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Canesten 100mg Pessary (2010)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Bayer plc
Διεύθυνση Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
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Name of the medicinal product

Canesten 100mg Pessary.

Qualitative and quantitative composition

Clotrimazole 100mg. For excipients, see 6.1

Pharmaceutical form

Pessary.

Therapeutic indications

Canesten 100mg Pessaries are recommended for the treatment of candidal vaginitis.

Posology and method of administration

The pessaries should be inserted into the vagina, as high as possible, using the applicator provided. This is best achieved when lying back with legs bent up. Adults: Two pessaries should be inserted daily ...

Contraindications

Hypersensitivity to clotrimazole or any other ingredient in this medicine.

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 100mg Pessaries, medical advice must be sought if any of the ...

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 ...

Use during pregnancy and lactation

Data on a large number of exposed pregnancies indicate no adverse effects of Clotrimazole on pregnancy or on the health of the foetus/newborn child. To date, no relevant epidemiological data are available. ...

Effects on ability to drive and use machines

Not applicable.

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

In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). It should ...

Pharmacodynamic properties

ATC Code: G01AF02 Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity. Mechanism of Action Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition ...

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

There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SPC.

List of excipients

Calcium lactate pentahydrate Maize starch Crospovidone Silica, colloidal anhydrous Lactic acid Lactose Monohydrate Magnesium Stearate Hypromellose Cellulose, microcrystalline

Incompatibilities

Not applicable.

Shelf life

48 months.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

Six pessaries are packed in a blister pack (foil 25µm PA + 45µm Al soft + 60µm PVC) sealed with aluminium backing foil (foil 20µm Al hard + 7g/m² HSL sealable to PVC/PVDC). An applicator is also provided. ...

Special precautions for disposal and other handling

Pull out plunger A until it stops. Place pessary into the applicator. Insert applicator containing the pessary carefully as deeply as is comfortable into the vagina. (This is best done with the patient ...

Marketing authorization holder

Bayer plc Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA Trading as: Bayer plc, Consumer Care Division

Marketing authorization number(s)

PL 0010/0015R

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 August 1988 Date of last renewal of authorisation: 17 February 1999

Date of revision of the text

12/08/2010
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