CLOMAZOL Vaginal cream (2022)

Βιβλιογραφική αναφορά

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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 full list ...

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 may ...

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 possible ...

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 should ...

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 be ...

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 (Category A) ...

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 size, ...

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 absorption) ...

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 ...

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 into ...

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 and ...

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 White soft ...

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 ...

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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