Kraj: Republika Południowej Afryki
Język: angielski
Źródło: South African Health Products Regulatory Authority (SAHPRA)
Lennon
PANAMOR - 25 TABLETS PANAMOR AT - 50 TABLETS PANAMOR - 75 SR TABLETS PANAMOR - 100 SR TABLETS PANAMOR - 75 INJECTION PANAMOR SUPPOSITORIES - 12,5 PANAMOR SUPPOSITORIES - 25 PANAMOR SUPPOSITORIES - 100 SCHEDULING STATUS: S3 S2 (See indications below) PROPRIETARY NAME (and dosage form): PANAMOR - 25 TABLETS PANAMOR AT - 50 TABLETS PANAMOR - 75 SR TABLETS PANAMOR - 100 SR TABLETS PANAMOR - 75 INJECTION PANAMOR SUPPOSITORIES - 12,5 PANAMOR SUPPOSITORIES - 25 PANAMOR SUPPOSITORIES - 100 COMPOSITION: Film-coated tablets (which are also enteric coated) containing 25 mg or 50 mg diclofenac sodium, and film-coated tablets containing 75 mg or 100 mg diclofenac sodium tablets in a sustained-release form. These are also enteric-coated. Each 3 mL ampoule contains 25 mg/mL diclofenac sodium with 4% v/v benzyl alcohol as preservative. Each suppository contains 12,5 mg, 25 mg or 100 mg diclofenac sodium. PHARMACOLOGICAL CLASSIFICATION: A 3.1: Anti-rheumatics (anti-inflammatory agents). PHARMACOLOGICAL ACTION: Diclofenac sodium is a non-steroidal anti-inflammatory compound with analgesic, anti-inflammatory, antirheumatic and antipyretic properties. Plasma concentrations show a linear relationship to the size of the dose. Peak levels are attained in 1 to 4 hours with the tablets, and in the case of the suppositories, less than 1 hour. The peak-plasma concentration of Panamor - 75 SR and 100 - SR tablets, though comparable to that reached after a single coated tablet of 25 mg, is maintained over a longer period due to the larger quantity of active substance. Diclofenac sodium is eliminated principally by metabolism and subsequent urinary and biliary excretion of glucuronide and sulphate conjugates of the metabolites. The principal metabolite in man is the 4-hydroxy derivative o Przeczytaj cały dokument