Norepinephrine Kalceks 1 mgml concentrate for solution for infusion

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

noradrenaline tartrate

Tilgængelig fra:

EUCOGEN SDN BHD

INN (International Name):

noradrenaline tartrate

Enheder i pakken:

10 ampoules x 4 ml

Fremstillet af:

HBM PHARMA S.R.O.

Produktets egenskaber

Font size 11 pt, as measure in Times New Roman
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Norepinephrine Kalceks 1 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of concentrate for solution for infusion contains
norepinephrine tartrate equivalent to 1 mg
norepinephrine.
Each ampoule containing 4 ml of concentrate for solution for infusion
contains norepinephrine tartrate
equivalent to 4 mg norepinephrine.
When diluted as recommended, each ml contains norepinephrine tartrate
equivalent to 4 micrograms
norepinephrine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless or yellowish solution, practically free from visible
particles.
Description after dilution:
Clear, colourless or yellowish solution, practically free from visible
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For blood pressure control in certain acute hypotensive states (e.g.
pheochromocytomectomy,
sympathectomy, poliomyelitis, spinal anaesthesia, myocardial
infarction, septicaemia, blood
transfusion, and drug reactions).
As an adjunct in the treatment of cardiac arrest and profound
hypotension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Restoration of blood pressure in acute hypotensive state:_
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 ischemia,
norepinephrine can be administered before and concurrently with blood
volume replacement.
_Diluent: _
Norepinephrine Kalceks should be diluted in glucose 50 mg/ml (5%) or
sodium chloride
9 mg/ml (0.9%) with glucose 50 mg/ml (5%) solution for injection.
These glucose containing fluids
are protection against significant loss of potency due to oxidation.
Administration in saline solution
alone is not recommended. Whole blood or plasma, if indi