Klacid 250mg/5ml granules for oral suspension

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

clarithromycin

Disponibil de la:

AbbVie S.r.l.

Codul ATC:

J01FA09

INN (nume internaţional):

clarithromycin

Dozare:

250mg/5ml

Forma farmaceutică:

granules for oral suspension

Unități în pachet:

plastic container 100ml and measuring syringe or measuring spoon

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2015-07-03

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
CLARITHROMYCIN
1. NAME OF THE MEDICINAL PRODUCT
KLACID
GRANULES FOR ORAL SUSPENSION
DOSAGE: 125 MG /5 ML, 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: White to off-white
granules for suspen-
sion
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 Mycobac-
terium intracellulare;
• acute otitis media.
It is necessary to take into account official guidance on the
appropriate use of antibacte-
rial 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 max-
imum dose of 500 mg 2 times a day with non-mycobacterial infections.
The usual dura-
tion of treatment is 5-10 days depending on the pathogen and the
severity of the pa-
tient's condition. The finished slurry should be ingested without food
(milk can).
The table shows the dosing