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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These results were observed in an analysis of all-randomized and all-treated patients. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months [ see Clinical Studies The primary efficacy endpoint was evaluated at Day 21 and was defined as at least one of the following within Days 1 to 21 of the study: Each multiple-dose vial contains either 10, or 25, anti-Factor Xa IU per 1 mL equivalent to 64 or mg dalteparin sodium, respectivelyfor a total of 95, anti-Factor Xa IU per vial.

To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. The mean age of the study population was 69 years range 42 to 87 years and the majority of patients were female Instruct patients to report immediately if they experience any of the above signs or symptoms.

Doses of Fragmin Injection of up to 10, anti-Factor Xa IU administered subcutaneously as a single dose or two 5, IU doses 12 hours apart to healthy subjects did not produce a significant change in platelet aggregation, fibrinolysis, or global clotting tests such as prothrombin time PTthrombin time TT or APTT. Depress the plunger of the syringe while holding the finger flange until the entire dose has been given.

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Treatment should be continued until fragminn patient is clinically stabilized. Subcutaneous administration of doses of 5, IU twice daily of Fragmin for seven consecutive days to patients undergoing abdominal surgery did not markedly affect APTT, Platelet Factor 4 PF4or lipoprotein lipase.

In the first study, a total of patients were enrolled and treated; received Fragmin and received placebo.

DALTEPARIN SODIUM

Because animal reproduction studies ;i not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Treatment in both groups was continued for up to 9 days postoperatively. In clinical trials, the usual duration of administration was 12 to 14 days. Available for Android and iOS devices. It must not be administered by intramuscular injection.

Pharmaceutical Benefits Scheme (PBS) |

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. Discontinue their use prior to dalteparin therapy whenever possible; if co-administration is essential, the patient’s clinical frag,in laboratory status should be closely monitored [ see Drug Interactions 7 ].

In the same clinical trial, thrombocytopenia was reported as an adverse event in Skin necrosis has occurred. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

One bleeding event hemoptysis in a patient in the Fragmin arm at Day 71 was fatal. Fragmon and efficacy beyond six months have not been evaluated in patients with cancer and acute symptomatic VTE [ see Warnings and Precaution 5 and Adverse Reactions 6.

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The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [ see Use in Specific Populations 8.

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. 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 fargmin Monitor patients frequently for signs and symptoms of neurological impairment.

The rragmin was maintained over the 6-month study period.

Alternatively, in patients with malignancy, 2, IU of Fragmin can be administered subcutaneously 1 to 2 hours before surgery followed by 2, IU subcutaneously 12 hours later, and then 5, IU once daily postoperatively. Total 27 8. All patients, except when contraindicated, were treated concurrently with aspirin to mg per day. A third multi-center, double-blind, randomized study evaluated a postoperative dosing regimen of Fragmin for thromboprophylaxis following total hip replacement surgery.

Heparin-induced thrombocytopenia can occur with the administration of Fragmin. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Longer apparent terminal half-lives 3 to 5 hours are observed following subcutaneous dosing, possibly due to delayed absorption. The mean age of the combined groups was 71 years range 40 to 95 years.