Fraxiparine

Package leaflet: Information for the patient

Fraxiparine, 2,850 IU anti-Xa/0.3 ml, solution for injection
Fraxiparine, 3,800 IU anti-Xa/0.4 ml, solution for injection
Fraxiparine, 5,700 IU anti-Xa/0.6 ml, solution for injection
Fraxiparine, 7,600 IU anti-Xa/0.8 ml, solution for injection
Fraxiparine, 9,500 IU anti-Xa/1 ml, solution for injection
(Nadroparinum calcicum)
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Fraxiparine is and what it is used for

Fraxiparine is a medicine that helps prevent the formation of blood clots in blood vessels or treat existing clots. This type of medicine is known as an anticoagulant.
The medicine is administered by subcutaneous or intravenous injection.

Indications:

• Prevention of venous thromboembolic disease in surgery and orthopedic surgery;
• Prevention of venous thromboembolic disease in immobilized patients due to non-surgical conditions, in whom there is a high risk of thromboembolic complications (e.g. severe chronic obstructive pulmonary disease, heart failure, serious infections, etc.);
• Prevention of blood clotting in the extracorporeal circulation system during hemodialysis;
• Treatment of deep vein thrombosis with or without pulmonary embolism;
• Treatment of unstable angina and non-Q-wave myocardial infarction in combination with acetylsalicylic acid.

2. Important information before using Fraxiparine

When not to use Fraxiparine

• if the patient is allergic to the active substance, calcium nadroparin, heparin, or a similar product (such as enoxaparin, bemiparin, dalteparin), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced a decrease in platelet count—blood cells involved in blood clotting—after receiving Fraxiparine (nadroparin-dependent thrombocytopenia);
• if the patient has bleeding or any medical condition causing reduced blood coagulation;
• if the patient has a medical condition associated with an increased risk of bleeding [e.g. active peptic ulcer of the stomach and/or duodenum];
• if the patient has recently had a hemorrhagic stroke;
• if the patient has acute infective endocarditis;
• if the patient has severe renal impairment and is being treated with medication for thrombosis, e.g. in the lungs (pulmonary embolism) or in the leg (deep vein thrombosis);
• if the patient has severe renal impairment and is being treated for heart disease (e.g. unstable angina or non-Q-wave myocardial infarction).

Warnings and precautions
When using Fraxiparine, a decrease in platelet count may rarely occur, which may sometimes be severe. During treatment, the doctor will recommend blood tests to detect whether this effect occurs.
Before using Fraxiparine, the patient should inform the doctor if:

• the patient has conditions that increase the risk of bleeding, particularly if:
  • the patient has peptic ulcer disease of the stomach and/or duodenum,
  • the patient has coagulation disorders,
  • the patient has recently undergone surgery involving the brain, spinal cord, or eye,
  • the patient has high blood pressure (hypertension);
• the patient has severe liver dysfunction;
• the patient has renal impairment;
• the patient has eye diseases affecting blood vessels (vascular disorders of the choroid and retina);
• the patient is taking other medicines affecting blood coagulation (see section: "Fraxiparine with other medicines").

In case of bleeding, contact the doctor immediately.
If skin necrosis occurs, which may be preceded by small subcutaneous hemorrhages or hard, painful redness of the skin, discontinue the medicine immediately and contact the doctor.
Use of Fraxiparine may lead to increased potassium levels in the blood. If the patient has conditions in which elevated potassium levels may occur, such as diabetes, severe kidney disease, pre-existing metabolic acidosis, or if the patient is taking other medicines that increase blood potassium levels, the doctor may recommend periodic blood tests. If the patient is unsure whether they are taking such medicines, they should consult their doctor.
If the patient undergoes epidural or intrathecal anaesthesia, or lumbar puncture (spinal tap) while receiving Fraxiparine, there is a risk of bleeding into the spinal canal at the puncture site, which may lead to serious consequences. During such procedures, the patient's condition will be closely monitored for any concerning symptoms.
If the patient is elderly (over 65 years of age), the doctor may recommend blood tests before starting Fraxiparine treatment.
The needle cap of the pre-filled syringe may contain latex [see section: "Packaging contains latex (natural rubber)"].

