Rifampicin 60mg-Isoniazid 30mg Tablets tablets dispersible

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

rifampicin, isoniazid

MAH:

Lupin Limited

ATC_code:

J04AM02

INN:

rifampicin, isoniazid

dosage:

60mg+ 30mg

pharmaceutical_form:

tablets dispersible

units_in_package:

(84/14x6/) in strip

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2017-10-05

SPC

Isoniazid/Rifampicin 3 0 mg/60 mg
WHOPAR Part 4
January 2013
Dispersible Tablets
(Lupin
Ltd),
TB184
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
Isoniazid/Rifampicin 3 0 mg/60 mg
WHOPAR Part 4
January 2013
Dispersible Tablets
(Lupin
Ltd),
TB184
Page 2 of 20
1.
NAME OF THE MEDICINAL PRODUCT
RIFAMPICIN 60 MG - ISONIAZID 30 MG TABLETS
_I Rifampicin –Isoniazid. This product is intended for use in
children. Nonetheless, safety information is _
_provided for adult health issues such as liver disease, pregnancy and
lactation, to allow full access to all _
_relevant information. _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains:
Isoniazid 30 mg Rifampicin 60 mg
Each tablet also contains:
Aspartame 2 mg
Ponceau 4R (cochineal red A) 150 micrograms For a
full list of excipients see 6.1
3.
PHARMACEUTICAL FORM
Brick-red, flat-faced, bevel-edged, mottled, circular uncoated tablet
with break-line on one side and plain
on other side with characteristic flavour.
The break-line is for decorative purposes and not to divide the tablet
into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rifampicin 60 mg - Isoniazid 30 mg is indicated for the treatment of
tuberculosis in children, caused by
Mycobacterium tuberculosis, according to the guidelines of WHO
(Treatment of Tuberculosis: guidelines
4th edition, WHO, available at:
http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf
Also, Rapid Advice, Treatment of Tuberculosis in Children, 2010,
available at:
http://whqlibdoc.who.int/publications/2010/9789241500449_eng.pdf
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
CHILD'S WEIGHT DOSE (SINGLE DAILY DOSE)
5-7 kg
1 tablet daily
8-14 kg
2 tablets daily
15-20 kg 3 tablets daily
Children weighing over 20 kg should be treated with products
containing higher amounts of the drugs.
(See General references below.)
The required number of Rifampicin 60 mg - Isoniazid 30 mg should be
dispersed in approximately 50 ml
water and the entire mixture should be swallowed. The mixture (table