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

Posology

Dosage in patients with normal renal and hepatic function

Treatment of infections

Adults: 8 to 12 g/day, divided into 4-6 daily administrations.

Paediatric population: 100 to 200 mg/kg/day divided into 4-6 daily administrations, without exceeding 12 g/day.

Prevention of postoperative infections in adults: the antibioprophylaxis must be of short duration, usually limited to the intraoperative period, 24 hours, but never more than 48 hours:

• 2 g IV with induction of anesthesia,
• thereafter 1 g IV every 2 hours in case of prolonged intervention.

The duration of treatment should cover the entire duration of the surgery until skin closure.

Method of administration

Monoclox injection is for intramuscular or intravenous administration.

There has not been reported any incident of overdose of cloxacillin but should it occur discontinue medication, treat symptomatically and institute supportive measures as required.

36 months.

Reconstituted solution: The product should be used immediately.

Store below 25°C.

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.

No special precautions for disposal.

Preparation of the solution for i.m administration: Add 5 ml of water for injections into each vial of Monoclox 1g, respectively and shake well until complete dissolution. The solution should not be mixed with another product. Any solution left pending must be discarded.

The content of each vial of Monoclox 250 mg should be dissolved in 1.5ml of water for injections and shake well until complete dissolution. The solution should not be mixed with another product. Any solution left pending must be discarded.

The content of each vial of Monoclox 500 mg should be dissolved in 2.5ml of water for injections and shake well until complete dissolution. The solution should not be mixed with another product. Any solution left pending must be discarded.

DO NOT USE INTRAMUSCULAR SOLVENT BY INTRAVENOUS ROUTE.

Preparation for i.v. administration: Add 20 ml of water for injections into each vial of Monoclox 1g, respectively and shake well. For intravenous injection each vial of Monoclox 250 mg and 500 mg, respectively, should be dissolved in 10-20ml water for injection and shake well.

For slow intravenous infusion Monoclox can be further diluted in 100 ml of an infusion fluid. Infuse the solution slowly over a period of 60 minutes.

Reconstitution should be carried out under suitable aseptic precautions. Following reconstitution the solution should be visually examined for any foreign particulate matter and discarded if any is observed. It is recommended that reconstituted solution is used immediately following preparation.