Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Temodal 2.5 mg/ml powder for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for infusion. White powder. |
Each vial contains 100 mg of temozolomide.
After reconstitution, 1 ml solution for infusion contains 2.5 mg temozolomide.
Excipient with known effect: Each vial contains 2.4 mmol sodium.
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 |
|---|
|
Mannitol (E421) |
Clear type I glass vial sealed with bromobutyl rubber stopper and aluminium overseal with peach-coloured flip-off bonnet. Each vial contains 100 mg TMZ.
Temodal 2.5 mg/ml is supplied as a pack of 1 vial.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/98/096/023
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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