CLOMAZOL Vaginal cream (2022)
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Περιεχόμενα
1. Name of the medicinal product
Clomazol 1% vaginal cream.
Clomazol 2% vaginal cream.
2. Qualitative and quantitative composition
Clomazol 1% vaginal cream contains 10 mg/g (1% w/w) of clotrimazole in a cream base.
Clomazol 2% vaginal cream contains 20 mg/g (2% w/w) of clotrimazole in a cream base.
See section 6.1 for the ful...
3. Pharmaceutical form
Clomazol 1% vaginal cream is presented as a white smooth semi-solid cream.
Clomazol 2% vaginal cream is presented as a white smooth semi-solid cream.
4.1. Therapeutic indications
Clomazol 1% (6-day) and Clomazol 2% (3-day) treatment vaginal creams are indicated for the topical treatment of vulvovaginal candidiasis. Application of the cream to the glans penis of the partner ...
4.2. Posology and method of administration
Clomazol 1% vaginal cream (6-day treatment):
Once daily, preferably in the evening for six successive days, one applicator should be filled with cream (approx. 5 g) and inserted as deeply as possib...
4.3. Contraindications
Hypersensitivity to the active substance, clotrimazole, or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
If the patient has a fever (temperature of 38°C or above), lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal haemorrhage and/or associated shoulder pain the patient ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels, and similarly with sirolimus. Patients should thus...
4.6. Fertility, pregnancy and lactation
Fertility
No human studies of the effects of clotrimazole on fertility have been performed, however animal studies have not demonstrated any effects of the medicine on fertility.
Pregnancy (Categor...
4.7. Effects on ability to drive and use machines
The medication has no or negligible influence on the ability to drive or use machinery.
4.8. Undesirable effects
Frequencies not known. The following adverse reactions have been identified during postapproval use of clotrimazole. Because these reactions are reported voluntarily from a population of uncertain ...
4.9. Overdose
No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorp...
5.1. Pharmacodynamic properties
ATC Code:
G01AF02, antifungals for vaginal use – imidazole and triazole derivatives
Mechanism of action
Azoles (e.g. clotrimazole) are usually recommended for the local treatment of vulvovaginal c...
5.2. Pharmacokinetic properties
Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3 – 10%) is absorbed. Due to the rapid hepatic metabolisation of absorbed clotrimazole ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction...
6.1. List of excipients
Clomazol 1% and 2% Vaginal Cream:
Benzyl alcohol
Cetomacrogol 1000
Cetostearyl alcohol
Dimeticone
Disodium edetate
Glyceryl monostearate
Liquid paraffin
Propylene glycol
Purified water
Whi...
6.2. Incompatibilities
None known.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store at or below 25°C.
6.5. Nature and contents of container
Clomazol 1%:
tube containing 35 g of vaginal cream, 10 mg clotrimazole per gram (1% w/w) packed in a carton with six single-use disposable applicators and patient instruction sheet.
Clomazol 2%:
...
6.6. Special precautions for disposal and other handling
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
7. Marketing authorization holder
Multichem NZ Ltd, Private Bag 93527, Takapuna, AUCKLAND 0740
Telephone: (09) 478 3841
9. Date of first authorization / renewal of the authorization
Date of first approval:
Clomazol 1% vaginal cream - 2/10/2003
Clomazol 2% vaginal cream - 19/06/2008
10. Date of revision of the text
07/07/2022
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