added to the tube draining 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 injection of 50 IU to 100 IU/kg (0.5 to 1 mg/kg) per kilogram of body weight if necessary.

Self-administration of an Inhixa injection using a pre-filled syringe without a needle shield

If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to inject yourself unless you have been trained to do so. If you are unsure what to do, consult your doctor or nurse immediately.

Correctly administering the injection under the skin (called a “subcutaneous injection”) will help reduce pain and bruising at the injection site.

Before injecting Inhixa

• Check the medicine’s expiry date. Do not use if expired.
• 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.
• Verify the dose to be injected.
• Check whether your last injection caused redness, skin discoloration, swelling, oozing, or is still painful. If so, speak with your doctor or nurse.
• Choose the injection site. Alternate between the right and left side of your abdomen (stomach) each time you inject. This medicine should be injected just under the skin of the abdomen, but not too close to the navel or any scars (at least 5 cm away from them).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa

1. Wash your hands and the injection site with water and soap. Dry them.
2. Sit or lie down in a comfortable, relaxed position. Ensure you can see the injection site. A couch, reclining chair, or bed with cushions for support is most suitable.
3. Choose a site on the right or left side of your abdomen. It should be more than 5 cm away from the navel and toward the sides.

Remember. Do not inject within 5 cm of the navel or near scars or bruises. Inject on the opposite side from your previous injection (alternating the right and left sides of the abdomen).

1. Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and take out the pre-filled syringe.

2. Carefully remove the needle cap by pulling it off. The syringe is pre-filled and ready to use.

Do not press the plunger to remove the air bubble before injecting. It is not necessary to remove the air bubble, and doing so may cause loss of medicine. Once the cap is removed, do not touch anything with the needle to ensure it remains clean (sterile).

1. Hold the syringe in your writing hand (like a pencil) and, with your other hand, gently pinch the abdominal skin between your index finger and thumb to form a skin fold.

Make sure to hold the skin fold throughout the entire injection.

1. Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the entire needle into the skin fold.

1. Press the plunger with your thumb to inject the medicine into the fatty tissue of the abdomen. Continue holding the skin fold during the injection.

2. Remove the needle by pulling it straight out.

To avoid bruising, do not rub the injection site after injecting.

1. Place the used syringe in a sharps container. Close the container lid tightly and keep it out of the reach of children.

When the container is full, dispose of it as instructed by your doctor or pharmacist. Do not throw it in the household trash.

Self-administration of an Inhixa injection using a pre-filled syringe with a needle shield

Your pre-filled syringe includes a needle shield to protect you from needle-stick injury.

If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to inject yourself unless you have been trained to do so. If you are unsure what to do, consult your doctor or nurse immediately.

Correctly administering the injection under the skin (called a “subcutaneous injection”) will help reduce pain and bruising at the injection site.

Before injecting Inhixa

• Check the medicine’s expiry date. Do not use if expired.
• 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.
• Verify the dose to be injected.
• Check whether your last injection caused redness, skin discoloration, swelling, oozing, or is still painful. If so, speak with your doctor or nurse.
• Choose the injection site. Alternate between the right and left side of your abdomen (stomach) each time you inject. This medicine should be injected just under the skin of the abdomen, but not too close to the navel or any scars (at least 5 cm away from them).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa

1. Wash your hands and the injection site with water and soap. Dry them.
2. Sit or lie down in a comfortable, relaxed position. Ensure you can see the injection site. A couch, reclining chair, or bed with cushions for support is most suitable.
3. Choose a site on the right or left side of your abdomen. It should be more than 5 cm away from the navel and toward the sides.

Remember. Do not inject within 5 cm of the navel or near scars or bruises. Inject on the opposite side from your previous injection (alternating the right and left sides of the abdomen).

1. Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and take out the pre-filled syringe.

2. Carefully remove the needle cap by pulling it off. The syringe is pre-filled and ready to use.

Do not press the plunger to remove the air bubble before injecting. It is not necessary to remove the air bubble, and doing so may cause loss of medicine. Once the cap is removed, do not touch anything with the needle to ensure it remains clean (sterile).

1. Hold the syringe in your writing hand (like a pencil) and, with your other hand, gently pinch the abdominal skin between your index finger and thumb to form a skin fold.

Make sure to hold the skin fold throughout the entire injection.

1. Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the entire needle into the skin fold.

1. Press the plunger with your thumb to inject the medicine into the fatty tissue of the abdomen. Continue holding the skin fold during the injection.

2. Remove the needle by pulling it straight out. Do not stop pressing the plunger!

To avoid bruising, do not rub the injection site after injecting.

1. Release the plunger and allow the syringe to move upward until the entire needle is retracted and securely locked in place.