Fraxiparine with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Concomitant use of Fraxiparine with the following medicines is not recommended due to the risk of bleeding. If this cannot be avoided, the doctor will closely monitor the patient's condition. This applies to the following medicines:

• acetylsalicylic acid (e.g. aspirin),
• non-steroidal anti-inflammatory drugs - NSAIDs (medicines used to relieve pain, such as ibuprofen),
• antiplatelet medicines (used to prevent blood clots, such as clopidogrel).

Fraxiparine should be used with caution with:

• oral anticoagulants (medicines preventing blood clotting, such as warfarin),
• glucocorticoids (steroid medicines used, among others, in the treatment of bronchial asthma),
• dextran (a medicine administered intravenously to increase circulating blood volume).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Fraxiparine may be used during pregnancy only if the doctor considers that the expected benefits outweigh the potential risks.
It is not known whether the components of Fraxiparine pass into human milk; therefore, breastfeeding should not be undertaken during treatment with Fraxiparine.
There is no data available on the effect of nadroparin on fertility.

Driving and operating machinery
There is no data available on the effect of Fraxiparine on the ability to drive or operate machinery.

Packaging may contain latex (natural rubber)
The packaging of the medicine (needle cap) may contain latex rubber. It may cause severe allergic reactions.

3. How to use Fraxiparine

This medicine should always be used exactly as your doctor has instructed. If you are unsure, you should
contact your doctor or pharmacist.
Method of administration
Fraxiparine should be administered by subcutaneous or intravenous injection.
Fraxiparine must not be given by intramuscular injection.
Pre-filled syringes with a graduated scale facilitate the administration of appropriate doses, especially when dose adjustment according to the patient's body weight is required.
When administering Fraxiparine by subcutaneous injection, the usual injection site is the anterolateral abdominal wall, alternating between the right and left side. The thigh may also be used as an alternative injection site.
Detailed instructions on how to perform subcutaneous injections are provided in the section: “Instructions for self-administration of subcutaneous injections of Fraxiparine”.
Recommended dosage
The dosage is determined by the doctor individually for each patient, depending on the indication,
clinical condition, and body weight.
Use in children and adolescents
Fraxiparine should not be used in children and adolescents.
Elderly patients (over 65 years of age)
Kidney function may be impaired in these patients. Therefore, your doctor may recommend kidney function tests and adjust the dose of Fraxiparine accordingly.
Impaired kidney function
Your doctor will adjust the dose of Fraxiparine according to the severity of kidney impairment.
Fraxiparine is contraindicated in patients with severe kidney impairment.
Use of a higher than recommended dose of Fraxiparine
If a higher than recommended dose is administered, you should contact your doctor immediately. The main symptom of overdose is bleeding.
Missing a dose of Fraxiparine
Continue using the medicine as prescribed, without increasing the next dose. Do not shorten the time interval between doses.
Do not use a double dose to make up for a missed dose.
Stopping Fraxiparine treatment
Fraxiparine should be used for as long as your doctor recommends. Do not stop using Fraxiparine without consulting your doctor.
If you wish to discontinue treatment with Fraxiparine, you should discuss this first with your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Stop the medicine immediately and contact your doctor if any of the following occur:

• hypersensitivity reaction presenting as: urticaria (pinkish, itchy skin blisters), angioedema (swelling of the face or lips causing breathing difficulties),
• skin necrosis at the injection site – preceded by subcutaneous bleeding or hard, painful redness of the skin, with or without concomitant general symptoms.

Very common adverse reactions (may affect more than 1 in 10 patients):

• bleeding at various sites, more frequent in patients with other risk factors,
• minor bruising at the injection site. In some cases, hard lumps may appear, which do not indicate heparin crystallization and should disappear within a few days.

Common adverse reactions (may affect up to 1 in 10 patients):

• skin reaction at the injection site,
• increased blood levels of liver-derived enzymes (aminotransferases), usually transient (detected in blood test results).

Uncommon adverse reactions (may affect up to 1 in 1,000 patients):

• decreased platelet count (thrombocytopenia),
• increased platelet count (thrombocytosis),
• rash, urticaria, redness, itching of the skin,
• subcutaneous calcification at the injection site.

