Klion-D 100 tablets vaginal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

metronidazole, miconazole (miconazole nitrate)

Available from:

Gedeon Richter PLC

ATC code:

G01AF20

INN (International Name):

metronidazole, miconazole (miconazole nitrate)

Dosage:

100mg+ 100mg

Pharmaceutical form:

tablets vaginal

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-05-05

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Klion-D® 100 vaginal tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mg metronidazole and 100 mg miconazole nitrate in each vaginal
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Almost white, biconvex, almond shaped vaginal tablets of about 24 mm x
14 mm diameter
with an imprinting “100” on one side and unmarked on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local treatment of female urogenital trichomoniasis and/or fungal
infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_In trichomoniasis:_ Concurrently with oral metronidazole treatment 1
Klion-D 100 vaginal tablet,
slightly moistened before application, should be inserted deeply into
the vagina once a day (in the
evening, before going to bed) for 10 days.
During the same 10 days 2 (2x250 mg) oral Klion tablets should be
taken every day (one in the
morning and one in the evening) during or after meals without chewing.
Treatment of the male sexual partner is also recommended with oral
Klion tablets at the same time.
In case of ineffective treatment, the 10 day cure can be repeated.
_ _
_In candidiasis:_ 1 Klion-D 100 vaginal tablet, slightly moistened
before application, should be inserted
high up into the vagina once a day (in the evening, before going to
bed) for 10 days.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients
listed in section 6.1.
First trimester of pregnancy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
During Klion-D 100 treatment and at least one day afterwards the
consumption of alcoholic beverages
is forbidden.
Sexual activity should be avoided during treatment with Klion-D 100
vaginal tablet.
Cases of severe hepatotoxicity/acute hepatic failure, including cases
with a fatal outcome with very
rapid onset after treatment initiation in patients with Cockayne
syndrome have been reported with
products containing metronidazole for systemic use. In this
population, metronidazole should therefore
be