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 samples were collected before and 3—4 hours after daily injections of IU dalteparin. The mean age of the study population was 68 years range 40 to 90 years and the majority of patients were white Remove the needle shield.
To view content sources and attributions, please refer to our editorial policy. Abdominal surgery patients at risk include those who are over 40 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.
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An excessive dosage of Fragmin Injection may lead to hemorrhagic complications. 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 fragmib in two double-blind, randomized, controlled clinical trials performed in patients undergoing major abdominal surgery.
The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [ see Warnings and Precautions 5. 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.
The median age of patients was 64 years range: The first dose of warfarin sodium was given the evening before surgery, then continued daily at a dose adjusted for INR 2 to 3. Treatment with Fragmin was initiated with a 2, IU dose subcutaneously within 2 hours before surgery, followed by a 2, IU fragmmin subcutaneously the evening of the day of surgery.
If the APTT measured 2 to 4 hours after the first infusion feagmin prolonged, a second infusion of 0. Increasing the dose from 2, to 10, IU resulted in an overall increase in anti-Factor Xa AUC that was greater than proportional by about one-third. The prefilled syringes are preservative-free.
A total of 3, patients were enrolled and treated: Oral frafmin 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. In clinical trials, the usual duration of administration was 12 to 14 feagmin.
The risk for bleeding varies with the indication and may increase with higher doses. Subcutaneous administration of doses of 5, IU twice daily of Fragmin for seven consecutive days to patients undergoing abdominal surgery did not markedly affect APTT, Platelet Factor 4 PF4or lipoprotein lipase. In patients undergoing abdominal surgery with a risk of p complications, the recommended dose of Fragmin is 2, IU administered by subcutaneous injection once daily, starting 1 to 2 hours prior to surgery and repeated once daily postoperatively.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.
Patients on preoperative Fragmin thromboprophylaxis can be assumed to have altered coagulation. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.
In patients with cancer and symptomatic venous thromboembolism, the recommended dosing of Fragmin is as follows: The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [ see Use in Specific Populations 8. 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. In patients undergoing abdominal surgery associated with a high risk of thromboembolic complications, such as malignant disorder, the recommended dose of Fragmin is 5, IU subcutaneously the evening before surgery, then once daily postoperatively.
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Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low-birth weight infants treated with medications that contain the preservative benzyl alcohol. Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Discard any unused solution after 2 weeks. The molecular weight distribution is:.
In the second study, frgmin total of patients were enrolled and treated; received Fragmin and received heparin.
Target anti-Xa range is 0. The majority of patients had postoperative indwelling epidural catheters placed for analgesia or received additional drugs affecting hemostasis.
Consider these risks when scheduling patients for spinal procedures. A total of patients were enrolled and treated; received Fragmin and received placebo. In a second single-center, double-blind study of patients undergoing hip replacement surgery, Fragmin 5, IU once daily subcutaneously starting the evening before surgery, was compared with heparin 5, U subcutaneously three times a day, starting the morning of surgery.
Limited published data indicate that dalteparin is present in human milk in small amounts see Data. Bleeding can occur at any site during therapy with Fragmin.
Hold the syringe assembly by the open sides of the device. Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given. In medical patients with severely restricted mobility during acute illness, the recommended dose of Fragmin is 5, IU administered by subcutaneous injection once daily.