Source: Υπουργείο Υγείας (CY) Revision Year: 2013 Publisher: Codal-Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus
Syntoclav 375mg film-coated tablets.
Syntoclav 625mg film-coated tablets.
Syntoclav 156.25mg/5ml powder for oral suspension.
Syntoclav Forte 312.50mg/5ml powder for oral suspension.
| Pharmaceutical Form |
|---|
|
Syntoclav 375mg: white film-coated tablets. |
Each film-coated tablet of Syntoclav 375mg contains amoxicillin trihydrate E.P equivalent to 250mg amoxicillin base and potassium clavulanate E.P equivalent to 125mg clavulanic acid.
Each film-coated tablet of Syntoclav 625mg contains amoxicillin trihydrate E.P equivalent to 500mg amoxicillin base and potassium clavulanate E.P equivalent to 125mg clavulanic acid.
After reconstitution each 5ml of Syntoclav contains amoxicillin trihydrate E.P equivalent to 125mg amoxicillin base and potassium clavulanate E.P equivalent to 31.25mg clavulanic acid.
After reconstitution each 5ml of Syntoclav Forte contains amoxicillin trihydrate E.P equivalent to 250mg amoxicillin base and potassium clavulanate E.P equivalent to 62.5mg clavulanic acid.
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. |
|
| 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 |
|---|
|
Syntoclav film-coated tablets (500 + 125) mg/tablet and (250 +125) mg/tablet: Magnesium stearate, cellulose microcrystalline, colloidal anhydrous silica, sodium starch glycolate, talc, polyethylene glycol, propylene glycol, methyl cellulose, titanium dioxide (E131). Syntoclav power for oral suspension (125 + 31.25) mg/5 ml and Forte (250 + 62.5) mg/5 ml: Xanthan gum, hydroxy-propyl methyl cellulose, colloidal anhydrous silica, Syloid Al-1, saccharin sodium, strawberry flavour, lemon flavour, peach flavour, succinic acid. |
Film-coated tablets 375mg and 625mg: Tropicalised blisters, of aluminium-polyvinylchloride-aluminium, packs of 16 and 20 tablets with patient information leaflet are available.
Powder for suspension: Amber (type III) glass bottles, sealed with an aluminium roll on, pilfer proof cap, containing powder to give 60ml or 100ml of suspension when reconstituted as directed. Bottle, with patient information leaflet and plastic measuring spoon, is supplied in a carton.
Codal-Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus
Syntoclav 375mg FC Tablets: M.L. No. 17800
Syntoclav 625mg FC Tablets: M.L. No. 17801
Syntoclav 156.25mg /5ml DPFOS: M.L. No. 17802
Syntoclav 312.5mg/5ml DPFOS: M.L. No. 17803
Syntoclav 375mg FC Tablets: 10/07/1998
Syntoclav 625mg FC Tablets: 10/07/1998
Syntoclav 156.25mg/5ml DPFOS: 10/07/1998
Syntoclav 312.5mg/5ml DPFOS: 10/07/1998
| Drug | Countries | |
|---|---|---|
| SYNTOCLAV | Cyprus, Hong Kong |
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