Fromilid tablets film-coated

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

clarithromycin

Saatavilla:

KRKA d.d.

ATC-koodi:

J01FA09

INN (Kansainvälinen yleisnimi):

clarithromycin

Annos:

500mg

Lääkemuoto:

tablets film-coated

Kpl paketissa:

(14/2x7/) in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2023-11-25

Valmisteyhteenveto

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
Fromilid film-coated tablets are indicated for the treatment of the
following bacterial infections in
adults and children 12 years and older, when caused by
clarithromycin-susceptible bacteria (see
section 4.4 and 5.1):
-
Bacterial pharyngitis
-
Mild to moderate community acquired pneumonia
-
Acute bacterial sinusitis (adequately diagnosed)
-
Acute exacerbation of chronic bronchitis
-
Skin infections and soft tissue infections of mild to moderate
severity
-
In appropriate combination with antibacterial therapeutic regimens and
an appropriate ulcer
healing agent for the eradication of Helicobacter pylori in patients
with Helicobacter pylori
associated ulcers (see section 4.2)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of Fromilid film-coated tablets depends on the type and
severity of the infection and has to
be defined in any case by the physician.
Patients with respiratory tract/skin and soft tissue infections:
_Adults and adolescents (12 years and older) _
The usual recommended dosage of clarithromycin in adults is one 250mg
tablet twice daily. In more
severe infections, the dosage can be increased to 500mg twice daily.
The usual duration of therapy is 6
to 14 days.
_Children younger than 12 years: _
The use of clarithromycin tablets has not been studied in children
under 12 years. Clinical trials have
been conducted using clarithromycin paediatric suspension in children
6 months to 12 years of age.
Therefore, children under 12 year