Hepaxane 10,000 IU (100 mg)/1 ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hepaxane 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe

Hepaxane 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe

Hepaxane 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringe

Hepaxane 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringe

Hepaxane 10,000 IU (100 mg)/1 mL solution for injection in pre-filled syringe

Hepaxane 12,000 IU (120 mg)/0.8 mL solution for injection in pre-filled syringe

Hepaxane 15,000 IU (150 mg)/1 mL solution for injection in pre-filled syringe

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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Hepaxane is and what it is used for

Hepaxane contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).

Hepaxane works in two ways:

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

Hepaxane can be used to:

• treat 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 facing 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 the dialysis apparatus (used in people with serious kidney problems).

2. What you need to know before using Hepaxane

Do not use Hepaxane

• 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 known as 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 brain or eye surgery), including recent hemorrhagic stroke.
• If you are using Hepaxane to treat blood clots and you are scheduled to receive spinal or epidural anaesthesia or a lumbar puncture within 24 hours.

Warnings and precautions

Hepaxane 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 starting to use Hepaxane if:

• You have ever had a reaction to heparin causing a severe decrease in platelet count.
• You are scheduled to receive spinal or epidural anaesthesia or a lumbar puncture (see “Surgery and anaesthesia”): a time delay must be observed between the use of Hepaxane and these procedures.
• 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 eye vessel problems (diabetic retinopathy).
• You have recently undergone eye or brain surgery.
• You are elderly (over 65 years old), particularly if over 75 years old.
• 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 medications that affect bleeding (see below “Other medicines and Hepaxane”).

You may need to have a blood test before starting and while using this medicine to monitor the levels of blood cells involved in clotting (platelets) and blood potassium levels.

Other medicines and Hepaxane

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

• Warfarin, used to reduce blood clotting.
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see also section 3 “Switching anticoagulant treatment”).
• Dextran injection, used as a blood volume expander.
• Ibuprofen, diclofenac, ketorolac, or 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 pills), and some medicines used to treat heart problems.

Surgery and anaesthesia

If you are scheduled for a lumbar puncture or a surgical procedure involving spinal or epidural anaesthesia, inform your doctor that you are using Hepaxane (see “Do not use Hepaxane”). Also inform your doctor if you have any spinal problems or have previously undergone spinal surgery.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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.

Driving and using machines

Hepaxane does not affect the ability to drive or operate machinery.

Hepaxane contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

It is recommended that the healthcare professional record the brand name and batch number of the medicine you are using.

3. How to use Hepaxane

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

Use of the medicine

• Usually, your doctor or nurse will administer Hepaxane, as it must be given by injection.

• When you return home, you may need to continue using Hepaxane and may have to self-administer it (see instructions on how to do so).

• Hepaxane is generally administered by subcutaneous injection (injection under the skin).

• Hepaxane may be administered by intravenous injection (into the vein) after certain types of heart attacks and surgical procedures.

• Hepaxane can be added to the tube draining blood from the body (arterial line) at the beginning of a dialysis session.

Do not administer Hepaxane into muscle (intramuscular route).

What dose will be administered

• Your doctor will decide the dose of Hepaxane you should receive. The dose depends on why you are being treated.
• If you have kidney problems, you may receive a lower dose of Hepaxane.

1. Treatment of blood clot formation:

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

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

   a) Surgery or periods of limited mobility due to illness

• The dose depends on your risk of developing a blood clot. You will usually receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of Hepaxane daily.

• If you are undergoing surgery, the first injection is usually given 2 or 12 hours before the procedure.

• If you have limited mobility due to illness, you will usually receive 4,000 IU (40 mg) of Hepaxane daily.

• Your doctor will decide how long you will receive Hepaxane.

  b) After a heart attack

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

STEMI-type 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 aspirin (acetylsalicylic acid).
• Your doctor will decide how long you will receive Hepaxane.

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

• You will receive an initial intravenous injection of 3,000 IU (30 mg) of Hepaxane.
• At the same time, you will receive a subcutaneous injection (under the skin) of Hepaxane. 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 aspirin (acetylsalicylic acid).
• Your doctor will decide how long you will receive Hepaxane.

STEMI-type 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 Hepaxane administered during the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you will receive Hepaxane.

If you are undergoing percutaneous coronary intervention (PCI):

Depending on when you last received a Hepaxane injection, your doctor may decide to administer an additional dose of Hepaxane before a PCI procedure. This would be given as an intravenous injection.

