Ghemaxan

Patient Information Leaflet

Ghemaxan 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringe, 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringe, 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringe, 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringe, 10,000 IU (100 mg)/1 ml solution for injection in pre-filled syringe, 12,000 IU (120 mg)/0.8 ml solution for injection in pre-filled syringe, 15,000 IU (150 mg)/1 ml solution for injection in pre-filled syringe

Enoxaparin sodium
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

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

Contents of this leaflet

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

1. What Ghemaxan is and what it is used for

Ghemaxan contains an active substance called enoxaparin sodium, which is a low molecular weight heparin.
Ghemaxan works in two ways.

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

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

2. What you should know before using Ghemaxan

Do not use Ghemaxan
 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:
skin 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 had a reaction to heparin in the last 100 days causing a severe reduction in the number of blood clotting cells (platelets) – this reaction is called heparin-induced thrombocytopenia – or if you have antibodies against enoxaparin in your blood.
• If you are actively bleeding or have a condition with a high risk of bleeding (such as stomach ulcer, recent brain or eye surgery), including recent hemorrhagic stroke.
• If you are using Ghemaxan to treat blood clots and you will undergo spinal or epidural anaesthesia or a lumbar puncture within 24 hours.

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

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

Other medicines and Ghemaxan
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

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

Surgery and anaesthesia
If you are scheduled for a spinal puncture or surgery requiring epidural or spinal
anaesthesia, inform your doctor that you are using Ghemaxan. See “Do not use
Ghemaxan”. Also inform your doctor if you have any spinal problems or have undergone
spinal surgery.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking this medicine.
If you are pregnant and have a mechanical heart valve, you may be at increased risk of developing
blood clots. Your doctor will discuss this with you.
Driving and using machines
Ghemaxan does not affect the ability to drive or use machines.
Ghemaxan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
It is recommended that the healthcare professional record the brand name and batch number of the product you are using.

3. How to use Ghemaxan

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

Administration of the medicine

• Ghemaxan is usually administered by a doctor or nurse, as it must be given by injection.
• When discharged from the hospital, you may need to continue using Ghemaxan and therefore self-administer it (see instructions below on how to do so).
• Ghemaxan is usually administered by subcutaneous (under the skin) injection.
• Ghemaxan may be administered by intravenous (into a vein) injection following certain types of heart attack or surgical procedures.
• Ghemaxan may be added to the tube draining from the body (arterial line) at the beginning of a dialysis session. Do not inject Ghemaxan into a muscle.

Dosage

• Your doctor will determine the dose of Ghemaxan you should receive. The amount depends on the reason for its use.
• If you have kidney problems, you may need to receive a lower dose of Ghemaxan.

1. Treatment of blood clots

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

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

   a) Surgery or periods of reduced mobility due to illness

   • The dose depends on how likely you are to develop a clot. You may receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of Ghemaxan per day.
   • If surgery is planned, the first injection is usually given 2 hours or 12 hours before the operation.
   • In cases of reduced mobility due to illness, 4,000 IU (40 mg) of Ghemaxan is usually administered daily.
   • Your doctor will decide how long you should continue receiving Ghemaxan.

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

   NSTEMI-type heart attack:

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

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

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

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

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

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

3. Prevention of blood clots in dialysis machine tubing

   • The usual dose is 100 IU (1 mg) per kilogram of body weight.
   • Ghemaxan 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 dose of 50–100 IU (0.5–1 mg) per kilogram of body weight if needed.

Method of administration
The pre-filled syringe is ready for use.
This medicine must not be administered intramuscularly.

Injection into the arterial line of the extracorporeal circuit:
To prevent blood clots in the dialysis machine tubing, this medicine must be administered by injection into the tube draining from your body (arterial line).

Intravenous injection (only for the indication of acute STEMI heart attack):
In the treatment of acute STEMI heart attack, treatment should begin with a single rapid intravenous injection, immediately followed by a subcutaneous (under the skin) injection.

Subcutaneous injection technique (injection under the skin):
This medicine is usually administered by subcutaneous injection.
The injection should preferably be given with the patient lying down, using a deep subcutaneous injection.
Administration should alternate between the left and right anterolateral or posterolateral abdominal walls.
The injection should be performed by inserting the needle fully and perpendicularly into a skin fold created between the operator’s thumb and index finger. The skin fold should be maintained throughout the injection. Do not rub the injection site after administration.
If you are using 20 mg or 40 mg pre-filled syringes, do not remove air bubbles from the syringe before injection, as this may result in a reduced dose.
The pre-filled syringe is for single use only.
Do not use this medicine if you notice any change in the appearance of the solution.

How to self-administer a Ghemaxan injection
If you are able to self-administer this medicine, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself unless you have been properly trained.
If you are unsure about what to do, consult your doctor or nurse immediately.

