Active ingredients: Sertaconazole (Sertaconazole nitrate)
SERTAGYN 300 mg egg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
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01.0 NAME OF THE MEDICINAL PRODUCT -
SERTAGYN 300 mg egg
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
An egg contains:
Active ingredient: sertaconazole nitrate 300 mg.
03.0 PHARMACEUTICAL FORM -
Ovule
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Local treatment of clinically established vaginal candidiasis.
04.2 Posology and method of administration -
Introduce the egg deeply into the vagina, preferably in the supine position, in the evening at bedtime. The treatment involves a single administration.
In case of persistence of the symptoms, a second egg can be introduced after 7 days.
04.3 Contraindications -
Hypersensitivity to components or other closely related substances from a chemical point of view. In particular towards the antifungals of the imidazole group.
Generally contraindicated in pregnancy and lactation (see section "Pregnancy and lactation").
04.4 Special warnings and appropriate precautions for use -
In the case of candidiasis also involving the vulvar and / or perianal areas, it is recommended to combine the therapy with sertaconazole in ovules for vaginal use with local treatment with another antifungal.
In order to prevent reinfections with the so-called ping-pong mechanism, treatment of the partner with antifungals is also essential.
For local hygiene we recommend the use of soaps with neutral or alkaline pH, as soaps with acidic pH can favor the proliferation of Candida.
In case of local intolerance or allergic reaction, the treatment must be interrupted and the removal of the residual product can be carried out by vaginal irrigations.
Use of the product may interfere with the efficacy of latex contraceptive devices (condoms and diaphragms), as it can cause them to break.
The product can also be used in the menstrual period.
04.5 Interactions with other medicinal products and other forms of interaction -
The concomitant use of spermicides is not recommended, as the product can reduce or inactivate their contraceptive activity.
04.6 Pregnancy and breastfeeding -
Imidazole antifungals, despite their minimal systemic absorption, are generally not recommended during pregnancy as adverse fetal effects have been reported in animal studies.
However, studies carried out with sertaconazole on various animal species have not shown embryotoxic and / or teratogenic effects.
There are no adequate and well-controlled studies on the use of the drug in pregnancy or lactation. Therefore, the medicine should be used only in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.
04.7 Effects on ability to drive and use machines -
None known.
04.8 Undesirable effects -
Rarely have been reported manifestations of local intolerance, such as a burning sensation or itching, which usually resolved spontaneously.
Allergy phenomena are possible.
An increase in liver enzymes has rarely been reported.
04.9 Overdose -
Phenomena related to drug overdose are not foreseeable.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Sertaconazole is a new topical antifungal belonging to the class of imidazoles, with a broad spectrum of activity.
In vitro it has been shown to be active on yeasts of the genus Candida, such as C. albicans, C. pseudotropicalis, C. parapsilosis, C. glabrata.
The mechanism of action is expressed through a mycostatic and fungicidal activity determined by the inhibition of the synthesis of ergosterol and by the alteration of the permeability mechanisms of the cell membrane.
The antifungal activity has been confirmed in vivo on classical animal models. Furthermore, sertaconazole has also been shown to be active on Gram + bacteria (staphylococci and streptococci) involved in infections of the mucous membranes and skin.
05.2 "Pharmacokinetic properties -
After application of the labeled product on the vaginal mucosa in two different animal species, the systemic absorption of the drug was null or almost absent.
Furthermore, after administration, in healthy women and in women with vaginal candidiasis, of marked or cold sertaconazole, in ova, plasma concentrations always lower than the limit of determination of the analytical methods used were found.
05.3 Preclinical safety data -
Long-term toxicity studies conducted in various animal species have shown modest toxicity for sertaconazole, qualitatively identical to that of other imidazole antifungals and, in any case, at plasma rates significantly higher than those achievable in women after vaginal administration.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Solid semisynthetic glycerides (WITEPSOL H19), solid semisynthetic glycerides (SUPPOCIRE NAI-50), anhydrous colloidal silica.
06.2 Incompatibility "-
Local vaginal treatments can inactivate local contraception with spermicides.
06.3 Period of validity "-
3 years when properly stored intact packaging.
06.4 Special precautions for storage -
Do not store above 30 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Carton containing 1 egg in a white PVC / PE cell.
06.6 Instructions for use and handling -
None in particular.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
SHIRE ITALIA S.p.A.
Riviera Francia, 3 / A - 35127 Padua
08.0 MARKETING AUTHORIZATION NUMBER -
AIC n. 033928019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
19/06/2000
10.0 DATE OF REVISION OF THE TEXT -
June 2000
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