Aseptone Syrup 5mgml

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

Methadone HCl

Доступна з:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

ІПН (Міжнародна Ім'я):

Methadone HCl

Одиниць в упаковці:

60 ml

Виробник:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
ASEPTONE SYRUP
Methadone hydrochloride (5mg/ml)
WHAT IS IN THE LEAFLET
1.
What ASEPTONE SYRUP
is used for
2.
How ASEPTONE SYRUP
works
3.
Before
you
use
ASEPTONE SYRUP
4.
How
to
use
ASEPTONE
SYRUP
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
ASEPTONE SYRUP
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ASEPTONE SYRUP IS
USED FOR
This medicine is for treatment
of addiction in opioid drugs.
ASEPTONE
SYRUP
is
only
available
with
a
doctor’s
prescription.
HOW
ASEPTONE
SYRUP
WORKS
ASEPTONE SYRUP contains
methadone
hydrochloride
as
the active ingredient. It belongs
to a group of medicines called
opioid.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE YOU USE ASEPTONE
SYRUP
-
_When you must not use it_
Do not take this
medicine
if
you have an allergy to:

methadone

any other opioid drugs

any
of
the
other
ingredients
listed
at
the
end of this leaflet
Symptoms
of
an
allergic
reaction may include

shortness of breath

wheezing

difficulty in breathing

swelling of the face, lips,
tongue or any other parts
of the body

rash, itching or hives on the
skin.
Do
not
take
ASEPTONE
SYRUP if you

suffer from a lung disorder
such
as
asthma
or
any
illness causing difficulty in
breathing

have a recent head injury
or
increased
pressure
in
the head

have
a
bowel
condition
known as ulcerative colitis

have severe liver problem

alcoholism

are taking, or have taken
in
the
last
two
weeks,
drugs
for
depression
known
as
Monoamine
Oxidase
Inhibitors
(MAOIs),

paralytic ileus (paralysis of
the intestinal muscle)
If any of these apply to you,
get
advice
from
a
doctor
or
pharmacist.
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows signs of tampering.
If it has expired or is damaged,
return it to your pharmacist

Характеристики продукта

*All text and graphic must be 2mm away from diecut outline and glue
area.
40
BASE
40mm x 112mm
38
5
2 5 4
2
56
Spine
Glue
Glue
40
LEAFLET FRONT
40mm x 569mm
61
5
2
2
56
55
56
56
55
56
56
55
54
Glue
Glue
Pg 2
Pg 3
Pg 4
Pg 5
Pg 6
Pg 7
Pg 8
Pg 9
Pg 10
Pg 11
40
LEAFLET INSIDE
40mm x 569mm
54
7
2
56
55
55
56
55
56
56
51
5
61
Pg 12
Pg 13
Pg 14
Pg 15
Pg 16
Pg 17
Pg 18
Pg 19
Pg 20
Pg 1
DESCRIPTION
A red coloured syrup.
COMPOSITION
Each ml contains Methadone Hydrochloride 5mg.
PHARMACODYNAMICS
Methadone HCl is a primarily μ opioid agonist. It binds with
stereospecific receptors at
many sites within the central nervous system (CNS). The most prominent
involve the
CNS and organs composed of smooth muscle.
PHARMACOKINETICS
Protein binding : High
Half life : 15 – 25 hours; increases with repeated administration.
Onset of action : Oral: 30 – 60 minutes
Time to peak effect : Oral: 1.5 – 2 hours
1500012091 N.2
Each 1 ml contains
_METHADONE HCI 5MG_
Preservatives:
Methyl Paraben 1mg
Propyl Paraben 0.10mg
PRODUCT REGISTRATION HOLDER:
DUOPHARMA MANUFACTURING
(BANGI) SDN. BHD.
Lot No. 2, 4, 6, 8 & 10, Jalan P/7,
Section 13, Bangi Industrial Estate,
43650 Bandar Baru Bangi,
Selangor, Malaysia.
MANUFACTURER:
DUOPHARMA MANUFACTURING
(BANGI) SDN. BHD.
Lot No. 2 & 4, Jalan P/7, Section 13,
Bangi Industrial Estate,
43650 Bandar Baru Bangi,
Selangor, Malaysia.
Reg. No. : MAL05041880AZ
Store below 30ºC.
Protect from light.
Keep out of reach of children.
JAUHKAN DARIPADA KANAK-KANAK
_PLEASE REFER PACKAGE INSERT FOR_
_FULL INFORMATION._
ROUTE OF ADMINISTRATION : ORAL
This
preparation
may
be
habit
forming
on
prolonged
use.
Avoid
alcoholic
beverages.
Aseptone
Syrup
is
available
with
sodium
saccharin
as
a
sweetening
agent.
Phenylketonurics
are
warned
that
this product, in some form, contains
phenylalanine.
STORAGE CONDITIONS
Store below 30
o
C. Keep out of reach of children.
Jauhkan daripada kanak-kanak.
PACK SIZE : 60ml
SHELF LIFE: Please refer to outer package.
THE PHYSICIAN MUST REMEMBER, HOWEVER, THAT METHADONE IS A
LONG-ACTING
DEPRE