Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα
®
 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

GYNO-DAKTARIN Vaginal cream (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: