Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Cymevene 500 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). White to off-white solid cake. |
Each vial contains 500 mg of ganciclovir (as ganciclovir sodium).
After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir.
Excipient(s) with known effect: approximately 43 mg (2 mEq) sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ganciclovir |
Ganciclovir, 9-(1,3-dihydroxy-2-propoxymethyl)guanine or DHPG, is a broadspectrum virustatic agent which inhibits the replication of viruses, including viruses of the herpes group, both in vivo and in vitro: herpes simplex types 1 and 2 (HSV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes zoster (HZV). |
| List of Excipients |
|---|
|
Sodium hydroxide (for pH-adjustment) |
Single-dose glass vials of 10 mL with fluoro-resin laminated/siliconised rubber stopper and aluminum closure with flip-off cap.
Available in packs of 1 vial or 5 vials.
Not all pack sizes may be marketed.
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
PL 27041/0013
Date of first authorisation: 15 June 1988
Date of latest renewal: 28 April 2016
| Drug | Countries | |
|---|---|---|
| CYMEVENE | Austria, Australia, Brazil, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa |
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