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 because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet 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 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 due to causes 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 active bleeding or any 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 had 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 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 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 a gastric and/or duodenal ulcer,
  • 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 medicines affecting blood coagulation (see section: "Fraxiparine with other medicines").

In case of bleeding, contact a 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.
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 regular 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 cerebrospinal fluid is withdrawn from the space around the spinal cord (lumbar puncture) 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.
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 such combination 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, e.g. ibuprofen),
• antiplatelet agents (medicines used to prevent blood clots, e.g. clopidogrel).

Fraxiparine should be used with caution with:

• oral anticoagulants (medicines preventing blood clotting, e.g. 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 plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Fraxiparine may be used during pregnancy only if the doctor considers the expected benefits to outweigh the possible risks.
It is unknown whether Fraxiparine passes into human milk; therefore, breastfeeding should not be performed 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, which may cause severe allergic reactions.

3. How to use Fraxiparine

This medicine should always be used as directed by the physician. If in 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.
Prefilled syringes with a graduated scale 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 should 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 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 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 treatment with Fraxiparine
Fraxiparine should be used for as long as directed by the physician. Do not stop using Fraxiparine without consulting your doctor.
If the patient wishes to discontinue treatment with Fraxiparine, this should first be discussed with the 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 everybody 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 (facial or lip swelling 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 enzymes (aminotransferases), usually transient (detected in blood tests).

Uncommon adverse reactions (may affect up to 1 in 1000 patients):

• decrease in platelet count (thrombocytopenia),
• increase in 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,
• increase in eosinophil count (a type of white blood cells) – transient after discontinuation of treatment (detected in blood tests),
• increased potassium levels in blood,
• prolonged, painful penile erection (priapism) – if this occurs, seek urgent medical advice, as treatment may be required to prevent serious complications.

Not known (frequency cannot be estimated from available data):

• headache,
• migraine.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 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 to the marketing authorization holder.
Reporting adverse reactions helps to 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. 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 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 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 packaged in pre-filled syringes with a needle safety shield to prevent needlestick injury after administration.
The pack contains 2 or 10 pre-filled syringes with a safety shield, individually blister-packed in a cardboard carton.

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 Product Characteristics Document.

INSTRUCTIONS FOR SELF-ADMINISTRATION OF SUBCUTANEOUS INJECTIONS OF FRAXIPARINE

1. Wash your hands thoroughly with soap and water, then 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 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 between your fingers to create a skin fold. Hold the skin fold firmly between your thumb and index finger throughout the entire injection (Picture 2).
Picture 2

6. Hold the pre-filled syringe securely 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 and 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 shield
Syringe grip
Picture 5

10. After completing the injection, slide the protective shield over the needle to prevent needlestick injury (Picture 6). Firmly hold the syringe grip with one hand, and with the other hand grasp the outer shield 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 deployment of the safety shield

(Picture 7).
Safety shield
Syringe grip
Picture 7

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