3. Prevention of blood clot formation in dialysis equipment tubing

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Hepaxane 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 injection of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight if necessary.

Method of administration

The pre-filled syringe is ready for immediate use.

This medicine must not be administered intramuscularly.

Injection via the arterial line of the extracorporeal circuit

To prevent blood clot formation in the tubing of dialysis equipment, this medicine will be injected into the tube draining blood from the body (arterial line).

Intravenous injection technique [only for the indication of acute ST-segment elevation myocardial infarction (STEMI)]

In the treatment of acute STEMI, treatment should begin with a single rapid intravenous injection, immediately followed by a subcutaneous injection (under the skin).

Subcutaneous injection technique (injection under the skin)

This medicine is usually administered by subcutaneous injection (under the skin).

Subcutaneous deep injection is best performed while the patient is lying down. The injection site should alternate between the left and right anterolateral and posterolateral abdominal walls. Pinch a skin fold between the thumb and index finger and insert the entire needle vertically. Do not release the skin fold until the injection is completely finished.

Do not massage the injection site after administration.

If using 20 mg or 40 mg pre-filled syringes, do not attempt to remove the air bubble before injection, as this may result in a reduced administered dose.

The pre-filled syringe is for single use only.

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

How to self-administer Hepaxane injection

If you are able to self-administer Hepaxane, your doctor or nurse will teach you how to do so. Do not attempt to inject yourself unless you have been properly trained. If you have any doubts, consult your doctor or nurse immediately.

Before self-injecting Hepaxane

• Check the medicine's expiration date. Do not use if expired.
• Check that the syringe is undamaged and that the solution inside is clear and transparent. If not, use another syringe.
• Do not use this medicine if you observe any changes in the appearance of the product.
• Make sure you know the correct dose to inject.
• Examine your abdomen to check whether the last injection caused redness, skin discoloration, swelling, discharge, or ongoing pain. If so, speak with your doctor or nurse.
• Choose the injection site. Change the injection site each time, alternating between the left and right sides of your abdomen. Hepaxane should be injected just under the skin of your abdomen, but not too close to the navel or any scars (at least 5 cm away from these areas).

The pre-filled syringe is for single use and may have a system that covers the needle after use.

• with needle protection system that covers the needle after injection
• without needle protection system after injection

Instructions for self-injecting Hepaxane

Lie down and administer Hepaxane by deep subcutaneous injection. Choose an area on the left or right side of your abdomen, more than 5 cm away from the navel and toward the sides.

Hepaxane pre-filled syringes are for single use and may or may not have a system that covers the needle after use.

Remove the pre-filled syringe from its packaging by pulling the tab as indicated on the package. Do not pull the syringe by the plunger, as this may damage it.

1. Remove the needle cap by pulling it off.

2. Gently pinch between your thumb and index finger the cleaned abdominal area, forming a skin fold. Be sure not to release this fold until the injection is completely finished. Insert the entire needle into the skin fold and inject the syringe contents by pushing the plunger fully to the end.

3. Remove the syringe from the injection site while keeping your finger on the plunger. You may now release the pinched skin fold. To avoid bruising, do not massage the injection site after injection.

4a) For pre-filled syringes equipped with a needle protection system: After completing the injection, firmly hold the syringe barrel with one hand. With the other hand, grasp the base of the barrel (wing-shaped) and pull until you hear a click. The needle is now fully covered and protected. The safety shield is equipped with a locking mechanism that allows the safety system to be unlocked and locked.

Immediately dispose of the syringe in the appropriate container.

4b) For prefilled syringes not equipped with a needle protection system

Immediately dispose of the syringe in the appropriate container.

Changing anticoagulant treatment

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

Your doctor will request a blood test to measure a parameter called INR and will tell you when to stop treatment with Hepaxane.

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

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

• Switching from Hepaxane to direct oral anticoagulants

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

• Switching from direct oral anticoagulant treatment to Hepaxane

Stop taking the direct oral anticoagulant. Do not start treatment with Hepaxane until 12 hours after the last dose of the direct oral anticoagulant.

Use in children and adolescents

The safety and efficacy of Hepaxane have not been evaluated in children or adolescents.

If you use more Hepaxane than you should

If you think you have used too much or too little Hepaxane, inform your doctor, nurse, or pharmacist immediately, even if you do not notice any signs of problems. If a child accidentally injects or swallows Hepaxane, take them immediately to the hospital emergency department.

You may also contact the Toxicology Information Service at telephone number 915620420, indicating the medication and the amount used.

