Heptral powder lyophilized for solution for injection

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

ademetionine

Доступна с:

Famar L'Aigle

код АТС:

A16AA02

ИНН (Международная Имя):

ademetionine

дозировка:

400mg

Фармацевтическая форма:

powder lyophilized for solution for injection

Штук в упаковке:

(5) glass vials and (5) solvent in ampoules 5ml

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2017-06-02

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTIC
ADEMETIONINE
1
NAME OF THE MEDICINAL PRODUCT
Heptral 400 mg/5 ml lyophilized powder and solvent>
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heptral
400 mg/5 ml lyophilized powder and solvent
One vial of lyophilized powder contains 400 mg Heptral

3
PHARMACEUTICAL FORM
Heptral 400 mg/5 ml Lyophilized
powder and solvent
Lyophilized powder: White to yellowish lyophilized cake
Solvent: Clear, colourless to yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Heptral is indicated for treatment of adults with:
•
Intrahepatic cholestasis in pre-cirrhotic and cirrhotic states
•
Intrahepatic cholestasis in pregnancy
•
Depressive symptoms
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment is usually started with parenteral administration of the
drug and continued by the use of
the drug in the form of tablets or immediately with the use of
tablets. The daily dose of tablets can
be divided into 2-3 doses. Prepare the solution for injection should
be immediately before use.
_Initial therapy_
IV or IM: The recommended dosing is 5-12 mg/kg/day. The usual starting
dose is 400 mg/day IV or
IM, total daily dose not to exceed 800 mg. Duration of initial
parenteral therapy is 15-20 days in
the treatment of depressive syndromes and 2 weeks in the treatment of
liver diseases.
Oral: for oral administration the drug should be used Heptral
film-coated tablets.The recommended
dosing is 10-25 mg/kg/day orally. The usual starting dose is 800
mg/day (2 tablets), total daily dose
not to exceed 1600 mg (4 tablets).
_Maintenance therapy_
Apply inside 2-4 tablets per day (800-1600 mg/day).
The duration of therapy depends on the severity and course of the
disease and is determined
individually.
For intravenous or intramuscular use, the lyophilized powder is
dissolved in a special solvent,
which is attached, immediately before use. For intravenous
administration, the necessary dose of
ademetionine should be further diluted in 250 ml of saline or