GYNOXIN Vaginal cream (2010)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Gynoxin 2% vaginal cream.
Qualitative and quantitative composition
Gynoxin contains 20 mg of the active ingredient fenticonazole nitrate in 1 g of cream. For excipients, see 6.1.
Pharmaceutical form
Vaginal cream. White homogenous cream.
Therapeutic indications
Treatment of vulvovaginal candidiasis.
Posology and method of administration
Route of Administration Intravaginal. Adults One applicator full (about 5 g) is administered into the vagina by a re-usable applicator (morning and evening for three days). Gynoxin is not greasy, does ...
Contraindications
Ascertained hypersensitive to the product and to other imidazole derivatives.
Special warnings and precautions for use
The product should not be used in conjunction with barrier contraceptives. In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and the physician ...
Interaction with other medicinal products and other forms of interaction
Not investigated. Since systemic absorption of fenticonazole after application is low, interactions with other drugs are unlikely.
Pregnancy and lactation
Oral administration of fenticonazole in rats has been reported to produce prolonged gestation and embryotoxic effects after doses above 40mg/kg/day. Fenticonazole does not interfere with the function of ...
Effects on ability to drive and use machines
None.
Undesirable effects
After intravaginal administration slight transient burning, which usually disappears rapidly, may occasionally occur. Prolonged topical application may cause sensitisation reactions.
Overdose
Because of the low systemic absorption after vaginal application, overdosage is unlikely. In case of a suspected accidental oral ingestion emesis should be induced or gastric lavage may be attempted. Irrespective ...
Pharmacodynamic properties
ATC code: G01AF12 Fenticonazole is a broad-spectrum antimycotic agent. In vitro: high fungistatic and fungicidal activity against Candida albicans In vivo: healing of vaginal mycoses due to Candida within ...
Pharmacokinetic properties
Pharmacokinetic studies in humans have shown that systemic absorption of fenticonazole nitrate after vaginal administration is minimal.
Preclinical safety data
LD<sub>50</sub> mice: oral>3000mg/kg; i.p 1276mg/kg (M), 1265mg/kg (F) LD<sub>50</sub> rats: oral>3000mg/kg; s.c>750mg/kg; i.p. 440mg/kg (M), 309mg/kg (F) Chronic toxicity: following oral administration ...
List of excipients
Propylene glycol Wool fat, hydrogenated Almond oil Polyglycolic ester of fatty acids Cetyl alcohol Glyceryl monostearate Sodium edetate Purified water
Incompatibilities
None.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Store in the original container.
Nature and contents of container
Epoxy-lined blind-end aluminium tubes with a low density polyethylene screw cap, plus polyethylene applicator. Pack size: 1 30 g.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Recordati Industria Chimica e Farmaceutica SpA, Via Matteo Civitali, 1-20148, Milano, Italy
Marketing authorization number(s)
PL 04595/0006
Date of first authorization / renewal of the authorization
22/09/99
Date of revision of the text
30/09/2010
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