If you forget to use Hepaxane

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 Hepaxane

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

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

Stop treatment with Hepaxane 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).

Like other similar medicines (medicines used to reduce blood clots), Hepaxane may cause bleeding that could potentially be life-threatening. In some cases, bleeding may not be obvious.

Contact your doctor immediately if:

• You notice any episode of bleeding that does not stop on its own.
• You notice signs of excessive bleeding such as feeling very weak, fatigue, paleness, dizziness, headache, or unexplained swelling.

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

You must inform your doctor immediately if:

• You experience 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, which are symptoms of deep vein thrombosis.

• Difficulty breathing, chest pain, fainting, or coughing up blood, which are symptoms of pulmonary embolism.

• 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.

Other possible adverse 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 Hepaxane 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 to touch and swelling of the stomach. This could indicate gastrointestinal bleeding.
• Large, irregular red lesions on the skin, with or without blisters.
• Skin irritation (local irritation).
• You may notice that your skin or eyes turn yellow, along with darkening of the urine. This could be due to a liver problem.

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

• Serious 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.
• Increased number of eosinophils (a type of white blood cell) in the blood. Your doctor can check this with a blood test.
• Hair loss.
• Osteoporosis (a condition in which bones become more likely to fracture).
• Tingling, numbness, and muscle weakness (especially in the lower part of the body) after having had a lumbar puncture or spinal anesthesia.
• Loss of bladder or bowel control (inability to control urination or defecation).
• Hardening or a nodule at the injection site.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hepaxane

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

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

Do not freeze.

Pre-filled Hepaxane syringes are for single use only. Dispose of any unused medicine.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Hepaxane

• Each pre-filled syringe contains sodium enoxaparin with an anti-Xa activity of 2,000 IU (equivalent to 20 mg) in 0.2 mL of water for injectable preparations.
• Each pre-filled syringe contains sodium enoxaparin with an anti-Xa activity of 4,000 IU (equivalent to 40 mg) in 0.4 mL of water for injectable preparations.
• Each pre-filled syringe contains sodium enoxaparin with an anti-Xa activity of 6,000 IU (equivalent to 60 mg) in 0.6 mL of water for injectable preparations.
• Each pre-filled syringe contains sodium enoxaparin with an anti-Xa activity of 8,000 IU (equivalent to 80 mg) in 0.8 mL of water for injectable preparations.
• Each pre-filled syringe contains sodium enoxaparin with an anti-Xa activity of 10,000 IU (equivalent to 100 mg) in 1 mL of water for injectable preparations.
• Each pre-filled syringe contains sodium enoxaparin with an anti-Xa activity of 12,000 IU (equivalent to 120 mg) in 0.8 mL of water for injectable preparations.
• Each pre-filled syringe contains sodium enoxaparin with an anti-Xa activity of 15,000 IU (equivalent to 150 mg) in 1 mL of water for injectable preparations.
• The other ingredient is water for injectable preparations.

Appearance of the product and contents of the container

Hepaxane is a clear, colourless to pale yellow injectable solution in a type I glass pre-filled syringe, equipped with an injection needle and needle protector. The syringe may or may not be equipped with a needle protection system activated after injection.

1. Syringes equipped with a needle protection system activated after injection

• Hepaxane 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes:

Packs containing 2, 6 and 10 pre-filled syringes, and multipacks containing 12 (2 packs of 6), 20 (2 packs of 10), 24 (4 packs of 6), 30 (3 packs of 10), 50 (5 packs of 10) and 90 (9 packs of 10) pre-filled syringes.

• Hepaxane 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringes:

Packs containing 2, 6 and 10 pre-filled syringes, and multipacks containing 12 (2 packs of 6), 20 (2 packs of 10), 24 (4 packs of 6), 30 (3 packs of 10), 50 (5 packs of 10) and 90 (9 packs of 10) pre-filled syringes.

• Hepaxane 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringes:

Packs containing 2, 6 and 10 graduated pre-filled syringes, and multipacks containing 12 (2 packs of 6), 20 (2 packs of 10), 24 (4 packs of 6), 30 (3 packs of 10), 50 (5 packs of 10) and 90 (9 packs of 10) graduated pre-filled syringes.

• Hepaxane 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringes:

Packs containing 2, 6 and 10 graduated pre-filled syringes, and multipacks containing 12 (2 packs of 6), 20 (2 packs of 10), 24 (4 packs of 6), 30 (3 packs of 10), 50 (5 packs of 10) and 90 (9 packs of 10) graduated pre-filled syringes.

