Canesten Clotrimazole Thrush Treatment Once Soft Vaginal Pessary

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Clotrimazole 500mg (micronised)

Commercializzato da:

Bayer New Zealand Limited

INN (Nome Internazionale):

Clotrimazole 500 mg (micronised)

Dosaggio:

500 mg

Forma farmaceutica:

Pessary

Composizione:

Active: Clotrimazole 500mg (micronised) Excipient: Gelatin Glycerol Liquid paraffin Purified water Quinoline yellow Sunset yellow FCF Titanium dioxide White soft paraffin

Confezione:

Blister pack, PVC/PVdC/PVC blister with aluminium foil lid with heat sealing lacquer, 1 pessary

Classe:

Restricted

Tipo di ricetta:

Restricted

Prodotto da:

Bayer Hispania SL

Indicazioni terapeutiche:

Canesten Clotrimazole Thrush Treatment Once and 6 Day vaginal pessaries are indicated for the topical treatment of vaginal candidiasis.

Dettagli prodotto:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/PVC blister with aluminium foil lid with heat sealing lacquer - 1 pessaries - 36 months from date of manufacture stored at or below 30°C

Data dell'autorizzazione:

2011-02-10

Scheda tecnica

_ _
_Canesten Data Sheet _
_4 April 2022_
NEW ZEALAND DATA SHEET
Page 1 of 9
RESTRICTED
CANESTEN
®
CANESTEN CLOTRIMAZOLE THRUSH 6 DAY CREAM, INTERNAL VAGINAL CREAM 10
MG/G (1%)
CANESTEN CLOTRIMAZOLE THRUSH 3 DAY CREAM, INTERNAL VAGINAL CREAM 20
MG/G (2%)
CANESTEN CLOTRIMAZOLE THRUSH 1 DAY CREAM, INTERNAL VAGINAL CREAM 100
MG/G (10%)
CANESTEN CLOTRIMAZOLE THRUSH 6 DAY PESSARY, VAGINAL PESSARY 100 MG
CANESTEN CLOTRIMAZOLE THRUSH 1 DAY PESSARY, VAGINAL PESSARY 500 MG
CANESTEN CLOTRIMAZOLE THRUSH 1 DAY PESSARY & CREAM, VAGINAL PESSARY
500 MG +
TOPICAL CREAM 10 MG/G (1%)
1.
NAME OF THE MEDICINAL PRODUCT
Clotrimazole
1-(o-chloro- α, α - diphenylbenzyl) imidazole
C
22
H
17
ClN
2
Molecular Weight 344.84
Clotrimazole is a colourless, crystalline, weakly alkaline substance,
melting point 141°- 145°C, soluble in
acetone, chloroform and ethanol and practically insoluble in water. It
forms stable salts with both organic and
inorganic acids. It is not photosensitive but is slightly hygroscopic,
and may be hydrolysed in acid media.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT
All formulations: clotrimazole
_Canesten Data Sheet _
_4 April 2022_
Page 2 of 9
RESTRICTED
QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT
Canesten Clotrimazole Thrush 6 Day Cream contains 10 mg/g (1% w/w) of
clotrimazole in a vanishing cream
base.
Canesten Clotrimazole Thrush 3 Day Cream contains 20 mg/g (2% w/w) of
clotrimazole in a vanishing cream
base.
Canesten Clotrimazole Thrush 1 Day Cream contains 100 mg/g (10% w/w)
of clotrimazole in a vanishing cream
base
Canesten Clotrimazole Thrush 6 Day Pessary contains 100 mg of
clotrimazole in each pessary.
Canesten Clotrimazole Thrush 1 Day Pessary contains 500 mg of
clotrimazole in each pessary.
Canesten Clotrimazole Thrush 1 Day Pessary & Cream contains 500 mg of
clotrimazole in each pessary and 10
mg/g clotrimazole in the cream.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
CANESTEN CLOTRIMAZOLE THRUSH 6 DA