1. Place the used syringe in a sharps container. Close the container lid tightly and keep it out of the reach of children.

When the container is full, dispose of it as instructed by your doctor or pharmacist. Do not throw it in the household trash.

Self-administration of an Inhixa injection using a pre-filled syringe with an Ultrasafe Passive needle shield

Your pre-filled syringe includes an Ultrasafe Passive needle shield to protect you from needle-stick injury.

If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to inject yourself unless you have been trained to do so. If you are unsure what to do, consult your doctor or nurse immediately.

Correctly administering the injection under the skin (called a “subcutaneous injection”) will help reduce pain and bruising at the injection site.

Before injecting Inhixa

• Check the medicine’s expiry date. Do not use if expired.
• 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.
• Verify the dose to be injected.
• Check whether your last injection caused redness, skin discoloration, swelling, oozing, or is still painful. If so, speak with your doctor or nurse.
• Choose the injection site. Alternate between the right and left side of your abdomen (stomach) each time you inject. This medicine should be injected just under the skin of the abdomen, but not too close to the navel or any scars (at least 5 cm away from them).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa

1. Wash your hands and the injection site with water and soap. Dry them.
2. Sit or lie down in a comfortable, relaxed position. Ensure you can see the injection site. A couch, reclining chair, or bed with cushions for support is most suitable.
3. Choose a site on the right or left side of your abdomen. It should be more than 5 cm away from the navel and toward the sides.

Remember. Do not inject within 5 cm of the navel or near scars or bruises. Inject on the opposite side from your previous injection (alternating the right and left sides of the abdomen).

1. Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and take out the pre-filled syringe.

2. Carefully remove the needle cap by pulling it off. The syringe is pre-filled and ready to use.

Do not press the plunger to remove the air bubble before injecting. It is not necessary to remove the air bubble, and doing so may cause loss of medicine. Once the cap is removed, do not touch anything with the needle to ensure it remains clean (sterile).

1. Hold the syringe in your writing hand (like a pencil) and, with your other hand, gently pinch the abdominal skin between your index finger and thumb to form a skin fold.

Make sure to hold the skin fold throughout the entire injection.

1. Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the entire needle into the skin fold.

1. Press the plunger with your thumb to inject the medicine into the fatty tissue of the abdomen. Continue holding the skin fold during the injection.

2. Remove the needle by pulling it straight out. Do not stop pressing the plunger!

To avoid bruising, do not rub the injection site after injecting.

1. Release the plunger and allow the syringe to move upward until the entire needle is retracted and securely locked in place.

1. Place the used syringe in a sharps container. Close the container lid tightly and keep it out of the reach of children.

When the container is full, dispose of it as instructed by your doctor or pharmacist. Do not throw it in the household trash.

Self-administration of an Inhixa injection using a pre-filled syringe with a manually activated needle shield

Your pre-filled syringe includes a manually activated needle shield to protect you from needle-stick injury.

If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to inject yourself unless you have been trained to do so. If you are unsure what to do, consult your doctor or nurse immediately.

Correctly administering the injection under the skin (called a “subcutaneous injection”) will help reduce pain and bruising at the injection site.

Before injecting Inhixa

• Check the medicine’s expiry date. Do not use if expired.
• Check that the syringe is undamaged and the liquid inside is clear. If not, use another syringe.
• Do not use this medicine if you notice any changes in its appearance.
• Verify the dose to be injected.
• Check whether your last injection caused redness, skin discoloration, swelling, oozing, or is still painful. If so, speak with your doctor or nurse.
• Choose the injection site. Alternate between the right and left side of your abdomen (stomach) each time you inject. This medicine should be injected just under the skin of the abdomen, but not too close to the navel or any scars (at least 5 cm away from them).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Inhixa

1. Wash your hands and the injection site with water and soap. Dry them.
2. Sit or lie down in a comfortable, relaxed position. Ensure you can see the injection site. A couch, reclining chair, or bed with cushions for support is most suitable.
3. Choose a site on the right or left side of your abdomen. It should be more than 5 cm away from the navel and toward the sides.

Remember. Do not inject within 5 cm of the navel or near scars or bruises. Inject on the opposite side from your previous injection (alternating the right and left sides of the abdomen).

1. Remove the plastic blister containing the pre-filled syringe from the box. Open the blister and take out the pre-filled syringe.
2. Carefully remove the needle cap by pulling it off. The syringe is pre-filled and ready to use.

Do not press the plunger to remove the air bubble before injecting. It is not necessary to remove the air bubble, and doing so may cause loss of medicine. Once the cap is removed, do not touch anything with the needle to ensure it remains clean (sterile).

1. Hold the syringe in your writing hand (like a pencil) and, with your other hand, gently pinch the abdominal skin between your index finger and thumb to form a skin fold.

