Canesten Clotrimazole Thrush 1 Day Cream

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Clotrimazole 10%{relative} (Micronised )

Prieinama:

Bayer New Zealand Limited

INN (Tarptautinis Pavadinimas):

Clotrimazole 10% w/w (Micronised )

Dozė:

10 %

Vaisto forma:

Vaginal cream

Sudėtis:

Active: Clotrimazole 10%{relative} (Micronised ) Excipient: Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Isopropyl myristate Polysorbate 60 Purified water Sorbitan stearate

Vienetai pakuotėje:

Tube, aluminium, plus applicator, 5 g

Klasė:

Restricted

Recepto tipas:

Restricted

Pagaminta:

Bayer Hispania SL

Terapinės indikacijos:

Canesten Clotrimazole Thrush Treatment Once, 3 Day and 6 Day creams are indicated for the topical treatment of vulvovaginal candidiasis. Canesten Clotrimazole cream may also be used in conjunction with Canesten Clotrimazole vaginal pessaries 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.

Produkto santrauka:

Package - Contents - Shelf Life: Tube, aluminium, plus applicator - 5 g - 36 months from date of manufacture stored at or below 25°C

Leidimo data:

1994-02-21

Pakuotės lapelis

_Canesten 1 Day Cream CMI _
_8 September 2017_
Consumer Medicine Information
1
CANESTEN
 CLOTRIMAZOLE THRUSH 1 DAY
CREAM
CLOTRIMAZOLE INTERNAL VAGINAL CREAM 100 MG/G
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Canesten
®
Clotrimazole Thrush 1 Day
Cream.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your pharmacist has weighed the
risks of you using
Canesten
®
Clotrimazole Thrush 1 Day Cream against the benefits they expect it
will have for
you.
If you have any concerns about using this treatment, ask your doctor
or pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CANESTEN
® CLOTRIMAZOLE THRUSH 1 DAY CREAM IS USED FOR
Canesten
®
Clotrimazole Thrush 1 Day Cream is used to treat a fungal infection in
the vagina
and vulval area (thrush).
This medicine belongs to a group of medicines called azole
antifungals.
_WHAT IS VAGINAL THRUSH? _
_Candida albicans_ is a yeast fungus that can multiply rapidly and
cause symptoms in the
vagina when other micro-organisms aren’t present in a normal
balance.
Some situations which can increase susceptibility to thrush are:

diabetes

obesity

illness

fatigue

hormonal fluctuations (pregnancy, menstrual cycle, oral contraceptive
pill, HRT
[hormone replacement therapy])

prolonged use of antibiotics or steroids
_Canesten 1 Day Cream CMI _
_8 September 2017_
Consumer Medicine Information
2
Thrush may cause the following symptoms:

vaginal itching

vaginal soreness

a white odourless discharge from the vagina (like cottage cheese)

pain during intercourse
The symptoms below are NOT usually signs of thrush:

abnormal or irregular vaginal bleeding

blood stained discharge

vulva or vaginal sores, ulcers or blisters

lower abdominal pain

pain when passing urine

fever or chills

foul smelling and/or unusual coloured discharge
See your doctor if you experienc

Prekės savybės

_ _
_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