Macmiror Complex cream vaginal

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Fachinformation Fachinformation (SPC)
31-12-2020

Wirkstoff:

nifuratel, nystatine

Verfügbar ab:

Doppel Farmaceutici S.r.l.

ATC-Code:

G01AA51

INN (Internationale Bezeichnung):

nifuratel, nystatine

Dosierung:

10g/100g+ 4000000IU/100g

Darreichungsform:

cream vaginal

Einheiten im Paket:

30g aluminium tube and dosing syringe applicator

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2020-12-31

Fachinformation

                                _ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Macmiror Complex 10 g / 4,000,000 I.U. vaginal cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of vaginal cream contains:
Active substances: nifuratel 10 g and nystatin 4,000,000 I.U
Excipients
with
known
effect:
methyl
parahydroxybenzoate,
propyl
parahydroxybenzoate
and
propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal cream.
Description of the product: dark yellow fluid homogeneous cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Combination therapy of vulvovaginal conditions caused by
drug-sensitive germs: bacteria,
trichomonas, Candida fungi.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2.5 g of vaginal cream, once or twice a day, in the evening and/or the
morning,
for 8 days,
according
to the medical prescription.
Method of administration
The required dose of vaginal cream is applied using the dosing
syringe.
Instructions for using the dosing syringe
1.
Screw the dosing syringe onto the tube of vaginal cream and squeeze
the latter until the
syringe contains the required amount of vaginal cream (according to
the marks indicating
grams of cream).
2.
Unscrew the syringe from the tube and insert it into the vagina,
pushing the plunger in.
3.
Where required, remove the cannula from the plunger and screw it onto
the opposite end of
the syringe before inserting it into the vagina.
One plastic applicator is enclosed in the packaging. After using the
applicator it should be washed
completely, and that way prepared for the next use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any one of the
excipients listed in section 6.1.
_ _
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of this medicinal product, particularly where prolonged, can lead
to sensitisation phenomena.
If any hypersensitivity reactions arise, administration of the
medicinal product must be stopped.
During the treatment sexual intercourse must be abstained from.
This medicine contains the 
                                
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