Macmiror Complex capsules vaginal soft

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

nifuratel, nystatin

Fáanlegur frá:

Doppel Farmaceutici S.r.l.

ATC númer:

G01AA51

INN (Alþjóðlegt nafn):

nifuratel, nystatin

Skammtar:

500mg+ 200 000IU

Lyfjaform:

capsules vaginal soft

Einingar í pakka:

(8/1x8/) in blister

Gerð lyfseðils:

Prescription

Leyfisstaða:

Registered

Leyfisdagur:

2020-12-31

Vara einkenni

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Macmiror Complex 500 mg / 200,000 I.U. soft vaginal capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal capsule contains:
_Active substances_: nifuratel 500 mg, nystatin 200,000 I.U.
Excipients with known effect:
Sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft vaginal capsules.
Description of product: soft gelatine oval capsules of mustard colour
containing slightly yellow oily
suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Multi-purpose treatment for vulvo-vaginal conditions caused by
pathogenic microorganisms: Candida,
Trichomonas and bacteria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One vaginal capsule per day
in the evening before bedtime during 8 days,
or according to the
medical prescription.
Method of administration
To achieve the best results, the capsule must be inserted as high as
possible into the vagina.
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 then administration of the
medicinal product must be stopped.
During the treatment sexual intercourse must be abstained from.
This medicine contains the excipients sodium ethyl p-hydroxybenzoate
and sodium propyl
p-hydroxybenzoate thatmay cause allergic reactions (even delayed).
_ _
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No pharmacological interactions with the ingredients of Macmiror
Complex have been described.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
There are no or limited amount of data from the use of
Nifuratel-Nystatin association in pregnant
women.
During pregnancy, the product should only be administered when
absolutely necessary and under
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