Klacid granules for oral suspension

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clarithromycin

Available from:

AbbVie S.r.l.

ATC code:

J01FA09 օրիգինալ դեղի հաջորդ դեղաչափ

INN (International Name):

clarithromycin

Dosage:

125mg/5ml plastic container 100ml and measuring syringe

Pharmaceutical form:

granules for oral suspension

Units in package:

125mg/5ml plastic container 100ml and measuring syringe

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-07-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CLARITHROMYCIN
Page 1 of 24
1. NAME OF THE MEDICINAL PRODUCT
Klacid granules for oral suspension 125 mg /5 ml
Klacid granules for oral suspension 250 mg/5 ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clarithromycin 125 mg/5 ml, Granules for Oral Suspension (Pediatric
Suspension):
Each 5 ml of the granules for suspension contains 125 mg of
clarithromycin.
Clarithromycin 250 mg/5 ml, Granules for Oral Suspension (Pediatric
Suspension):
Each 5 ml of the granules for suspension contains 250 mg of
clarithromycin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clarithromycin Granules for Oral Suspension: granules –
light-flowing granules, white
to off-white with fruit flavour; the finished suspension – opaque,
white to off-white with
fruit flavour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infections caused by susceptible to clarithromycin
microorganisms:
•
Upper respiratory tract infection (tonsillitis, pharyngitis,
sinusitis);
•
Lower respiratory tract infections (bronchitis, pneumonia, bacterial
and atypical);
•
Skin and soft tissue infections (impetigo, erysipelas, follicular-lit,
boils and infected
wounds);
•
Disseminated
mycobacterial
infection
caused
by
Mycobacterium
avium
and
Mycobacterium intracellulare;
•
Acute otitis media.
Consideration should be given to national official guidance on the
appropriate use of
antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Conducted clinical studies using clarithromycin pediatric suspension
involving children
aged 6 months to 12 years. Thus, you should use clarithromycin
pediatric suspension
(granules for suspension for internal use) for children under 12
years.
The recommended daily dose of clarithromycin granules for suspension
for internal use
(125 mg / 5 mL and 250 mg / 5 ml) in children is 7.5 mg / kg 2 times
per day to a
maximum dose of 500 mg 2 times a day with non-mycobacterial
infections. The usual
duration of treatment is 5-10 days depending on the pat