MAXOLON Solution for injection Ref.[7320] Active ingredients: Metoclopramide

Posology

Route of administration

The solution can be administered intravenously or intramuscularly.

Intravenous doses should be administered as a slow bolus (at least over 3 minutes).

All indications (adult population)

For prevention of PONV a single dose of 10mg is recommended.

For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10mg, repeated up to three times daily.

The maximum recommended daily dose is 30mg or 0.5mg/kg body weight.

The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible.

All indications (paediatric patients aged 1-18 years)

The recommended dose is 0.1 to 0.15mg/kg body weight, repeated up to three times daily by intravenous route. The maximum dose in 24 hours is 0.5mg/kg body weight.

Dosing table:

The maximum treatment duration is 48 hours for treatment of established post operative nausea and vomiting (PONV).

The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

Method of administration

A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).

Diagnostic indications

A single dose of ‘Maxolon’ may be given 5-10 minutes before the examination.

Subject to body weight consideration, (see above)

Special population

Elderly

In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment

In patients with end stage renal disease (Creatinine clearance ≤15 ml/min), the daily dose should be reduced by 75%.

In patients with moderate to severe renal impairment (Creatinine clearance 15-60ml/min), the dose should be reduced by 50% (see section 5.2).

Hepatic impairment

In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).

Paediatric population

Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).

Symptoms

Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.

Management

In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).

A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.

60 months.

Do not store above 25°C. If ampoules are removed from their carton, they should be stored away from light. If inadvertent exposure occurs, ampoules showing discolouration must be discarded.

Clear glass 2ml ampoules (Ph. Eur. Type I neutral glass) in packs of 1 or 12 ampoules or 1 ampoule plus 12 tablets in an aluminium canister as a home visit pack.

Not all pack sizes may be marketed.

Protect from light.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.