ABIMONO * 1 OV VAG 600MG

ABIMONO * 1 OV VAG 600MG

Therapeutic indications

Fungal vulvovaginal infections also with bacterial superinfection.

Dosage and method of use

Vaginal ovum: 1 egg to be introduced deeply into the vagina. The possibility of a treatment longer than one day must be evaluated by the attending physician.Vaginal cream: one application per day and for one week, unless otherwise prescribed. 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. A 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 section 6.1. Known or suspected hypersensitivity to other antifungal imidazole derivatives.

Side effects

Adverse reactions observed with this type of medication have been reported vaginal burning, irritation and pain, pelvic cramps, rash, headache, dizziness. In these cases it is necessary to suspend the treatment and institute a suitable therapy. The same will be done in the case of non-sensitive 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 drug. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Special warnings

Avoid contact with eyes; it is recommended to wash your hands thoroughly after using the medicine. During the treatment and in the days immediately following it is necessary, to avoid reinfection, to change daily and sterilize by boiling, towels and underwear. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena (see section 4.8). In this case, treatment must be interrupted and appropriate therapy instituted. The simultaneous 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 in conjunction with latex diaphragms or 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 (eg contact dermatitis).

Pregnancy and breastfeeding

Pregnancy In the event of pregnancy, patients should be advised that the applicator for the administration of ABIMONO should be used with caution (see also section 4.2). In pregnant women, the product should be administered in cases of real need, under the direct medical supervision. Breastfeeding It is not known whether isoconazole or isoconazole nitrate is excreted in human milk. A risk to infants cannot be excluded. Fertility Non-clinical data indicate no risk to fertility.

Expiration and retention

Pessaries: Do not store above 30 ° C. Vaginal cream: This medicinal product does not require any special storage conditions.

Interactions with other drugs

Cross-sensitivity reactions are possible between isoconazole, miconazole, econazole and tioconazole. Concomitant treatments with intra-vaginally administered isoconazole nitrate and coumarin-like anticoagulants (for example: warfarin) may increase the plasma levels of the anticoagulant.

Overdose

There are no known cases of overdose.

Active principles

ABIMONO 600 mg vaginal suppositoriesOne egg contains Active ingredient: Isoconazole nitrate 600 mgABIMONO 1% vaginal cream100 g of cream contain: Active ingredient: Isoconazole nitrate 1 g For the full list of excipients, see section 6.1.

Excipients

Ovules: Boric acid, semisynthetic glycerides. Vaginal cream: Sorbitanmonostearate, Polyoxyethylene sorbitanmonostearate, Cetylstearyl alcohol, White Vaseline, Isopropyl myristate, Distilled water.