NORADRENALINE AGUETTANT 1MGML CONCENTRATE FOR SOLUTION FOR INFUSION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Noradrenaline tartrate 2mg/ml equiv. Noradrenaline

Available from:

AGUETTANT ASIA PACIFIC PTE. LTD.

ATC code:

C01CA03

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Noradrenaline tartrate 2mg/ml equiv. Noradrenaline 1mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Laboratoire AGUETTANT

Authorization status:

ACTIVE

Authorization date:

2018-12-04

Summary of Product characteristics

106372
DESCRIPTION
Norepinephrine (sometimes referred to as
_l-arterenol/Levarterenol_
or
_l-norepinephrine_
) is a sympathomimetic amine which differs from
epinephrine by the absence of a methyl group on the nitrogen atom.
Norepinephrine Tartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl
alcohol tartrate (1:1) (salt) monohydrate and has the following
structural
formula:
NORADRENALINE AGUETTANT is supplied in sterile aqueous solution
in the form of the tartrate salt to be administered by intravenous
infusion
following dilution. Norepinephrine is sparingly soluble in water, very
slightly soluble in alcohol and ether, and readily soluble in acids.
Each mL
contains the equivalent of 1 mg base of norepinephrine, and the
following
excipients: sodium chloride, hydrochloric acid or sodium hydroxide
(for pH
adjustment), and water for injection. It has a pH of 3.0 to 4.0. The
air in the
ampuls has been displaced by nitrogen gas.
CLINICAL PHARMACOLOGY
NORADRENALINE AGUETTANT functions as a peripheral
vasoconstrictor (alpha-adrenergic action) and as an inotropic
stimulator of
the heart and dilator of coronary arteries (beta-adrenergic action).
These actions result in an increase in systemic blood pressure and
coronary
artery blood flow. In myocardial infarction accompanied by
hypotension,
norepinephrine usually increases aortic blood pressure, coronary
artery
blood flow, and myocardial oxygenation, thereby helping to limit the
area of myocardial ischaemia and infarction. Venous return is
increased
and the heart tends to resume a more normal rate and rhythm than in
the
hypotensive state. In hypotension that persists after correction of
blood
volume deficits, norepinephrine helps raise the blood pressure to an
optimal
level and establish a more adequate circulation.
INDICATIONS AND USAGE
For blood pressure control in certain acute hypotensive states (e.g.
myocardial infarction, septicemia, blood transfusion, and drug
reactions).
As an adjunct in the treatment of cardiac arrest and profound
hypotension.
CONTRAINDICATIONS
NOR