Most of the difference occurred during the first month of treatment (see Table 16 ).Dalteparin (Fragmin) is a self-injectable drug used to prevent and treat blood clots.These may generally be stopped by slow intravenous injection of protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa IU of FRAGMIN given.Adjust the timing of the dose on Postoperative Day 1 accordingly.
Table 7 summarizes bleeding reactions that occurred in clinical trials which studied FRAGMIN 2,500 and 5,000 IU administered once daily to abdominal surgery patients.
Includes three treated patients who did not undergo a surgical procedure.FRAGMIN should not be mixed with other injections or infusions ( 2 ).If any of these symptoms occur the patient should contact his or her physician immediately.At the end of the six-month study, a total of 46 (13.6%) patients in the FRAGMIN arm and 62 (18.5%) patients in the OAC arm experienced any bleeding event.Alternatively, in patients with malignancy, 2,500 IU of FRAGMIN can be administered subcutaneously 1 to 2 hours before surgery followed by 2,500 IU subcutaneously 12 hours later, and then 5,000 IU once daily postoperatively.
In a double-blind, multi-center, randomized, placebo-controlled clinical trial, general medical patients with severely restricted mobility who were at risk of venous thromboembolism were randomized to receive either FRAGMIN 5,000 IU or placebo subcutaneously once daily during Days 1 to 14 of the study.
The purpose of this study is to test the hypothesis that Fragmin.Subcutaneous administration of doses of 5,000 IU twice daily of FRAGMIN for seven consecutive days to patients undergoing abdominal surgery did not markedly affect APTT, Platelet Factor 4 (PF4), or lipoprotein lipase.Table 5 summarizes major bleeding reactions that occurred with FRAGMIN, heparin, and placebo in clinical trials of unstable angina and non-Q-wave myocardial infarction.The entire length of the needle should be inserted at a 45 to 90 degree angle.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.Doses of FRAGMIN Injection of up to 10,000 anti-Factor Xa IU administered subcutaneously as a single dose or two 5,000 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 (PT), thrombin time (TT) or APTT.
Distributed by Pfizer Labs Division of Pfizer Inc New York, NY 10017.Pictures of Fragmin (Dalteparin), drug imprint information, side effects for the patient.
FRAGMIN administered once daily subcutaneously beginning prior to surgery and continued for 5 to 10 days after surgery, reduced the risk of DVT in patients at risk for thromboembolic complications in two double-blind, randomized, controlled clinical trials performed in patients undergoing major abdominal surgery.Use caution in conditions with increased risk of hemorrhage ( 5.1 ).
The mean age of the combined groups was 71 years (range 40 to 95 years).Fixed dose syringes: To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection.Based on limited published data dalteparin is minimally excreted in human milk.
Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative.