WARIMAZOL VAG 1% Vaginal cream (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

WARIMAZOL VAG 1%, vaginal cream.

2. Qualitative and quantitative composition

1 g of WARIMAZOL VAG 1%, vaginal cream, contains 10 mg clotrimazole. Excipients with known effect: Contains cetostearyl alcohol (see section 4.4). For a full list of excipients, see section 6.1. ...

3. Pharmaceutical form

Vaginal cream.

4.1. Therapeutic indications

Inflammation of the vagina and discharge caused by fungi usually Candida as well as superinfections by Clotrimazole-sensitive bacteria.

4.2. Posology and method of administration

Posology Unless otherwise prescribed, one applicator filling (approx. 5 g) per day – in the evening on 6 consecutive days – is emptied as deeply as possible into the vagina. If necessary, a second course ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

In the first third of pregnancy, vaginal creams should only be used under special precaution and previous consideration of possible alternative therapeutics (see also section 4.2). Using the applicator ...

4.5. Interaction with other medicinal products and other forms of interaction

Clotrimazole reduces the efficacy of amphotericin and other polyene antibiotics (e. g. nystatin, natamycin). Dexamethasone in high doses can possibly reduce the efficacy of clotrimazole.

4.6. Pregnancy and lactation

In the first third of pregnancy, vaginal creams and vaginal tablets should only be used under special precaution and previous consideration of possible alternative therapeutics (see also section 4.2, 4.4). ...

4.7. Effects on ability to drive and use machines

There are no experiences available regarding effects on ability to drive and use machines.

4.8. Undesirable effects

When evaluating side effects, the following definitions are taken as a basis: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare (<1/10000), ...

4.9. Overdose

Not known.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Imidazole derivative, Broad-spectrum antimycotic for topical use ATC-Code: G01AF02 Clotrimazole is a chlorine substituted triphenylmethyl-imidazole belonging to ...

5.2. Pharmacokinetic properties

Applying it topically a namable systemic availability can be excluded even under unfavorable conditions (skin lesions, occlusive bandage). The concentration of clotrimazole when it is applied on the skin ...

5.3. Preclinical safety data

a) Data for topical tolerance: The tests regarding tolerance of clotrimazole were carried out on albino rabbits using a cream (1% clotrimazole in standard oil-in-water emulsion) and a solution (1% clotrimazole ...

6.1. List of excipients

Sorbitan stearate Polysorbate 60 Cetyl esters wax (= synthetic cetaceum) Cetostearyl alcohol Benzyl alcohol 2-octyl-1-dodecanol Purified water

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Not to be stored above 30°C.

6.5. Nature and contents of container

Aluminum tube, containing 35 g cream (1% clotrimazole) and 6 applicators.

6.6. Special precautions for disposal and other handling

No special precautions.

7. Marketing authorization holder

COSTAKIS TSISIOS & CO. LTD, 22, Filopoimenos street, 4002 Mesa Geitonia, Limassol, Cyprus

8. Marketing authorization number(s)

16168

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 28 June 1995 Date of latest renewal: 06 September 2011

10. Date of revision of the text

05/11/2021

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