KIDIMAC (Azithromycin for Oral Suspension USP 200 mg5 ml)

Страна: Малайзия

Език: английски

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

Активна съставка:

AZITHROMYCIN DIHYDRATE

Предлага се от:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Международно Name):

AZITHROMYCIN DIHYDRATE

Броя в опаковка:

15 ml; 30 ml

Произведено от:

ZIM Laboratories Limited

Листовка

KIDIMAC
_Consumer Medication Information Leaflet (RiMUP)_
Azithromycin for Oral Suspension USP 200 mg/5 ml
1
WHAT IS IN THIS LEAFLET
1.
What KIDIMAC is used for
2.
How KIDIMAC works
3.
Before you use KIDIMAC
4.
How to use KIDIMAC
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
KIDIMAC
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS KIDIMAC USED FOR
KIDIMAC is used to treat infections
caused by certain bacteria and other
micro-organisms which include:
•
Chest,
throat
or
nasal
infections
(such
as
bronchitis,
pneumonia,
tonsillitis,
sore
throat
(pharyngitis)
and sinusitis)
• Ear infections
• Skin and soft tissue infections (such
as an abscess or boil)
•Sexually-transmitted diseases caused
by
organisms
called
Chlamydia
trachomatis or Neisseria gonorrhoea.
You must talk to a doctor if you do not
feel better or if you feel worse.
HOW KIDIMAC WORKS
Azithromycin
is
an
antibiotic
belonging to the group of medicines
called a macrolides. This medicine
work
by
killing
or
stopping
the
growth of bacteria and other micro-
organisms which cause infections.
BEFORE YOU USE KIDIMAC
_-When you must not use it _
•
If
you/your
child
are
allergic
to
KIDIMAC
or
any
other
macrolide
antibiotic
such
as
erythromycin
or
clarithromycin
or
any
of
the
ingredients
listed
in
Product
Description
section.
An
allergic
reaction
may
cause
skin
rash
or
wheezing.
•
If
you
are
taking
any
ergot
derivatives such as ergotamine (used
to treat migraine) as these medicines
should
not
be
taken
together
with
KIDIMAC.
_ _
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.
_-Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before taking KIDIMAC if you/your
child have or have had any of the
following:
• Kidney problems
• Heart conditions
• Diabetes
• Liver problems: your doctor may
need to monitor your

Данни за продукта

Artwork Code : *P6372/X/XX/XX
Language : English
Date of Preparation : 25/06/2020
REV.00
Folding : Six Folds
( Three Vertical and Three Horizontal)
Black
Colours : Black
Other Instruction : Not Applicable
Size : (L) 300 x (W) 280 (After fold (L) 75 x (W) 35 mm
Material : 60 GSM, Maplitho Paper (Export quality)
PRODUCT NAME : LEAFLET OF KIDIMAC
*P6372/X/XX/XX Where X is variable and it will be change at the time
of commercialised.
·
Elderly
patients:
elderly
patients
may
be
more
susceptible to drug-associated effects on the QT
interval.
RENAL IMPAIRMENT
·
Patients currently receiving treatment with other
active substance known to prolong QT interval such
as antiarrhytmics of classes IA and III, antipsychotic
agents, antidepressants and fluoroquinolones.
·
Patients with clinically relevant bradycardia, cardiac
arrhythmia or severe cardiac insufficiency.
CLOSTRIDIUM DIFFICILE ASSOCIATED DIARRHOEA (CDAD):
possibility
of
ergotism,
azithromycin
and
ergot
derivatives should not be co-administrated.
PROLONGATION OF THE QT INTERVAL
·
Patients with electrolyte disturbance, particularly in
case of hypokalaemia and hypomagnesemia.
INFANTILE HYPERTROPHIC PYLORIC STENOSIS (IHPS)
Clostridium difficile associated diarrhoea (CDAD) has
been reported with use of nearly all antibacterial agents,
including azithromycin, and may range in severity from
mild diarrhoea to fatal colitis. Strains of C. difficile
producing
hypertoxin
A
and
B
contribute
to
the
development of CDAD. Hypertoxin producing strains
of C. difficile cause increased morbidity and mortality,
as these infections can be refractory to antimicrobial
therapy and may require colectomy. Therefore, CDAD
must
be
considered
in
patients
who
present
with
diarrhoea during or subsequent to the administration of
any antibiotics. Careful medical history is necessary
since CDAD has been reported to occur over two
months after the administration of antibacterial agents.
In patients with severe renal impairment (GFR <10
ml/min)
a
33%
increase
in
systemic
exposure
to
azithromycin was