Tonofungyn capsules hard

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

fluconazole

Предлага се от:

Egyptian International Pharmaceutical Industries Company (EIPICO)

АТС код:

J02AC01

INN (Международно Name):

fluconazole

дозиране:

150mg

Лекарствена форма:

capsules hard

Броя в опаковка:

(2/2x1/) in strip

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2019-09-09

Данни за продукта

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1
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TONOFUNGYN 150 MG CAPSULE
SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tonofungyn®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains:
Fluconazole 150 mg
Excipient(s) with known effects: each hard capsule also contains 125
mg lactose monohydrate.
For full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Hard gelatin capsule
150 mg hard gelatin capsule of size No1 with opaque sky-blue cap and
white body containing
hygroscopic white powder.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
Tonofungyn is indicated for the treatment of the following infections
when caused by fungi
that are known or likely to be fluconazole-susceptible:
Acute or recurrent vaginal candidiasis.
For treatment of partners with associated candidal balanitis.
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
_Posology _
_Adults (16 to 60 years) _
Vaginal candidiasis or candidal balanitis - 150mg as a single oral
dose.
_Pediatric population (children under 16 years) _
Not recommended in children aged under 16 years unless antifungal
treatment is imperative,
and no suitable alternative agent exists, due to insufficient safety
and efficacy (see section 5.2).
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2
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TONOFUNGYN 150 MG CAPSULE
SPC
_Special population _
_Elderly _
Not recommended in patients aged over 60 years.
_Use in renal impairment _
Fluconazole is excreted predominantly in the urine as unchanged drug.
No adjustments in
single dose therapy are required.
_Use in patients with hepatic insufficiency _
Tonofungyn should only be administered with special care and under
careful monitoring in
patients with liver insufficiency (see section 4.4).
_Method of administration _
For oral administration. The capsules should be swallowed whole and
independent of food
intake.
_4.3 CONTRAINDICATIONS _
Fluconazole should not be used in patients with hypersensitivity to
the active substance, to
related azole substances, or to any of the excipients listed in
section 6.1.
Co-administration of terfenadine is contraindicated in pat