Active ingredients: Cidofovir
Cidofovir Tillomed 75 mg/ml Concentrate for Solution for Infusion.
Concentrate for solution for infusion.
Clear and colourless solution.
The concentrate for solution is adjusted to pH 7.4.
Each ml contains 75 mg cidofovir anhydrous. Each vial contains 375 mg/5 ml cidofovir anhydrous as the active substance.
Excipients with known effect: Each vial contains approximately 2.5 mmol (or 57 mg) sodium per vial (5 ml) as a constituent of the excipients.
For a full list of excipients, see section 6.1.
Cidofovir suppresses HCMV replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of HSV-1, HSV-2 and HCMV DNA polymerases by cidofovir diphosphate, the active intracellular metabolite of cidofovir.
Sodium hydroxide (for pH – adjustment)
Hydrochloric acid (for pH – adjustment)
Water for injections
5 ml clear glass vials with a 5 ml nominal fill volume. The container/closure components include: Type I clear highly resistant borosilicate glass vials, Dark grey bromobutyl rubber stoppers, and aluminium seals with a flip off plastic tab. Each pack contains one 5 ml vial.
Cidofovir 75 mg/ml Concentrate for Solution for Infusion is supplied in single-use vials. Partially used vials should be discarded.
Tillomed Laboratories Limited, 220 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom
PL 11311/0587
10/06/2016