Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Moxilen 250 mg hard capsules.
Moxilen 500 mg hard capsules.
Moxilen 125mg/5ml powder for oral suspension.
Moxilen Forte 250mg/5ml powder for oral suspension.
Moxilen 500 mg powder for solution for injection or infusion.
Moxilen 1g powder for solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Capsule, hard. Moxilen hard capsules, Moxilen powder for oral suspension and Moxilen Forte powder for oral suspension are for oral administration. Moxilen powder for solution for injection or infusion is for parenteral administration. Pharmaceutical form description:
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Moxilen hard capsules contain the equivalent of either 250mg or 500mg amoxicillin as amoxicillin trihydrate.
Following reconstitution, Moxilen powder for oral suspension contains the equivalent of either 125mg/5ml or 250mg/5ml (Moxilen Forte) amoxicillin as amoxicillin trihydrate.
Moxilen powder for solution for injection or infusion provides the equivalent of 500mg or 1g amoxicillin as amoxicillin sodium.
Excipients with known effect:
Moxilen 500mg hard capsules:
Moxilen powder for oral suspension and Moxilen Forte powder for oral suspension:
Moxilen powder for solution for injection or infusion:
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. |
| List of Excipients |
|---|
|
Moxilen powder for solution for injection or infusion contain no excipients. Moxilen capsules 250 mg contain magnesium stearate. The capsule shell contains: Gelatine Moxilen capsules 500 mg contain magnesium stearate. The capsule shell contains: Gelatine Moxilen and Moxilen Forte powder for oral suspension contain: Sucrose |
Moxilen hard capsules 250 mg and 500 mg are packed in polyvinylchloride film-aluminium foil blisters with a leaflet, in cartons. Cartons containing 16, 20, 100, 250, 500 or 1000 capsules are available.
Moxilen and Moxilen Forte powder for oral suspension are presented in amber (type III) glass bottles sealed with aluminium pilfer proof caps with an inert PVC liner.
Bottles containing powder to give 60 ml and 100 ml of suspension following reconstitution are available.
Moxilen powder for solution for injection or infusion is presented in clear 8 ml type III glass vials, sealed with a rubber stopper of 20 mm diameter and an aluminium overcap, with a leaflet, in card cartons.
Cartons containing 1, 10, 50 or 100 vials are available.
Not all pack sizes may be marketed.
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Moxilen capsules 250 mg: 7236
Moxilen capsules 500 mg: 7237
Moxilen Powder for Oral Suspension 125 mg/5ml: 7278
Moxilen Forte Powder for Oral Suspension 250 mg/5ml: 7277
Moxilen powder for solution for injection or infusion 500 mg: 12960
Moxilen powder for solution for injection or infusion 1g: 12961
Moxilen capsules 250 mg: Date of first authorisation: 14.12.1979 / 14.01.2015
Moxilen capsules 500 mg: Date of first authorisation: 14.12.1979 / 14.01.2015
Moxilen Powder for Oral Suspension 125 mg/5ml: Date of first authorisation: 11.01.1980/04.10.2013
Moxilen Forte Powder for Oral Suspension 250 mg/5ml: Date of first authorisation: 11.01.1980 / 15.07.2013
Moxilen powder for solution for injection or infusion 500 mg: Date of first authorisation: 16.10.1990 / 14.01.2015
Moxilen powder for solution for injection or infusion 1g: Date of first authorisation: 16.10.1990 / 14.01.2015
| Drug | Countries | |
|---|---|---|
| MOXILEN | Albania, Cyprus, Estonia, Hong Kong, Malta, Romania, Singapore |
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