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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Adjust the timing of the dose on Postoperative Day 1 accordingly. With reference to the W. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae. Some studies framin that the risk of bleeding increases with age.

Total 27 8.

Increasing the dose from 2, to 10, IU resulted in an overall increase in anti-Factor Xa AUC that was greater than proportional by about one-third. Cases of anaphylactoid reactions have been reported. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.

DALTEPARIN SODIUM

In the same clinical trial, thrombocytopenia was reported as an framin event in Subscribe to receive email notifications whenever new articles are published. In patients with chronic renal insufficiency requiring hemodialysis, the mean terminal half-life of anti-Factor Xa activity following a single intravenous dose of 5, IU Fragmin was 5.

The mean age of the combined groups was 71 years range 40 to 95 years. Mean peak levels of plasma anti-Factor Xa activity following single subcutaneous doses of 2, 5, and 10, IU were fragmim. When prescribing Fragmin in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including Fragmin multiple-dose vial contains 14 mg of benzyl alcohol per mL and other drugs containing benzyl alcohol.

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A third multi-center, double-blind, randomized study evaluated a postoperative dosing ppi of Fragmin for thromboprophylaxis following total hip replacement surgery. Of the total number of patients in clinical studies of Fragmin, patients were 65 years of age or older and were 75 or fraagmin. The second postoperative dose 2, or 5, IU should occur no sooner than 24 hrs after the fragmih dose. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: Postmarketing surveillance and literature reports have not revealed additional differences in the safety of Fragmin between elderly and younger patients.

A total of 27 8. Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.

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Table 7 summarizes bleeding reactions that occurred in clinical trials which studied Fragmin 2, and 5, IU administered once daily to abdominal surgery patients. Peak anti-Factor Xa activity increased more or less linearly with dose over the same dose range.

These hematomas may result in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as Fragnin, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [ see Boxed Warning and Adverse Reactions 6.

In some cases the hematoma resulted in long-term or permanent paralysis frragmin or complete [ see Boxed Warning ].

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins LMWH or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. It must not be administered by intramuscular injection. Skin necrosis has occurred.

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A study evaluated samples of maternal blood and breast milk in 15 lactating women receiving prophylactic doses of dalteparin in the immediate postpartum period days 4—8 after Cesarean-section. In patients with cancer and symptomatic venous thromboembolism, the recommended dosing of Fragmin is as follows: The molecular weight distribution is:. There are risks to the mother associated with untreated venous thromboembolism VTE in pregnancy, and a potential for adverse effects on the preterm infant when dalteparin is used in pregnancy see Clinical Considerations.

In a trial comparing Fragmin 5, IU once daily to Fragmin 2, IU once daily in patients undergoing surgery for malignancy, the incidence of bleeding reactions was 4. Dalteparin sodium has not been tested for its carcinogenic potential in long-term animal studies.

These results were observed in an analysis of all-randomized and all-treated patients. Treatment for all groups was continued for 4 to 8 days postoperatively, after which time all patients underwent bilateral venography. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [ see Warnings and Precautions 5.

Discard any unused solution after 2 weeks. The incidence of deep vein thrombosis DVTas determined by evaluable venography, was significantly lower for the group treated with Fragmin compared with patients treated with warfarin sodium see Table Secondary Endpoints – 6 day timepoint Death, MI, intravenous heparin, i. Table 2 presents the dosing options for patients undergoing hip replacement surgery.