GYNO-PEVARYL Vaginal Pessaries (2016)
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Περιεχόμενα
Name of the medicinal product
GYNO-PEVARYL 150 mg Vaginal Pessaries.
Qualitative and quantitative composition
Vaginal pessaries each containing 150 mg econazole nitrate. For a full list of excipients, see section 6.1.
Pharmaceutical form
White to off-white torpedo-shaped pessaries.
Therapeutic indications
Vaginitis due to Candida albicans and other yeasts.
Posology and method of administration
For vaginal administration. Adults One pessary should be inserted high into the vagina each evening for three consecutive days. Pregnant women should thoroughly wash their hands before self-administering ...
Contraindications
Hypersensitivity to any imidazole preparation, other vaginal antifungal products, or to any ingredients of Gyno-Pevaryl 150mg vaginal pessaries.
Special warnings and precautions for use
For intravaginal use only. This preparation is not for oral use. Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued. Contact between contraceptive diaphragms ...
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 Vaginal Pessaries are expected to be consistent with adverse drug reactions already listed in Section 4.8. (Undesirable effects). In the ...
Pharmacodynamic properties
Pharmacotherapeutic classification: (Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives) ATC code: G01AF05 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
Wecobee M Wecobee FS
Incompatibilities
None stated.
Shelf life
Three years.
Special precautions for storage
Do not store above 30°C. Keep out of reach and sight of children.
Nature and contents of container
Available in PVC/PE strips containing three pessaries.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0227
Date of first authorization / renewal of the authorization
1st October 1995 / June 2003
Date of revision of the text
29 July 2016
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