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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Noradrenaline

Available from:

AS Kalceks

ATC code:

C01CA03

INN (International Name):

Noradrenaline

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

norepinephrine

Authorization status:

Marketed

Authorization date:

2020-05-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOREPINEPHRINE KALCEKS 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
norepinephrine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
‒
Keep this leaflet. You may need to read it again.
‒
If you have any further questions, ask your doctor or nurse.
‒
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Norepinephrine Kalceks is and what it is used for
2.
What you need to know before you are given Norepinephrine Kalceks
3.
How Norepinephrine Kalceks will be given
4.
Possible side effects
5.
How to store Norepinephrine Kalceks
6.
Contents of the pack and other information
1.
WHAT NOREPINEPHRINE KALCEKS IS AND WHAT IT IS USED FOR
Norepinephrine Kalceks contains the active substance norepinephrine
and act as a vasoconstrictor
(causes narrowing of blood vessels).
Norepinephrine Kalceks is used in adults in an emergency to increase
blood pressure to normal levels.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NOREPINEPHRINE KALCEKS
YOU SHOULD NOT BE GIVEN NOREPINEPHRINE KALCEKS
•
if you are allergic to norepinephrine or any of the other ingredients
of this medicine (listed in
section 6)
•
if you have low blood pressure that has been caused by low blood
volume
•
if you receive some anaesthetics such as halothane or cyclopropane
(this may increase the risk
of irregular heart beat).
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given norepinephrine if
you:
•
have diabetes
•
have liver failure
•
have severe kidney disorders
•
suffer from high blood pressure
•
have an over-active thyroid gland
•
have low levels of oxygen in the blood
•
have high levels of carbon dioxide in the blood
•
have elevated pressure inside the skull (intracranial pressure)
•
have clots or obstructions in the blood vessels supplying the heart,
intestines, or other pa

Summary of Product characteristics

Health Products Regulatory Authority
07 July 2022
CRN00CV0Q
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of concentrate for solution for infusion contains
noradrenaline tartrate equivalent to 1 mg noradrenaline.
Each ampoule containing 2 ml of concentrate for solution for infusion
contains noradrenaline tartrate equivalent to 2 mg
noradrenaline.
Each ampoule containing 4 ml of concentrate for solution for infusion
contains noradrenaline tartrate equivalent to 4 mg
noradrenaline.
Each ampoule containing 5 ml of concentrate for solution for infusion
contains noradrenaline tartrate equivalent to 5 mg
noradrenaline.
Each ampoule containing 8 ml of concentrate for solution for infusion
contains noradrenaline tartrate equivalent to 8 mg
noradrenaline.
Each ampoule containing 10 ml of concentrate for solution for infusion
contains noradrenaline tartrate equivalent to 10 mg
noradrenaline.
When diluted as recommended, each ml contains noradrenaline tartrate
equivalent to 40 micrograms noradrenaline.
Excipient with known effect
8 ml of concentrate for solution for infusion contains 26.4 mg (or
1.12 mmol) sodium.
10 ml of concentrate for solution for infusion contains 33 mg (or 1.40
mmol) sodium.
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.
pH ranges between 3.0 and 4.0.
Osmolality 260‑310 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for
infusion is recommended 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_
Add 2 ml of Noradrenaline (Norepinephrine) 1 mg/ml concentrate for
solution for infusion t