TEMODAL Hard capsule Ref.[8449] Active ingredients: Temozolomide

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Temodal 5 mg hard capsules.

Pharmaceutical Form

Hard capsule (capsule).

The hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink. The cap is imprinted with “Temodal”. The body is imprinted with “5 mg”, the Schering-Plough logo and two stripes.

Qualitative and quantitative composition

Each hard capsule contains 5 mg temozolomide.

Excipient with known effect: Each hard capsule contains 132.8 mg of anhydrous lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Temozolomide

Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC). The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position. Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.

List of Excipients

Capsule content:

Anhydrous lactose
Colloidal anhydrous silica
Sodium starch glycolate type A
Tartaric acid
Stearic acid

Capsule shell

Gelatin,
Titanium dioxide (E 171)
Sodium laurilsulfate
Yellow iron oxide (E 172)
Indigo carmine (E 132)

Printing ink:

Shellac
Propylene glycol
Purified water
Ammonium hydroxide
Potassium hydroxide
Black iron oxide (E172)

Pack sizes and marketing

Bottle presentation: Type I amber glass bottles with polypropylene child-resistant closures containing 5 or 20 hard capsules. The carton contains one bottle.

Sachet presentation: Sachets are composed of linear low density polyethylene (innermost layer), aluminium and polyethylene terephthalate. Each sachet contains 1 hard capsule and is dispensed in a cardboard carton. The carton contains 5 or 20 hard capsules, individually sealed in sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/98/096/001
EU/1/98/096/002
EU/1/98/096/024
EU/1/98/096/025

Date of first authorisation: 26 January 1999
Date of latest renewal: 26 January 2009

Drugs

Drug Countries
TEMODAL Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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