Canesten Clotrimazole Thrush Treatment Once Soft Vaginal Pessary + Cream

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Clotrimazole 500mg (Micronised); Clotrimazole 10 mg/g

MAH:

Bayer New Zealand Limited

INN:

Clotrimazole 500 mg (Micronised)

pharmaceutical_form:

Combination

composition:

Active: Clotrimazole 500mg (Micronised) Excipient: Gelatin Glycerol Liquid paraffin Purified water Quinoline yellow Sunset yellow FCF Titanium dioxide White soft paraffin Active: Clotrimazole 10 mg/g Excipient: Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Octyldodecanol Polysorbate 60 Purified water Sorbitan stearate

units_in_package:

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

class:

Restricted

prescription_type:

Restricted

manufactured_by:

Bayer Hispania SL

therapeutic_indication:

Canesten Clotrimazole Thrush Treatment Once Pessary + Cream is indicated for the topical treatment of vulvovaginal candidiasis. The cream can also be used in the management of Candida vulvovaginitis or infection of the peri-anal area, while application of the cream to the glans penis of the partner may help prevent re-infection of the female.

leaflet_short:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/PVC blister with aluminium foil lid with heat sealing lacquer - 1 pessaries - 0 months Not applicable - Combination pack, 1 pessary + 10g tube - 1 dose units - 36 months from date of manufacture stored at or below 30°C - Tube, Aluminim tube with polyethylene cap with spike - 10 g - 0 months Not applicable

authorization_date:

2011-02-10

SPC

_ _
_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