Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Activo Health (Pty) Ltd, Block B, Arena Office Park, 272 West Avenue, Centurion, 0157
ACTIMENTIN 600 BD (600 mg/42,9 mg per 5 ml) powder for oral suspension.
| Pharmaceutical Form |
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Powder for oral suspension. ACTIMENTIN 600 BD is a white to yellowish powder with strawberry flavour packed in a glass bottle. |
When reconstituted, every 1 ml of ACTIMENTIN 600 BD oral suspension contains amoxicillin trihydrate equivalent to 120 mg amoxicillin and potassium clavulanate equivalent to 8,58 mg of clavulanic acid (i.e. each 5 ml contains amoxicillin trihydrate equivalent to 600 mg amoxicillin and potassium clavulanate equivalent to 42,9 mg clavulanic acid).
The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate in a ratio of 14:1.
Excipients with known effect: ACTIMENTIN 600 BD contains maltodextrin (glucose) as an ingredient of the flavourant. It also contains 1,92 mg acesulfame potassium (E950) and 0,96 mg saccharin sodium (E954) per 1 ml, as sweeteners.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Amoxicillin |
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 |
Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. |
| List of Excipients |
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Acesulfame potassium (E950) |
ACTIMENTIN 600 BD is available as 30 ml, 50 ml, 70 ml or 100 ml oral suspension. It is filled in amber type III glass bottles, with a nominal volume of 60 ml (for 30 ml oral suspension), 100 ml (for 50 ml or 70 ml oral suspension) or 150 ml (for 100 ml oral suspension). Bottles are closed with HDPE or PP white screw caps containing a liner (or sealing disk). The bottles are packed together with a dosing device; either:
The glass bottles and dosing device are packed into outer cartons.
Not all pack sizes may be marketed.
Activo Health (Pty) Ltd, Block B, Arena Office Park, 272 West Avenue, Centurion, 0157
| Drug | Countries | |
|---|---|---|
| ACTIMENTIN | South Africa |
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