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 combined groups was 71 years range 40 to 95 years. Hold the syringe assembly by the open sides of the device. Three of the major bleeding reactions that occurred by Day 21 were fatal, all due to gastrointestinal hemorrhage two patients in the group treated with Fragmin and one in the group receiving placebo.

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. Fragmin is also indicated for the prophylaxis of deep vein thrombosis DVTwhich may lead to pulmonary embolism PE:. With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner.

We fraagmin with the HONcode standard for trustworthy health information – verify here. Table 7 summarizes bleeding reactions that occurred in clinical trials which studied Fragmin 2, and 5, IU administered once daily to abdominal surgery patients.

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Use of indwelling epidural catheters Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs NSAIDsplatelet inhibitors, other anticoagulants. Remove the needle shield. The pH of both formulations is 5.

Instructions for using the prefilled single-dose syringes preassembled with needle guard devices. The first postoperative Fragmin thromboprophylaxis dose 2, IU should be administered 6 to 8 hrs postoperatively. A total of 3, patients were enrolled and treated: 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. In patients with chronic renal insufficiency requiring hemodialysis, the mean terminal half-life of anti-Factor Xa activity following a single intravenous dose of 5, IU Fragmin was 5.

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial frsgmin time APTT.

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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 pu the clinical trials of another drug and may not accurately reflect the rates observed in practice.

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.

To view content sources and attributions, please refer to our editorial vragmin. In a double-blind, multi-center, randomized, placebo-controlled clinical trial, general medical patients frwgmin 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.

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Print this page Add to My Med List. In a second single-center, double-blind study of patients undergoing hip replacement surgery, Fragmin 5, IU tragmin daily subcutaneously starting the evening before surgery, was compared with heparin 5, U subcutaneously three times a day, starting the morning of surgery.

The incidence of this complication is unknown at present. However, patients with multiple bleeding episodes that occurred at different time intervals were counted once in each interval in which the event occurred. Medically reviewed on Sep 1, Patients on preoperative Fragmin thromboprophylaxis can be assumed to have altered coagulation. These results were observed in an analysis fragmij all-randomized and all-treated patients.

In the second study, a total of patients were enrolled and treated; received Fragmin and received heparin.

DALTEPARIN SODIUM

Treatment with Fragmin was initiated with a 2, IU dose subcutaneously within 2 hours before surgery, followed by a 2, IU dose subcutaneously the evening of the day of surgery.

Dalteparin sodium has not been tested for its carcinogenic potential in long-term animal studies. If any of these symptoms occur the patient should contact his or her physician immediately. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity.

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.