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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The mean age of the study population was 64 years range 25 to 92 years and the majority of patients were white Discard the syringe assembly in approved containers. The following adverse reactions have been identified during postapproval use of Fragmin.

It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. Inspect Fragmin prefilled syringes and vials visually for particulate matter and discoloration prior to administration. The most commonly reported adverse reactions are hematoma at the injection site and hemorrhagic complications. The total daily dose should not exceed 18, IU.

Serious adverse reactions including fatal reactions and the “gasping syndrome’ occurred in premature neonates and low-birth weight infants in the neonatal intensive care unit who received benzyl alcohol preserved medications. The entire length of the needle should be inserted at a 45 to 90 degree angle. No overall differences in effectiveness were observed between these subjects and younger subjects. Print this page Add to My Med List.

The usual duration of administration is 5 to 10 days after surgery; up to 14 days of treatment with Fragmin have been well tolerated in clinical trials. 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.

The injection site should be varied daily. Of the 1, patients enrolled, 1, patients were treated; received Fragmin and received heparin.

TGA eBS – Product and Consumer Medicine Information

In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of Fragmin is 2, IU administered by fratmin injection once daily, starting 1 to 2 hours prior to surgery and repeated once daily postoperatively.

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Fragmn of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. In the second study, a total of patients were enrolled and treated; received Fragmin and received heparin.

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. Subscribe to free Drugs. Po these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months [ see Clinical Studies Types of tumors were: Table 4 lists the dose of Fragmin to be administered once daily for a range of patient weights during months 2—6.

Fragmin – FDA prescribing information, side effects and uses

The first postoperative Fragmin thromboprophylaxis dose 2, IU should be administered 6 to 8 hrs postoperatively. Concurrent aspirin therapy is recommended except when contraindicated. It must not be administered by intramuscular injection. The usual duration of administration is 5 to 10 days.

If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet dragmin, or other anticoagulants, inform the patients to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness especially in the lower limbs and muscular weakness.

When monitoring anti-Xa in these patients, perform sampling 4—6 hrs after Fragmin dosing and only after the patient has received 3—4 doses. 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: Fragmin Injection dalteparin sodium injection is a sterile, low molecular weight heparin.

It was not mutagenic in the in vitro Ames Test, mouse lymphoma cell forward mutation test and human lymphocyte chromosomal aberration test and in the in vivo mouse micronucleus test. Another group received the first dose of Fragmin 2, IU subcutaneous at least 4 hours 6. The third group of patients received warfarin sodium the evening of the day of surgery, then continued daily at a dose adjusted to maintain INR 2 to 3.

The first dose of warfarin sodium was given the evening before surgery, then continued daily at a dose adjusted for INR 2 to 3. Discontinue their use prior fratmin dalteparin therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored [ see Drug Interactions 7 ].

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Hold the syringe assembly by the open frgamin of the device. The combined incidence of the endpoint of death or myocardial infarction was lower for Fragmin compared with placebo at 6 days after initiation of therapy. The second postoperative dose 2, or 5, IU should occur no sooner than 24 hrs after the first dose.

Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided. Fragmin fragmln 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. One group of patients received the first dose of Fragmin 2, IU subcutaneous within 2 hours before surgery, followed by another dose of Fragmin 2, IU subcutaneous at least 4 hours 6.

DALTEPARIN SODIUM

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. 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.

Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. 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, IU or placebo subcutaneously once daily during Days 1 to 14 of the study.

In the same clinical trial, thrombocytopenia was reported as an adverse event in Table 7 summarizes bleeding reactions that occurred in clinical trials which studied Fragmin 2, and 5, IU administered once daily to abdominal surgery patients.

Abdominal surgery patients at risk include those who are over ftagmin years of age, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes, or who have additional risk factors such as malignancy or a history of deep vein thrombosis or pulmonary embolism.