FRAGMIN PI PDF

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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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A third multi-center, double-blind, randomized study evaluated a postoperative dosing regimen of Fragmin for thromboprophylaxis following total hip replacement surgery.

The prefilled syringes are preservative-free. The risk for bleeding varies with the indication and may increase with higher doses.

A total of 27 8. Anti-Factor Xa may be used to monitor the anticoagulant effect of Fragmin, such as in patients with severe renal impairment or if abnormal coagulation fagmin or bleeding occurs during Fragmin therapy. In clinical trials, the usual duration of administration was 12 to 14 days. The total daily dose should not exceed 18, IU.

TGA eBS – Product and Consumer Medicine Information

Skin necrosis has occurred. The prophylactic effect was sustained through Day The majority of patients were female The risk of these events is higher frgmin the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, 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.

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The first dose of warfarin sodium was given the evening before surgery, then continued daily at a dose adjusted for INR 2 to 3. 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. Discard the syringe assembly in approved containers.

DALTEPARIN SODIUM

Treatment was continued for 6 to 8 days. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin fragimn APTT. With reference to the W.

When given at a dose of 5, IU once a day subcutaneously, Fragmin significantly reduced the incidence of thromboembolic reactions including verified DVT by Day 21 see Table 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. No additional hemostasis-altering medications should be administered due to the additive effects.

Mean peak levels of plasma anti-Factor Frag,in activity following single subcutaneous doses of 2, 5, and fdagmin, IU were 0.

The following adverse reactions have been identified during postapproval use of Fragmin. 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. No overall differences in effectiveness were observed between these subjects and younger subjects. Although a specific recommendation for timing of a subsequent Fragmin dose after catheter removal cannot be made, consider delaying this next dose for at least four hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

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The corresponding mean disposition half-lives were 1. If the APTT measured 2 to 4 hours after the first infusion remains prolonged, a second infusion of 0.

The molecular weight distribution is:. Published data describe that women with a previous history of VTE in pregnancy are at higher risk for recurrence during subsequent pregnancies compared to those with no risk factor for VTE 4.

Fragmin – FDA prescribing information, side effects and uses

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. It was not mutagenic in the in vitro Ames Test, mouse lymphoma cell forward mutation test and human lymphocyte chromosomal aberration test and in the in vivo mouse micronucleus test.

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. The follow-up extended through Day Postmarketing surveillance and literature reports have not revealed additional differences in the safety of Fragmin between elderly and younger patients.

fragmni All patients, except when contraindicated, were treated concurrently with aspirin to mg per day. These results were observed in an analysis of all-randomized and all-treated patients.