Before self-injecting Ghemaxan

• Check the medicine’s expiry date. Do not use it if the date has passed.
• Check that the syringe is undamaged and that the medicine inside is a clear solution. If not, use another syringe.
• Do not use this medicine if you notice any change in the appearance of the solution.
• Make sure you know how much medicine you are about to inject.
• Check your abdomen to see if the previous injection caused redness, skin discoloration, swelling, oozing, or if it is still painful; if so, contact your doctor or nurse.
• Decide where to inject the medicine. Change the injection site each time, alternating between the right and left sides of the abdomen. Ghemaxan must be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away from these areas).

Pre-filled syringes are for single use only and are available in the following types:

• With needle safety device
• Without needle safety device

Instructions for self-injecting Ghemaxan
You should be lying down, and Ghemaxan must be administered by deep subcutaneous injection.
Choose an area on the right or left side of your abdomen at least 5 cm away from your navel.
Ghemaxan pre-filled syringe and graduated pre-filled syringe are for single use only and are available with or without a needle safety device.
Remove the syringe from the blister pack by tearing at the slightly raised tab. Do not pull on the plunger rod, as this may damage the syringe.

1. Remove the needle cap by pulling it off the syringe.

2. Gently pinch a clean area of your abdomen between your index finger and thumb to form a skin fold. Make sure to keep the skin fold during the injection. Insert the needle fully into the skin fold and inject the medicine by pushing the plunger to the bottom of the syringe.

3. Remove the syringe from the injection site while keeping your finger on the plunger rod. You may now release the skin fold. To minimize the risk of bruising, do not rub the site where you just injected.

4a) For pre-filled syringes with a needle safety device:
After injection, hold the syringe firmly in one hand. With the other hand, hold the base "wings" of the syringe and pull until you hear a click. The used needle is now fully protected. The safety system includes a lock to prevent accidental unlocking.

Immediately dispose of the syringe in a designated sharps container.

4b) For pre-filled syringes without a needle safety device:
Immediately dispose of the syringe in a designated sharps container.

Switching anticoagulant therapy

• Switching from Ghemaxan to vitamin K antagonist anticoagulants (e.g., warfarin)
  Your doctor will ask you to have a blood test called INR and will tell you when to stop Ghemaxan based on the results.

• Switching from vitamin K antagonist anticoagulants (e.g., warfarin) to Ghemaxan
  Stop treatment with vitamin K antagonists. Your doctor will ask you to have an INR blood test and will tell you when to start Ghemaxan based on the results.

• Switching from Ghemaxan to direct oral anticoagulants
  Stop treatment with Ghemaxan. Start taking the direct oral anticoagulant 0–2 hours before the time of your next scheduled injection, then continue as usual.

• Switching from direct oral anticoagulants to Ghemaxan
  Stop treatment with the direct oral anticoagulant. Start treatment with Ghemaxan only 12 hours after the last dose of the direct oral anticoagulant.

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

If you use more Ghemaxan than you should
If you think you have used too much or too little Ghemaxan, inform your doctor, nurse, or pharmacist immediately, even if you have no symptoms. If a child accidentally injects or swallows Ghemaxan, take them immediately to the emergency department.

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

If you stop using Ghemaxan
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
It is important that you continue receiving Ghemaxan injections until your doctor decides to stop them. Stopping treatment on your own may be very dangerous, as a blood clot could form.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Stop using Ghemaxan and contact your doctor or nurse immediately if you develop any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
Stop using Ghemaxan and contact your doctor immediately if you notice any of the following symptoms:
A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually occur early in treatment (acute generalized exanthematous pustulosis).
Like other similar anticoagulant medicines, Ghemaxan may cause bleeding, which could potentially be life-threatening. In some cases, bleeding may not be obvious. Contact your doctor immediately:

• if you experience any bleeding events that do not stop on their own
• if you experience signs of excessive bleeding, such as excessive weakness, fatigue, paleness, dizziness with headache or unexplained swelling. Your doctor may decide to monitor you closely or change your medication.

You must inform your doctor immediately

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

Other side effects:
Very common (may affect more than 1 in 10 people)

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache that may be a sign of bleeding in the brain.
• Stomach pain and swelling. This may be a sign of bleeding in the stomach.
• Large, irregularly shaped red skin lesions with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and darker urine. This may indicate a liver problem.

