Fraxiparine

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, 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. Important information 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. Medicines of this type are called anticoagulants.
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 for reasons other than surgical procedures, in whom there is a high risk of thromboembolic complications (e.g. severe chronic obstructive pulmonary disease, heart failure, severe 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 (nadroparin-dependent thrombocytopenia) after receiving Fraxiparine;
• if the patient has bleeding or any medical condition causing reduced blood clotting;
• if the patient has a medical condition associated with an increased risk of bleeding [e.g. active gastric and/or duodenal ulcer];
• if the patient has recently suffered a hemorrhagic stroke;
• if the patient has acute infective endocarditis;
• if the patient has severe renal impairment and is being treated with anticoagulant medicines 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 can sometimes be severe. During treatment, the doctor will recommend blood tests to monitor for this effect.
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 gastric or duodenal ulcer disease,
  • the patient has coagulation disorders,
  • the patient has recently undergone surgery on the brain, spinal cord, or eye,
  • the patient has high blood pressure (hypertension);
• the patient has severe liver dysfunction;
• the patient has impaired kidney function;
• the patient has eye diseases affecting blood vessels (vascular disorders of choroid and retina);
• the patient is taking other medicines affecting blood clotting (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, the medicine must be discontinued immediately and the doctor contacted without delay.
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 spinal 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, has recently taken, or plans to take.
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. These include:

• acetylsalicylic acid (e.g. aspirin),
• non-steroidal anti-inflammatory drugs – NSAIDs (medicines used to relieve pain, such as ibuprofen),
• antiplatelet agents (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),
• glucocorticosteroids (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 must always be used as directed by the physician. If in doubt, consult a
doctor or pharmacist.
Method of administration
Fraxiparine should be administered by subcutaneous or intravenous injection.
Fraxiparine must not be administered by intramuscular injection.
Prefilled syringes with graduation markings facilitate administration of appropriate doses when dose adjustment according to body weight is required.
When administering the medicine by subcutaneous injection, the usual injection site is the anterolateral abdominal wall, alternating between the right and left side. Another possible injection site is the thigh.
Detailed instructions for performing subcutaneous injections of Fraxiparine are provided in the section: “Instructions for self-administration of subcutaneous injections of Fraxiparine”.
Recommended dosage
The dosage is determined individually by the physician, depending on the indication,
clinical condition, and patient's body weight.
Use in children and adolescents
Fraxiparine must not be used in children and adolescents.
Elderly patients (over 65 years of age)
Renal function may be impaired in these patients. Therefore, the physician may recommend kidney function tests and adjust the dose of Fraxiparine accordingly.
Renal impairment
The physician will adjust the dose of the medicine according to the severity of renal impairment.
Fraxiparine is contraindicated in patients with severe renal impairment.
Use of a higher than recommended dose of Fraxiparine
If a higher than recommended dose has been administered, contact a doctor immediately. The main symptom of overdose is bleeding.
Missed dose of Fraxiparine
Continue using the medicine as prescribed, without increasing the next dose. Do not shorten the interval between doses.
Do not use a double dose to make up for a missed dose.
Discontinuation of Fraxiparine
Fraxiparine should be used for as long as directed by the physician. Do not discontinue Fraxiparine without consulting the physician.
If the patient wishes to discontinue treatment with Fraxiparine, this should first be discussed with the physician or pharmacist.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

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

• hypersensitivity reaction presenting as: urticaria (bright pink, itchy skin blisters), angioedema (facial or lip swelling making breathing difficult),
• skin necrosis at the injection site – preceded by subcutaneous bleeding or hard or 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,
• small bruises 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 enzymes (aminotransferases), usually transient (detected in blood tests).

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.

Very 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 cells) – transient after treatment discontinuation (detected in blood tests),
• increased potassium levels in blood,
• prolonged, painful penile erection (priapism) – if this occurs, urgent medical attention is required, as treatment may be necessary to avoid serious complications.

Unknown frequency (cannot be estimated from available data):

• headache,
• migraine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fraxiparine

Keep this medicine out of the 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. This will help protect the environment.

6. Contents of the pack and other information

What Fraxiparine contains

• The active substance is: 2,850 IU AXa of calcium nadroparin in 0.3 ml of injection solution
  3,800 IU AXa of calcium nadroparin in 0.4 ml of injection solution
  5,700 IU AXa of calcium nadroparin in 0.6 ml of injection solution
  7,600 IU AXa of calcium nadroparin in 0.8 ml of injection solution
  9,500 IU AXa of calcium nadroparin in 1 ml of injection solution
• Other components: 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 equipped with a needle safety guard to prevent needlestick injury after administration.
The pack contains 2 or 10 pre-filled syringes with needle safety guard, individually blister-packed in a cardboard outer.

Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
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

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

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 sides.
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 of the needle with any surface before injection.
• The presence of a small air bubble in the pre-filled syringe is normal. Do not remove the air bubble before injection – this may result in loss of part of the dose. 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

holder.
Insert the full length of the needle 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 massage the injection site.
Picture 4

9. Appearance of the pre-filled syringe after

injection (Picture 5).
Safety cap
Syringe holder
Picture 5

10. After injection, slide the protective needle

shield forward to protect against needlestick injury (Picture 6). Firmly hold the syringe holder with one hand, use the other hand to grasp the outer shield of the syringe and slide it toward the needle. This will unlock the shield. Then slide the shield forward until it locks into place, completely covering the needle. Resistance will be felt during activation and locking of the shield.
Picture 6

11. Appearance of the pre-filled syringe after

engaging the safety shield (Picture 7).
Safety cap
Syrine holder
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.