Fluconazole capsules

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

fluconazole

זמין מ:

Arpimed LLC

קוד ATC:

J02AC01

INN (שם בינלאומי):

fluconazole

כמות:

150mg

טופס פרצבטיות:

capsules

יחידות באריזה:

(10/1x10/) in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2020-03-10

מאפייני מוצר

SUMMARY PRODUCT CHARACTERISTIC (SPC)
FLUCONAZOLE 150 MG CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
Fluconazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule_ _of _Fluconazole _contains:
_ACTIVE INGREDIENT: _fluconazole - 150 mg;
_INACTIVE INGREDIENTS:_ lactose monohydrate, ethylcellulose
_ _
_COMPOSITION OF EACH HARD GELATIN CAPSULE: _
_CAP AND BODY :_ Brilliant Blue FCF (E133, C.I number 42090) (BLUE
Nº1), Sunset Yellow FCF
(E110, C.I number 15985) (YELLOW Nº6) , Quinoline Yellow WS (E104,
C.I number 47005)
(YELLOW Nº10), Titannium Dioxide (Е 171, C.I number 77891),
Propylene Glycol (E1520),
MethylParaben (E218), PropylParaben (E216)
, SLS (Е487), Acetic Acid (E260), Colloidal Silicon
Dioxide (Е551), Gelatin q.s.p.
3.
PHARMACEUTICAL FORM
Capsules
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluconazole is a triazole antifungal used for treatment of vaginal
candidiasis and candidal balanitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Fluconazole is given by mouth.
IN ADULT
Fluconazole, 150 mg by mouth as a single dose may be used for vaginal
candidiasis or candidal
balanitis.
IN CHILDREN
Despite extensive data supporting the use of Fluconazole in children
there are limited data
available on the use of Fluconazole for genital candidiasis in
children below 16 years. Use at
present is not recommended unless antifungal treatment is imperative
and no suitable alternative
agent exists.
ELDERLY PATIENTS do not require correction dosing regimen.
4.3 CONTRAINDICATIONS
Fluconazole is contraindicated in patients with known hypersensitivity
to the drug or any ingredient
in the respective formulation.
Coadministration of terfenadine is contraindicated in patients
receiving Fluconazole at multiple
doses of 400 mg per day or higher based upon results of a multiple
dose interaction study.
Coadministration of other medicinal products known to prolong the QT
interval and which are
metabolised
via
the
cytochrome
P450
(CYP)
3A4
such
as
cisapride,
astemizole,
pimozide,
quinidine and erythromycin are contraindic