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ghemaxan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible changes in the appearance of the solution.
Do not freeze the medicine.
Ghemaxan pre-filled syringes are for single use only. Dispose of any unused medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ghemaxan contains
Each pre-filled syringe contains enoxaparin sodium 2,000 IU anti-Xa (equivalent to
20 mg) in 0.2 mL water for injections
Each pre-filled syringe contains enoxaparin sodium 4,000 IU anti-Xa (equivalent to
40 mg) in 0.4 mL water for injections
Each pre-filled syringe contains enoxaparin sodium 6,000 IU anti-Xa (equivalent to 60
mg) in 0.6 mL water for injections
Each pre-filled syringe contains enoxaparin sodium 8,000 IU anti-Xa (equivalent to 80
mg) in 0.8 mL water for injections
Each pre-filled syringe contains enoxaparin sodium 10,000 IU anti-Xa (equivalent to 100
mg) in 1 mL water for injections
Each pre-filled syringe contains enoxaparin sodium 12,000 IU anti-Xa (equivalent to 120
mg) in 0.8 mL water for injections
Each pre-filled syringe contains enoxaparin sodium 15,000 IU anti-Xa (equivalent to 150
mg) in 1 mL water for injections
The other component is water for injections.

Description of the appearance of Ghemaxan and package contents
Ghemaxan is a clear, colourless or pale yellow injectable solution contained in a pre-filled glass syringe of Type I, equipped with a needle, needle cap, and needle protection device.
The syringes may or may not be provided with a needle protection device.

1. The syringe is equipped with a needle protection device

Ghemaxan 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringes:
packs of 2, 6 or 10 pre-filled syringes and multiple packs 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.
Ghemaxan 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringes:
packs of 2, 6 or 10 pre-filled syringes and multiple packs 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.
Ghemaxan 6,000 IU (60 mg)/0.6 ml solution for injection in graduated pre-filled syringes:
packs of 2, 6 or 10 graduated pre-filled syringes and multiple packs 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.
Ghemaxan 8,000 IU (80 mg)/0.8 ml solution for injection in graduated pre-filled syringes:
packs of 2, 6 or 10 graduated pre-filled syringes and multiple packs 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.
Ghemaxan 10,000 IU (100 mg)/1 ml solution for injection in graduated pre-filled syringes:
packs of 2, 6 or 10 graduated pre-filled syringes and multiple packs 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.
Ghemaxan 12,000 IU (120 mg)/0.8 ml solution for injection in graduated pre-filled syringes:
packs of 2, 6 or 10 graduated pre-filled syringes and multiple packs containing 30 (3 packs of 10) and 50 (5 packs of 10) graduated pre-filled syringes.
Ghemaxan 15,000 IU (150 mg)/1 ml solution for injection in graduated pre-filled syringes:
packs of 2, 6 or 10 graduated pre-filled syringes and multiple packs containing 30 (3 packs of 10) and 50 (5 packs of 10) graduated pre-filled syringes.

2. The syringe is not equipped with a needle safety device

Ghemaxan 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringes:
packs of 2 and 10 pre-filled syringes.
Ghemaxan 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringes:
packs of 2 and 10 pre-filled syringes and multiple pack containing 30 (3 boxes of 10) pre-filled syringes.
Ghemaxan 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringes:
packs of 2 and 10 graduated pre-filled syringes and multiple pack containing 30 (3 boxes of 10) graduated pre-filled syringes.
Ghemaxan 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringes:
packs of 2 and 10 graduated pre-filled syringes and multiple pack containing 30 (3 boxes of 10) graduated pre-filled syringes.
Ghemaxan 10,000 IU (100 mg)/1 ml solution for injection in pre-filled syringes:
packs of 2 and 10 graduated pre-filled syringes and multiple pack containing 30 (3 boxes of 10) graduated pre-filled syringes.
Ghemaxan 12,000 IU (120 mg)/0.8 ml solution for injection in pre-filled syringes:
packs of 10 graduated pre-filled syringes and multiple pack containing 30 (3 boxes of 10) graduated pre-filled syringes.
Ghemaxan 15,000 IU (150 mg)/1 ml solution for injection in pre-filled syringes:
packs of 10 graduated pre-filled syringes and multiple pack containing 30 (3 boxes 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.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Chemi S.p.A.
Via dei Lavoratori 54 - 20092 Cinisello Balsamo (MI)
Tel: +39.02.64431
Fax: +39.02.6128960
e-mail: [email protected]

Manufacturer
Italfarmaco S.p.A
Viale F. Testi, 330
20126 Milano

This medicinal product is authorized in the European Economic Area countries under the following names:
UK: Ghemaxan
Belgium: Ghemaxan
Germany: Hepaxane
Denmark: Ghemaxan
Greece: Havetra
Spain: Hepaxane
Finland: Ghemaxan
Netherlands: Ghemaxan
Norway: Ghemaxan
Austria: Ghemaxan
France: Ghemaxan
Ireland: Ghemaxan
Sweden: Ghemaxan
Portugal: Hepaxane
Hungary: Hepaxane
Romania: Hepaxane
Slovakia: Ghemaxan

More information on this medicinal product is available at the following website:
https://www.aifa.gov.it/hu/trova-farmaco