Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Medochemie Iberia, S.A., Rua Jose Maria Nicolau, no 6, 7oB, São Domingos de Benfica, Lisboa 1500 662, Portugal
Temelor 4 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. A clear, colourless or almost colourless hypertonic solution, free from visible particles. |
Each ampoule contains 4 mg/ml lorazepam (4 mg per 1 ml ampoule).
Excipients with known effect: benzyl alcohol, propylene glycol.
Each ml contains 21 mg benzyl alcohol.
Each ml contains 840 mg propylene glycol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lorazepam |
Lorazepam is a benzodiazepine with anxiolytic, sedative and hypnotic properties. |
| List of Excipients |
|---|
|
Macrogol |
Temelor is packed in Type I (Ph.Eur), clear glass ampoule of 2 ml filling capacity. The ampoules are placed in moulded polyvinyl chloride trays, which are then sealed by a protective PE transparent foil.
The polyvinyl chloride trays are inserted in a carton box together with a leaflet.
Box of 5 and 10 ampoules of 1 ml solution.
Not all pack sizes may be marketed.
Medochemie Iberia, S.A., Rua Jose Maria Nicolau, no 6, 7oB, São Domingos de Benfica, Lisboa 1500 662, Portugal
MA1210/00201
06th August 2019
| Drug | Countries | |
|---|---|---|
| TEMELOR | Cyprus, Estonia, Croatia, Malta, Romania |
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