FRAGMIN PI PDF

Fragmin (dalteparin sodium) is used to prevent blood clots forming in blood vessels. It is used in different conditions such as deep vein thrombosis, unstable . dalteparin sodium 10 anti-Xa units/mL injection, 10 x 1 mL syringes (PI, CMI), 2, 20, 3 dalteparin sodium 12 anti-Xa units/ mL injection, 10 x mL. To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

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Three of the major bleeding reactions that occurred by Day 21 were fatal, all due to gastrointestinal hemorrhage two patients in the group treated with Fragmin and one in the group receiving placebo. Instructions for using the prefilled single-dose syringes preassembled with needle guard devices. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months [ see Clinical Studies With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner.

When administered at recommended prophylaxis doses, routine coagulation tests such as Prothrombin Time PT and Activated Partial Thromboplastin Time APTT are relatively insensitive measures of Fragmin activity and, therefore, unsuitable for monitoring the anticoagulant effect of Fragmin.

In a trial comparing Fragmin 5, IU once daily to heparin 5, U twice daily, in the malignancy subgroup the incidence of bleeding reactions was 3.

TGA eBS – Product and Consumer Medicine Information

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Of the total number of patients in clinical studies of Fragmin, patients were 65 years of age or older and were 75 or older.

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When monitoring anti-Xa in these patients, perform sampling 4—6 hrs after Fragmin dosing and only after the patient has received 3—4 doses. No oi hemostasis-altering medications should be administered due to the additive effects.

A total of 3, patients were enrolled and treated: Dalteparin sodium has not been tested for its carcinogenic potential in long-term animal studies.

Both dosing regimens of Fragmin were more effective than warfarin sodium in reducing the incidence of thromboembolic reactions following hip replacement surgery. It must not be administered by intramuscular injection. In fragmni patients with severely restricted mobility during acute illness, the recommended dose of Fragmin is 5, IU administered by subcutaneous injection once daily. Use Fragmin with extreme feagmin in patients who have an increased risk of hemorrhage, such as those with severe uncontrolled hypertension, bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal or ophthalmological surgery.

One group of patients received the first dose of Fragmin 2, IU subcutaneous within 2 hours before surgery, framgin by another dose of Fragmin 2, IU subcutaneous at least 4 hours 6. Available data from published literature and postmarketing reports have not reported a clear association with dalteparin and adverse developmental outcomes.

The follow-up extended through Day The entire length of the frafmin should be inserted at a 45 to 90 degree angle. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin.

In this trial, ;i angina was defined to include only angina with EKG changes. However, patients with multiple bleeding episodes that occurred at different time intervals were counted once in each interval in which the event occurred.

DALTEPARIN SODIUM

A history of traumatic or repeated epidural or spinal punctures A history of spinal deformity or spinal surgery Optimal timing between the administration of Fragmin and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment.

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Inspect Fragmin prefilled syringes and vials visually for particulate matter and discoloration prior to administration.

These studies revealed no evidence of teratogenicity or embryo-fetal toxicity. In an open-label randomized study, Fragmin 5, IU administered once daily subcutaneously was compared with warfarin sodium, administered orally, in patients undergoing hip replacement surgery.

Fragmin – FDA prescribing information, side effects and uses

These hematomas may result in long-term or permanent paralysis. Total 27 8. Primary Endpoints – 6 day timepoint Death, MI. Fragmin is administered by subcutaneous injection. Available for Android and iOS devices.

The benefit was maintained over the 6-month study period. The combined incidence of the endpoint of death or myocardial infarction was lower for Fragmin compared with placebo at 6 days after initiation of therapy. The most commonly reported adverse reactions are hematoma at the injection site and hemorrhagic complications.

An excessive dosage of Fragmin Injection may lead to hemorrhagic complications. Monitor patients frequently for signs and symptoms of neurological impairment. In the second study, a total of patients were enrolled and treated; received Fragmin and received heparin.

Skin necrosis has occurred. The mean age of the study population was 64 years range 40 to 98 years and the majority of patients were female Patients on preoperative Fragmin thromboprophylaxis can be assumed to have altered coagulation.