Noradrenaline (Biomed)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Noradrenaline acid tartrate monohydrate 0.12 mg/mL equivalent to 0.06mg/mL noradrenaline base;  

Available from:

Biomed Limited

INN (International Name):

Noradrenaline acid tartrate monohydrate 0.12 g/L (equivalent to 0.06 g/L noradrenaline base)

Dosage:

0.06 mg/mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Noradrenaline acid tartrate monohydrate 0.12 mg/mL equivalent to 0.06mg/mL noradrenaline base   Excipient: Glucose Sodium metabisulfite Water for injection

Units in package:

Syringe, polypropylene, 50 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cambrex Profarmaco Milano Srl

Therapeutic indications:

For the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion, and drug reactions).

Product summary:

Package - Contents - Shelf Life: Syringe, polypropylene with BD rubber stopper and plastic over pouch - 50 mL - 12 months unopened stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2010-10-15

Summary of Product characteristics

NEW ZEALAND DATA SHEET
NORADRENALINE (BIOMED) 0.06 MG/ML, 0.1 MG/ML, 0.12 MG/ML, 0.16 MG/ML
SOLUTION FOR INFUSION
Page 1 of 7
1
PRODUCT NAME
Noradrenaline 0.06 mg/mL Solution for infusion
Noradrenaline 0.1 mg/mL Solution for infusion
Noradrenaline 0.12 mg/mL Solution for infusion
Noradrenaline 0.16 mg/mL Solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
All strengths indicated above relate to noradrenaline base, which is
added as noradrenaline
acid tartrate monohydrate.
All strengths contain sodium metabisulphite 0.2 mg/mL as an
antioxidant and glucose 5% for
tonicity.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Noradrenaline is a sterile solution containing noradrenaline acid
tartrate available in a range
of ready to use strengths in flexible bags and syringes.
The pH range of the infusions is 3.0 – 4.6.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For
the
restoration
of
blood
pressure
in
certain
acute
hypotensive
states
(e.g.
phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal
anaesthesia, myocardial
infarction, septicaemia, blood transfusion, and drug reactions).
As an adjunct in the treatment of cardiac arrest. To restore and
maintain an adequate blood
pressure after an effective heartbeat and ventilation have been
established by other means.
4.2
DOSE AND METHOD OF ADMINISTRATION
Noradrenaline is intended for use undiluted. It contains no
antimicrobial preservatives.
Discoloured solutions or those containing a precipitate should not be
used.
Avoid contact with iron salts, alkalis, or oxidising agents.
RESTORATION OF BLOOD PRESSURE IN ACUTE HYPOTENSIVE STATES
Blood
volume
depletion
should
always
be
corrected
as fully
as
possible
before
any
vasopressor is administered. When, as an emergency measure,
intra-aortic pressures must
be maintained to prevent cerebral or coronary artery ischaemia,
noradrenaline can be
administered before and concurrently with blood volume replacement.
Administer by slow intravenous infusion, observing the response to an
initia