Fromilid tablets film-coated

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

clarithromycin

Dostupno od:

KRKA d.d.

ATC koda:

J01FA09

INN (International ime):

clarithromycin

Doziranje:

250mg

Farmaceutski oblik:

tablets film-coated

Jedinice u paketu:

(14/2x7/) In blister

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2018-10-03

Svojstava lijeka

PI_Text003598_1
– Updated:
Page 1 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Fromilid
®
250 mg film-coated tablets
Fromilid
®
500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg or 500 mg clarithromycin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The 250 mg and 500 mg tablets are slightly brownish yellow, oval and
biconvex, covered with film
coating.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections of mild to moderate severity caused by microorganisms
sensitive to the drug in adults and
children over 12 years of age:
Upper respiratory tract infections (tonsillopharyngitis, acute otitis
media (in children), acute maxillary
sinusitis), lower respiratory tract infections (acute bacterial
bronchitis, acute exacerbation of chronic
bronchitis, community-acquired pneumonia and atypical pneumonia), skin
and subcutaneous tissue
infections (uncomplicated), treatment and prevention of disseminated
mycobacterial infections of mild
and moderate severity caused by sensitive isolates of _Micobacterium
avium_ and _Micobacterium _
_intracellulare_ in patients with progressive HIV infection.
Eradication of _Helicobacter pylori_ in patients with a duodenal or
gastric ulcer (always in combination
with other drugs).
Fromilid tablets are indicated in adults and children 12 years and
older.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should not be broken. They should be swallowed whole and
washed down with liquid.
Posology
_Adults and children over 12 years of age_ are given the tablets,
usually 250 mg every 12 hours. For the
treatment of sinusitis, severer infections and when the infection is
caused by _Haemophilus influenzae_,
500 mg is given every 12 hours.
For the eradication of _H. pylori_, 500 mg are given twice daily,
usually for 10-14 days, together with
other drugs.
For the treatment of disseminated