AZITHROMYCIN JUBILANT 500MG FILM COATED TABLETS

País: Chipre

Idioma: griego

Fuente: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ingredientes activos:

AZITHROMYCIN DIHYDRATE

Disponible desde:

JUBILANT PHARMACEUTICALS NV (0000007886) AXXES BUSINESS PARK, GULDENSPORENPARK 22, BLOCK C, MERELBEKE, 9820

Código ATC:

J01FA10

Designación común internacional (DCI):

AZITHROMYCIN

Dosis:

500MG

formulario farmacéutico:

FILM COATED TABLETS

Composición:

AZITHROMYCIN DIHYDRATE (8000001873) 524,04MG

Vía de administración:

ORAL USE

tipo de receta:

Εθνική Διαδικασία

Área terapéutica:

AZITHROMYCIN

Resumen del producto:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 3 TABS IN BLISTER(S) (300035602) 3 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή

Ficha técnica

Jubilant Pharmaceuticals nv
Azithromycin Jubilant 250 mg Film-coated tablets
Azithromycin Jubilant 500 mg Film-coated tablets
SPCE – p. 1/19
December 2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azithromycin Jubilant 250 mg Film-coated tablets
Azithromycin Jubilant 500 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azithromycin Jubilant 250 mg film-coated tablets
Each tablet contains azithromycin dihydrate equivalent to 250 mg of
azithromycin.
Excipient with known effect: Lactose monohydrate. Each tablet contains
5.40 mg lactose
monohydrate.
Azithromycin Jubilant 500 mg film-coated tablets
Each tablet contains azithromycin dihydrate equivalent to 500 mg of
azithromycin.
Excipient with known effect: Lactose monohydrate. Each tablet contains
10.80 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Azithromycin Jubilant 250 mg film-coated tablets
White to off-white, capsule shaped, film-coated tablets of
approximately 13.7 mm length, 6.8 mm
width and 5.9 mm thickness, debossed with ‘AZ’ and ‘250’ on
one side and plain on other side of the
tablet.
Azithromycin Jubilant 500 mg film-coated tablets
White to off-white, capsule shaped, film-coated tablets of
approximately 17.7 mm length, 9.2 mm
width and 7.1 mm thickness, debossed with ‘AZ’ and ‘500’ on
either side of scoreline on one side and
plain on other side of the tablets.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the following bacterial infections induced by
micro-organisms susceptible to
azithromycin (see sections 4.4 and 5.1):
-
infections of the lower respiratory tract: acute exacerbation of
chronic bronchitis (adequately
diagnosed) and mild to moderate community-acquired pneumonia;
-
infections of the upper respiratory tract: sinusitis and
pharyngitis/tonsillitis;
-
acute otitis media;
-
infections of the skin and soft tissues of mild to moderate severity
e.g. folli