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VISTIDE Concentrate for solution for infusion (2017)

Active ingredients: Cidofovir

Product Name and Form

Cidofovir Tillomed 75 mg/ml Concentrate for Solution for Infusion.

Pharmaceutical form

Concentrate for solution for infusion.

Clear and colourless solution.

The concentrate for solution is adjusted to pH 7.4.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Cidofovir

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.

List of excipients

Sodium hydroxide (for pH – adjustment)
Hydrochloric acid (for pH – adjustment)
Water for injections

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Tillomed Laboratories Limited, 220 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom

10/06/2016

Marketing authorization number:

PL 11311/0587