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 ingredients or container (including benzyl alcohol when using the 25,000 IU multi-dose vial) or to other low molecular weight heparins (LMWHs) and/or heparin or pork products; 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 confirmed or suspected low platelet count (thrombocytopenia) due to heparin, or a positive antiplatelet antibody test in the presence of Fragmin or other heparin or low molecular weight heparin products; bacterial infection of the heart (septic endocarditis); severe uncontrolled 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. Spinal or epidural anesthesia should not be used while receiving repeated high doses of Fragmin.

BEFORE you take FRAGMIN talk to your healthcare professional about any health conditions or problems you may have, including if you: have artificial heart valves; have heart disease, including angina and recent heart attack; are taking 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; have bleeding disorders (such as hemophilia); have low platelets (thrombocytopenia) or platelet defects; have liver or kidney problems; have diabetes, metabolic acidosis, increased potassium, or taking potassium sparing drugs, due to the risk for high levels of potassium; are allergic to latex (natural rubber); are at higher risk of bleeding (including elderly patients, patients with kidney problems or who are underweight or overweight or children); are pregnant or breastfeeding.

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 healthcare professional 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).