NASOLAM

Posology Standard dosages are provided in the table 1 below. Additional details are provided in the text following the table. 75 mg * depending on desired level and duration of sedation Conscious sedation and premedication dosage • NASOLAM must only be used by healthcare professionals in conscious sedation or premedication.

Adequate observation of the patient after administration is mandatory. • NASOLAM can be administered in any position, including lying or sitting patients. • The dose indicated in table 1 should be administered intranasally into one nostril, at 5-10 minutes before the procedure is initiated.

• The onset of action is circa 4-8 minutes after the nasal administration of the first dose. The onset of sedation may vary individually depending on the physical status of the patient. • If required, one subsequent dose may be administered intranasally into the opposite nostril of the first dose, at least 10 minutes after the initial dose, according to the individual need.

• The maximum dose for conscious sedation purposes or premedication is 10 mg. • If after administration of the recommended doses of midazolam (see table 1), the level of sedation is not sufficient, no further intranasal midazolam doses should be administered.

Other midazolam options should be considered. • Paediatric patients < 12 kg: The safety and efficacy of NASOLAM in this paediatric patients group have not been established. No data are available. NASOLAM should not be used in this patient group.

• The administration of a second NASOLAM dose may result in prolonged sedation. 4). 5 mg administered intranasally 5-10 minutes before the procedure is initiated. 4). 4). • Premedication with midazolam given shortly before a procedure produces sedation (induction of sleepiness or drowsiness and relief of apprehension) and preoperative impairment of memory.

Close and continuous monitoring of the patients after administration of premedication is mandatory as inter- individual sensitivity varies and symptoms of overdose may occur. Treatment of prolonged, acute, convulsive seizures dosage • NASOLAM must only be used by parents/care givers where the patient has been diagnosed to have epilepsy • NASOLAM prescribers should consider the following prior to starting treatment: 1.

for patients at increased risk of respiratory depression from benzodiazepines, administration of NASOLAM under healthcare professional supervision should be considered prior to starting treatment with NASOLAM. This administration may be performed in the absence of a seizure.

Summary of safety profile The following undesirable effects have been reported (frequency not known, cannot be estimated from the available data) to occur when midazolam is injected: Frequency categories are 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) Not known (cannot be estimated from the available data) Immune System disorders frequency not known Hypersensitivity, angioedema, anaphylactic shock Psychiatric Disorders frequency not known very rare Disorientation, emotional and mood disturbances, changes in libido, excitation*, physical drug dependence and withdrawal syndrome, abuse.

Agitation*, hostility*, aggression*, anger*, confusional state, euphoric mood, hallucinations. Nervous System Disorders common very rare Decreased alertness, depressed levels of consciousness, sedation (prolonged and postoperative), somnolence.

Involuntary movements (including tonic/clonic movements and muscle tremor)*, hyperactivity*, headache, dizziness, ataxia, paradoxical reactions, anterograde amnesia**, the duration of which is directly related to the administered dose.

Drug withdrawal convulsions. Cardiac Disorders very rare Cardiac arrest, bradycardia Vascular disorders very rare Hypotension, vasodilatation Respiratory System disorders common very rare Sneezing, cough, itching nose, nasal congestion, nasal dryness, rhinorrhea, yawning, respiratory depression Apnoea, respiratory arrest, dyspnea, laryngospasm, hiccups Gastrointestinal Disorders common very rare Nausea, vomiting Constipation, dry mouth.

Skin and subcutaneous tissue disorder uncommon Rash, urticarial, pruritis General Disorders and Administration Site Conditions very rare Fatigue Injury, Poisoning and Procedural complications frequency unknown Falls, fractures*** Social circumstances very rare Assaults* Eye disorders frequency not known Diplopia, blurred vision, excessive blinking * Such paradoxical drug reactions have been reported, particularly among children and the elderly after intravenous midazolam, which may be of relevance to intranasal administration.

4.

Paediatric patients For children < 12 kg:

NASOLAM should not be used. The safety and efficacy of midazolam in these children, has not been established. No data are available. 4.

For children > 12 kg:

NASOLAM should be used according to table 1. In particular, young children should receive a second dose only in the presence of a health care professional. 4. Method of administration NASOLAM is for intranasal use only. Each NASOLAM single-dose container contains just one dose and is intended for single use only in a single nostril.

In young children, the nozzle may not fit in the nostril. In this case, make sure the nozzle seals the nostril before administration. Do not test or prime the product before administration as NASOLAM only delivers one single dose. If you need a second dose, use a new single-dose container and administer the second dose in the other nostril than the one that was used for administering the first NASOLAM dose.

6. 1. - severe respiratory failure or acute respiratory depression, - severe hepatic impairment, - myasthenia gravis or sleep apnoea syndrome, - acute angle glaucoma; benzodiazepines can be used with open-glaucoma only if they are administered according to the appropriate dose, - cyanogen congenital heart disease, - severe sepsis.

4 Special warnings and precautions for use Respiratory insufficiency Special caution is required for patients with impaired respiratory function, because midazolam may further depress respiration. 2). g. parents, caregivers) for the correct usage of NASOLAM in case support is needed in the emergency situation.

g. 2) and should be continuously monitored for early signs of alterations of vital functions. g. patients with chronic respiratory insufficiency, patients with chronic renal failure, or with impaired hepatic- or cardiac function that require conscious sedation or premedication.

1. - severe respiratory failure or acute respiratory depression, - severe hepatic impairment, - myasthenia gravis or sleep apnoea syndrome, - acute angle glaucoma; benzodiazepines can be used with open-glaucoma only if they are administered according to the appropriate dose, - cyanogen congenital heart disease, - severe sepsis.