Azithromycin Powder For Oral Suspension 200mg5ml Lesvi Lab

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

AZITHROMYCIN DIHYDRATE

Tilgængelig fra:

ZIWELL MEDICAL SDN BHD

INN (International Name):

AZITHROMYCIN DIHYDRATE

Enheder i pakken:

15ml mL; 30ml mL

Fremstillet af:

Neuraxpharm Pharmaceuticals S.L.

Indlægsseddel

Consumer Medica on Informa on Leaflet (RiMUP)
Azithromycin Powder for Oral Suspension 200mg/5ml Lesvi Lab
Azithromycin 200mg/5ml
What is in this leaflet
1.
What Azithromycin Powder for
Oral Suspension 200mg/5ml
Lesvi Lab is used for
2.
How it works
3.
Before you use
4.
How to use
5.
While you are using
6.
Side effects
7.
Storage and disposal
8.
Product descrip on
9.
Manufacturer and Product
Registra on Holder
10. Date of Revision

Health problems, including:
i.
Liver problems
ii.
Kidney problems
iii.
Heart problems
iv.
Diabetes
v.
Hereditary fructose
intolerance
vi.
Glucose-galactose
malabsorp on or
saccharise-isomaltase
deficiency
Taking other medicines
appropriate for you. This medicine can be
taken with or without food.
For children, the dosage is based on their
weight and must be determined by a
doctor. Please give the medicine to your
child based on the doctor’s instruc
ons.
How long to use it
Your doctor will tell you how long you
should take the medicine.
If you forget to use it
Do not take a double dose to make up for
a missed dose.
What Azithromycin Powder for Oral
Suspension 200mg/5ml Lesvi Lab is used
for
This medicine is usually prescribed to
treat:

Chest, throat, ear or nasal
infec
ons (e.g. bronchi
s,
pneumonia, tonsilli
s,
pharyngi
s, acute o
s media
and sinusi
s)

Skin and so
ssue infec
ons

Sexually-transmi
ed diseases
due to Chlamydia, Haemophilus
or Gonorrhoea
How it works
Azithromycin belongs to the macrolide
an bio cs group. It stops the growth of
certain bacteria.
Before you use
When you must not use
Do not take this medicine if you are
allergic to azithromycin, erythromycin,
macrolide or ketolide an bio cs, or any
of the ingredients in this medicine.
Pregnancy and lacta on
Tell your doctor or pharmacist if you are
pregnant, planning to get pregnant or
breast-feeding before taking any
medicine. You should not use this
medicine during pregnancy or breast-
feeding, unless your doctor has
prescribed it.
Before you start to use it
Tell your doctor if you have any of the
follow

Produktets egenskaber

PACK INSERT
PRODUCT NAME
Azithromycin Film-coated
_ _
Tablet 500mg Lesvi Lab
Azithromycin
_ _
Powder for Oral Suspension 200mg/5ml Lesvi Lab
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Azithromycin Film-coated tablets 500mg Lesvi Lab:
Azithromycin dihydrate 524.03mg equivalent to azithromycin 500mg
Azithromycin
_ _
Powder for Oral Suspension 200mg/5ml Lesvi Lab:
Azithromycin dihydrate 209.62mg equivalent to azithromycin 200mg/5ml
PRODUCT DESCRIPTION
Film-coated tablets
Oblong, biconvex tablets, scored on one side and with the inscription
“500” on the other.
Powder for oral suspension.
Nearly white powder presented in a bottle. A whitish suspension is
obtained after its
reconstitution with water.
PHARMACODYNAMICS
Azithromycin is the first of a subclass of macrolides antibiotics,
known as azalides, and is
chemically different from erythromycin. Chemically it is derived by
insertion of a nitrogen atom
into the lactone ring of erythromycin A. The mode of action of
azithromycin is inhibition of
protein synthesis in bacteria by binding to the 50s ribosomal subunit
and preventing translocation
of peptides.
Azithromycin demonstrates activity in vitro against a wide range of
bacteria including:
Gram-positive Aerobic Bacteria
_Staphylococcus aureus, Streptococcus pyogenes _
(group A beta-hemolytic streptococci),
_Streptococcus pneumoniae, alpha-hemolytic streptococci _
(viridans group) and other streptococci,
and
_Corynebacterium diphtheriae_
. Azithromycin demonstrates cross-resistance with
erythromycin-resistant Gram-positive strains, including
_Streptococcus faecalis _
(enterococcus)
and most strains of methicillin-resistant staphylococci.
Gram-negative Aerobic Bacteria
_Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella
catarrhalis, Acinetobacter _
species,
_Yersinia _
species,
_Legionella pneumophila_
,
_Bordetella pertussis, Bordetella _
_parapertussis, Shigella species, Pasteurella species, Vibrio cholerae
_
and
_parahaemolyticus, _
_Plesiomonas shigelloides_
. Activities against
_Escherichia coli, Salmo