Levophed™ 1:1000

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Noradrenaline acid tartrate monohydrate 2 mg/mL equivalent to Noradrenaline base 1 mg/mL

Доступно од:

Pfizer New Zealand Limited

INN (Међународно име):

Noradrenaline acid tartrate monohydrate 2 mg/mL (equivalent to Noradrenaline base 1 mg/mL)

Дозирање:

1 mg/mL

Фармацеутски облик:

Concentrate for injection

Састав:

Active: Noradrenaline acid tartrate monohydrate 2 mg/mL equivalent to Noradrenaline base 1 mg/mL Excipient: Sodium chloride Sodium metabisulfite Water for injection

Тип рецептора:

Prescription

Произведен од:

Cambrex Profarmaco Milano Srl

Терапеутске индикације:

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

Резиме производа:

Package - Contents - Shelf Life: Vial, glass, Type 1 amber glass with rubber stopper & aluminium seal 4mL - 10 dose units - 18 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Датум одобрења:

2013-12-04

Карактеристике производа

Version: pfdlevoi10822
Supersedes: pfdlevoi10720
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
LEVOPHED
TM
1:1000 Concentrate for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains noradrenaline (norepinephrine) 4 mg in 4 mL
(1:1000), present as 8 mg of
noradrenaline (norepinephrine) acid tartrate in 4 mL.
Excipient(s) with known effects:
•
Sodium metabisulfite
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
LEVOPHED
TM
1:1000 is a sterile colourless (or practically colourless),
concentrated solution for
injection. It has a pH of 3.0 to 4.5.
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
LEVOPHED
TM
1:1000 contains noradrenaline (norepinephrine) as the acid tartrate.
It is a
concentrated, potent injection which must be diluted in dextrose
containing solutions prior to
infusion. An infusion of noradrenaline (norepinephrine) should be
given into a large vein (see
Section 4.4).
LEVOPHED
TM
1:1000 contains no antimicrobial preservative. It is for single use in
one patient
only. Discard any residue.
Parenteral drug products should be inspected visually for particulate
matter and discolouration
prior to use, whenever solution and container permit.
Discoloured solutions or those containing a precipitate should not be
used.
Avoid contact with iron salts, alkalis, or oxidising agents.
Version: pfdlevoi10822
Supersedes: pfdlevoi10720
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,