Fragmin

Leaflet accompanying the packaging: patient information

FRAGMIN

2,500 anti-Xa IU/0.2 mL, solution for injection

FRAGMIN

5,000 anti-Xa IU/0.2 mL, solution for injection

FRAGMIN

7,500 anti-Xa IU/0.3 mL, solution for injection

FRAGMIN

10,000 anti-Xa IU/0.4 mL, solution for injection

FRAGMIN

12,500 anti-Xa IU/0.5 mL, solution for injection

FRAGMIN

15,000 anti-Xa IU/0.6 mL, solution for injection

FRAGMIN

18,000 anti-Xa IU/0.72 mL, solution for injection
Dalteparinum natricum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Fragmin and what is it used for
• 2. Important information before using Fragmin
• 3. How to use Fragmin
• 4. Possible side effects
• 5. How to store Fragmin
• 6. Contents of the packaging and other information

1. What is Fragmin and what is it used for

Fragmin is an anticoagulant medicine, in the form of dalteparin sodium. Dalteparin sodium is a low molecular weight heparin. The anticoagulant effect of dalteparin is related to its ability to enhance the inhibition of factor Xa and thrombin.
Fragmin is indicated for use in adult patients over 18 years of age for:

• Treatment of acute deep vein thrombosis.
• Unstable angina (e.g., rest angina, myocardial infarction without Q-wave).
• Chronic treatment of symptomatic venous thromboembolism (proximal deep vein thrombosis and pulmonary embolism) to reduce the risk of recurrent venous thromboembolism in patients with cancer.
• Prevention of blood clotting in extracorporeal circulation, e.g., during hemodialysis and hemofiltration in acute or chronic renal failure.
• Prophylactic anticoagulation associated with surgical procedures.
• Prophylactic anticoagulation in medically immobilized patients: with congestive heart failure in class III or IV NYHA or acute respiratory failure, with acute infection, with acute rheumatic disease or acute inflammatory bowel disease, and at least one additional risk factor for deep vein thrombosis, e.g., age over 75, obesity, cancer, history of deep vein thrombosis.

Fragmin is indicated for use in children for:

• Treatment of blood clots in the veins (venous thromboembolism (VTE)) in children and adolescents from 1 month of age and older.

2. Important information before using Fragmin

When not to use Fragmin

• If the patient is allergic to dalteparin sodium or other low molecular weight heparins, or unfractionated heparin, or any of the other ingredients of this medicine (listed in section 6);
• Confirmed or suspected heparin-induced thrombocytopenia of immunological origin;
• Active bleeding, e.g., from the gastrointestinal tract or cerebral vessels;
• Severe coagulation disorders;
• Acute or subacute bacterial endocarditis;
• Recent injuries or surgical procedures in the central nervous system, eyes, and/or ears. Due to the increased risk of bleeding, high doses of dalteparin sodium (e.g., those used for the treatment of deep vein thrombosis, pulmonary embolism, or unstable angina) should not be used in patients who have undergone spinal anesthesia or epidural anesthesia, or other procedures that require lumbar puncture.

Warnings and precautions

Before starting treatment with Fragmin, you should discuss it with your doctor or pharmacist.

• In patients before spinal anesthesia (epidural or spinal) or lumbar puncture. Patients receiving anticoagulant medications such as low molecular weight heparins or heparinoids for the prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can cause long-term or permanent paralysis. The risk of such complications is increased in cases where a permanent epidural catheter is inserted for the administration of anesthetics, and in cases where anticoagulant medications that affect hemostasis, such as non-steroidal anti-inflammatory drugs, antiplatelet agents, and other anticoagulant medications, are used concurrently. Traumatic or repeated epidural or spinal puncture also appears to increase this risk. Such patients should be monitored frequently, checking for signs of neurological changes. In patients with:

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are listed according to their frequency.
Frequent(may occur in no more than 1 in 10 people)

• mild, reversible thrombocytopenia (type I)
• bleeding
• transient increase in liver enzyme activity (transaminases, AspAT, AlAT)
• subcutaneous hematoma at the injection site
• pain at the injection site

Infrequent(may occur in no more than 1 in 100 people)

• hypersensitivity

Rare(may occur in no more than 1 in 1,000 people)

• skin necrosis
• transient alopecia

Frequency not known(cannot be estimated from the available data)

• heparin-induced immunological thrombocytopenia (type II, with or without thrombotic complications)
• anaphylactic reactions
• intracranial bleeding (some fatal)
• bleeding into the retroperitoneal space (some fatal)
• rash
• subarachnoid or epidural hematoma

Heparin products can cause hypoaldosteronism (decreased aldosterone secretion - a hormone of the adrenal cortex), which can lead to increased potassium levels in the blood (hyperkalemia). Rarely, especially in patients with chronic renal failure and diabetes, clinically significant hyperkalemia may occur.
In the case of long-term use of Fragmin, there is a risk of osteoporosis.
It is estimated that the side effects in children will be the same as in adults, but there is only limited data on the occurrence of possible side effects during long-term treatment in children.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 representative of the marketing authorization holder or the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fragmin

The medicine should be stored out of sight and reach of children.
The pre-filled syringes should be stored at a temperature below 25°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.
From a microbiological point of view, the medicine should be used immediately. If it is not used immediately, the user is responsible for the storage time and conditions during use.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fragmin contains

• The active substance of the medicine is dalteparin sodium. The potency is expressed in anti-Xa international units (IU) in accordance with the First International Standard for Low Molecular Weight Heparins.
• The other ingredients are:

What Fragmin looks like and what the pack contains

The solution for injection is available in a pre-filled syringe with a needle containing a single dose of the medicine (Type I glass) with a needle shield (rubber), plunger stopper (chlorobutyl rubber), and plunger (polypropylene or polystyrene) with or without a Needle-Trap as a safety device. The needle shield may contain latex.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

2,500 anti-Xa IU/0.2 ml; 5,000 anti-Xa IU/0.2 ml; 7,500 anti-Xa IU/0.3 ml
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs-Sint-Amands
Belgium
Catalent France Limoges S.A.S.
Z.I. Nord, 53 rue de Dion Bouton
87280 Limoges
France
10,000 anti-Xa IU/0.4 ml, 12,500 anti-Xa IU/0.5 ml; 15,000 anti-Xa IU/0.6 ml;
18,000 anti-Xa IU/0.72 ml
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs-Sint-Amands
Belgium
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet: 06/2025

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-fragmin and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
http://www.urpl.gov.pl .