OZALIN Oral solution Ref.[7755] Active ingredients: Midazolam

Ozalin oral solution should only be administered by healthcare professionals.

General fasting guidelines should be respected before sedation.

Posology

The dose must be adapted to the patient’s weight.

Ozalin should be used orally at a single dose of 0.25 mg/kg in paediatric population from the age of six months. An immediate subsequent dose is not recommended (see section 5.2).

The maximum dose should not exceed 20 mg of midazolam (corresponding to 2 ampoules), even for children weighing more than 80 kg.

Ozalin is indicated for single dose administration and there is no data available for repetitive administration of Ozalin.

In obese children the dose should be given according to actual body weight, up to the limit of 20 mg.

The dose must be adapted to the patient’s weight. The oral applicator is graduated in kilograms, from 3 kg to 40 kgbody weight (see section 6.6, n°6), with three types of graduation marks:

• A small graduation mark corresponding to 1 kg, i.e.: 0.25 mg of midazolam,
• An intermediate graduation mark corresponding to 5 kg, i.e.: 1.25 mg of midazolam,
• A large graduation mark corresponding to 10 kg, i.e.: 2.5 mg of midazolam

For patients above 40 kg, 2 ampoules are needed. The minimal dose to be sampled from an ampoule should correspond to a 3 kg dose. For patients weighing 41 and 42 kg, needing more than one ampoule, take a dose lower than 40 kg in the first ampoule and the supplement to dose in the second ampoule, see examples below:

• For a patient of 41 kg, it is recommended to take 30 kg in the first ampoule and 11 kg in the second ampoule
• For a patient of 42 kg, take a dose corresponding to 30 kg in the first ampoule and 12 kg in the second ampoule.

Special population

Renal impairment

Ozalin should be used with caution in patients with chronic renal failure because elimination of midazolam may be delayed and its effects prolonged.

Hepatic impairment

Hepatic impairment decreases the clearance of midazolam, which increases terminal half-life (for elimination) as well as bioavailability. Careful monitoring of these effects and of vital signs is necessary following the administration of midazolam in these patients (see Section 4.4). OZALIN is contraindicated in patients with severe hepatic impairment (see Section 4.3).

Paediatric population

The safety and efficacy of Ozalin in children under the age of six months have not been established. No data are available.

Method of administration

Ozalin is for oral use only and should be administered with its specific oral applicator graduated in kg.

Ozalin should be administered on average 30 minutes before the procedure or anaesthesia.

The oral applicator and filter straw are single use sampling and administration devices.

After use, the ampoule, the oral applicator and the filter straw should be discarded.

Complete instructions are provided in Section 6.6.

Symptoms

Like all benzodiazepines, midazolam commonly causes drowsiness, ataxia, dysarthria and nystagmus. Midazolam overdose is rarely life-threatening if the product is taken alone, but an overdose can cause areflexia, apnoea, hypotension, cardiorespiratory depression and in rare cases coma. The respiratory depressant effects of benzodiazepines are more serious in patients with respiratory or heart disease or if the drug is combined with other central nervous system depressants, including alcohol.

Treatment

In most cases, monitoring of vital signs is necessary.

In case of overdose, special attention should be paid to respiratory and cardiovascular functions in intensive care.

In case of overdose, vomiting should be induced (as soon as possible and in any event within an hour of the oral administration of midazolam) if the patient is conscious, or gastric lavage undertaken while protecting the airways if the patient is unconscious. If gastric lavage is not effective, activated charcoal should be administered to reduce absorption.

Flumazenil, a benzodiazepine antagonist, is indicated in case of severe intoxication accompanied by respiratory depression or coma. This treatment should only be administered under close supervision. The half-life of flumazenil is short (about an hour), which means that monitoring is required after the effect of this product has worn off. Extreme caution is required when using flumazenil in case of overdose following a concomitant administration of different drugs in a patient and in patients with epilepsy already treated with benzodiazepines. Flumazenil should only be used with extreme caution in patients treated with tricyclic antidepressants or epileptogenic drugs and in patients with ECG anomalies (QRS or QT prolongation).

Before opening: 24 months.

After opening: the product should be used immediately after opening and then discarded.

Do not store at temperatures above 30°C.

Do not refrigerate or freeze.

Store in the original package in order to protect from light.

5 ml amber glass ampoule (type I glass), one filter straw and one oral applicator packaged together into an individual blister.

Box of 1 ampoule, 1 filter straw and 1 oral applicator.

Box of 5 ampoules, 5 filter straws and 5 oral applicators.

Box of 10 ampoules, 10 filter straws and 10 oral applicators.

Oral applicator and filter straw are for single-use. Oral applicator is presented with graduations in kg of bodyweight: from 3 kg to 40 kg, with increments in one kg.

Not all pack sizes may be marketed.

Use in the paediatric population

Ozalin is for oral use only.

Instruction for safe use of Ozalin ampoule, oral applicator and filter straw provided on the blister. Ozalin should be only administered with its dedicated, specific oral applicator graduated in kg:

(1) The administration to the patient requires use of the ampoule, the filter straw and the oral applicator.
(2) Connect the filter straw to the end-piece of the oral applicator.
(3) Tap the top of the ampoule to ensure all the liquid has flowed to the bottom. Cover the top of the ampoule with a compress and place the thumb of one hand on the white dot.
(4) Hold the ampoule firmly with the white dot pointing upwards and facing you. Push back on the neck of the ampoule and it will open easily.

(5) Insert the filter straw into the ampoule. Before adjusting the dosage and in order to eliminate the possible air in the filter straw, a short pumping with the applicator (fill and empty) of the solution inside the ampoule is recommended.
(6) While holding the ampoule in an upright position, fill the oral applicator to the graduation mark corresponding to the weight of the patient in kilograms (kg). Align the line mark with the top of the flange to take the correct dose.
(7) Remove the filter straw from the end piece of the oral applicator.

(8) Empty the contents of the oral applicator into the patient’s mouth. The solution should be swallowed immediately.

(9) After use, discard the ampoule, filter straw, oral applicator and any unused contents into a container prepared for this purpose according to the local requirements for controlled substances and pharmaceutical accessories.