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Therapeutic indications
Mycotic vulvovaginal infections also with bacterial superinfection.
Dosage and method of use
Vaginal ovum: 1 egg to be inserted deeply into the vagina. The possibility of treatment lasting more than one day must be evaluated by the attending physician.Vaginal cream: one application per day for one week, unless otherwise prescribed by a doctor. The applicator filled with cream must be introduced deeply into the vagina, emptied into the cavity and then thrown away after use. Treatment should not be carried out during menstruation. Simultaneous use of ABIMONO dermatological cream by the partner is recommended. Using the disposable applicator: • Remove the tube cap and screw the applicator onto the tube. • Push the plunger progressively to the stop position. • Fill the applicator by applying light pressure on the tube. • Remove the applicator from the tube and replace the cap. • Introduce the filled applicator deeply into the vagina and empty it into the cavity, pushing the plunger.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Known or presumed hypersensitivity to other imidazole antifungal derivatives.
Side effects
The adverse reactions observed with this type of medicines have been reported burning, vaginal irritation and pain, pelvic cramps, skin rashes, headache, dizziness. In these cases it is necessary to suspend treatment and institute suitable therapy. The same will be done in the case of non-susceptible microorganisms.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important. as it allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa
Special warnings
Avoid contact with eyes; it is recommended to wash your hands thoroughly after using the medicine. During treatment and in the days immediately following it is necessary, to avoid reinfection, to change towels and underwear daily and sterilize them by boiling. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena (see paragraph 4.8). In this case treatment must be interrupted and appropriate therapy instituted. Concomitant use of latex condoms or diaphragms with vaginal antimicrobial preparations may decrease the effectiveness of the latex contraceptive. Therefore, products such as ABIMONO should not be used together with diaphragms or latex condoms. Patients using spermicides should consult their doctor as any local vaginal treatment can make the spermicide inactive. The vaginal cream contains cetostearyl alcohol as an excipient which can cause local skin reactions (e.g. contact dermatitis).
Pregnancy and breastfeeding
Pregnancy In case of pregnancy, patients must be informed that the applicator for the administration of ABIMONO must be used with caution (see also section 4.2). In pregnant women, the product should be administered in cases of actual need, under the direct medical supervision. Breast-feeding It is not known whether isoconazole or isoconazole nitrate is excreted in breast milk. The risk to infants cannot be excluded. Fertility Preclinical data do not indicate risks for fertility.
Expiration and conservation
Ovules: Do not store above 30°C Vaginal cream: This medicinal product does not require any particular storage conditions.
Interactions with other drugs
Cross-sensitivity reactions between isoconazole, miconazole, econazole and tioconazole are possible. Concomitant treatments with isoconazole nitrate administered intravaginally and coumarin-type anticoagulants (for example: warfarin) may increase plasma levels of the anticoagulant.
Overdose
There are no known cases of overdose.
Active principles
ABIMONO 600 mg vaginal ovulesOne egg contains Active ingredient: Isoconazole nitrate 600 mgABIMONO 1% vaginal cream100 g of cream contains: Active ingredient: Isoconazole nitrate 1 g For the complete list of excipients, see section 6.1.
Excipients
Ovules: Boric Acid, Semi-synthetic glycerides. Vaginal cream: Sorbitan monostearate, Polyoxyethylene sorbitan monostearate, Cetylstearyl alcohol, White petrolatum, Isopropyl myristate, Distilled water.