TEMELOR Solution for injection Ref.[50422] Active ingredients: Lorazepam

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

Product name and form

Temelor 4 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

A clear, colourless or almost colourless hypertonic solution, free from visible particles.

Qualitative and quantitative composition

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
Benzyl alcohol
Propylene glycol

Pack sizes and marketing

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.

Marketing authorization holder

Medochemie Iberia, S.A., Rua Jose Maria Nicolau, no 6, 7oB, São Domingos de Benfica, Lisboa 1500 662, Portugal

Marketing authorization dates and numbers

MA1210/00201

06th August 2019

Drugs

Drug Countries
TEMELOR Cyprus, Estonia, Malta, Romania

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