CECLOR Granules Ref.[51128] Active ingredients: Cefaclor

Source: Medicines Authority (MT)  Revision Year: 2019  Publisher: Phadisco Ltd., 185 Yiannou Kranidioti Avenue, CY-2234 Latsia, Cyprus Tel.:+357 22715000

Product name and form

Ceclor 125mg/5ml.

Ceclor 250mg/5ml.

Pharmaceutical Form

Granules for oral suspension.

Qualitative and quantitative composition

Each 5ml of reconstituted 125mg/5ml suspension contains, as the active ingredient, cefaclor monohydrate PhEur, equivalent to 125mg of cefaclor base.

Each 5ml of reconstituted 250mg/5ml suspension contains, as the active ingredient, cefaclor monohydrate PhEur, equivalent to 250mg of cefaclor base.

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

125 mg/5ml and 250mg/5ml suspensions:

Sucrose
Erythrosine aluminium lake
Methylcellulose 15
Sodium lauryl sulphate
Artificial strawberry flavour
Dimethicone
Xanthan gum
Starch pregelatinised

Pack sizes and marketing

The product is filled into high density polyethylene bottles with screw caps containing 100ml of cefaclor.

Marketing authorization holder

Phadisco Ltd., 185 Yiannou Kranidioti Avenue, CY-2234 Latsia, Cyprus
Tel.:+357 22715000

Marketing authorization dates and numbers

125mg/5ml suspension: MA056/00601
250mg/5ml suspension: MA056/00602

10th November 2005

Drugs

Drug Countries
CECLOR Austria, Australia, Brazil, Cyprus, Spain, Hong Kong, Malta, Mexico, Poland, Romania, Turkey

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