Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Temodal 5 mg hard capsules.
| Pharmaceutical Form |
|---|
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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. |
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 Capsule shell Gelatin, Printing ink: Shellac |
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.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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
| 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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