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SPC, UK: CANESTEN THRUSH INTERNAL CREAM 10% w/w Vaginal cream (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Canesten Thrush Internal Cream 10% w/w vaginal cream.

Qualitative and quantitative composition

Clotrimazole 10% w/w. Excipients with known effects: cetostearyl alcohol. For the full list of excipients, see 6.1.

Pharmaceutical form

Vaginal cream.

Therapeutic indications

Canesten Thrush Internal Cream is indicated for the treatment of candidal vaginitis.

Posology and method of administration

The cream should be administered intravaginally using the applicator supplied. Adults The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at ...

Contraindications

Hypersensitivity to clotrimazole or any other excipients listed in section 6.1.

Special warnings and precautions for use

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis. Before using Canesten Thrush Internal Cream, medical advice must be sought if any of ...

Interaction with other medicinal products and other forms of interaction

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be ...

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 drug on fertility. Pregnancy There are limited ...

Effects on ability to drive and use machines

The medication has no or negligible influence on the ability to drive or use machinery.

Undesirable effects

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible. Immune system disorders: allergic reaction (syncope, hypotension, ...

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) ...

Pharmacodynamic properties

Pharmacotherapeutic group: Gynaecological antiinfectives and antiseptics – imidazole derivatives ATC Code: G01AF02 Mechanism of Action Clotrimazole acts against fungi by inhibiting ergosterol synthesis. ...

Pharmacokinetic properties

Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3–10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity and carcinogenicity. Clotrimazole was not teratogenic in reproductive toxicity studies in ...

List of excipients

Sorbitan stearate Polysorbate 60 Cetyl palmitate Cetostearyl alcohol Isopropyl myristate Benzyl alcohol Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

A single dose applicator consisting of a body of HDPE, piston of LDPE, cap of LDPE, with a separate plunger of polystyrene. One applicator is contained in a blister pack. Pack size 5g.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization number(s)

PL 0010/0654

Date of first authorization / renewal of the authorization

07/01/2016

Date of revision of the text

22/01/2018

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