Active ingredients: Isoconazole (Isoconazole nitrate)
ABIMONO 600 mg vaginal ovule
ABIMONO Vaginal cream 1% 1 tube of 30 g (with 6 applicators)
ABIMONO Dermatological cream 1% 1 tube of 20g
Indications Why is Abimono used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Vaginal Ovule-Cream: Gynecological antimicrobials and antiseptics.
Dermatological cream: Antifungal for topical use.
THERAPEUTIC INDICATIONS
Vaginal Ovule-Cream: vulvo-vaginal fungal infections even with bacterial superinfection.
Dermatological cream: superficial mycoses of the hairless or hair-covered skin (dermatophytias, candidiasis, pityriasis versicolor).
Contraindications When Abimono should not be used
Known or suspected hypersensitivity to the components of the specialty or to other antifungal imidazole derivatives.
Precautions for use What you need to know before taking Abimono
Vaginal Ovule-Cream: during treatment or in the days immediately following it is necessary, to avoid reinfection, to change daily and sterilize by boiling, towels and underwear.
Dermatological cream: to ensure the success of the treatment, it is necessary to scrupulously observe the hygiene precautions, including that of carefully drying the interdigital spaces in case of localized mycosis of the feet.
A local treatment of fungal infections must generally last 2/3 weeks and sometimes even 4, in rebellious cases (especially at the level of the interdigital spaces).
On specific medical prescription, treatments of longer duration are also possible. It is often advisable, in case of injuries, to insert a gauze pad soaked in cream between the fingers.
To avoid recurrence, treatment should be continued for at least 2 weeks after clinical recovery.
Interactions Which drugs or foods can modify the effect of Abimono
No negative interactions with other drugs have been identified.
Warnings It is important to know that:
In pregnant women, the product should be administered only in case of real need and under direct medical supervision. In case of application to the face, avoid placing ABIMONO in contact with the eyes. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute an adequate therapy. The same applies in the case of development of non-sensitive microorganisms.
KEEP OUT OF REACH OF CHILDREN.
Dose, Method and Time of Administration How to use Abimono: Posology
Vaginal ovum: insert 1 egg of 600mg deeply into the vagina. The possibility of excess treatment on the first day must be evaluated by the attending physician.
Gynecological cream: one application per day and for one week, unless otherwise prescribed. To use, screw the applicator to the tube, fill it completely with cream, then introduce it into the vagina and empty it by pressure on the plunger. After each introduction, disassemble the applicator and dispose of in the appropriate waste.
Treatment with ABIMONO should not be practiced during the menstrual period.
A simultaneous use of ABIMONO Dermatological cream by the partner is recommended.
Dermatological cream: unless otherwise prescribed, the dosage is two applications per day.
Overdose What to do if you have taken too much Abimono
There are no known cases of overdose.
Side Effects What are the side effects of Abimono
Vaginal Ovule-Cream: Vaginal burning and irritation, pelvic cramps, skin rashes and headache have been reported with medicines of this type.
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.
Dermatological cream: skin irritation phenomena, of rare onset.
Expiry and Retention
SPECIAL STORAGE PRECAUTIONS
Ovum: Do not store above 30 ° C.
Vaginal cream - Dermatological cream: none.
VALIDITY OF THE FINISHED PRODUCT AS PACKAGED FOR SALE
Ovum: 3 years.
Vaginal cream - Dermatological cream: 2 years.
Other information
COMPOSITION
ABIMONO vaginal ovum
An egg contains:
Active ingredient: Isoconazole nitrate g 0.6
Excipients: Boric acid, semisynthetic glycerides.
ABIMONO gynecological cream 1%
100 g of cream contain:
- Active ingredient: Isoconazole nitrate g 1.00
- Excipients: Sorbitan monostearate, polyoxyethylene sorbitanmonostearate, cetylstearyl alcohol, petroleum jelly, isopropyl myristate, distilled water.
ABIMONO dermatological cream 1%
100 g of cream contain:
- Active ingredient: Isoconazole nitrate g 1.00
- Excipients: Polysorbate 60, sorbitanstearate, cetylstearyl alcohol, liquid paraffin, white petroleum jelly, distilled water.
PHARMACEUTICAL FORMS AND CONTENT
1 vaginal suppository 600 mg.
Vaginal cream tube 30 g 1% with 6 applicators.
