TRAMASURE-100 Tramadol Hydrochloride Injection 50mgml

Country: Malaysia

Language: English

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

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

TRAMADOL HYDROCHLORIDE

Units in package:

4 x 2 ml Ampoules

Manufactured by:

MANKIND PHARMA LIMITED

Patient Information leaflet

Not Applicable

Summary of Product characteristics

TRAMASURE-100
(TRAMADOL HYDROCHLORIDE INJECTION 50MG/ML)
MANKIND PHARMA LIMITED
Regd. Office:
208, Okhla Industrial Estate, Phase-3, New Delhi-110020, INDIA
TRAMASURE-100
(Tramadol Hydrochloride Injection 50mg/ml)
PRODUCT NAME:
TRAMASURE-100 (Tramadol Hydrochloride Injection 50mg/ml)
NAME AND STRENGTH OF ACTIVE INGREDIENTS:
TRAMASURE-100: Each 2 mL contains Tramadol Hydrochloride Ph.
Eur.
100 mg and
Water for injection USP qs.
PRODUCT DESCRIPTION:
Before reconstitution: Clear and colorless solution.
After reconstitution with infusion solutions:
Clear and colorless solution when mixed with below diluents.
-
0.9% Sodium Chloride Intravenous Infusion
-
5% Glucose Intravenous infusion
-
Sodium Lactate Solution
Light brownish color solution when mixed with below diluent
-
Haemaccel
PHARMACOLOGICAL PROPERTIES
PHARMACOTHERAPEUTIC GROUP: OTHER OPIOIDS; ATC-CODE N02AX02.
PHARMACODYNAMICS PROPERTIES
Tramadol is a centrally acting opioid analgesic. It is a nonselective
pure agonist at micro,
δ-and κ-opioid receptors with a higher affinity to the micro
receptor. Other mechanisms,
which may contribute to its
analgesic effect,
are inhibition of
neuronal
re-uptake of
noradrenaline and enhancement of serotonin release.
Tramadol possesses antitussive properties. At variance to morphine,
tramadol administered
at
therapeutic
doses
has
a
negligible
depressive
effect
on
respiration.
Equally,
gastrointestinal motility is affected to a lesser extent. Effects on
the cardiovascular system
are rather small.
The analgesic potency of tramadol
is stated to be 1/10 to 1/6 of that
of morphine.
The
onset of the analgesic effect of tramadol is rapid and lasts for
several hours (4-6 hrs).
PHARMACOKINETICS PROPERTIES
More than 90% of tramadol
is absorbed after oral
administration.
The half- life of the
distribution phase t1/2a is about 0.8 h. Tramadol and its metabolites
are eliminated via the
kidneys.
The half-life of the terminal
elimination phase t1/2b in human is in favourable
range for analgesics (about 6 h). The biological half- lives of t