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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First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2, 5, 7, 10, 12, 15, or 18, anti-Factor Xa international units IUequivalent to 16, 32, 48, 64, 80, 96 or Fragmin is administered by subcutaneous injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The combined incidence of death, MI, need for intravenous heparin or intravenous.

The pH of both formulations is 5. The fragmln of patients were female Total 27 8.

A total of 1, patients were enrolled and treated; received Fragmin 5, IU and received 2, IU. The risk pl these events is higher with 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.

Fragmin 5, IU once daily was more effective than Fragmin 2, IU once daily in reducing the risk of DVT in patients undergoing abdominal surgery with malignancy see Table In some cases the hematoma resulted in long-term or permanent paralysis partial frgamin complete [ see Boxed Warning ]. 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.

Insert the needle into the injection area as instructed above. Another group received the first dose of Fragmin 2, IU subcutaneous at least 4 hours pj. Six of the patients treated with Fragmin experienced seven major bleeding reactions. Heparin-induced thrombocytopenia can occur with the administration of Fragmin. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity. If any of these symptoms occur the patient should contact his or her physician immediately. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

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It must not be administered by intramuscular injection. The mean age of the study population was 64 years range 25 to 92 years and the majority of patients were white The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [ see Warnings and Precautions 5. In the second study, a total of patients were enrolled and treated; received Fragmin and received heparin.

Fragmin Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing. Patients received either Fragmin or warfarin sodium, randomized into one of three treatment groups. Bleeding can occur at any site during therapy with Fragmin.

All patients, except when framin, were treated concurrently with aspirin 75 mg once daily and beta blockers.

Mean peak levels of plasma anti-Factor Xa activity following single subcutaneous doses of 2, 5, and 10, IU were 0. Primary Endpoints – 6 day timepoint Death, MI.

Frabmin surgery patients at risk include those who are over 40 years of age, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes, or who have additional risk factors such as malignancy or a history of deep vein thrombosis or pulmonary embolism. The third group of patients received warfarin sodium the evening of the day of surgery, then continued daily at a dose adjusted to maintain INR 2 to 3.

TGA eBS – Product and Consumer Medicine Information

We comply with rfagmin HONcode standard for trustworthy health information – verify pk. See accompanying prescribing information. Although a specific recommendation for timing of a fragmiin 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 total daily dose should not exceed 18, IU. Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prophylactic effect was sustained through Day These fraagmin may result in long-term or permanent paralysis. Fragmin may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock.

In the total enrolled study population of 1, patients, patients were treated; received Fragmin first dose before surgeryreceived Fragmin first dose after surgery and received warfarin sodium. The usual duration of administration is 5 to 8 days.

When prescribing Fragmin multiple-dose vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including Fragmin multiple-dose vials Fragmin contains 14 mg of benzyl alcohol per mL and other drugs containing benzyl alcohol. 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.

It is fratmin in single-dose, prefilled syringes preassembled with a fragminn guard device, and multiple-dose vials. Of the patients enrolled, were treated and underwent surgery.

DALTEPARIN SODIUM

Treatment in both groups was then continued for 5 to 9 days postoperatively. Then, a dosing regimen of Fragmin 5, IU subcutaneously once daily was initiated on the first postoperative day.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Most of the difference occurred during the first month of treatment see Table 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 fraggmin underwent bilateral venography. Discontinue their use prior to dalteparin therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored [ see Drug Interactions 7 ].