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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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.

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Fragmin is also indicated for the prophylaxis of deep vein thrombosis DVTwhich may lead to pulmonary frahmin PE:. A third multi-center, double-blind, randomized study evaluated a postoperative dosing regimen of Fragmin for thromboprophylaxis following total hip replacement surgery. Limited published data indicate that dalteparin is present in human milk in small amounts see Data. Pl the area around the navel or the thigh is used, using the thumb and forefinger, you must lift up a fold of skin while giving the injection.

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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. Of the 1, patients enrolled, 1, patients were treated; received Fragmin and received heparin. FDA alerts for all medications. In this trial, unstable angina was defined to include only angina with EKG changes. Table 3 lists the dose of Fragmin to be administered once daily during the first month for a range of patient weights. The following serious adverse reactions are described in more detail in other sections of the prescribing information.

The prophylactic effect was frwgmin through Day In an open-label randomized study, Fragmin 5, IU administered once daily fragmmin was compared with warfarin sodium, administered orally, in patients undergoing hip replacement surgery. Fragmin is administered by subcutaneous injection. Mean peak levels of plasma anti-Factor Xa activity following single subcutaneous doses of 2, 5, and 10, IU were 0. The first dose of warfarin sodium was given the evening before surgery, then continued daily at a dose adjusted for INR 2 to 3.

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The usual duration of administration is 5 to 8 days. Remove the needle shield.

In patients undergoing abdominal surgery with a risk of fdagmin complications, the recommended dose of Fragmin is 2, IU fragmjn by subcutaneous injection once daily, starting 1 to 2 hours prior fravmin surgery and repeated once daily postoperatively. No overall differences in effectiveness were observed between these subjects and younger frqgmin. It must not be administered by intramuscular injection. Fragmin 5, IU once daily was more effective than Fragmin 2, IU once daily in reducing the risk of DVT in patients undergoing abdominal surgery with malignancy see Table 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.

Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Patients on preoperative Fragmin thromboprophylaxis can be assumed to have altered coagulation. Safety 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.

DALTEPARIN SODIUM

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [ see Warnings and Precautions 5. To view content sources and attributions, please refer to our editorial policy. Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs NSAIDsplatelet inhibitors, other anticoagulants. Both dosing regimens of Fragmin were more effective than warfarin sodium in reducing fragimn incidence of thromboembolic reactions following hip replacement surgery.

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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.

Patients received either Fragmin or warfarin sodium, randomized into one of three treatment groups. 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 known Monitor patients frequently for signs and symptoms of neurological impairment.

In the rragmin clinical trial, thrombocytopenia was reported as an adverse event in See accompanying prescribing information. Postmarketing surveillance and literature reports have not revealed additional differences in the safety of Fragmin between elderly and younger patients. Depress the plunger of the syringe while holding the finger flange until the frgmin dose remaining in the syringe has been frxgmin. We comply with the HONcode standard for trustworthy health information – verify here.

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. Minor bleeding was classified as clinically overt bleeding that did not meet criteria for major bleeding. Because benzyl alcohol may cross the placenta, use caution when administering Fragmin preserved with benzyl alcohol to pregnant women. Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during the course of treatment with Fragmin.

Closely monitor thrombocytopenia of any degree.

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 fragmjn once daily.

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