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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

Enoxaparin sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. 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. By preventing existing blood clots from getting larger. This helps your body to break them down and prevents further damage.
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 operations
  • when you have an acute illness and are facing a period of reduced mobility
  • if you have developed blood clots due to cancer, to prevent new clots from forming
  • in cases of unstable angina (a condition where insufficient blood reaches the heart)
  • after a heart attack

• prevent blood clots from forming 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 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 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 diseases with a 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 the same activity or usage instructions.

Consult your doctor or pharmacist before using Inhixa if:

• you have ever had a reaction to heparin causing 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 respected between Inhixa administration and this 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 blood vessel problems in the eyes due to diabetes (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 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 a blood test before starting this medicine and while using it, to monitor levels of blood cells involved in clotting (platelets) and potassium levels in the blood.

Children and adolescents

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

Use of Inhixa with other medicines

Inform 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, “Changing anticoagulant treatment”)
• Dextran injection – used as a blood volume 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 (medicines that remove fluid), and some medicines used to treat heart problems.

Surgery and anaesthesia

If you are scheduled for a lumbar puncture or surgery involving 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 blood clots. Your doctor will discuss this with you.

If you are breastfeeding or planning to breastfeed, you should 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 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 (found 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; therefore, it is essentially "sodium-free".

3. How to use Inhixa

Follow exactly the administration instructions for this medicine 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. 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 usually 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 why it is being used.
• If you have any 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 limited 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 can be used in two different types of heart attacks, known as STEMI (ST-segment elevation myocardial infarction) or non-STEMI (NSTEMI). The dose of Inhixa you receive will depend 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 advise you to also take acetylsalicylic acid (aspirin).
• Your doctor will decide how long you will receive Inhixa.

STEMI heart attack if under 75 years of age:

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

STEMI heart attack if 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 given during 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 Inhixa injection was given, your doctor may decide to administer 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 dose 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 needle guard

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 expiry date of the medicine. 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 change in its appearance.
• Verify the dose to be injected.
• Check whether the previous injection caused redness, skin discoloration, swelling, discharge, or ongoing pain. If so, speak with your doctor or nurse.
• Choose the injection site. Alternate each time between the right and left side of the abdomen (abdominal area). 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 soap and water. 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 supportive pillows is most suitable.
3. Select an injection 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 around the navel or near scars or bruises. Inject on the opposite side from your previous injection (alternating 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 for use.

Do not press the plunger to remove the air bubble before injecting. Removing the air bubble is not necessary and 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 the 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. Ensure you 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 into a sharps container. Close the container tightly and keep it out of children's reach.

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 needle guard

Your pre-filled syringe includes a needle guard to protect you from needle-stick injuries.

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. 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 expiry date of the medicine. 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 change in its appearance.
• Verify the dose to be injected.
• Check whether the previous injection caused redness, skin discoloration, swelling, discharge, or ongoing pain. If so, speak with your doctor or nurse.
• Choose the injection site. Alternate each time between the right and left side of the abdomen (abdominal area). 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 soap and water. 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 supportive pillows is most suitable.
3. Select an injection 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 around the navel or near scars or bruises. Inject on the opposite side from your previous injection (alternating 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 for use.

Do not press the plunger to remove the air bubble before injecting. Removing the air bubble is not necessary and 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 the 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. Ensure you 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 into a sharps container. Close the container tightly and keep it out of children's reach.

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 medicines to reduce blood clotting (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 medicines (e.g., warfarin) to Inhixa

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

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

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

• Switching from direct oral anticoagulant treatment 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 forget any doses, keeping a diary may be helpful.

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 may 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, the bleeding might not be obvious.

If you notice any episode of bleeding that does not stop on its own, or if you experience 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 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 experience any signs of a blood vessel blockage caused by a blood clot such as:

cramp-like pain, redness, warmth, or swelling in one of your legs – which are symptoms of deep vein thrombosis

difficulty breathing, chest pain, fainting, or coughing up blood – which are symptoms of pulmonary embolism

• If you have 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.
• 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 to touch and swelling of the stomach. 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 become fragile and more likely to fracture).
• Tingling, numbness, and muscle weakness (especially in the lower part of the body) after having a lumbar puncture or spinal anaesthesia.
• Loss of bladder or bowel control (inability to control urination or defecation).
• Hardening or a lump 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 included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Inhixa Storage Instructions

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 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 changes 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 properly dispose of unused medicines and their packaging. 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 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.

Appearance of the product and contents of the pack

Inhixa 12,000 IU (120 mg)/0.8 ml is 0.8 ml of solution contained in:

• a clear, colourless, neutral type I glass syringe, with fixed needle and needle protector closed with a chlorobutyl rubber stopper and a purple polypropylene plunger. The syringe may additionally be equipped with a needle shield.

This medicinal product is available in pack sizes of:

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

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

• a clear, colourless, neutral type I glass syringe, with fixed needle and needle protector closed with a chlorobutyl rubber stopper and a dark blue polypropylene plunger. The syringe may additionally be equipped with a needle shield.

This medicinal product is available in pack sizes of:

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

Only certain 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 on this medicinal product, 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. +421233331071
Italy Techdow Pharma Italy S.R.L. Tel: +39 0256569157	Finland/Suomi 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.