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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Use Fragmin with extreme caution in patients who have an increased risk fratmin 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.

TGA eBS – Product and Consumer Medicine Information

If anticoagulation with Fragmin is needed during pregnancy, use preservative-free formulations; where possible [ see Use in Specific Populations 8. Treatment in both groups was then continued for 5 to 9 days postoperatively.

Of the total number of patients in clinical studies of Fragmin, patients were 65 years of age or older and were 75 or rfagmin.

All patients, except when contraindicated, were treated concurrently with aspirin 75 mg once daily and beta blockers. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity. In the same clinical trial, thrombocytopenia was reported as an adverse event in 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 NSAIDs, with traumatic or repeated frzgmin or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [ see Boxed Warning and Adverse Reactions 6.

Hold the syringe assembly by the open sides of the device. Adjust the timing of the dose on Postoperative Day 1 accordingly. Table 8 summarizes major bleeding reactions that occurred in a clinical trial of medical patients with severely restricted mobility during acute illness. Patients on preoperative Fragmin thromboprophylaxis can be assumed to have altered coagulation. The mean age of the study population was 63 years range 18 fragminn 91 years and the majority of patients were white Because clinical trials are conducted under widely varying conditions, adverse reaction rates fragmih in the clinical trials of a drug cannot be directly compared to rates in the fragjin trials of another drug and may not accurately reflect the rates observed in practice.

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DALTEPARIN SODIUM

Of the patients enrolled, were treated and underwent surgery. The prefilled syringes are preservative-free.

A total of 1, patients were enrolled and treated; received Fragmin 5, IU and received 2, IU. Oral absorption of dalteparin is expected to be low, but the clinical implications, if any, of this small amount of anticoagulant activity on a breastfed infant are unknown. Then, a dosing regimen of Fragmin 5, IU subcutaneously once daily was initiated on the first postoperative day.

Because this study evaluated colostrum or transitional milk at a single timepoint during the hour dosing interval, the clinical relevance of this data is unclear in frabmin to passage of drug into mature milk and the quantification of drug exposure to the infant over the full dosing interval.

Remove needle from the patient. Peak anti-Factor Xa activity increased more or less linearly with dose over the same dose range.

The combined incidence of death, MI, need for intravenous heparin or intravenous. The following serious adverse reactions are described ppi more detail in other sections of the prescribing information.

Print this page Add to My Med List. Patients were evaluated for recurrence of symptomatic venous thromboembolism VTE every two fratmin for six months. All patients, except when contraindicated, were treated concurrently with aspirin to mg per day.

Of those who underwent surgery, 67 received Fragmin and 69 received heparin. Fragmin Injection dalteparin sodium injection is a sterile, low molecular weight heparin.

Instructions for using the prefilled single-dose syringes preassembled with needle guard devices. 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 Most of the difference occurred during the first month of treatment see Table No overall differences in effectiveness were observed between these subjects and younger subjects.

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Take particular care to avoid overdosage with protamine sulfate. Inspect Fragmin prefilled syringes and vials visually for particulate matter and discoloration prior to administration. In a second single-center, double-blind study of patients undergoing hip replacement surgery, Fragmin 5, IU once daily subcutaneously starting the evening before surgery, was compared with heparin 5, U subcutaneously three times a day, starting the morning of surgery.

Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. Fragmin is also indicated for the prophylaxis of deep vein thrombosis DVTwhich may lead to pulmonary embolism PE:. 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.

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. The majority of patients had postoperative indwelling epidural catheters placed for analgesia or received additional drugs affecting hemostasis.

There are no data on the effects of the drug on milk production. 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.