FRAGMIN PI PDF

Samples for anti-Xa level should be drawn 4 hours after administration of Fragmin. Individualize the maintenance dose of Fragmin based on the dose that achieves target anti-Xa level collected 4 hours after administration of Fragmin. Monitor anti-Xa level periodically in pediatric patients to maintain anti-Xa level between 0. Whenever possible, administer benzyl alcohol-free formulations prefilled syringes in pediatric patients [see Warnings and Precautions 5. Target anti-Xa range is 0. When monitoring anti-Xa in these patients, perform sampling 4—6 hours after Fragmin dosing and only after the patient has received 3—4 doses.

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Bacage In patients undergoing abdominal surgery associated with a high risk li thromboembolic complications, such as malignant disorder, the recommended dose of Fragmin is 5, IU subcutaneously the evening before surgery, fragmij once daily postoperatively. 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. Oral absorption of dalteparin is expected to be low, but the clinical implications, if any, of fragmi small amount of anticoagulant activity on a breastfed infant are unknown. Mean peak levels of plasma anti-Factor Xa activity following single subcutaneous doses of 2, 5, and 10, IU were 0. In this trial, unstable angina was defined to include only angina with EKG changes.

Types of tumors were: It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. Of those who underwent surgery, 67 received Fragmin and 69 received heparin. See accompanying prescribing information.

If anticoagulation with Fragmin is needed during pregnancy, use preservative-free formulations; where possible [ see Use in Specific Populations 8. Table 4 lists the dose of Fragmin to be administered once daily for a range of patient weights fragmib months 2—6.

One bleeding event hemoptysis in a patient in the Fragmin arm at Day 71 was fatal. If neurological compromise is noted, urgent treatment is necessary. The mean age of the study population was 69 years range 42 to 87 years and the majority of patients were female In the total enrolled study population of 1, patients, patients were treated; received Fragmin first dose before surgeryreceived Fragmin first dose after surgery and received warfarin sodium.

Instruct patients to report immediately if they experience any of the above signs or symptoms. The pH of both formulations is 5.

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. When prescribing Fragmin in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including Fragmin multiple-dose vial contains 14 mg of benzyl alcohol per mL and other drugs containing benzyl alcohol.

Fragmin — FDA prescribing information, side effects and uses The needle guard will not be activated unless the entire dose has been given. Dalteparin is a low molecular weight heparin with antithrombotic properties.

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

Subscribe rfagmin free Drugs. The mean age of the combined groups was 71 years range 40 to 95 years. 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.

The usual duration of administration is 5 to 10 days. When given at a dose of 5, IU once a day subcutaneously, Fragmin significantly reduced the incidence of thromboembolic reactions including verified DVT by Day 21 see Table Secondary Endpoints — 6 day timepoint Death, MI, intravenous heparin, i. The incidence of the combined endpoint of death, myocardial infarction, or recurrent angina during this 1-week treatment period 5 to 8 days was 9.

Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs NSAIDsplatelet inhibitors, other anticoagulants. Peak anti-Factor Xa activity increased more or less linearly with dose over the same dose range.

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.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Insert the needle into the injection area as instructed above. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. It must not be administered by intramuscular injection.

These studies revealed no evidence of teratogenicity or embryo-fetal toxicity. The incidence of this complication is unknown at present. Limited published data indicate that dalteparin is present in human milk in small amounts see Data.

In a trial comparing Fragmin 5, IU once daily to heparin 5, U twice daily, in the malignancy subgroup the incidence of bleeding reactions was 3. A total of 27 8. Table 8 summarizes major bleeding reactions that occurred in a clinical trial of medical patients pu severely restricted mobility during acute illness.

The prophylactic effect was sustained through Day Longer apparent terminal half-lives 3 to 5 hours are observed following subcutaneous dosing, possibly due to delayed absorption. Related Posts

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Monitor anti-Xa level periodically in pediatric patients to maintain anti-Xa level between 0. Whenever possible, administer benzyl alcohol-free formulations prefilled syringes in pediatric patients [see Warnings and Precautions 5. Target anti-Xa range is 0. It must not be administered by intramuscular injection. FRAGMIN Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing. 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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If any of these symptoms occur the patient should contact his or her physician immediately. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [ see Warnings and Precautions 5. 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. Then, both of these groups began a dosing regimen of Fragmin 5, IU once daily subcutaneous on postoperative day 1. The risk for bleeding varies with the indication and frsgmin increase with higher doses. 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 Of the patients enrolled, were treated and underwent surgery.

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