Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
DALTEPARIN SODIUM
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
B01AB04
SOLUTION FOR INJECTION
DALTEPARIN SODIUM 5000 IU / 0.2 ML
I.V, S.C
Required
PFIZER MANUFACTURING BELGIUM NV/SA
DALTEPARIN
DALTEPARIN
Prevention of clotting during haemodialysis and haemofiltration in connection with acute renal failure or chronic renal insufficiency. Treatment of acute deep venous thrombosis and/or pulmonary embolism.Unstable coronary artery disease. Thromboprophylaxis in conjunction with surgery. Prophylaxis in patients with substantially increased risk for venous thromboembolism and that are temporarily immobilized due to acute illness such as cardiac insufficiency respiratory insufficiency and severe infections.Cancer patients : Treatment and secondary prevention of deep-vein thrombosis and/or pulmonary embolism.
2021-04-30
Fragmin LPD CC 27 October 2020 2015-0009954, 2016-0015333, 2016-0021600, 2019-0053629, 2019-0056880 1 _ _ FULL PRESCRIBING INFORMATION NAME OF THE MEDICINAL PRODUCT FRAGMIN ® 2500 IU /0.2 ML FRAGMIN ® 2500 IU/ML FRAGMIN ® 10000 IU/ML FRAGMIN ® 25000 IU/ML QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Dalteparin sodium Potency is described in International anti-Factor Xa units (IU) of the 1st International Standard for Low Molecular Weight Heparin. Each single dose syringe contains either: 2,500 IU (anti-Factor Xa)/ 0.2 ml; 5000 IU (anti-Factor Xa)/ 0.2 ml 7,500 IU (anti- Factor Xa)/ 0.3 mL,10,000 IU(anti-Factor Xa)/ 0.4mL, 12,500 IU(anti-Factor Xa)/ 0.5 mL, 15,000 IU(anti-Factor Xa)/ 0.6 mL or 18,000 IU(anti-Factor Xa)/ 0.72 mL Each ampoule contains either: 2,500 IU (anti- Factor Xa)/ml (4ml) or 10,000 IU (anti-Xa)/ml (1ml) For the full list of excipients, _see_ _Description (11)_ in this leaflet. PHARMACEUTICAL FORM Solution for injection for subcutaneous or intravenous administration. WARNING: SPINAL/EPIDURAL HEMATOMAS EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS WHO ARE ANTICOAGULATED WITH LOW MOLECULAR WEIGHT HEPARINS (LMWH) OR HEPARINOIDS AND ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES. FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING EPIDURAL OR SPINAL HEMATOMAS IN THESE PATIENTS INCLUDE: ● USE OF INDWELLING EPIDURAL CATHETERS ● CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS, OTHER ANTICOAGULANTS. ● 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. IF NEUROLOGICAL COMPROMISE IS NOTED, URGENT TREATMENT IS NECE Citiți documentul complet