Posology : מינונים

4.2 Posology and method of administration

Posology
Standard doses are indicated below:
Age range                               Dose                                Label colour 3 to 6 months                           2.5 mg                                 Yellow hospital setting
> 6 months to < 1 year                       2.5 mg                                 Yellow 1 year to < 5 years                         5 mg                                   Blue 5 years to < 10 years                       7.5 mg                                 Purple 10 years to < 18 years                       10 mg                                  Orange 
Carers should only administer a single dose of midazolam. If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professional to provide information on the dose received by the patient.

A second or repeat dose when seizures re-occur after an initial response should not be given without prior medical advice (see section 5.2).

Special populations
Renal impairment
No dose adjustment is required, however, BUCCOLAM should be used with caution in patients with chronic renal failure as elimination of midazolam may be delayed and the effects prolonged (see section 4.4).

Hepatic impairment
Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal half-life.
Therefore, the clinical effects may be stronger and prolonged, hence careful monitoring of the clinical effects and vital signs is recommended following administration of midazolam in patients with hepatic impairment (see section 4.4).

BUCCOLAM is contraindicated in patients with severe hepatic impairment (see section 4.3).

Paediatric population
The safety and efficacy of midazolam in children aged 0 to 3 months has not been established. No data are available.

Method of administration
BUCCOLAM is for oromucosal use. The full amount of solution should be inserted slowly into the space between the gum and the cheek. Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution. If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side.

For detailed instructions on how to administer the medicinal product, see section 6.6.

Precautions to be taken before handling or administering the medicinal product No needle, intravenous tubing or any other device for parenteral administration should be attached to the oral syringe.

BUCCOLAM is not for intravenous use.

The oral syringe cap should be removed before use to avoid risk of choking.