Rare adverse reactions (may affect up to 1 in 10,000 patients):

• hypersensitivity reactions, including angioedema and skin reactions,
• pseudoanaphylactic reaction (symptoms similar to anaphylactic – allergic reaction; see beginning of this section),
• skin necrosis,
• increased number of eosinophils (a type of white blood cell) – transient after discontinuation of treatment (detected in blood test results),
• increased potassium levels in blood,
• prolonged, painful penile erection (priapism) – if this occurs, seek urgent medical advice, as treatment may be required to avoid serious complications.

Unknown frequency (frequency cannot be estimated from available data):

• headache,
• migraine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fraxiparine

Keep this medicine out of sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines and syringes must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fraxiparine contains

• The active substance is: 2,850 IU AXa calcium nadroparin in 0.3 ml of injection solution
  3,800 IU AXa calcium nadroparin in 0.4 ml of injection solution
  5,700 IU AXa calcium nadroparin in 0.6 ml of injection solution
  7,600 IU AXa calcium nadroparin in 0.8 ml of injection solution
  9,500 IU AXa calcium nadroparin in 1 ml of injection solution
• Other ingredients: calcium hydroxide solution or diluted hydrochloric acid for pH adjustment, water for injections.

What Fraxiparine looks like and contents of the pack
Fraxiparine is a solution for injection. The pre-filled syringe contains a clear to slightly opalescent, colourless or slightly yellowish or slightly brownish or slightly dark yellow solution. The medicine is supplied in pre-filled syringes with a needle safety guard to prevent needlestick injury after administration.
The pack contains 2 or 10 pre-filled syringes with a needle safety guard, individually blister-packed in a cardboard box.

Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel.: 22 546 64 00

Manufacturer
Aspen Notre Dame de Bondeville
1, rue de l’Abbaye
76960 Notre-Dame de Bondeville
France
or
GlaxoSmithKline Pharmaceuticals S.A.
ul. Grunwaldzka 189
60-322 Poznań
Poland

Information for healthcare professionals
Detailed dosage and administration instructions are provided in section 4.2 of the approved Summary of Product Characteristics.

INSTRUCTIONS FOR SELF-ADMINISTRATION OF SUBCUTANEOUS INJECTIONS OF FRAXIPARINE

1. Wash your hands thoroughly with soap and water and dry them completely.
2. Sit or lie down in a comfortable

position.
Choose an injection site on the lateral side of the abdomen (Picture 1). Alternate injections between the left and right side.
Picture 1

3. Clean the injection site with an alcohol swab.
4. Remove the needle cap. Discard the needle cap.

Important notes

• Do not touch the needle and avoid contact between the needle and any surface before injection.
• The presence of a small air bubble in the pre-filled syringe is normal. Do not attempt to remove the air bubble before injection – this may result in loss of some of the medicine. 5. Gently pinch the previously

cleaned skin to form a skin fold. Hold the skin fold between your thumb and index finger throughout the entire injection (Picture 2).
Picture 2

6. Hold the pre-filled syringe firmly by the

flange with your fingers.
Insert the entire needle length perpendicularly into the skin fold (Picture 3).
Picture 3

7. Inject the entire contents of the pre-filled syringe by pressing the plunger down until resistance is felt.
8. Remove the syringe with the needle from the skin

(Picture 4). Do not rub the injection site.
Picture 4

9. Appearance of the pre-filled syringe after injection

(Picture 5).
Safety cap
Syringe flange
Picture 5

10. After completing the injection, slide the protective cap over the syringe to prevent needlestick injury (Picture 6). Firmly hold the syringe flange with one hand, grasp the outer cap with the other hand and slide it toward the needle. This will unlock the cap. Then slide the cap forward until it locks into place, fully covering the needle. Resistance will be felt during unlocking and locking of the cap.
    Picture 6

11. Appearance of the pre-filled syringe after deployment of the safety cap

(Picture 7).
Safety cap
Syrine flange
Picture 7

12. Do not dispose of used pre-filled syringes in household waste. Dispose of them according to your doctor’s or pharmacist’s instructions.