NORADRENALINE KALCEKS

País: Israel

Idioma: anglès

Font: Ministry of Health

Compra'l ara

Descargar Fitxa tècnica (SPC)
04-12-2023

ingredients actius:

NORADRENALINE AS TARTRATE

Disponible des:

A.L. MEDI-MARKET LTD.

Codi ATC:

C01CA03

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

NORADRENALINE AS TARTRATE 1 MG / 1 ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

HBM PHARMA S.R.O., SLOVAKIA

Área terapéutica:

NOREPINEPHRINE

indicaciones terapéuticas:

Noradrenaline Kalceks is indicated for blood pressure control in certain acute hypotensive states (e.g., pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions). As an adjunct in the treatment of cardiac arrest and profound hypotension.

Data d'autorització:

2023-01-16

Fitxa tècnica

                                1.
NAME OF THE MEDICINAL PRODUCT
Noradrenaline Kalceks
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Noradrenaline (as tartrate) 1 mg/ml.
Each ampoule of 4 ml contains 4 mg of noradrenaline (as tartrate).
This medical product contains 3.3 mg sodium per ml (13.2 mg sodium per
4 ml ampoule).
For the full list of excipients, see section 12.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless or yellowish solution, practically free from visible
particles.
pH ranges between 3.0 and 4.0. Osmolality 260-310 mOsm/kg.
4.
INDICATIONS AND USAGE
For blood pressure control in certain acute hypotensive states (e.g.,
pheochromocytomectomy, sympathectomy, poliomyelitis,
spinal anesthesia, myocardial infarction, septicemia, blood
transfusion, and drug reactions).
As an adjunct in the treatment of cardiac arrest and profound
hypotension.
5.
DOSAGE AND ADMINISTRATION
Noradrenaline tartrate Injection is a concentrated, potent drug which
must be diluted prior to infusion. An infusion of
Noradrenaline Kalceks should be given into a large vein (see _Warnings
and PRECAUTIONS_).
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, intraaortic pressures must be maintained to prevent
cerebral or coronary artery ischemia, Noradrenaline
Kalceks can be administered before and concurrently with blood volume
replacement.
Diluent: Noradrenaline Kalceks should be diluted in sodium chloride 9
mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution,
or sodium chloride 9 mg/ml (0.9%) with glucose 50 mg/ml (5%) solution.
Whole blood or plasma, if indicated to increase blood
volume, should be administered separately (for example, by use of a
Y-tube and individual containers if given simultaneously).
_Average Dosage: _Add a 4 ml ampoule (4 mg) of Noradrenaline Kalceks
to 1,000 ml of a sodium chloride 9 mg/ml (0.9%) solution
or glucose 50 mg/ml (5%) solution, or sodium chloride 9 mg/
                                
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