FRAGMIN Safety Information

FRAGMIN (dalteparin sodium injection) is used to: prevent blood clotting (coagulation) when surgery is performed; treat the acute formation of blood clots in deep veins; treat symptomatic blood clots to prevent recurrence of the clots in patients with cancer; treat unstable coronary artery disease; prevent clotting in those at risk when mobility is restricted during acute illness; and prevent clotting in blood dialysis and filtration equipment in connection with acute kidney failure or chronic kidney disease.

When FRAGMIN should not be used. If you have had or currently suffer from any of the following conditions, it is necessary that you inform your doctor before starting treatment: allergy to FRAGMIN or any of its constituents or to other low molecular weight heparins (LMWHs) and/or heparin; bleeding due to acute gastroduodenal ulcer (stomach or intestinal bleed/ulcer); a history of cerebral hemorrhage (bleeding in or against the brain); a severe blood clotting disorder (hemorrhagic diathesis); a history of thrombocytopenia (decrease in the number of platelets); bacterial infection of the heart (septic endocarditis); high blood pressure; disorders of the retina of the eye due to diabetes or bleeding; injuries to and/or operations on the central nervous system, eyes or ears; or any other diseases that could involve an increased risk of bleeding.

Because benzyl alcohol may cross the placenta, FRAGMIN 25 000 IU 3.8 mL multi-dose vials, which are preserved with benzyl alcohol, should not be used in pregnant women. Benzyl alcohol preparations should be used with caution in pediatric patients.

BEFORE you use FRAGMIN talk to your doctor or pharmacist if you have had or currently have: artificial heart valves; heart disease, including angina and recent heart attack; if you take any medications (such as acetylsalicylic acid [ASA], other drugs to reduce blood clotting such as warfarin or nonsteroidal anti-inflammatory drugs [NSAIDS] to treat painful and/or inflammatory conditions of muscles or joints), including those that you buy without a prescription; bleeding disorders (such as hemophilia); liver or kidney problems; hypersensitivity to latex (natural rubber). If you are pregnant or breastfeeding, tell your doctor so the possible risks to you and your child can be assessed.

Certain medications may intensify the anticoagulant effect (e.g., blood thinning effect) of FRAGMIN. It is important for you to tell your doctor about any medications you are taking.

Follow the instructions of your doctor or nurse carefully. Give yourself the injections prescribed for the entire time period specified by your doctor. Do not take any drugs other than those prescribed by your doctor while you are taking FRAGMIN. FRAGMIN is administered as an injection underneath the surface of the skin (subcutaneously) and should not be administered intramuscularly. If you need to consult with another doctor or see your dentist, tell them that you are being treated with FRAGMIN.

FRAGMIN should be inspected visually for clarity, particulate matter, precipitation, discolouration and leakage prior to administration. Do not use the product if the mixture (solution) shows haziness, particulate matter, discolouration or leakage. Store your prefilled syringes at room temperature (15-30ºC).

Common side effects of FRAGMIN

The most common side effects are pain and bruising at the injection site. Talk to your doctor or pharmacist if you experience purplish or reddish discolouration or pain, and bruising around the injection site.

Stop taking FRAGMIN and contact your doctor if you experience:

  • Severe discolouration, pain or bruising around the injection site
  • Bruising without apparent cause
  • Nosebleed
  • Bleeding from the mouth, gums, abdomen, anus or vagina
  • Bleeding at the injection site or from a surgical site
  • Allergic reactions
  • Blood in the urine
  • A stroke (bleeding inside the brain).

For any unexpected effects while taking FRAGMIN, contact your doctor or pharmacist immediately.