DORMYRA

Posology Standard doses are indicated below:

Age range Dose Label colour 1 year to < 5 years 5 mg Blue 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.

2). Special populations Renal impairment No dose adjustment is required; however, Midazolam should be used with caution in patients with chronic renal failure as elimination of midazolam may be delayed and the effects prolonged. 4) Hepatic impairment Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal half- life.

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 Midazolam 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.

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. Midazolam is not for intravenous use.

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

Respiratory insufficiency Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration. Paediatric patients aged 3 to 6 months Given the higher metabolite to parent drug ratio in younger children, a delayed respiratory depression as a result of high active metabolite concentrations in the 3-6 months age group cannot be excluded.

Therefore, the use of Midazolam in the 3–6-month age group should be limited for use only under the supervision of a health care professional where resuscitation equipment is available and where respiratory function can be monitored and equipment for respiratory assistance, if needed, is available.

Altered elimination of midazolam Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.

Concomitant use with other benzodiazepines Debilitated patients are more prone to the central nervous system (CNS) effects of benzodiazepines and, therefore, lower doses may be required. Medical history of alcohol or drug abuse Midazolam should be avoided in patients with a medical history of alcohol or drug abuse.

Amnesia Midazolam may cause anterograde amnesia. Excipients Sodium This medicine contains less than 1 mmol sodium (23 mg) per oral syringe, that is to say essentially ‘sodium-free’.

1. Myasthenia gravis. Severe respiratory insufficiency. Sleep apnoea syndrome. Severe hepatic impairment.