GANAZOLO 6 OV VAG 150MG

GANAZOLO

active ingredients

GANAZOLO 10 mg/g vaginal cream 1 g cream contains: Active ingredient: Econazole nitrate 10 mg Eccipients with known effects: propylene glycol 100 mg; methyl p-hydroxybenzoate 1.5 mg; propile p-hydroxybenzoate 0.8 mg. For the full list of excipients see paragraph 6.1 GANAZOLO 150 mg eggs Each egg contains: Active ingredient: Econazole nitrate 150 mg. For the full list of excipients see paragraph 6.1 GANAZOLO 1 mg/ml vaginal solution Each 150 ml bottle contains: Active ingredient: Econazole 150 mg. Excipients with known effects: propylene glycol 10 g; methyl p-hydroxybenzoate 0.20 mg; propile p-hydroxybenzoate 0.02 mg. For the full list of excipients see paragraph 6.1

Excellent

Ganazole 10 mg/g Vaginal cream: Exterior Polyglycolic of saturated fatty acids - Propilene glycol- P-hydroxybenzoate - Propile pidrossibenzoato - deionized water. Ganazole 150 mg eggs: Semisynthetic triglycerides. Ganazole 1 mg/ml vaginal solution: Glycol propylene - Lactic acid - P-hydroxybenzoate methyl - P-hydroxybenzoate propylene - P-toluensulphonate methylcetylammonium - Lavender Perfume - deionized water.

Therapeutic indications

GANAZOLO 10 mg/g vaginal cream GANAZOLO 150 mg ovuli vulvovaginal mycosis, mycotic Balanitis. GANAZOLO 1 mg/ml vaginal solution Helpful in the therapy of vulvovaginal affections of mycotic origin and/or bacterial sensitive to chemotherapy.

Contraindications

Hypersensitivity to the active ingredient or other substances related to the chemical or any of the excipients listed in the paragraph 6.1.

Population

GANAZOLO 10 mg/g vaginal cream Deeply introduce into the vagina an applicator filled with vaginal cream (5 cc) for 15 days each evening before bedtime, preferably in supine position. Treatment should also be protracted after the disappearance of subjective disorders (pruritus, leucorrea). Treatment of the partner: the cream applies once a day for 15 consecutive days after washing with hot water glans and foreskin. GANAZOLO 150 mg ovum Deeply introduce into the vagina, preferably in supine position, an ovulus every evening before bedtime, for three consecutive days. In the event of relapse or in the event that after a week of treatment the check crop examination will be positive, a second cycle of therapy will be repeated. GANAZOLO 1 mg/ml vaginal solution It is administered using the monodose packaging and the cannula to lose. The recommended posology is of a lavender per day for five days and then of five other lavenders practiced at alternate days. Posology should however be adapted by the doctor to the severity of the clinical picture and adapted to its variations.

Conservation

These medicines do not require special conditions of conservation.

Warnings

Concurrent use of latex condoms or diaphragms with anti-infectious preparations can reduce the effectiveness of rubber contraceptives. Therefore, products such as GANAZOLO should not be used in conjunction with diaphragms or latex condoms. Patients using spermicide contraceptives should consult the doctor, as local vaginal treatments may inhibit the effectiveness of spermicide. GANAZOLO should not be used in conjunction with other products for the internal or external treatment of genitals. If you manifest marked irritation or awareness, stop treatment. In patients with imidazole sensitivity, nitrate econazole was also detected. Do not use for ophthalmic or oral use. Vaginal Solution: the specialty is in solution already ready for use and for each single-dose container a cannula for vaginal irrigation is available individually packaged. At the time of use remove the closing peduncle placed on the cap and insert a reed in the hole present on the cap, making it enter with a slight pressure. The manoeuvre of the vaginal irrigation must be performed gently both in the introduction of the cannula in the vagina, and in pressure the container to push the liquid into the vaginal canal. The container and the cannula should be thrown after use. Important information about some excipients GANAZOLO 10 mg/g vaginal cream and GANAZOLO 1 mg/ml vaginal solution contain: - p-hydroxybenzoate methyl and p-hydroxybenzoate propile which can cause allergic reactions (also delayed). - glycol propylene GANAZOLO 10 mg/g vaginal cream contains 500 mg of glycol propylene for applicator equivalent to 100 mg/g. GANAZOLO 1 mg/ml vaginal solution contains 10 g g glycol propylene per bottle equivalent to 66,67 mg/ml. Glycol propylene can cause skin irritation.

Interactions

Econazole is a well-known cytochrome inhibitor CYP3A4/2C9. Despite poor systemic availability after vaginal application, significant interactions may occur in the clinical profile and have been found in patients taking anticoagulants, such as warfarin or acenocumarol. With such patients it is necessary to use caution and monitor the INR with greater frequency. During treatment with econazole and after its interruption it may be necessary to correct the dosage of oral anticoagulant.

Effects

The most common side effects reported in clinical trials have been reactions in the application site, such as burning and point feeling, itching and erythema. With medications of this type have been reported, in the early times of treatment, burning and vaginal irritation, pelvic cramps, skin rashes and cephalee. In these cases it is necessary to suspend treatment and establish suitable therapy. Other possible undesirable reactions to the drug, from the post-marketing experience, with unknown frequency, may be the following: angioedema, rash, hives and hypersensitivity. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

So far no overdose has been reported with nitrate econazole. In case of accidental ingestion, nausea, vomiting and diarrhea may arise. If necessary, treat with symptomatic therapy.

Pregnancy

In animal studies, nitrate econazole has not shown teratogenic effects, but has proved to be high-dose fetotoxic. The relevance of this effect on human beings is not known. Because of vaginal absorption, GANAZOLO should not be used in the first trimester of pregnancy, unless the doctor considers it necessary for the health of the patient. GANAZOLO can be used during the second and third quarter if potential benefits exceed the possible risks to the fetus.

Food

After oral administration of nitrate econazole in nursing rats, econazole and/or its metabolites were excreted in milk and were found in small ones. It is not known if nitrate econazole is excreted in breast milk. Use GANAZOLO with caution when administered to breastfeeding patients.

Source: Farmadati