Ethambutol Hydrochloride tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ethambutol (ethambutol hydrochloride)

Available from:

Macleods Pharmaceuticals Ltd.

ATC code:

J04AK02

INN (International Name):

ethambutol (ethambutol hydrochloride)

Dosage:

100mg

Pharmaceutical form:

tablets film-coated

Units in package:

(100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-10-06

Summary of Product characteristics

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