Noradrenaline (Norepinephrine) Kabi 1 mg/ml concentrate for solution for infusion

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Sodium chloride; Noradrenaline tartrate

Disponibbli minn:

Fresenius Kabi Deutschland GmbH

Kodiċi ATC:

C01CA03

INN (Isem Internazzjonali):

Sodium chloride; Noradrenaline tartrate

Dożaġġ:

1 milligram(s)/millilitre

Għamla farmaċewtika:

Concentrate for solution for infusion

Żona terapewtika:

norepinephrine

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2021-05-14

Karatteristiċi tal-prodott

Health Products Regulatory Authority
16 December 2021
CRN00CNGX
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noradrenaline (Norepinephrine) Kabi 1 mg/ml concentrate for solution
for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml concentrate for solution for infusion contains 1 mg
noradrenaline (norepinephrine) base equivalent to 2 mg
noradrenaline (norepinephrine) tartrate.
The composition per ampoule is given in the following table:
Amount of concentrate
Amount of noradrenaline base
Amount of noradrenaline tartrate
1 ml
1 mg
2 mg
4 ml
4 mg
8 mg
5 ml
5 mg
10 mg
8 ml
8 mg
16 mg
10 ml
10 mg
20 mg
When diluted as recommended, each ml contains 40 micrograms
noradrenaline base equivalent to 80 micrograms
noradrenaline tartrate.
Excipient with known effects:
This medicinal product contains 3.4 mg sodium per ml.
8 ml of concentrate for solution for infusion contains 27.2 mg sodium.
10 ml of concentrate for solution for infusion contains 34 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear, colourless to pale yellow solution, practically free from
visible particles.
pH: 3.0 – 4.0
Osmolarity: approximately 300 mOsm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Noradrenaline (Norepinephrine) Kabi is indicated in adults for use as
an emergency measure in the restoration of blood
pressure in cases of acute hypotension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
When diluted as recommended in section 6.6, the final concentration of
the infusion solution is 40 mg/litre noradrenaline base,
which is equivalent to 80 mg/litre noradrenaline tartrate.
Some clinicians may prefer to dilute to other concentrations. If
dilutions other than 40 mg/l are used, check the infusion rate
calculation carefully before starting treatment.
_Initial rate of infusion:_
Health Products Regulatory Authority
16 December 2021
CRN00CNGX
Page 2 of 9
The initial rate of infusion should be between 10 ml/