GYNO-PEVARYL Vaginal cream (2016)
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Περιεχόμενα
Name of the medicinal product
Gyno-Pevaryl Cream.
Qualitative and quantitative composition
Each 100 g of cream contains 1 g econazole nitrate (1% w/w). For a full list of excipients, see section 6.1.
Pharmaceutical form
Vaginal cream.
Therapeutic indications
For the treatment of mycotic vulvovaginitis and mycotic balanitis.
Posology and method of administration
Route of Administration For vaginal/penile administration. <u>Females:</u> One applicator full (approximately 5 g) intravaginally once daily at night for not less than 14 days. The cream should also be ...
Contraindications
Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any ingredients of Gyno-Pevaryl cream.
Special warnings and precautions for use
Not for ophthalmic or oral use. Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued. Contact between contraceptive diaphragms or condoms and this product ...
Interaction with other medicinal products and other forms of interaction
Econazole is a known inhibitor of CYP3A4/2C9. Due to the limited systemic availability after vaginal application (see Section 5.2. Pharmacokinetic Properties), clinically relevant interactions are unlikely ...
Fertility, pregnancy and lactation
Pregnancy In animals, econazole nitrate has shown no teratogenic effects but is foetotoxic at high doses. The significance of this to man is unknown as there is no evidence of an increased risk when taken ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The safety of Gyno-Pevaryl Vaginal Cream and Vaginal Pessaries was evaluated in 3630 patients who participated in 32 clinical trials. Based on pooled safety data from these clinical trials, the most commonly ...
Overdose
Adverse events associated with overdose or misuse of Gyno-Pevaryl Cream are expected to be consistent with adverse drug reactions already listed in Section 4.8. (Undesirable effects). In the event of accidental ...
Pharmacodynamic properties
Pharmacotherapeutic classification: (Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives) ATC code: G01A F05 Econazole nitrate has no anti-inflammatory action, ...
Pharmacokinetic properties
Econazole nitrate is poorly absorbed from the vagina and skin. If given orally, peak plasma levels occur six hours after dosing. About 90% of the absorbed dose is bound to plasma proteins. Metabolism is ...
Preclinical safety data
Low neonatal survival and foetal toxicity was associated with high doses. In animal studies, econazole nitrate has shown no teratogenic effects but was foetotoxic in rodents at maternal subcutaneous doses ...
List of excipients
Tefose 63 Labrafil M 1944 CS Mineral oil Butylated hydroxyanisole (E320) Benzoic acid (E210) Purified water
Incompatibilities
None stated.
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Aluminium lacquered tubes. Pack sizes 78 g, 30g, 15g.
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0229
Date of first authorization / renewal of the authorization
22 September 1995 / June 2003
Date of revision of the text
29 July 2016
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