AZITHROMYCIN JUBILANT 500MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

AZITHROMYCIN DIHYDRATE

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

J01FA10

INN (Διεθνής Όνομα):

AZITHROMYCIN

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

AZITHROMYCIN DIHYDRATE (8000001873) 524,04MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

AZITHROMYCIN

Περίληψη προϊόντος:

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

Αρχείο Π.Χ.Π.

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