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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Dalteparin is a low molecular weight heparin with antithrombotic properties. The injection site should be varied daily. FDA alerts for all medications. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, give protamine sulfate only when resuscitation techniques and treatment for anaphylactic shock are readily available. Table 2 presents the dosing options for patients undergoing hip vragmin surgery.
Instructions for using the prefilled single-dose syringes preassembled with needle guard devices. See accompanying prescribing information. Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. 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.
The incidence of deep vein thrombosis DVTas determined by evaluable venography, was significantly lower for the group treated with Fragmin compared with patients treated with warfarin sodium see Table Use Fragmin with extreme caution in patients who have an increased risk of 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.
It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials.
Table 4 lists the dose of Fragmin to be administered once daily for a range of patient weights during months 2—6. Of the patients enrolled, were treated and underwent surgery. Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins LMWH or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture.
Treatment in both groups was then continued for 5 to 9 days postoperatively. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be ip for thromboprophylaxis [ see Warnings and Precautions 5.
Then, both of these groups began a dosing regimen of Fragmin 5, IU once daily subcutaneous on postoperative day 1. Primary Endpoints – 6 ppi timepoint Death, MI. If neurological compromise is noted, urgent treatment is necessary.
Fragmin – FDA prescribing information, side effects and uses
Of the total number of patients in clinical studies of Fragmin, patients were 65 years of age or older and were 75 or older. Treatment was continued for 6 to 8 days.
In a trial comparing Fragmin 5, IU once daily to Fragmin 2, IU once daily in patients undergoing surgery for malignancy, the incidence of bleeding reactions was 4. Treatment for all groups was continued for 4 fragkin 8 days postoperatively, after which time all patients underwent bilateral venography. Frxgmin mean age of the study population was 63 years range 20 to 92 years and the majority of patients were white Fragmin administered once daily subcutaneously beginning prior to frgamin 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.
Skin necrosis has occurred. 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.
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It must not be administered by intramuscular injection. Factors that can increase the risk of developing epidural fraymin spinal hematomas in these patients include: The first dose of warfarin sodium was given the evening before surgery, then continued daily at a dose adjusted for INR 2 to 3.
Target anti-Xa range is 0. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.
The mean age of the study population was 68 years range 40 to 90 years and the majority of patients were white The mean age of the combined groups was 71 years range 40 to 95 years.
The corresponding mean disposition half-lives were 1. Both dosing regimens of Fragmin were more effective than warfarin sodium in reducing the incidence of thromboembolic reactions following hip replacement surgery.
The entire length of the needle should be inserted at a 45 to 90 degree angle. In a double-blind, multi-center, randomized, placebo-controlled clinical trial, general medical patients with severely restricted mobility who were at fragmon of venous thromboembolism were randomized to receive either Fragmin 5, IU or placebo subcutaneously once daily during Days 1 to 14 of the study.
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: Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of dalteparin is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.