MIPROSED

5mg/kg administered 15-30 minutes before the intervention. Maximum per dose: 20mg. 5mg/kg administered 15-30 minutes before the induction of anaesthesia. Maximum per dose: 20mg. The dose should be adapted to the patient’s weight and administered rounded to the nearest syringe graduation in millilitres.

5mg/kg). In obese children the dose should be given according to the actual body weight up to the maximum limit of 20mg. General fasting guidelines should be respected before sedation with Miprosed. 4). Hepatic impairment Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal half-life.

4). 3). Children under 6 months The safety and efficacy of midazolam in children aged 0 to 6 months for the indications listed above has not been established. Miprosed should not be used in children under 6 months of age. Method of administration For oral administration only.

The oral solution should be administered using the oral syringes provided. Miprosed may be mixed with and administered in apple juice and diluted blackcurrant cordial. 6 for any special precautions related to the manipulation or administration of the product.

The safety of orally administered Midazolam Oral Solution in conscious sedation in children has been evaluated from the results of 32 clinical studies in which 4148 patients participated.

The frequency of adverse reactions is classified as follows:

Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000) and Not known (cannot be estimated from the available data). Frequency System Organ Class Common Uncommon Rare Not known Cardiac disorders Kounis syndrome* Eye disorders Diplopia Gastrointestinal disorders Nausea Vomiting Injury, poisoning, procedural complication Sedation complication Nervous system disorders Agitation Somnolence Dyskinesia Ataxia Dizziness Headache Compulsive lip biting Excessive/prolonged sedation Aphasia Psychiatric disorders Paradoxical reactions Crying Gait disorders Anger Hallucination Mood swings Aggression Screaming Irritability Respiratory Hiccups Oxygen Respiratory disorder saturation decreased Surgical and medical procedures Endotracheal intubation Vascular disorders Hypotension *particularly after parenteral administration From the available clinical studies reporting the use of oral midazolam as a premedicant before induction of anaesthesia, it has not been possible to estimate the frequency of adverse events.

The adverse events that have been reported in these clinical studies in patients receiving oral midazolam include: nausea, vomiting, salivation, hypoxia, hypertension, tachycardia, agitation, vertigo, euphoria, excitation, restlessness and nocturnal enuresis.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Midazolam should be administered only by experienced physicians in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the recognition and management of expected adverse events including respiratory and cardiac resuscitation.

Midazolam should be used with caution in patients with mild or moderate hepatic impairment, heart failure or chronic renal failure. Midazolam or its metabolite may accumulate in patients with chronic renal failure or with liver failure, and the clearance of midazolam may be decreased in patients with heart failure.

Oral midazolam should be used with caution in patients in poor general health as they are more sensitive to the effects of benzodiazepines on the central nervous system.

Risk from concomitant use of opioids:

Concomitant use of midazolam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as midazolam with opioids should be reserved for patients for whom alternative treatment options are not possible.

2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Respiratory insufficiency Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration.

Paediatric patients aged less than 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 children under 6 months age group cannot be excluded.

Therefore, Midazolam Oral solution should not be used in children under 6 months of age. Altered elimination of midazolam Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function.

1 • Severe hepatic impairment • Severe respiratory failure or acute respiratory depression • Myasthenia gravis • Sleep apnea • Anatomical respiratory impairment or lung diseases