Active ingredients: Nifuratel, Nystatin
MACMIROR COMPLEX 500 mg + 200,000 I.U. ova
Macmiror Complex package inserts are available for pack sizes:- MACMIROR COMPLEX 500 mg + 200,000 I.U. ova
- MACMIROR COMPLEX 10 g + 4.000.000 I.U. cream
Why is Macmiror Complex used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antiprotozoal, antibacterial, antifungal.
THERAPEUTIC INDICATIONS
Polyvalent therapy of vulvovaginal diseases caused by pathogenic microorganisms: Candida, Trichomonas and bacteria.
Contraindications When Macmiror Complex should not be used
The product is contraindicated in patients hypersensitive to nystatin and nifuratel.
Precautions for use What you need to know before taking Macmiror Complex
The use, especially if prolonged, of the product can give rise to sensitization phenomena.
In the event of hypersensitivity reactions, the administration of the drug must be interrupted.
During the treatment refrain from sexual intercourse.
Dosage and method of use How to use Macmiror Complex: Dosage
One egg per day or according to medical prescription.
To obtain the most favorable therapeutic result, it is necessary that the eggs are brought, with a finger, to the highest part of the vagina.
Side Effects What are the side effects of Macmiror Complex
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform the doctor or pharmacist of the appearance of undesirable effects, even those not described in the package leaflet.
Expiry and Retention
WARNING: Do not use the medicine after the expiry date indicated on the package.
This date refers to the intact product correctly stored.
Keep this medicine out of the reach and sight of children
COMPOSITION
Each egg contains: 500 mg nifuratel; nystatin U.I. 200,000;
Excipient: dimethylpolysiloxane AK 1000;
Components of the gelatinous shell: gelatin; glycerin; sodium ethyl-4-hydroxybenzoate; sodium propyl-4-hydroxybenzoate; titanium dioxide; yellow iron oxide.
PHARMACEUTICAL FORM AND CONTENT
12 vaginal suppositories
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
MACMIROR COMPLEX 500 MG + 200.000 I.U. OVULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each egg contains: 500 mg nifuratel; nystatin U.I. 200,000.
03.0 PHARMACEUTICAL FORM
Vaginal suppositories.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Polyvalent therapy of vulvovaginal diseases caused by pathogenic microorganisms: Candida, Trichomonas and bacteria.
04.2 Posology and method of administration
1 egg per day or according to medical prescription.
In order to obtain the most favorable therapeutic effect, it is necessary that the eggs are brought to the highest part of the vagina.
04.3 Contraindications
The product is contraindicated in patients hypersensitive to nystatin and nifuratel.
04.4 Special warnings and appropriate precautions for use
The prolonged use of the product can give rise to sensitization phenomena.
In the event of a hypersensitivity reaction, the administration of the drug must be interrupted.
During the treatment refrain from sexual intercourse.
04.5 Interactions with other medicinal products and other forms of interaction
No drug interactions have been described with the components of MACMIROR COMPLEX.
04.6 Pregnancy and lactation
There are no contraindications in this regard.
04.7 Effects on ability to drive and use machines
No adverse effects are reported.
04.8 Undesirable effects
No undesirable effects were reported.
04.9 Overdose
Not to be considered, given the route of administration.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
MACMIROR COMPLEX is made up of the "association of nifuratel and nystatin. Nifuratel is a synthetic chemotherapy, developed in the POLI Research Laboratories, which performs an" intense and effective trichomonicide, antibacterial and mycostatic action.
Nystatin is a well-known antibiotic with fungicidal action, particularly active on fungi of the genus Candida.
The nifuratel-nystatin association presents "in vitro" a broad spectrum of action with antifungal, trichomonicide and antibacterial effects, without establishing negative interactions between the two active ingredients.
Indeed, in an antifungal sense, an evident positive synergism between the two drugs was noted.
05.2 "Pharmacokinetic properties
It has been documented that, after vaginal use in animals (rabbit and dog) of daily doses repeated over time, equal to 30 times the therapeutic ones, the substances making up the association are not absorbed and therefore do not cause systemic effects.
05.3 Preclinical safety data
Vaginal LD50 in dogs> 60 DTS (human single therapeutic dose).
Prolonged vaginal administration in rabbits of up to 30 DTDs (human daily therapeutic dose) did not cause any toxic effects.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Dimethylpolysiloxane AK 1000.
Capsule components: gelatin; glycerine; sodium ethyl-4-hydroxybenzoate; sodium propyl-4-hydroxybenzoate; titanium dioxide; yellow iron oxide.
06.2 Incompatibility
No incompatibilities have been reported.
06.3 Period of validity
36 months.
06.4 Special precautions for storage
Nothing to report
06.5 Nature of the immediate packaging and contents of the package
Lithographed box containing 12 eggs packed in Al / PVC + PVDC blisters.
06.6 Instructions for use and handling
Nothing to report.
07.0 MARKETING AUTHORIZATION HOLDER
Farmitalia S.r.l.
Viale Alcide De Gasperi 165 / B Catania
08.0 MARKETING AUTHORIZATION NUMBER
AIC. n ° 023432038
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
12-10-1976/31-05-2005
10.0 DATE OF REVISION OF THE TEXT
April 2007
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