FRAGMIN PI PDF

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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One bleeding event hemoptysis in a patient in the Fragmin arm frgamin Day 71 was fatal. Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during the course of treatment with Fragmin.

The mean ffragmin of the study population was 69 years range 26 to 99 years These patients had an acute medical condition requiring a projected hospital stay of at least 4 days, and were confined to bed during waking hours. A total of 3, patients were enrolled and treated: In a third double-blind, randomized study performed in patients undergoing major abdominal surgery with malignancy, Fragmin 5, IU subcutaneous once daily was compared with Fragmin 2, IU subcutaneous once daily.

In patients with cancer and symptomatic venous thromboembolism, the recommended dosing of Fragmin is as follows: In the total enrolled study population of 1, patients, patients were treated; received Fragmin first dose before surgeryreceived Fragmin first dose after surgery and rragmin warfarin sodium. No additional hemostasis-altering medications should be administered due to the additive effects. 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.

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Subscribe to receive email notifications whenever new articles are published. The mean age of the combined groups was 71 years range 40 to 95 years. The first dose of warfarin sodium was given the evening before surgery, then continued daily at a dose adjusted for INR 2 to 3. No overall differences in effectiveness were observed between these rfagmin and younger subjects. Heparin-induced thrombocytopenia framgin occur with the administration of Fragmin.

Patients should be sitting or lying down and Fragmin administered by deep subcutaneous injection.

In this trial, unstable angina was defined to include only angina with EKG changes. Monitor patients frequently for signs and symptoms of neurological impairment. Even with these additional doses of protamine, the APTT may fragmkn more prolonged than would usually be found following administration of unfractionated heparin.

Discard any unused solution after 2 weeks.

The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [ see Warnings and Precautions 5. Frqgmin following serious adverse reactions are described in more detail in other sections of the prescribing information.

The mean age of the study population was 63 years range 20 to 92 years and the majority of patients were white By clicking Subscribe, I agree to the Drugs.

The mean age of the study population was 68 years range 40 to 90 years and the majority of patients were white Each prefilled syringe also contains Water for Injection pl sodium chloride, when required, to maintain physiologic ionic strength.

DALTEPARIN SODIUM

The benefit was maintained over the 6-month study period. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

In the Fragmin clinical trial of patients with cancer and acute symptomatic venous thromboembolism treated with Fragmin for up to 6 months, asymptomatic increases in transaminase levels, AST and ALT, greater than three times the upper limit of normal of the laboratory reference range were reported in 8. Fragmin Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing.

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Fragmin – FDA prescribing information, side effects and uses

We comply with the HONcode standard for trustworthy health information – verify here. The incidence of deep vein thrombosis DVTas frwgmin by evaluable venography, was significantly lower for the group treated with Fragmin compared with patients treated with warfarin sodium see Table The needle guard will not be activated unless the entire dose has been given.

A third multi-center, double-blind, randomized study evaluated a postoperative dosing regimen of Fragmin for thromboprophylaxis following total hip replacement surgery. If neurological compromise is noted, urgent treatment is necessary. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not accurately reflect the rates observed in practice.

In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of Fragmin is 2, IU administered by subcutaneous injection once daily, starting 1 to 2 hours prior to surgery and repeated once daily postoperatively. Dalteparin sodium has not been tested for its carcinogenic potential in frahmin animal studies.