Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: PRIMEX PHARMACEUTICALS OY, Mariankatu 21 C, 00170 Helsinki, Finland
OZALIN 2 mg/ml oral solution in single-dose container.
| Pharmaceutical Form |
|---|
|
Oral solution in single-dose container. Clear to slightly opalescent solution, pale yellow to slightly brown, with a pH between 3.6 and 4.2. |
Each ml of OZALIN contains 2 mg of midazolam.
Each 5 ml ampoule of OZALIN contains 10 mg of midazolam.
Excipients with known effects: ethanol (less than 100 mg per ampoule), sodium (less than 1 mmol (23 mg) per ampoule), cyclodextrin (400 mg per ampoule and less than the permitted daily exposure of 20 mg/kg/day at the recommended dose).
For the full list of excipients, see Section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Midazolam |
Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of midazolam to form water-soluble salts with acids. |
| List of Excipients |
|---|
|
Citric acid monohydrate |
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.
PRIMEX PHARMACEUTICALS OY, Mariankatu 21 C, 00170 Helsinki, Finland
PA1719/002/001
Date of first authorisation: 24th April 2020
| Drug | Countries | |
|---|---|---|
| OZALIN | Finland, France, Ireland, United Kingdom |
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