MONOCLOX Powder for solution for injection or infusion Ref.[28279] Active ingredients: Cloxacillin

Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Medochemie Ltd., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

MONOCLOX 250 mg powder for solution for injection or infusion.

MONOCLOX 500 mg powder for solution for injection or infusion.

MONOCLOX 1g powder for solution for injection or infusion.

Pharmaceutical Form
Powder for solution for injection or infusion. A white or almost white crystalline powder.

Qualitative and quantitative composition

Each vial contains 250mg, 500mg or 1g of cloxacillin dry powder for solution for injection or infusion (as cloxacillin sodium).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Cloxacillin	Cloxacillin is a semi-synthetic beta-lactamase resistant penicillin with activity against gram-negative and gram-positive bacteria including beta-lactamase producing staphylococci. Cloxacillin acts by interfering with the formation of new bacterial cell wall by dividing organisms.

List of Excipients
None.

Pack sizes and marketing

Clear type III glass vials, nominal capacity 8 ml sealed with 20mm rubber stopper, and aluminium caps, labelled, and packed in a card carton.

Boxes of 1, 10, 25, 50 and 100 vials are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

MONOCLOX 250 mg powder for solution for injection or infusion: 21024
MONOCLOX 500 mg powder for solution for injection or infusion: 21025
MONOCLOX 1g powder for solution for injection or infusion: 21026

22.08.2011 / 23/01/2017

Drugs

Drug	Countries
MONOCLOX	Cyprus, Hong Kong, Croatia

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