Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
DALTEPARIN SODIUM
PFIZER PRIVATE LIMITED
B01AB04
10000 iu/ml
INJECTION
DALTEPARIN SODIUM 10000 iu/ml
INTRAVENOUS, SUBCUTANEOUS
Prescription Only
PFIZER MANUFACTURING BELGIUM NV
ACTIVE
1995-02-28
LPD Reference: FRA-SIN-0213/1 Date of Last Revision: 07 Feb 2013 Country: Singapore Reference document: CDS version 6 & 7, effective 22 Jan 2013 Reason for change: Consolidate changes in Version 6 & 7 FRAGMIN ® Dalteparin Sodium Solution for Injection 1. NAME OF THE MEDICINAL PRODUCT FRAGMIN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: dalteparin sodium 3. PHARMACEUTICAL FORM Solution for Injection 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of acute deep-vein thrombosis. Prevention of clotting in the extra corporeal system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency. Thromboprophylaxis in conjunction with surgery. The prophylaxis of proximal deep venous thrombosis in patients bedridden due to a medical condition, including, but not limited to: congestive cardiac failure, acute respiratory failure or acute infection, who also have a predisposing risk factor for venous thromboembolism such as age over 75 years, obesity, cancer or previous history of VTE. Unstable coronary artery disease (unstable angina and non-ST-elevation myocardial infarction, also known as non-Q-wave myocardial infarction). Dalteparin should not be used in patients who have suffered a recent (within 3 months) stroke unless due to systemic emboli. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION See _SECTION 4.4_ SPECIAL WARNINGS AND PRECAUTIONS FOR USE PFIZER CONFIDENTIAL Page 1 LPD Reference: FRA-SIN-0213/1 Date of Last Revision: 07 Feb 2013 Country: Singapore Reference document: CDS version 6 & 7, effective 22 Jan 2013 Reason for change: Consolidate changes in Version 6 & 7 GENERAL - DO NOT ADMINISTER DALTEPARIN BY THE INTRAMUSCULAR ROUTE COMPATIBILITY WITH IV SOLUTIONS - Dalteparin is compatible with isotonic s Read the complete document
FRAGMIN ® Dalteparin Sodium Solution for Injection 1. NAME OF THE MEDICINAL PRODUCT FRAGMIN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: dalteparin sodium 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 1. Treatment of acute deep vein thrombosis (DVT) 2. Prevention of clotting in the extra corporeal system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency 3. Thromboprophylaxis in conjunction with surgery 4. The prophylaxis of proximal DVT in patients bedridden due to a medical condition, including, but not limited to: congestive cardiac failure, acute respiratory failure or acute infection, who also have a predisposing risk factor for venous thromboembolism such as age over 75 years, obesity, cancer or previous history of VTE 5. Unstable coronary artery disease (unstable angina and non-ST-elevation myocardial infarction, also known as non-Q-wave myocardial infarction) Dalteparin should not be used in patients who have suffered a recent (within 3 months) stroke unless due to systemic emboli. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION See _SECTION 4.4._ SPECIAL WARNINGS AND PRECAUTIONS FOR USE . GENERAL Do not administer dalteparin by the intramuscular route. COMPATIBILITY WITH INTRAVENOUS (IV) SOLUTIONS Dalteparin is compatible with isotonic sodium chloride (9 mg/mL) or isotonic glucose (50 mg/mL) infusion solution in glass bottles and plastic containers. The solution should be used within 12 hours. 1. TREATMENT OF ACUTE DVT Administer dalteparin subcutaneously (SC) either as a single daily injection or as two daily injections. Simultaneous anticoagulation with oral vitamin K antagonists can be started immediately. Continue combined treatment until the prothrombin complex tests have reached therapeutic levels (usually at least 5 days). Outpatient treatment is feasible using the same doses recommended for treatment in a medical institution. • ONCE-DAILY ADMINISTRATION - 200 IU/kg total bo Read the complete document