Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
rifampicin, isoniazid
Lupin Limited
J04AM02
rifampicin, isoniazid
60mg+ 30mg
tablets dispersible
(84/14x6/) in strip
Prescription
Registered
2017-10-05
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 Les hele dokumentet