Binozyt 200mg5ml Powder For Oral Suspension

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Azithromycin Monohydrate

Boleh didapati daripada:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Azithromycin Monohydrate

Unit dalam pakej:

15 ml

Dikeluarkan oleh:

Sandoz S.R.L.

Risalah maklumat

BINOZYT
® POWDER FOR ORAL SUSPENSION
Azithromycin 200mg/5ml Powder for Oral Suspension
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is BINOZYT used for?
2.
How BINOZYT works?
3.
Before you use BINOZYT
4.
How to use BINOZYT?
5.
While you are using it
6.
Side effects
7.
Storage and disposal of BINOZYT
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IS BINOZYT USED FOR?
This medicine is usually prescribed to
treat:
-
chest infections such as chronic
bronchitis, pneumonia
-
skin and soft tissue infections
-
ear infections (acute otitis media)
-
infections of the tonsils, throat
(pharyngitis) and sinuses
-
urethra and cervix infections caused
by chlamydia.
HOW BINOZYT WORKS?
BINOZYT is an antibiotic which
belongs to the group of macrolide
antibiotics. It stops the growth of certain
bacteria.
BEFORE YOU USE BINOZYT
_WHEN YOU MUST NOT USE IT _
-
if you are allergic (hypersensitive)
to azithromycin, erythromycin,
other macrolide or ketolide
antibiotics or to any of the other
excipients of BINOZYT.
PREGNANCY AND LACTATION
Tell your doctor or pharmacist if you
are pregnant, or are planning to become
pregnant or if you are breast-feeding
before taking any medicine. You
should not use this medicine during
pregnancy and when you are breast-
feeding unless your doctor has
specifically recommended it.
_BEFORE YOU START USE IT _
Tell your doctor if you have any of the
following illnesses before taking this
medicine:
-
Liver problems: your doctor
may need to monitor your liver
function or stop the treatment
-
Kidney problems: if you have
severe kidney problems, the
dose may have to be adjusted.
-
Nervous (neurological) or
mental (psychiatric) problems.
-
A certain type of muscle
weakness called myasthenia
gravis.
Since azithromycin may increase the
risk of abnormal heart rhythm please
tell your doctor if you have any of the
following problems before taking this
medicine:
-
Heart problems such as a weak
heart (heart failure), very slow
heart r

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Binozyt
®
200mg/5 mL Powder for Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mL made-up Binozyt
®
200 mg/5 mL Powder for Oral Suspension contains 204.8 mg azithromycin
monohydrate equivalent to 200 mg azithromycin.
_For a full list of excipients, see section 6.1. _
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
White to off white coloured powder; after reconstitution with water
resulting in a white to off white
coloured homogenous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Binozyt can be applied in situations where micro-organisms sensitive
to azithromycin have caused:
•
upper respiratory tract infections: sinusitis, pharyngitis,
tonsillitis
•
acute otitis media
•
lower respiratory tract infections: acute bronchitis and mild to
moderately severe community acquired
pneumonia
•
skin and soft tissue infections
•
uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis
Considerations should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults _
In uncomplicated Chlamydia trachomatis urethritis and cervicitis, the
dose is 1,000 mg as a single oral dose.
For all other indications, the dose is 1,500 mg, to be administered as
500 mg per day for three consecutive
days. As an alternative, the same total dose (1,500 mg) can also be
administered over a period of 5 days
with 500 mg on the first day and 250 mg on the second to the fifth
day.
_Older people _
The same dose as in adult patients is used in older people. Since
older patients can be patients with
ongoing proarrhythmic conditions a particular caution is recommended
due to the risk of developing cardiac
arrhythmia and torsades de pointes (see section 4.4).
Paediatric population
Azithromycin tablets should only be administered to children weighing
more than 45 kg when normal adult
dose should be used. For children under 45 kg other pharmaceutical
forms of azithromycin, e.g.,
suspensions, may be used.
Th