Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa, Tel: +27(0) 12 643 2000
RANCLAV 1 g Film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablets. White, film-coated, capsule shaped tablets debossed with ‘RX509’ on one side and a scoreline on the other. |
Each film-coated tablet contains:
Amoxicillin trihydrate equivalent to amoxicillin 875 mg
Clavulanate potassium equivalent to clavulanic acid 125 mg
Sugar free.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. |
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Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coat: Opadry 03858965 white |
Carton contains 10 tablets packed in a PVC/PVdC blister pack within a 4-layered laminated bag containing a desiccant sachet.
PVC/PVdC blister pack in a 4-layered laminated bag:
Clear PVC film coated with PVdC on the inner side with the lidding of hard tempered, aluminium foil coated with heat seal lacquer on the inner side.
One blister to be put into a 4-layered laminated bag containing a desiccant sachet.
The structure of the four layered laminated bag is as follows: Polyester film/ Aluminium foil/Polyester film/Polyethylene.
Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext 1, Roodepoort, 1724, South Africa, Tel: +27(0) 12 643 2000
A40/20.1.2/0568
August 2007
| Drug | Countries | |
|---|---|---|
| RANCLAV | South Africa |
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