GYNO-DAKTARIN Vaginal cream (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Gyno-Daktarin 20mg/g vaginal cream.
Qualitative and quantitative composition
Miconazole nitrate 2% w/w. (Each gram of cream contains 20mg miconazole nitrate) Excipients: Each gram of cream contains 2mg benzoic acid and 5 micrograms of butylated hydroxyanisole. For a full list of ...
Pharmaceutical form
Vaginal cream. The cream is white and homogeneous.
Therapeutic indications
For the local treatment of vulvovaginal candidosis and superinfections due to gram-positive bacteria.
Posology and method of administration
Gyno-Daktarin vaginal cream is for vaginal administration. Adults (aged 18 years and older) Administer the contents of one applicator (about 5g of cream) once daily before bedtime deeply into vagina for ...
Contraindications
Gyno-Daktarin vaginal cream is contraindicated in individuals with a known hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives or to any of the excipients listed in section 6.1. ...
Special warnings and precautions for use
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Gyno-Daktarin vaginal cream and with other miconazole formulations (see section 4.8). If ...
Interaction with other medicinal products and other forms of interaction
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients ...
Pregnancy and lactation
Pregnancy Although intravaginal absorption is limited, Gyno-Daktarin vaginal cream should be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The safety of GYNO-DAKTARIN was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g. vulvovaginal itching, burning/irritation), or signs of vulvar erythema, ...
Overdose
Symptoms In case of accidental ingestion, vomiting and diarrhoea may occur. Treatment In case of accidental ingestion, the treatment is symptomatic and supportive.
Pharmacodynamic properties
Pharmacotherapeutic classification: Anti-infectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives ATC code: G01AF04 Miconazole combines a potent antifungal activity against ...
Pharmacokinetic properties
Absorption Miconazole persists in the vagina for up to 72 hours after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1 to 2% following ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.
List of excipients
PEG-6, PEG-32 and glycol stearate Oleoyl macroglycerides Liquid paraffin Benzoic acid (E210) Butylated hydroxyanisole (E320) Purified water
Incompatibilities
None known.
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Tube containing 15 g, 40 g or 78 g of cream. The aluminium tube inner is lined with heat polymerised epoxy-phenol resin with a white polypropylene cap. The cream is supplied with disposable cardboard vaginal ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0015
Date of first authorization / renewal of the authorization
12 December 2008
Date of revision of the text
31 October 2018
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