FRAGMIN PI PDF

  • July 10, 2019

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.

Author: Neran Dozil
Country: Saint Lucia
Language: English (Spanish)
Genre: Music
Published (Last): 20 August 2013
Pages: 224
PDF File Size: 4.51 Mb
ePub File Size: 4.95 Mb
ISBN: 239-5-81130-270-1
Downloads: 56588
Price: Free* [*Free Regsitration Required]
Uploader: Ararisar

The primary efficacy fraymin was evaluated at Day 21 and was defined as at least one of the following within Days 1 to 21 of the study: Subscribe to receive email notifications whenever new articles are published. Because these reactions are reported voluntarily from cragmin population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months [ see Clinical Studies Then, both of these groups began a dosing regimen of Fragmin 5, IU once daily subcutaneous on postoperative day 1.

Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given. 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.

It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. The injection site should be varied daily.

The corresponding mean disposition half-lives were 1. In clinical trials, the usual duration of administration was 12 to 14 days. We comply with the HONcode standard for trustworthy health information – verify here.

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. Remove needle from the patient.

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 Use Fragmin with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding [ see Warnings and Precautions 5 ].

  DELFIN LEHRWERK DEUTSCH FREMDSPRACHE PDF

Although a specific recommendation for timing of a subsequent Fragmin dose after catheter removal cannot be made, consider delaying this next dose for at least four hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

A third multi-center, double-blind, randomized study evaluated a postoperative dosing regimen of Fragmin for thromboprophylaxis following total hip replacement surgery. 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 Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process.

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. Fragmin Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [ see Clinical Studies Inspect Fragmin prefilled syringes and vials visually for particulate matter and discoloration prior to administration.

All patients, except when contraindicated, were treated concurrently with aspirin 75 mg once daily and beta blockers. Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.

Total 27 8. Target anti-Xa range is 0. The incidence of this complication is unknown at present. Bleeding can occur at any site during therapy with Fragmin. Three of the major bleeding reactions that occurred by Day 21 were fatal, all pl to gastrointestinal hemorrhage two patients in the group treated with Fragmin and one in the group receiving placebo. The total daily dose should not pii 18, IU. Patients on preoperative Fragmin thromboprophylaxis can be assumed to have altered coagulation.

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular gragmin heparins LMWH or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture.

Print this page Add to My Med List. 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. Another group received the frragmin dose of Fragmin 2, IU subcutaneous at least 4 hours 6.

In an open-label randomized study, Fragmin 5, IU administered once daily subcutaneously was compared with warfarin sodium, administered orally, in patients undergoing hip replacement surgery.

TGA eBS – Product and Consumer Medicine Information

In patients with cancer and symptomatic venous thromboembolism, the recommended dosing of Fragmin is as follows: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. By clicking Subscribe, I agree to the Drugs. Table 8 summarizes major bleeding reactions that occurred in a clinical trial of medical patients with severely restricted mobility during acute illness.

  AL-HADITH MISHKAT-UL-MASABIH PDF

Insert the needle into the injection area as instructed above. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In the first study, a total of patients were enrolled and treated; received Fragmin and received placebo.

Anti-Factor Xa may be used to monitor the anticoagulant effect of Fragmin, such as in patients with severe renal impairment or if abnormal coagulation parameters or bleeding occurs during Fragmin therapy. 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.

A study evaluated samples of maternal blood and breast milk in 15 lactating women receiving prophylactic doses of dalteparin in ftagmin immediate postpartum period days 4—8 after Cesarean-section.

DALTEPARIN SODIUM

Alternatively, in patients with malignancy, 2, IU of Fragmin can be administered subcutaneously 1 to 2 hours before surgery followed by 2, IU subcutaneously 12 hours later, and then 5, IU once daily postoperatively. Peak anti-Factor Xa activity increased more or less linearly with dose over the same dose range. Remove the needle shield.

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 ppi frequently for signs and symptoms of neurological impairment. One group of patients received frqgmin 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.

If signs ffagmin 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.

The mean age of the study population was 69 years range 42 to 87 years and the majority of patients were female