KRATIUM Solution for injection/infusion Ref.[27829] Active ingredients: Diazepam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Kratium 10mg/2ml solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion.

Clear, colourless to light yellow solution for injection/infusion.

Qualitative and quantitative composition

Each 2ml of solution contain 10 mg of diazepam.

Excipients with known effect: benzyl alcohol. Each ml of Kratium contains 20 mg benzyl alcohol.

For the full list of excipients see section 6.1.

Active Ingredient Description
Diazepam

Diazepam is a psychotropic substance from the class of 1,4-benzodiazepines with marked properties of suppression of tension, agitation and anxiety as well as sedative and hypnotic effects. In addition, diazepam demonstrates muscle relaxant and anticonvulsive properties. It is used in the short-term treatment of anxiety and tension states, as a sedative and premedicant, in the control of muscle spasm and in the management of alcohol withdrawal symptoms.

List of Excipients

Propylene glycol EP
Sodium Benzoate EP
Benzoic acid EP
Benzyl alcohol EP
Water for injection EP

Pack sizes and marketing

Type I, 2 ml amber ampoules (primary package).

Boxes of 10 ampoules (2 blisters x 5 ampoules) and 100 ampoules (20 blisters x 5 ampoules).

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

20767

29/09/2010

Drugs

Drug Countries
KRATIUM Cyprus, Hong Kong, Malta

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.