Fraxiparine

1. What is Fraxiparine and what is it used for

Fraxiparine is a medicine that helps prevent the formation of blood clots in blood vessels or treats existing blood clots. Medicines of this type are called anticoagulants.
The medicine is administered by subcutaneous or intravenous injection.
Indications for use:

• prevention of venous thromboembolic disease in surgery and orthopedic surgery;
• prevention of venous thromboembolic disease in immobilized patients for reasons other than surgery, who have a high risk of thromboembolic complications (e.g. severe chronic obstructive pulmonary disease, heart failure, severe infections, etc.);
• prevention of clotting in the extracorporeal circulation system during hemodialysis;
• treatment of deep vein thrombosis with or without pulmonary embolism;
• treatment of unstable angina and myocardial infarction without Q-wave in combination with acetylsalicylic acid.

2. Important information before using Fraxiparine

When not to use Fraxiparine

Warnings and precautions

During treatment with Fraxiparine, a decrease in platelet count may rarely occur, which can sometimes be severe. During treatment, your doctor will prescribe blood tests to check for this side effect.
Before using Fraxiparine, you should tell your doctor if:

• you have conditions that increase the risk of bleeding, in particular, if:
• you have peptic ulcer disease of the stomach and (or) duodenum,
• you have coagulation disorders,
• you have recently had surgery in the brain, spinal cord, or eye,
• you have high blood pressure;
• you have severe liver dysfunction;
• you have kidney dysfunction;
• you have eye diseases involving blood vessels (vascular disorders of the retina and choroid);
• you are taking other medications that affect blood clotting (see "Fraxiparine and other medications").

In case of bleeding, you should immediately contact your doctor.
In case of skin necrosis, which may be preceded by small subcutaneous hemorrhages or hard or painful redness of the skin, you should immediately stop taking the medicine and contact your doctor.
Using Fraxiparine may cause an increase in potassium levels in the blood. If you have diseases that may cause an increase in potassium levels, such as diabetes, severe kidney disease, or previous metabolic acidosis, or if you are taking other medications that increase potassium levels in the blood, your doctor may prescribe control blood tests. If you are not sure if you are taking such medications, you should ask your doctor.
If you are undergoing spinal or epidural anesthesia, or if cerebrospinal fluid is being drawn, there is a risk of bleeding into the spinal cord at the injection site, which can lead to serious consequences. During such procedures, the patient's condition will be closely monitored to check for worrying symptoms.
If you are elderly (over 65 years old), your doctor may prescribe blood tests before starting treatment with Fraxiparine.
The needle shield of the pre-filled syringe may contain latex [see "The packaging of the medicine contains latex (natural rubber)"].

Fraxiparine and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
It is not recommended to use Fraxiparine with the following medications due to the risk of bleeding. If this cannot be avoided, your doctor will closely monitor your condition. This applies to the following medications:

• acetylsalicylic acid (e.g. aspirin),
• non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, e.g. ibuprofen),
• antiplatelet agents (used to prevent blood clot formation, e.g. clopidogrel).

Fraxiparine should be used with caution with:

• oral anticoagulants (medications that prevent blood clotting, e.g. warfarin),
• glucocorticosteroids (steroid medications used to treat e.g. asthma),
• dextran (a medication administered intravenously to increase blood volume).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Fraxiparine may be used during pregnancy only if your doctor considers that the expected benefits of using the medicine outweigh the possible risks.
It is not known whether the ingredients of Fraxiparine pass into breast milk, so you should not breastfeed during treatment with Fraxiparine.
There is no data on the effect of nadroparin on fertility.

Driving and using machines

There is no data on the effect of Fraxiparine on the ability to drive and use machines.

The packaging of the medicine may contain latex (natural rubber)

The packaging of the medicine (needle shield) may contain latex. This can cause severe allergic reactions.

3. How to use Fraxiparine

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Method of administration
Fraxiparine should be administered by subcutaneous or intravenous injection.
Fraxiparine should not be administered by intramuscular injection.
The pre-filled syringe with graduations facilitates the administration of the correct dose, if it is necessary to adjust the dose to the patient's body weight.
When administering the medicine by subcutaneous injection, the anterior abdominal wall is usually chosen as the injection site, alternating between the right and left sides. Another injection site may be the thigh.

Detailed instructions for self-administering subcutaneous injections of Fraxiparine can be found in the section "Instructions for self-administering subcutaneous injections of Fraxiparine".

Recommended dosage

The dosage is determined by the doctor, individually for each patient, 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.
Patient over 65 years old
These patients may have impaired kidney function. Therefore, the doctor may prescribe kidney function tests and adjust the dose of Fraxiparine accordingly.
Kidney dysfunction
The doctor will adjust the dose of the medicine according to the severity of kidney dysfunction.
Fraxiparine is contraindicated in patients with severe kidney dysfunction.

