KRATIUM Tablet Ref.[27828] Active ingredients: Diazepam

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: Medochemie Ltd, p.o box 51409, Limassol, CY – 3505, Cyprus

Product name and form

KRATIUM.

Pharmaceutical Form

Kratium 2mg: white, round, flat, scored tablets embossed MC with 8mm diameter.

Kratium 5mg: yellow, round, flat, scored tablets embossed “MC” or “5” with 8mm diameter.

Kratium 10mg: Blue, round, flat, scored tablets with diameter 8mm.

Qualitative and quantitative composition

Each tablet contains diazepam 2, 5 or 10mg.

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

Kratium 2mg contains the following excipients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch and magnesium stearate.

Kratium 5mg contains the following excipients: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, magnesium stearate, croscarmellose sodium, colloidal silicon dioxide, tartrazine yellow lake (E102).

Kratium 10mg contains the following excipients: lactose monohydrate, pregelatinised starch, colloidal silicon dioxide, indigo carmine lake (E132) and magnesium stearate.

Pack sizes and marketing

Kratium tablets 2mg are packed in PVC foil and Aluminium foil, packs of 40 tabs are available. PVC securitainers of 1000 tablets are also available.

Kratium tablets 5mg are packed in PVC foil and Aluminium foil, packs of 40 are available. PVC securitainers of 1000 tablets are also available.

Kratium tablets 10mg are packed in PVC foil and Aluminium foil, packs of 30, 40 and 100tablets are available. PVC securitainers of 1000 tablets are also available.

Marketing authorization holder

Medochemie Ltd, p.o box 51409, Limassol, CY – 3505, Cyprus

Marketing authorization dates and numbers

Kratium 2mg: 19844
Kratium 5mg: 19976
Kratium 10mg: 19868

Kratium 2mg: 19/12/2005
Kratium 5mg: 20/12/2005
Kratium 10mg: 29/12/2005

Drugs

Drug Countries
KRATIUM Cyprus, Hong Kong, Malta

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