Noradrenaline (base) 4mg/4ml concentrate for solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Noradrenaline acid tartrate

Available from:

base) 4mg/4ml concentrate for solution for infusion ampoules (Pfizer Ltd

ATC code:

C01CA03

INN (International Name):

Noradrenaline acid tartrate

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02070200; GTIN: 5013158015852

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORADRENALINE (NOREPINEPHRINE) 1MG/ML 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
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of this medicinal product is Noradrenaline (Norepinephrine) 1
mg/ml Concentrate for
Solution for Infusion but it will be referred to as Noradrenaline
(Norepinephrine) Concentrate
throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Noradrenaline (Norepinephrine) Concentrate is and what it is used
for
2.
What you need to know before you use Noradrenaline (Norepinephrine)
Concentrate
3.
How to use Noradrenaline (Norepinephrine) Concentrate
4.
Possible side effects
5.
How to store Noradrenaline (Norepinephrine) Concentrate
6.
Contents of the pack and other information
1. WHAT NORADRENALINE (NOREPINEPHRINE) CONCENTRATE IS AND WHAT IT IS
USED FOR
Noradrenaline (Norepinephrine) 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) CONCENTRATE
DO NOT TAKE NORADRENALINE (NOREPINEPHRINE) CONCENTRATE

if you are allergic to noradrenaline preparations or to any of the
other ingredients of this
medicine ( listed in section 6).
Tell your doctor if any of the above applies to you before this
medicine is used.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING NORADRENALINE
(NOREPINEPHRINE) CONCENTRATE
IF YOU HAVE:

diabetes

high blood pressure

Summary of Product characteristics

OBJECT 1
NORADRENALINE (NOREPINEPHRINE) 1 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 14-May-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Noradrenaline (Norepinephrine) 1 mg/ml Concentrate for Solution for
Infusion
2. Qualitative and quantitative composition
1 ml concentrate for solution for infusion contains 2 mg noradrenaline
tartrate equivalent to 1 mg
noradrenaline base.
1 ampoule of 2 ml contains 4 mg noradrenaline tartrate equivalent to 2
mg noradrenaline base.
1 ampoule of 4 ml contains 8 mg noradrenaline tartrate equivalent to 4
mg noradrenaline base.
When diluted as recommended, each ml contains 80 micrograms
noradrenaline tartrate equivalent to 40
micrograms noradrenaline base.
Excipient(s) with known effects:
1 ampoule of 2 ml contains 0.29 mmol (or 6.7 mg) sodium.
1 ampoule of 4 ml contains 0.58 mmol (or 13.3 mg) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
A clear colourless or yellowish solution
pH: 3.0 – 4.0
Osmolarity: approximately 280 mOsm/l
4. Clinical particulars
4.1 Therapeutic indications
Indicated 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
_Initial rate of infusion: _
When diluted as recommended in section 6.6 (the concentration of the
prepared infusion is 40 mg/litre
noradrenaline base (80 mg/litre noradrenaline tartrate)) the initial
rate of infusion, at a body weight of 70
kg, should be between 10 ml/hour and 20 ml/hour (0.16 to 0.33 ml/min).
This is equivalent to 0.4
mg/hour to 0.8 mg/hour noradrenaline base (0.8 mg/hour to 1.6 mg/hour
noradrenaline tartrate). Some
clinicians may wish to start at a lower initial infusion rate of 5
ml/hour (0.08 ml/min), equivalent to 0.2
mg/hour noradrenaline base (0.4 mg/hour noradrenaline tartrate).
_Titration of dose: _
Once an infusion of noradrenaline has been established the dose should
be titrated in steps