Using a higher dose of Fraxiparine than recommended

In case of using a higher dose of the medicine than recommended, you should immediately contact your doctor. The main symptom of overdose is bleeding.

Missing a dose of Fraxiparine

You should continue using the medicine without increasing the next dose. Do not shorten the time interval between consecutive doses.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Fraxiparine

Fraxiparine should be used for as long as your doctor recommends. Do not stop using Fraxiparine without consulting your doctor.
If you want to stop using Fraxiparine, you should discuss it with your doctor or pharmacist first.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fraxiparine can cause side effects, although not everybody gets them.
You should immediately stop taking the medicine and contact your doctor if you experience:

• an allergic reactioncharacterized by: hives (light red, itchy blisters on the skin), angioedema (swelling of the face or lips that can make breathing difficult),
• skin necrosis at the injection site -it is preceded by subcutaneous hemorrhages or hard or painful redness of the skin with or without general symptoms.

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

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

Common side effects(may affect up to 1 in 10 people):

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

Rare side effects(may affect up to 1 in 1000 people):

• decrease in platelet count (thrombocytopenia),
• increase in platelet count (thrombocytosis),
• rash, hives, redness, itching of the skin,
• calcification under the skin at the injection site.

Very rare side effects(may affect up to 1 in 10,000 people):

• allergic reactions, including angioedema and skin reactions,
• pseudoanaphylactic reaction (symptoms are similar to anaphylaxis -allergic
• see the beginning of this section),
• skin necrosis,
• increase in eosinophil count (a type of white blood cell) - transient after treatment (visible in blood test results),
• increase in potassium levels in the blood,
• prolonged, painful erection of the penis (priapism) - if this occurs, you should immediately contact your doctor, as you may need to start treatment to avoid serious complications.

Unknown(frequency cannot be determined from available data)

• headache,
• migraine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fraxiparine

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 specified month.
Medicines and syringes should not be disposed of in the sewage system or household waste containers.
Ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Fraxiparine contains

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

What Fraxiparine looks like and what the packaging contains

Fraxiparine is a solution for injection. The pre-filled syringe contains a clear to slightly opalescent, colorless or slightly yellowish or slightly brownish or slightly dark yellow solution. The medicine is packaged in pre-filled syringes with a protective needle shield.
The packaging contains 2 or 10 pre-filled syringes with a protective needle shield, in individual blisters, in a cardboard box.

Marketing authorization 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

Date of last revision of the leaflet: 02/2024

Information for healthcare professionals

Detailed dosage and administration instructions can be found in section 4.2 of the approved Summary of Product Characteristics.

INSTRUCTIONS FOR SELF-ADMINISTERING SUBCUTANEOUS INJECTIONS OF FRAXIPARINE

MEDICINE

• 1. Wash your hands thoroughly with soap and water and dry them with a towel.
• 2. Sit or lie down in a comfortable position. Choose an injection site on the side of your abdomen (Figure 1). Injections should be administered alternately on the left and right sides.

Figure 1

• 3. Clean the injection site with a swab soaked in spirit.
• 4. Remove the needle shield. Discard the needle shield.

Important notes

• Do not touch the needle and do not let it come into contact with other surfaces before injection.
• The presence of a small air bubble in the pre-filled syringe is normal. Do not remove the air bubble before administering the injection - this may lead to loss of some of the medicine.
• 5. Gently grasp the previously cleaned skin with your fingers, creating a skin fold. Hold the skin fold between your thumb and index finger during the entire injection process (Figure 2).

Figure 2

• 6. Hold the pre-filled syringe firmly with your fingers on the handle. Insert the entire length of the needle perpendicularly into the skin fold (Figure 3).

Figure 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 pre-filled syringe from the skin (Figure 4). Do not rub the injection site.

Figure 4

• 9. Appearance of the pre-filled syringe after injection (Figure 5).

Protective needle shield
Pre-filled syringe handle
Figure 5

• 10. After injection, slide the protective needle shield over the pre-filled syringe to protect against needlestick injury (Figure 6). Holding the pre-filled syringe handle firmly with one hand, use the other hand to grasp the outer shield of the pre-filled syringe and slide it towards the needle. The shield will unlock. Then, slide the shield to the position where it will lock, covering the entire needle. During shield release and locking, resistance is felt.

Figure 6

• 11. Appearance of the pre-filled syringe after sliding the protective needle shield (Figure 7).

Protective needle shield
Pre-filled syringe handle
Figure 7

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