Dermatological cream tube 20 g 1%.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ABIMONO
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ABIMONO vaginal ovum
An egg contains
Active principle:
Isoconazole nitrate 0.6 g
Excipients:
Boric acid g 0.3
Semisynthetic glycerides g 2,4
ABIMONO vaginal cream 1%
100 g of cream contain:
Active principle:
Isoconazole nitrate g 1.00
Excipients:
Sorbitanmonostearate g 1.00
Polyoxyethylene sorbitan monostearate 3.50 g
5.00 g cetylstearyl alcohol
White petroleum jelly g 10.00
Isopropyl myristate g 10.00
Boric acid g 1.00
Purified water 68.50 g
ABIMONO dermatological cream 1%
100 g of cream contain:
Active principle:
Isoconazole nitrate g 1.00
Excipients:
Polysorbate 60 g 3.50
Sorbitanmonostearate g 1.00
5.00 g cetylstearyl alcohol
Liquid paraffin g 10.00
White petroleum jelly g 10.00
Distilled water to taste to g 100
03.0 PHARMACEUTICAL FORM
Ovule - Vaginal cream - Dermatological cream for external use 1%.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Indications
Ovule - Vaginal Cream:
Fungal vulvo-vaginal infections also with bacterial superinfection.
Dermatological cream:
Superficial mycoses of hairless or hair-covered skin (dermatophytias, candidiasis, pityriasis versicolor).
04.2 Posology and method of administration
Vaginal ovum: insert 1 egg of 600 mg deeply into the vagina.
The possibility of treatment exceeding the first day must be evaluated by the attending physician.
Vaginal cream: one application per day and for one week, unless otherwise prescribed. To use, screw the applicator to the tube, fill it completely with cream, then introduce it into the vagina and empty it by pressure on the plunger. After each introduction, disassemble the applicator and throw in the appropriate waste.
Treatment with ABIMONO should not be practiced during the menstrual period.
A simultaneous use of ABIMONO dermatological cream by the partner is recommended.
Dermatological cream: unless otherwise prescribed, the dosage is 2 applications per day.
04.3 Contraindications
Known or suspected hypersensitivity to the components of the medicinal product and to other antifungal imidazole derivatives.
04.4 Special warnings and appropriate precautions for use
Vaginal Ovule-Cream:
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.
Dermatological cream:
To ensure the success of the treatment, it is necessary to strictly observe the hygiene precautions, including that of carefully drying the interdigital spaces in case of localized mycosis of the feet.
A local treatment of fungal infections must generally last 2-3 weeks and sometimes even 4, in rebellious cases (especially at the level of the interdigital spaces).
On specific medical prescription, treatments of longer duration are also possible.
It is often advisable, in case of injury, to insert a tablet soaked in cream between the fingers.
In case of application to the face, avoid placing the ABIMONO in contact with the eyes.
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute an adequate therapy. The same applies to the development of microorganisms.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
04.5 Interactions with other medicinal products and other forms of interaction
No negative interactions with other drugs have been identified.
04.6 Pregnancy and breastfeeding
In pregnant women, the product should be administered in cases of real need, under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
Absent
04.8 Undesirable effects
Vaginal Ovule-Cream:
Vaginal burning and irritation, pelvic cramps, rash and headache have been reported with medications of this type.
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.
Dermatological cream:
Skin irritation phenomena of very rare onset.
04.9 Overdose
There are no known cases of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ABIMONO (isoconazole nitrate) is endowed with low toxicity, in fact for single administration it proved to be devoid of local or systemic toxic effects, administered orally it has a DL of 2400, 73-2651.20 mg / kg in the mouse and 1923 , 40-2306.09 mg / kg in the rat.
Even for repeated administration (90 days), isoconazole nitrate, both by the epicutaneous and by the oral route, was well tolerated.
The fetal toxicity tests have shown that applied for 15 days before mating and for the entire duration of pregnancy, both on intact and abraded skin, it did not influence mating, the progress of pregnancy, nor the normal embryo-fetal development. .
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
06.2 Incompatibility
Not known.
06.3 Period of validity
Vaginal ovum: 36 months in unopened packaging.
Vaginal cream and dermatological cream: 24 months when packaged intact.
06.4 Special precautions for storage
Vaginal ovum: Do not store above 30 ° C
Vaginal cream and dermatological cream: none
06.5 Nature of the immediate packaging and contents of the package
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Farmitalia S.r.l. Viale A. De Gasperi, 165 / B 95127 Catania.
08.0 MARKETING AUTHORIZATION NUMBER
ABIMONO vaginal ovum 025358058
ABIMONO vaginal cream 025358045
ABIMONO dermatological cream 025358019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
01/05/2010
