Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Cefotaxime sodium
Sanofi-Aventis Ireland Limited T/A SANOFI
J01DD; J01DD01
Cefotaxime sodium
1 gram(s)
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Third-generation cephalosporins; cefotaxime
Marketed
1981-05-13
CLAFORAN POWDER FOR SOLUTION FOR INJECTION 500MG CLAFORAN POWDER FOR SOLUTION FOR INJECTION 1G Cefotaxime (as Cefotaxime Sodium) The following instruction is extracted from the SPC. TECHNICAL INFORMATION FOR THE PREPARATION AND ADMINISTRATION OF CEFOTAXIME 1. NAME OF THE MEDICINAL PRODUCT Claforan Powder for Solution for Injection 500mg Claforan Powder for Solution for Injection 1g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Claforan powder for solution for injection 500mg Each vial contains cefotaxime sodium equivalent to 500mg cefotaxime base Excipient(s) with known effect Sodium 24mg (see section 4.4) Claforan powder for solution for injection 1g Each vial contains cefotaxime sodium equivalent to 1g cefotaxime base. Excipient(s) with known effect Sodium 48mg (see section 4.4)For excipients, see 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white to pale yellow-white crystalline powder. 4. CLINICAL PARTICULARS 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Dosage: Claforan may be administered intravenously or by slow injection or infusion or intramuscularly. The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organism and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known. _Adults: _The recommended dosage for mild to moderate infections is 1g 12 hourly. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the patient. Therapy may be initiated before the results of sensitivity tests are known. In severe infections dosage may be increased up to 12g daily given in 3 or 4 divided doses. For infections caused by sensitive Psuedomonas spp. daily doses of greater than 6 g will usually be required. Dosage in Gonorrhea: A single injection of 1g may be administered intramuscularly or intravenously. _Children: _The usual dosage range is 100-150mg/kg/day in 2 to 4 divided doses. However, in very sev Lugege kogu dokumenti
Health Products Regulatory Authority 23 February 2023 CRN00CPW7 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Claforan Powder for Solution for Injection 1g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains cefotaxime sodium equivalent to 1g cefotaxime base. Excipient(s) with known effect Sodium 48mg (see section 4.4) For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white to pale yellow-white crystalline powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PROPERTIES: Claforan is a broad-spectrum bactericidal cephalosporin antibiotic. Claforan is exceptionally active _in vitro_ against Gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against Gram-positive organisms. INDICATION: Claforan is indicated in the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicaemias Respiratory Tract Infections such as acute and chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and post-operative chest infections. Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. Soft Tissue Infections such as cellulitis, peritonitis and wound infections. Bone and Joint Infections such as osteomyelitis, septic arthritis. Obstetric and Gynaecological Infections such as pelvic inflammatory disease. Gonorrhoea particularly when penicillin has failed or is unsuitable. Other Bacterial Infections, meningitis and other sensitive infections suitable for parenteral antibiotic therapy. PROPHYLAXIS: The administration of Claforan prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operations where infections would have serious effects. Health Lugege kogu dokumenti