ACEVIZ (Acetylcysteine Powder for Oral Solution 200 mg)

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

Acetylcysteine

זמין מ:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (שם בינלאומי):

Acetylcysteine

יחידות באריזה:

30 Sachets; 50 Sachets

תוצרת:

XL Laboratories Pvt. Ltd.

עלון מידע

ACEVIZ
_Consumer Medication Information Leaflet (RiMUP)_
Acetylcysteine Powder for Oral Solution 200 mg
1
WHAT IS IN THIS LEAFLET
1.
What ACEVIZ is used for
2.
How ACEVIZ works
3.
Before you use ACEVIZ
4.
How to use ACEVIZ
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ACEVIZ
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS ACEVIZ USED FOR
ACEVIZ is indicated for all
respiratory tract diseases leading to
the formation of thick secretions
difficult to be expectorated, such as
acute and chronic bronchitis,
laryngitis, sinusitis, tracheitis,
influenza, bronchial asthma and (as
complementary treatment)
mucoviscidosis.
HOW ACEVIZ WORKS
Each sachet contains the active
substance acetylcysteine.
Acetylcysteine belongs to a group of
medicines called mucolytics which
work by thinning the mucus
(phlegm) so that it can be coughed up
more easily.
BEFORE YOU USE ACEVIZ
-
_When you must not use it _
Do not take ACEVIZ if:
•
you are allergic to the
ingredients of this product
•
you are pregnant; trying to get
pregnant or think you may be
pregnant.
•
you are breast-feeding.
-
_Before you start to use it _
Ask your doctor or pharmacist for
advice before taking any medicine.
Please make sure you have
understood the explanation given by
your doctor or pharmacist before
taking this medicine.
Speak to your
doctor /pharmacist if you have any
other health related problems.
-
_Taking other medications _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from
a pharmacy, supermarket or health
food shop. Tell your doctor if you are
taking the following medicines
before starting ACEVIZ:
•
medicines to treat coughs (e.g.
cough syrup)
•
activated charcoal, used to treat
poisoning
•
drugs used to treat bacterial
infections, antibiotics (e.g.
cefalexin, cefuroxime,
cefadroxil, cefaclor, ceftriaxone)
•
medicines to treat angina
attacks, (tightness in your chest,
neck and arm) (e.g. glycer

מאפייני מוצר

Size : 165x120 mm
Manufactured by :
XL LABORATORIES PVT. LTD.
E-1223, Phase-I Extn., (Ghatal) RIICO Indl.
Area, Bhiwadi-301019, Rajasthan, India
Product Registration Holder:
HEALOL PHARMACEUTICALS SDN.BHD
74-3, Jalan Wangsa Delima 6,
KLSC Wangsa Maju,
53300 Kuala Lumpur, Malaysia.
ACEVIZ
Acetylcysteine Powder for Oral Solution 200 mg
PRODUCT NAME
ACEVIZ (Acetylcysteine Powder for Oral Solution 200 mg)
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Acetylcysteine 200 mg
PRODUCT DESCRIPTION
White to off-white, granular powder after reconstitution in warm water
forms a clear
solution.
PHARMACODYNAMICS & PHARMACOKINETICS
_Pharmacodynamics_
Pharmacotherapeutic group: Mycolytics, ATC code: R05CB01
N-acetyl-L-cysteine (NAC), the active ingredient in Acetylcysteine 200
mg Powder for Oral
Solution exerts an intense mucolytic-fluidizing action on mucous and
mucopurulent
secretions by depolymerizing the mucoproteic complexes and the nucleic
acids which
confer viscosity to the vitreous and purulent component of the sputum
and other secretions.
Furthermore, acetylcysteine exerts a direct antioxidant action, having
a free thiol (- SH)
nucleophilic group that is able to interact directly with
electrophilic groups of oxidant
radicals. Of particular interest is the recent finding that
acetylcysteine protects α1-
antitrypsin enzyme inhibiting elastase from inactivation by
hypochlorous acid (HOCl), a
powerful
oxidant
agent
produced
by
the
myeloperoxidase
enzyme
of
activated
phagocytes.
Due
to
its
molecular
structure,
acetylcysteine
can
readily
cross
cell
membranes. Inside the cell, NAC is deacetylated to L-cysteine, an
amino acid essential for
glutathione synthesis (GSH).
GSH is a highly reactive tripeptide found ubiquitously in the various
tissues of animals and
is essential for the maintenance of functional capacity as well as
cellular morphological
integrity. It is the most important protective intracellular mechanism
against oxidant
radicals, both exogenous and endogenous, as well as toward numerous
cytotoxic
substances.
These featu