NORADRENALINE 1 Mg/Ml Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NORADRENALINE ACID TARTRATE

Available from:

Hospira Enterprises B.V.

ATC code:

C01CA03

INN (International Name):

NORADRENALINE ACID TARTRATE

Dosage:

1 Mg/Ml

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Adrenergic and dopaminergic agents

Authorization status:

Authorised

Authorization date:

2005-10-28

Patient Information leaflet

Page 1 of 6
PFLEET 2017 0030714
PACKAGE LEAFLET: INFORMATION FOR THE
USER
NORADRENALINE (NOREPINEPHRINE) 1:1000 CONCENTRATE FOR SOLUTION FOR
INFUSION
NORADRENALINE (AS NORADRENALINE
TARTRATE)
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, please 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 Noradrenaline (norepinephrine) 1:1000 concentrate for solution
for infusion is and what it
is
used
for
2.
What you need to know before you are given Noradrenaline
(norepinephrine) 1:1000 concentrate for
solution for
infusion
3.
How you are given Noradrenaline (norepinephrine) 1:1000 concentrate
for solution for
infusion
4.
Possible side
effects
5.
How to store Noradrenaline (norepinephrine) 1:1000 concentrate for
solution for
infusion
6.
Contents of the pack and other
information
1. WHAT NORADRENALINE (NOREPINEPHRINE) 1:1000 CONCENTRATE FOR
SOLUTION
FOR INFUSION IS AND WHAT IT IS USED
FOR
Noradrenaline (norepinephrine) 1:1000 concentrate for solution for
infusion is used in an emergency
to
increase blood pressure to normal
levels.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NORADRENALINE
(NOREPINEPHRINE)
1:1000
CONCENTRATE FOR SOLUTION FOR
INFUSION
Do not use Noradrenaline (norepinephrine) 1:1000 concentrate for
solution for infusion
:
•
If you are allergic (hypersensitive) to noradrenaline preparations or
to any of the other ingredients
of
this medicine (listed section
6).
WARNINGS AND
PRECAUTIONS
•
You will not be given Noradrenaline (norepinephrine) 1:1000
concentrate for solution for infusion
if you have been given the anaesthetic gases cyclopropane or halothane
TALK TO YOUR DOCTOR OR NURSE BEFORE USING NORADRENALINE
(NOREPINEPHRINE) 1:1000 CONCENTRATE FOR
SOLUTION
FOR
INFUSION IF
YOU:
Page 2 of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noradrenaline (Norepinephrine) 1:1000 Concentrate For Solution For
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre (ml) of concentrate for solution for infusion contains
2 milligram (mg) of noradrenaline (norepinephrine)
tartrate, equivalent to 1 mg norepinephrine base. Each 2 ml ampoule
contains 4 mg of norephinephrine tartrate
equivalent to 2 mg norepinephrine base.
When diluted as recommended, each ml contains 80 micrograms
norepinephrine tartrate equivalent to 40 micrograms
norepinephrine base.
Excipients with known effect:
This medicinal product contains sodium. Each ml of concentrate for
solution for infusion contains 3.3 mg of sodium,
equivalent to 0.14 mmol. A 2 ml ampoule contains 6.7 mg sodium,
equivalent to 0.29 mmol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A sterile, clear colourless solution.
The solution has a pH ranging between 3.0 and 4.0 and osmolarity
ranging between 281- 285 mOsm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Norepinephrine 1:1000 is recommended for use as an emergency measure
in the restoration of blood pressure in cases
of acute hypotension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route of Administration:_
For intravenous use.
_Method of Administration:_
Norepinephrine 1: 1000 should be administered in a diluted solution
and it may be administered via a central venous
catheter. The infusion should be at a controlled rate using either a
syringe pump or an infusion pump or a drip counter.
For instructions on dilution of the product before administration, see
section 6.6.
_Site of infusion:_
If not using a central venous catheter, whenever possible, infusions
of norepinephrine tartrate should be administered
into a large vein, particularly an antecubital vein. When administered
into this vein, the risk of necrosis of the
overlying skin from prolonged vasoconstriction is reported to be very
slight. Some authors have in