Rifampicin Isoniazid Pyrazinamide tablets

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

rifampicin, isoniazid, pyrazinamide

Διαθέσιμο από:

Lupin Limited

Φαρμακολογική κατηγορία (ATC):

J04AM05

INN (Διεθνής Όνομα):

rifampicin, isoniazid, pyrazinamide

Δοσολογία:

60mg+ 30mg+ 150mg

Φαρμακοτεχνική μορφή:

tablets

Μονάδες σε πακέτο:

(84/4x16/) in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2016-12-08

Αρχείο Π.Χ.Π.

Isoniazid/Pyrazinamide/Rifampicin
30 mg/150 mg/60 mg Dispersible Tablets
(Lupin Ltd), TB185
WHOPAR Part 4
January 2013
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
Isoniazid/Pyrazinamide/Rifampicin
30 mg/150 mg/60 mg Dispersible Tablets
(Lupin Ltd), TB185
WHOPAR Part 4
January 2013
Page 2 of 22
1.
NAME OF THE MEDICINAL PRODUCT
AKuriT Z Kid
*
_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
Pyrazinamide 150 mg
Rifampicin 60
mg
Each tablet also contains:
Aspartame 4 mg
Ponceau 4R (cochineal red A) 400 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
AKuriT Z Kid is indicated for the initial 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.)
*
Trade names are not prequalified by WHO. This is under local DRA
responsibility. Throughout this WHOPAR
the proprietary name is given as an example only.
Isoniazid/Py