Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Gyno-Daktarin 20mg/g vaginal cream.
| Pharmaceutical Form |
|---|
|
Vaginal cream. The cream is white and homogeneous. |
Miconazole nitrate 2% w/w.
(Each gram of cream contains 20mg miconazole nitrate)
Excipients: Each gram of cream contains 2mg benzoic acid and 5 micrograms of butylated hydroxyanisole.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Miconazole |
Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis. |
| List of Excipients |
|---|
|
PEG-6, PEG-32 and glycol stearate |
Tube containing 15 g, 40 g or 78 g of cream.
The aluminium tube inner is lined with heat polymerised epoxy-phenol resin with a white polypropylene cap.
The cream is supplied with disposable cardboard vaginal applicators.
* Not all pack sizes are marketed.
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
PL 00242/0015
12 December 2008
| Drug | Countries | |
|---|---|---|
| DAKTARIN | Austria, Australia, Brazil, Cyprus, Germany, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa | |
| GYNO-DAKTARIN | Cyprus, Finland, Ireland, Mexico, Netherlands, United Kingdom, South Africa |
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