Make sure to hold the skin fold throughout the entire injection.

1. Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the entire needle into the skin fold.

1. Press the plunger with your thumb to inject the medicine into the fatty tissue of the abdomen. Continue holding the skin fold during the injection.

2. Remove the needle by pulling it straight out. Do not stop pressing the plunger.

To avoid bruising, do not rub the injection site after injecting.

1. Firmly hold the syringe barrel with one hand (A). With the other hand, grasp the base at the “wings” of the syringe (B), and pull the base until you hear a click (C). The used needle is now fully protected.

1. Place the used syringe in a sharps container. Close the container lid tightly and keep it out of the reach of children.

When the container is full, dispose of it as instructed by your doctor or pharmacist. Do not throw it in the household trash.

Switching anticoagulant therapy

• Switching from Inhixa to vitamin K antagonist anticoagulant medicines (e.g., warfarin)

Your doctor will request a blood test for a parameter called INR and will tell you when to stop Inhixa treatment.

• Switching from vitamin K antagonist anticoagulant medicines (e.g., warfarin) to Inhixa

Stop taking the vitamin K antagonist. Your doctor will request a blood test for a parameter called INR and will tell you when to start Inhixa.

• Switching from Inhixa to direct oral anticoagulants (e.g., apixaban, dabigatran, edoxaban, rivaroxaban)

Stop using Inhixa. Start taking the direct oral anticoagulant 0–2 hours before your next scheduled Inhixa injection, then continue as usual.

• Switching from direct oral anticoagulant therapy to Inhixa

Stop taking the direct oral anticoagulant. Do not start Inhixa treatment until 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 show signs of any problems. If a child accidentally injects or swallows Inhixa, take them immediately to the hospital emergency department.

If you forget to use Inhixa

If you forget to administer a dose, do so as soon as you remember. Do not use a double dose on the same day to make up for missed doses. To help ensure you do not miss any doses, it may be helpful to use a diary.

If you stop using Inhixa

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse. It is important that you continue receiving Inhixa until your doctor decides to stop treatment. If you stop using it, a blood clot could form, which could be very dangerous.

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 clots), Inhixa could cause bleeding, which could potentially be life-threatening. In some cases, bleeding may not be obvious.

If you notice any episode of bleeding that does not stop by itself, or if you notice signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately.

Your doctor may decide to keep you under strict monitoring or change your medication.

Stop treatment with Inhixa and inform your doctor or nurse immediately if you experience any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).

Stop treatment with enoxaparin and inform your doctor or nurse immediately if you experience 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 (acute generalized exanthematous pustulosis).

Inform your doctor immediately

• If you have any signs of a blood vessel blockage caused by a blood clot such as:

• Cramping pain, redness, warmth, or swelling in one of your legs – these are symptoms of deep vein thrombosis

• Difficulty breathing, chest pain, fainting, or coughing up blood – these are symptoms 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 request 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 could be due to a blood problem caused by a low platelet count
• Pinkish skin patches. These occur more frequently at the site where Inhixa was injected
• Skin rash (wheals, hives)
• Redness and itching of the skin
• Bruising or pain at the injection site
• Decrease in the number of red blood cells in the blood
• Increase in the 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
• Tenderness and swelling in the stomach area. This could indicate gastrointestinal bleeding
• Large, irregular red marks on the skin, with or without blisters
• Skin irritation (local irritation)
• Yellowing of the skin or eyes, and darkening of the urine. These could be signs of a liver problem

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

• Severe allergic reaction. Signs of this reaction may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
• Increased potassium levels in the blood. This is more likely to occur in people with kidney problems or diabetes. Your doctor can check this with a blood test
• Increase in white blood cells called eosinophils in the blood. Your doctor can check this with a blood test
• Hair loss
• Osteoporosis (a condition in which bones are more likely to fracture)
• Tingling, numbness, and muscle weakness (especially in the lower part of the body) when a lumbar puncture or spinal anaesthesia has been performed
• Loss of bladder or bowel control (so you cannot control urination or bowel movements)
• Hardening or nodule at the injection site

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month indicated.

Store below 25 °C. Do not freeze.

The solution must be used within 8 hours after dilution.

Do not use this medicine if you notice any visible change in the appearance of the solution.

Inhixa pre-filled syringes are for single use only. Discard any unused portion of the medicine.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Inhixa

• The active substance is enoxaparin sodium.

Each millilitre 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.

Nature and contents of the container

Inhixa 2,000 IU (20 mg)/0.2 ml is 0.2 ml of solution contained in:

• a transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a purple polypylene plunger. The syringe may additionally be equipped with a needle protector or a manual needle protector; or
• a transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a white polycarbonate plunger. The syringe may additionally be equipped with an UltraSafe Passive needle protector.

