Binozyt Powder for Oral Suspension 200mg5ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Azithromycin Monohydrate 204.8mg eqv Azithromycin

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

J01FA10

Dosage:

200mg/5ml

Pharmaceutical form:

POWDER, FOR SUSPENSION

Composition:

Azithromycin Monohydrate 204.8mg eqv Azithromycin 200mg/5ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Sandoz S.R.L.

Authorization status:

ACTIVE

Authorization date:

2009-12-01

Summary of Product characteristics

BINOZYT POWDER FOR ORAL SUSPENSION 200MG/5ML
1.
NAME OF THE MEDICINAL PRODUCT
Binozyt Powder for Oral Suspension 200 mg/5 mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml prepared suspension contains 204.8 mg azithromycin
monohydrate equivalent to
200 mg azithromycin.
Excipients:
Sucrose 3.70 g/ 5 ml
Aspartame 0.03 g/ 5 ml
For a full list of excipients see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white coloured powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for infections caused by susceptible
organisms; in lower respiratory
tract infections including bronchitis and pneumonia, in
odontostomatological infections, in skin
and soft tissue infections, in acute otitis media and in upper
respiratory tract infections including
sinusitis and pharyngitis/tonsillitis (Penicillin is the usual drug of
choice in the treatment of
_Streptococcus pyogenes _pharyngitis, including the prophylaxis of
rheumatic fever. Azithromycin
is generally effective in the eradication of streptococci from the
oropharynx; however, data
establishing the efficacy of azithromycin and the subsequent
prevention of rheumatic fever are
not available at present.)
In sexually transmitted diseases in men and women, azithromycin is
indicated for the treatment
of uncomplicated genital infections due to _Chlamydia trachomatis_. It
is also indicated for the
treatment of chancroid due to _Haemophilus ducreyi _and uncomplicated
genital infections due to
non-multiresistant _Neisseria gonorrhoeae_; concurrent infection with
_Treponema pallidum _
should be excluded.
Azithromycin is indicated, either alone or in combination with
rifabutin, for prophylaxis against
_Mycobacterium avium-_intracellulare complex (MAC) infection, an
opportunistic infection
prevalent in patients with advanced human immunodeficiency virus
(HIV).
Considerations should be given to official guidance on the appropriate
use of antibacterial
agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In Adults
For the tr