Isoniazid tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

isoniazid

Доступна с:

Macleods Pharmaceuticals Ltd.

код АТС:

J04AC01

ИНН (Международная Имя):

isoniazid

дозировка:

300mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(672/24x28/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2016-10-06

Характеристики продукта

Isoniazid 100 mg/Isoniazid 300 mg Tablets
(Macleods Pharmaceuticals Ltd),
TB178/TB179
WHOPAR part 4
September 2011
Section 6 updated : March 2016
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
Isoniazid 100 mg/Isoniazid 300 mg Tablets
(Macleods Pharmaceuticals Ltd),
TB178/TB179
WHOPAR part 4
September 2011
Section 6 updated : March 2016
Page 2 of 11
1. NAME OF THE MEDICINAL PRODUCT
Isoniazid 100 mg Tablets
*
Isoniazid 300 mg Tablets
*
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Isoniazid 100 mg or 300 mg
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Isoniazid 100 mg Tablets:
White to off-white, circular, biconvex, uncoated tablets with
breakline on one side and plain surface
on the other side.
Isoniazid 100 mg Tablets can be divided into equal halves.
Isoniazid 300 mg Tablets:
White, circular, biconvex, uncoated tablets having plain surface on
both the sides.
Isoniazid 300 mg Tablets should not be divided or crushed.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Isoniazid Tablets is indicated for the treatment of tuberculosis,
caused by
_Mycobacterium _
_tuberculosis._
The
most
recent
official
guidelines
on
the
treatment
of
tuberculosis
(e.g.
WHO
guideline:
http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf
_) _
should
be
taken
into
consideration for deciding on the appropriateness of therapy with
Isoniazid Tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
Isoniazid Tablets should be swallowed whole with water or another
drink.
The tablets should be taken on an empty stomach (at least one hour
prior to or two hours after a meal).
ACTIVE TUBERCULOSIS
For the treatment of active tuberculosis isoniazid must always be used
in combination with other
antituberculosis drugs
Daily therapy: In children 10mg/kg/day (range 10 to 15 mg/kg body
weight/day),
in adults 5 mg (range 4-6 mg/kg body weight/day)
*
Trade names are not prequalified by WHO. This is under local DRA
responsibility. Throughout this
WHOPAR the proprietary name is given as an examp