TRAMADOL STADA INJECTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TRAMADOL HYDROCHLORIDE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE

Unit dalam pakej:

5 Ampoules

Dikeluarkan oleh:

B. BRAUN MELSUNGEN AG.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TRAMADOL STADA INJECTION
Tramadol hydrochloride 100mg/2ml
1
WHAT IS IN THIS LEAFLET
1.
What Tramadol STADA Injection is
used for
2.
How
Tramadol
STADA Injection
works
3.
Before you use Tramadol STADA
Injection
4.
How
to
take
Tramadol
STADA
Injection
5.
While
you
are
using
Tramadol
STADA Injection
6.
Side effects
7.
Storage and Disposal of Tramadol
STADA Injection
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TRAMADOL STADA INJECTION IS
USED FOR
•
Treatment
of
moderate
to
severe
pain
HOW
TRAMADOL
STADA
INJECTION
WORKS
•
Tramadol
STADA
Injection
is
a
painkiller belonging to the class of
the opioids that acts on the central
nervous system. It relieves pain by
acting on specific nerve cells of the
spinal cord and brain.
BEFORE
YOU
USE
TRAMADOL
STADA
INJECTION
_When you must not take it _
•
if you are allergic to the active
substance tramadol hydrochloride
or to any of the other ingredients
of Tramadol STADA Injection
•
in acute intoxication with alcohol,
analgesics,
sedatives
or
other
psychotropic drugs
•
if you are also taking monoamine
oxidase (MAO) inhibitors
•
if you have taken MAO inhibitors
within two weeks of when you
will
start
taking
Tramadol
STADA Injection
_Before you start to take it _
You should tell your doctor if
•
The pressure inside your skull is
higher than normal.
•
You have difficulty in breathing
•
You suffer from consciousness
disorders
•
You suffer from a liver or kidney
disease
•
You think that you are addicted to
other pain relievers
_Taking other medicine _
•
Please tell your doctor or pharmacist
if you are using or have recently
used any other medicines, including
medicines
obtained
without
a
prescription.
•
DO NOT take Tramadol STADA
Injection with monoamine oxidase
inhibitors
(MAOI),
or
2
weeks
before
and
after
taking
these
medicines.
MAOs
are
medicines
used for depression.
•
The
effect
of
Tramadol
STADA
Injection may be greater if you are:
-
also
taking
other
m

Ciri produk

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany
®
TRAMADOL STADA
ACTIVE INGREDIENT
Tramadol hydrochloride
COMPOSITION
Each ampoule of 2 ml of injectable solution contains: Tramadol
hydrochloride, 100 mg; sodium acetate, water for
injection.
INDICATIONS
For moderate to severe pain.
PHARMACOLOGIC PROPERTIES
Tramadol hydrochloride is a cyclohexanol derivative with central
analgesic and antitussive activities. The drug (and its
active M1 metabolite) acts as an opiate agonist, apparently by
selective activity at the u-receptor. In addition to opiate
agonist activity, Tramadol inhibits reuptake of certain monoamine
(norepinephrine, serotonin) which appears to
contribute to the drug’s analgesic effect. Unlike morphine Tramadol
has no respiratory effect over a wide range of
analgesic doses. It also does not effect gastrointestinal motility.
Its effects on the cardiovascular system are relatively
slight.
PHARMACOKINETICS
Following oral administration (100 gm), tramadol is rapidly and almost
completely absorbed. The mean absolute
bioavailability of Tramadol after oral administration, irrespective of
simultaneous food intake, is 68%; following rectal
administration it is 79%, and following i.m. administration 100%. The
maximum first-pass effect after oral administration
is 30% and after rectal administration 20%.
Tramadol crosses the blood-brain barrier and the placental barrier. It
is found in breast milk, together with 0-desmethyl
derivative, in very low concentration (0.1% and 0.02% respectively of
the administered dose). The elimination half-life
t1/2 irrespective of the route of administration, is 5-7 hours. This
is slightly prolonged in patients over 65 years of age.
Tramadol and its metabolites are almost entirely excreted by the
kidney. In the presence of disorders of hepatic and
renal function, the half-lives are likely to be somewhat prolonged.
CONTRA-INDICATIONS
Tramadol STADA
®
must not be used in patients with:
-
known hypersensitivity to Tramadol
-
acute alcohol, analgesic (pain-killer), soporifi