SYNTOCLAV Powder for solution for injection or infusion Ref.[28257] Active ingredients: Amoxicillin Clavulanic acid

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Codal-Synto Ltd, 21 Constantinoupoleos, 3011 Limassol, Cyprus

Product name and form

Syntoclav 1.2g powder for solution for injection or infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

White or almost white sterile powder for reconstitution as an intravenous injection or infusion.

Qualitative and quantitative composition

Each vial of Syntoclav 1.2g sterile powder contains 1000mg of amoxicillin (as amoxicillin sodium) and 200mg of clavulanic acid (as potassium clavulanate).

This product does not contain any 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

None.

Pack sizes and marketing

20ml Glass vials Type II; packs of 1, 5, 10, 25, 50 and 100 vials are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Codal-Synto Ltd, 21 Constantinoupoleos, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

21586

20/08/2012 / 21/12/2020

Drugs

Drug Countries
SYNTOCLAV Cyprus, Hong Kong

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