• Hepaxane 10,000 IU (100 mg)/1 mL solution for injection in pre-filled syringes:

Packs containing 2, 6 and 10 graduated pre-filled syringes, and multipacks containing 12 (2 packs of 6), 20 (2 packs of 10), 24 (4 packs of 6), 30 (3 packs of 10), 50 (5 packs of 10) and 90 (9 packs of 10) graduated pre-filled syringes.

• Hepaxane 12,000 IU (120 mg)/0.8 mL solution for injection in pre-filled syringes:

Packs containing 2, 6 and 10 graduated pre-filled syringes, and multipacks containing 30 (3 packs of 10) and 50 (5 packs of 10) graduated pre-filled syringes.

• Hepaxane 15,000 IU (150 mg)/1 mL solution for injection in pre-filled syringes:

Packs containing 2, 6 and 10 graduated pre-filled syringes, and multipacks containing 30 (3 packs of 10) and 50 (5 packs of 10) graduated pre-filled syringes.

2. Syringes not equipped with a needle protection system activated after injection

• Hepaxane 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes:

Packs containing 2 and 10 pre-filled syringes.

• Hepaxane 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringes:

Packs containing 2 and 10 pre-filled syringes, and multipacks containing 30 (3 packs of 10) pre-filled syringes.

• Hepaxane 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringes:

Packs containing 2 and 10 graduated pre-filled syringes, and multipacks containing 30 (3 packs of 10) graduated pre-filled syringes.

• Hepaxane 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringes:

Packs containing 2 and 10 graduated pre-filled syringes, and multipacks containing 30 (3 packs of 10) graduated pre-filled syringes.

• Hepaxane 10,000 IU (100 mg)/1 mL solution for injection in pre-filled syringes:

Packs containing 2 and 10 graduated pre-filled syringes, and multipacks containing 30 (3 packs of 10) graduated pre-filled syringes.

• Hepaxane 12,000 IU (120 mg)/0.8 mL solution for injection in pre-filled syringes:

Packs containing 10 graduated pre-filled syringes, and multipacks containing 30 (3 packs of 10) graduated pre-filled syringes.

• Hepaxane 15,000 IU (150 mg)/1 mL solution for injection in pre-filled syringes:

Packs containing 10 graduated pre-filled syringes, and multipacks containing 30 (3 packs of 10) graduated pre-filled syringes.

The pre-filled syringes of 6,000 IU (60 mg)/0.6 mL, 8,000 IU (80 mg)/0.8 mL, 10,000 IU (100 mg)/1 mL, 12,000 IU (120 mg)/0.8 mL and 15,000 IU (150 mg)/1 mL are graduated.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Chemi S.p.A
Via dei Lavoratori 54,
20092 Cinisello Balsamo, Milan
Italy

Manufacturer

Italfarmaco S.p.A
Viale Fulvio Testi 330
20126 Milan
Italy

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

ITALFARMACO S.A.
C/ San Rafael 3,
28108 Alcobendas
Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Belgium: Ghemaxan
Germany: Hepaxane
Denmark: Ghemaxan
Greece: Havetra
Spain: Hepaxane
Finland: Ghemaxan
Italy: Ghemaxan
Netherlands: Ghemaxan
Norway: Ghemaxan
Austria: Ghemaxan
France: Ghemaxan
Ireland: Ghemaxan
Sweden: Ghemaxan
Portugal: Hepaxane
Hungary: Hepaxane
Romania: Hepaxane
Slovakia: Ghemaxan

Date of the most recent review of this leaflet: January 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) at http://www.aemps.gob.es.

You can access detailed and up-to-date information on how to administer this medicinal product by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You can also access the same information via the following internet addresses:

Hepaxane 2,000 IU (20 mg)/0.2 mL https://cima.aemps.es/info/83293	Hepaxane 4,000 IU (40 mg)/0.4 mL https://cima.aemps.es/info/83292
Hepaxane 6,000 IU (60 mg)/0.6 mL https://cima.aemps.es/info/83291	Hepaxane 8,000 IU (80 mg)/0.8 mL https://cima.aemps.es/info/83294
Hepaxane 10,000 IU (100 mg)/1 mL https://cima.aemps.es/info/83288	Hepaxane 12,000 IU (120 mg)/0.8 mL https://cima.aemps.es/info/83290
Hepaxane 15,000 IU (150 mg)/1 mL https://cima.aemps.es/info/83289