This medicine is available in pack sizes of:

• 1, 2, 6, 10, 20 and 50 pre-filled syringe(s)
• 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle protector
• 6, 10 and 20 pre-filled syringes with manual needle protector
• 2 and 6 pre-filled syringes with UltraSafe Passive needle protector

Inhixa 4,000 IU (40 mg)/0.4 ml solution for injection is 0.4 ml of solution contained in:

• a transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a yellow polypylene plunger. The syringe may additionally be equipped with a needle protector or a manual needle protector; or
• a transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a white polycarbonate plunger. The syringe may additionally be equipped with an UltraSafe Passive needle protector.

This medicine is available in pack sizes of:

• 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 protector
• 2, 6, 10, 20 and 50 pre-filled syringes with manual needle protector
• 2 and 6 pre-filled syringes with UltraSafe Passive needle protector

Inhixa 6,000 IU (60 mg)/0.6 ml solution for injection is 0.6 ml of solution contained in:

• a graduated transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and an orange polypylene plunger. The syringe may additionally be equipped with a needle protector or a manual needle protector; or
• a graduated transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a white polycarbonate plunger. The syringe may additionally be equipped with an UltraSafe Passive needle protector.

This medicine is available in pack sizes of:

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

Inhixa 8,000 IU (80 mg)/0.8 ml solution for injection is 0.8 ml of solution contained in:

• a graduated transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a red polypylene plunger. The syringe may additionally be equipped with a needle protector or a manual needle protector; or
• a graduated transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a white polycarbonate plunger. The syringe may additionally be equipped with an UltraSafe Passive needle protector.

This medicine is available in pack sizes of:

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

Inhixa 10,000 IU (100 mg)/1 ml solution for injection is 1 ml of solution contained in:

• a graduated transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a black polypylene plunger. The syringe may additionally be equipped with a needle protector or a manual needle protector; or
• a graduated transparent, colourless, neutral, type I glass syringe with a fixed needle and needle protector closed with a chlorobutyl rubber stopper and a white polycarbonate plunger. The syringe may additionally be equipped with an UltraSafe Passive needle protector.

This medicine is available in pack sizes of:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Techdow Pharma Netherlands B.V.

Zuidplein 28, Tower 1, Level 3 (Unit 5)

1077 XV Amsterdam

The Netherlands

Manufacturer

SciencePharma spólka z ograniczona odpowiedzialnoscia

Chelmska 30/34

00-725 Warsaw

Poland

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

Belgium/Belgium/Belgium Techdow Pharma Netherlands B.V. +31208081112	Lithuania Techdow Pharma Netherlands B.V. +37125892152
	Luxembourg/Luxembourg Techdow Pharma Netherlands B.V. +49 (0)30 220 13 6906
Czech Republic Techdow Pharma Netherlands B.V. +420255790502	Hungary Techdow Pharma Netherlands B.V. +3618001930
Denmark Techdow Pharma Netherlands B.V. +4578774377	Malta Mint Health Ltd +441483928995
Germany Co-marketing: Techdow Pharma Germany GmbH Potsdamer Platz 1, 10785 Berlin +49 (0)30 98 321 31 00	Netherlands Techdow Pharma Netherlands B.V. +31208081112
Estonia Techdow Pharma Netherlands B.V. +37125892152	Norway Techdow Pharma Netherlands B.V. +4721569855
Greece Techdow Pharma Netherlands B.V. +49 (0)30 220 13 6906	Austria Techdow Pharma Netherlands B.V. +43720230772
Spain TECHDOW PHARMA SPAIN, S.L. Tel: +34 91 123 21 16	Poland Techdow Pharma Netherlands B.V. +49 (0)30 220 13 6906
France Viatris Santé +33 4 37 25 75 00	Portugal Laboratórios Atral, S.A. +351308801067
Croatia Techdow Pharma Netherlands B.V. +385 17776255 Ireland Techdow Pharma England Ltd +441483928995	Romania Techdow Pharma Netherlands B.V. +49 (0)30 220 13 6906 Slovenia Techdow Pharma Netherlands B.V. +49 (0)30 220 13 6906
Iceland Techdow Pharma Netherlands B.V. +49 (0)30 220 13 6906	Slovakia Techdow Pharma Netherlands B.V. +42123331071
Italy Techdow Pharma Italy S.R.L. Tel: +39 0256569157	Finland Techdow Pharma Netherlands B.V. +358942733040
Cyprus MA Pharmaceuticals Trading Ltd +357 25 587112	Sweden Techdow Pharma Netherlands B.V. +46184445720
Latvia Techdow Pharma Netherlands B.V. +37125892152

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.