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Tell your doctor you are using FRAGMIN® (dalteparin sodium injection) before having
certain spinal procedures (spinal puncture or spinal/epidural anesthesia). Use of this medication
before these procedures may put you at risk of blood clots in or around the spine. This risk is
increased by drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors
such as aspirin, and other drugs that prevent clots, when used together with FRAGMIN®. These
blood clots around the spine may cause paralysis that may be permanent. Discuss the risks and
benefits of treatment with your doctor. Do not use FRAGMIN® (dalteparin sodium injection) and tell your doctor if you have active major bleeding (bleeding into major organs), an increased risk of bleeding, drop in platelet count known as "thrombocytopenia" or history of "heparin-induced thrombocytopenia." FRAGMIN® may cause thrombocytopenia (drop in platelet count). Thrombocytopenia needs to be monitored by a doctor. Do not use FRAGMIN® and tell your doctor if you are allergic or sensitive to the active ingredient called "dalteparin" or "dalteparin sodium," or heparin, or pork products. In certain situations, FRAGMIN® should not be used with a procedure numbing part of your body (known as regional anesthesia). Tell your doctor you are using FRAGMIN® if you are about to have regional anesthesia. This situation can put you at risk for bleeding, even when the recommended dose of FRAGMIN® is used. Tell your doctor immediately if you have any bleeding while using FRAGMIN®. This risk is increased when used with other "blood thinning" medications (eg, aspirin, clopidogrel) or NSAIDs (eg, ibuprofen, ketorolac, naproxen). Tell your doctor if you have any bleeding problems, liver or kidney disease, or eye problems caused by high blood pressure or diabetes. FRAGMIN® should be used with caution in these situations. Tell your doctor if you are or may be pregnant, or if you become pregnant while taking FRAGMIN® (dalteparin sodium injection). FRAGMIN® multiple-dose vials contain a preservative that may harm the fetus. FRAGMIN® must not be injected into the muscle and cannot be substituted with other types of heparins. Allergic reactions (ie, itching, rash, fever, injection site reaction, and blistering) have occurred rarely. A few cases of serious allergic reactions have been reported. Symptoms of a serious allergic reaction include: • hives • swelling of your face, eyelids, lips, tongue, or throat, and trouble swallowing • asthma (wheezing) or other breathing problems such as chest tightness or shortness of breath • shock (loss of blood pressure and consciousness) Get emergency help immediately if you have any of these symptoms. The most common side effects of FRAGMIN® are swelling and bruising at the site of injection. |
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