Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ethambutol (ethambutol hydrochloride)
Macleods Pharmaceuticals Ltd.
J04AK02
ethambutol (ethambutol hydrochloride)
100mg
tablets film-coated
(100/10x10/) in blister
Prescription
Registered
2016-10-06
Ethambutol Hydrochloride 100 mg Tablets WHOPAR part 4 August 2014 (Macleods Pharmaceuticals Ltd), TB226 Page 1 of 9_ _ SUMMARY OF PRODUCT CHARACTERISTICS Ethambutol Hydrochloride 100 mg Tablets WHOPAR part 4 August 2014 (Macleods Pharmaceuticals Ltd), TB226 Page 2 of 9_ _ 1. NAME OF THE MEDICINAL PRODUCT Ethambutol Hydrochloride 100 mg Tablets * 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg ethambutol hydrochloride. For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Ethambutol Hydrochloride 100 mg Tablets is a white, circular, shallow, biconvex, film-coated tablet with break-line on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS: Ethambutol Hydrochloride 100 mg Tablets is indicated in combination with other anti-tuberculosis agents for the treatment of all forms of tuberculosis caused by _Mycobacterium tuberculosis _in children weighing between 5 and 20 kg. _ _ Ethambutol Hydrochloride 100 mg Tablets is also used in the treatment of infections caused by atypical mycobacteria, such as_ Mycobacterium avium complex. _ _ _ Consideration should be given to official treatment guidelines for tuberculosis, e.g those of WHO: (http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf) _This product is intended for use in children. Nonetheless, safety information is provided with respect _ _to adult health issues such as liver disease, pregnancy and lactation, to allow full access to all _ _relevant information. _ _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use Ethambutol Hydrochloride 100 mg Tablets must always been given in combination with other antimycobacterial agents. _DAILY REGIMEN _ Ethambutol is administered as a single daily dose of 20 (range15-25) mg/kg body weight. _ _ * Trade names are not prequalified. This is the national medicines regulatory authority´s (NMRA) responsibility. Throughout this WHOPAR the proprietary name is given as an example only Ethambutol Hydrochloride 100 mg Tablets WHOPAR par Læs hele dokumentet