SYNTOCLOR Hard capsule Ref.[28271] Active ingredients: Cefaclor

Source: Υπουργείο Υγείας (CY)  Revision Year: 2013  Publisher: Codal Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus

Product name and form

Syntoclor 250 mg capsules.

Syntoclor 500 mg capsules.

Pharmaceutical Form

Lilac-ivory hard capsule.

For oral administration.

Qualitative and quantitative composition

Each capsule contains either 250mg or 500mg of cefaclor.

Excipient with known effect: azorubine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cefaclor

Cefaclor is a second-generation cephalosporin antibiotic. Cefaclor has no activity against Pseudomonas species or Acinetobacter species. Methicillin-resistant staphylococci and most strains of enterococci (eg, Str. faecalis) are resistant to cefaclor.

List of Excipients

The capsules also contain sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide (E171), azorubine (E122) and indigo carmine(E132).

Pack sizes and marketing

Capsules are in combination blisters of aluminium foil and polyvinylchloride film.

Cartons of 16, 100, 500 or 1000 capsules, with a patient information leaflet, are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Codal Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus

Marketing authorization dates and numbers

Syntoclor 250mg capsules: 20005
Syntoclor 500mg capsules: 20018

Syntoclor 250mg capsules: 29/12/2005
Syntoclor 500mg capsules: 29/12/2005

Drugs

Drug Countries
SYNTOCLOR Cyprus, Hong Kong

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