Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus.
Medoclor 250 mg capsules Medoclor 500 mg capsules.
Medoclor 125 mg/5 ml, granules for oral suspension.
Medoclor Forte 250 mg/5 ml, granules for oral suspension.
| Pharmaceutical Form |
|---|
|
Hard gelatin capsule. Granules for oral suspension. Medoclor 250 mg are lilac-ivory hard gelatine capsules size “2” or lilac-ivory hard gelatine capsules size “2” printed “MEDOCLOR 250”. Medoclor 500 mg are lilac-ivory hard gelatine capsules size “0”. Medoclor 125 mg/5ml: Red granules free from any foreign matter with characteristic strawberry odor, for oral suspension. Medoclor Forte 250 mg/5ml: Red granules free from any foreign matter with characteristic strawberry odor, for oral suspension. |
Each capsule contains either 250mg or 500mg of cefaclor.
Following reconstitution, each 5ml of suspension contains either 125mg or 250mg of cefaclor.
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 suspensions also contain xanthan gum, methocel a-15lv (methylcellulose), erythrosine lake (E127), sugar, dimethicone, sodium lauryl sulphate, pregelatinised starch, strawberry flavour and highly purified water. The capsules also contain sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide (E171), azorubine (E122) and indigo carmine FD&C Blue 2 (E132). |
Capsules are in combination blisters of aluminium foil and polyvinylchloride film. Cartons of 16, 500 or 1000 capsules, with a patient information leaflet, are available. Medoclor 500mg capsules are also available in cartons of 20 capsules.
Granules for oral suspension is in amber type III glass bottles with aluminium tamper evident closure. Bottles with sufficient powder for 60ml or 100ml of suspension following reconstitution are available, in a carton with a patient information leaflet and a 5ml spoon.
Not all pack sizes may be marketed.
Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus.
Medoclor 250mg capsules: M.L.No. 19932
Medoclor 500mg capsules: M.L.No. 16461
Medoclor 125mg/5ml granules for oral suspension: M.L.No. 14606
Medoclor Forte 250mg/5ml granules for oral suspension: M.L.No. 14605
Medoclor 250mg capsules: 20.12.2005 / 18.10.2012
Medoclor 500mg capsules: 29.12.1995 / 06.11.2012
Medoclor 125mg/5ml Suspension: 31.01.1994 / 24.09.2010
Medoclor Forte 250mg/5ml Suspension: 31.01.1994 / 24.09.2010
| Drug | Countries | |
|---|---|---|
| MEDOCLOR | Cyprus, Hong Kong |
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