País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
Garec
MEGAPEN 500 (capsules) MEGAPEN S (syrup) SCHEDULING STATUS: S4 PROPRIETARY NAMES (and dosage form): MEGAPEN 500 (capsules) MEGAPEN S (syrup) COMPOSITION: MEGAPEN 500 Gelatin capsule containing amoxycillin trihydrate equivalent to 250 mg amoxycillin and flucloxacillin sodium equivalent to 250 mg flucloxacillin . MEGAPEN S Powder for preparing a fruit-flavoured syrup. When dispensed as directed each 5 mL contains amoxycillin trihydrate equivalent to 125 mg amoxycillin and flucloxacillin -sodium equivalent to 125 mg flucloxacillin.. The powder contains 0,13% m/m sodium benzoate as a preservative. PHARMACOLOGICAL CLASSIFICATION: A.20.1.2 Penicillins PHARMACOLOGICAL ACTION: (a) Bacteriology MEGAPEN exhibits in vitro and in experimental animals in vivo, bactericidal activity against some Gram-positive and Gram-negative bacteria. In vitro sensitivity does not necessarily imply in vivo efficacy. (b) Absorption MEGAPEN is well absorbed orally. Peak serum levels are achieved 1 to 2 hours after dosing. (c) Excretion Approximately 50% of the dose is excreted unchanged into the urine within 6 hours, resulting in high urine levels of active drug. INDICATIONS: MEGAPEN is indicated for the treatment of bacterial infections, caused by susceptible organisms; in particular infections of mixed origin where penicillin-resistant staphylococci may be implicated. CONTRA-INDICATIONS' MEGAPEN should not be given to those subjects hypersensitive to penicillin. As there is currently no neonatal formulation, MEGAPEN should not be given to neonates. DOSAGE AND DIRECTIONS FOR USE: Adults: One 500 mg capsule three times a day. Children 2-12: 5 mL of syrup (containing 250 mg MEGAPEN) three times a day. Children under 2: 2,5 mL of syrup (containing 125 mg MEGAPEN) three times a day. Neonates: No formulation is availabl Llegiu el document complet