Noradrenaline (Norepinephrine) 1:1000 Concentrate For Solution For Infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Noradrenaline acid tartrate

Dostopno od:

Pfizer Healthcare Ireland

Koda artikla:

C01CA; C01CA03

INN (mednarodno ime):

Noradrenaline acid tartrate

Odmerek:

1 milligram(s)/millilitre

Farmacevtska oblika:

Concentrate for solution for infusion

Tip zastaranja:

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

Terapevtsko območje:

Adrenergic and dopaminergic agents; norepinephrine

Status dovoljenje:

Marketed

Datum dovoljenje:

1995-04-10

Navodilo za uporabo

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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:
•
have diabetes

Lastnosti izdelka

Health Products Regulatory Authority
21 June 2021
CRN009ZNW
Page 1 of 7
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.
Excipient with known effect
Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for
Infusion contains
6.7 mg of sodium in each 2 ml ampoule.
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 indicated