GYNO DAKTARIN 7

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MICONAZOLE NITRATE

Available from:

J-C HEALTH CARE LTD

ATC code:

G01AF04

Pharmaceutical form:

CREAM

Composition:

MICONAZOLE NITRATE 20 MG/G

Administration route:

VAGINAL

Prescription type:

Required

Manufactured by:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Therapeutic group:

MICONAZOLE

Therapeutic area:

MICONAZOLE

Therapeutic indications:

Local treatment of vulvovaginal candidosis (monoliasis) and superinfection due to Gram positive bacteria (streptococci and staphylococci).

Authorization date:

2012-07-31

Patient Information leaflet

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Summary of Product characteristics

Gyno Daktarin 7 _SPI_JAN2012
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
ב
רבמצד
2011
1.
NAME OF THE MEDICINAL PRODUCT
GYNO-DAKTARIN 7 _CREAM VAGINAL _
Miconazole nitrate 20 mg/g cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 20 mg of the active substance miconazole nitrate.
For excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
White, homogenous Cream for vulvar and vaginal use.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Local treatment of vulvovaginal candidosis (monoliasis) and
superinfections
due to gram-positive bacteria( Streptococci and staphylococci).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
GYNO-DAKTARIN Cream
Once daily before bedtime, administer the contents of 1 applicator
(about 5 g
of cream) deeply into the vagina (see Section 6.6, Instructions for
use and
handling). Repeat this procedure for 7 days, even if symptoms (e.g.
pruritus
and leukorrhea) have disappeared or menstruation begins.
Treatment of concurrent symptoms of mycotic balanitis of the male
partner:
apply the cream twice daily on the glans penis. The treatment duration
is the
same as for the female partner.
4.3.
CONTRAINDICATIONS
GYNO-DAKTARIN Cream, is contraindicated in individuals with a known
hypersensitivity
to
miconazole
nitrate
or
another
ingredient
of
the
formulations.
Gyno Daktarin 7 _SPI_JAN2012
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Should local sensitization or an allergic reaction occur, the
treatment should
be discontinued.
Appropriate therapy is indicated when the sexual partner is also
infected.
GYNO-DAKTARIN products do not stain skin or clothes.
The concurrent use of latex condoms or diaphragms with vaginal anti-
infective preparations may decrease the effectiveness of latex
contraceptive
agents.
Therefore,
GYNO-DAKTARIN
products
should
not
be
used
concurrently with a latex condom or latex diaphragm.
4.5.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER
FORMS OF INTERACTION
Miconazole administered systemica