Fraxiparine

Package leaflet: Information for the user

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 this medicine, as it contains
important information for you.

• 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 you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side 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 blood clots from forming in blood vessels or treats clots that have already formed. Medicines of this type are known as 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, 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 (nadroparin-dependent thrombocytopenia) after receiving Fraxiparine;
• if the patient is experiencing 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 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 medications for thrombosis, e.g. in the lungs (pulmonary embolism) or 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
During treatment with 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 renal impairment;
• the patient has eye diseases affecting blood vessels (vascular disorders of choroid and retina);
• the patient is taking other medications 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 medication immediately and contact the doctor.
Treatment with 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 medications that increase blood potassium levels, the doctor may recommend periodic blood tests. If the patient is unsure whether they are taking such medications, they should consult their doctor.
If the patient undergoes epidural or spinal anaesthesia, or lumbar puncture (spinal tap) during treatment with 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 cover of the pre-filled syringe may contain latex [see section: "Packaging contains latex (natural rubber)"].

Fraxiparine with other medicines
Inform your 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 co-administration 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 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 asthma treatment),
• 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 the expected benefits to outweigh the potential risks.
It is unknown whether the components of Fraxiparine pass into human milk; therefore, breastfeeding should be avoided 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 cover) may contain latex rubber, which may cause severe allergic reactions.

3. How to use Fraxiparine

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Method of administration
Fraxiparine should be administered by subcutaneous or intravenous injection.
Fraxiparine must not be administered by intramuscular injection.
Pre-filled syringes with graduation marks facilitate administration of appropriate doses, especially when dose adjustment according to the patient's body weight is required.
When administering the medicine by subcutaneous injection, the usual injection site is the anterior-lateral abdominal wall, alternating between the right and left side. The thigh may also be used as an alternative injection site.
Detailed instructions for performing subcutaneous injections are provided in the section: "Instructions
for self-administration of subcutaneous injections of Fraxiparine".
Recommended dosage
The dosage is determined individually by the doctor, depending on the indication, clinical condition,
and the 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 doctor may recommend kidney function tests and adjust the dose of Fraxiparine accordingly.
Impaired renal function
The doctor 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 dose higher than recommended is administered, contact your doctor immediately. The main symptom of overdose is bleeding.
Missed dose of Fraxiparine
Continue using the medicine as scheduled 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 treatment with Fraxiparine
Fraxiparine should be used for as long as prescribed by the doctor. Do not stop using Fraxiparine without consulting your doctor.
If the patient wishes to discontinue treatment with Fraxiparine, this should be discussed with the doctor or pharmacist beforehand.
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:

• allergic reaction presenting as: urticaria (bright pink, itchy skin blisters), angioedema (swelling of the face or lips making breathing difficult),
• skin necrosis at the injection site – this is preceded by subcutaneous haemorrhages or hard or painful redness of the skin, with or without accompanying 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 enzymes (aminotransferases), usually transient (visible 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):

• allergic 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 (visible in blood test results),
• increased blood potassium levels,
• 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 the 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 Adverse Drug Reactions of 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 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 of calcium nadroparin in 0.3 ml injection solution
  3,800 IU AXa of calcium nadroparin in 0.4 ml injection solution
  5,700 IU AXa of calcium nadroparin in 0.6 ml injection solution
  7,600 IU AXa of calcium nadroparin in 0.8 ml injection solution
  9,500 IU AXa of calcium nadroparin in 1 ml injection solution
• Other components are: calcium hydroxide solution or diluted hydrochloric acid for pH adjustment, water for injections.

What Fraxiparine looks like and contents of the pack
Fraxiparine is an injection solution. 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 packaged in pre-filled syringes with a needle safety guard to prevent needle-stick injury after administration.
The pack contains 2 or 10 pre-filled syringes with a safety guard, individually blister-packed in a cardboard box.

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 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 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 injecting – this may result in loss of some of the medicine. 5. Gently pinch the previously

cleaned skin to create 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

grip with your fingers.
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 needle with the syringe 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 grip
Picture 5

10. After completing the injection,

slide the protective cap over the syringe to prevent needle-stick injury (Picture 6). Firmly hold the syringe grip with one hand, and with the other hand grasp the outer cap of the syringe and slide it towards the needle. This will unlock the cap. Then slide the cap forward until it locks into place, completely covering the needle. Resistance will be felt during unlocking and locking of the cap.
Picture 6

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

(Picture 7).
Safety cap
Syrine grip
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.