Noradrenaline (Norepinephrine) 1mg/ml Concentrate for solution for Infusion

Nazione: Regno Unito

Lingua: inglese

Fonte: myHealthbox

Principio attivo:

noradrenaline tartrate

Commercializzato da:

FARMA MEDITERRANIA S.L.

Codice ATC:

C01CA03

INN (Nome Internazionale):

noradrenaline tartrate

Dosaggio:

2mg/ml

Forma farmaceutica:

Concentrate for solution for infusion

Via di somministrazione:

intravenous use

Confezione:

5 ampoules of 2 ml in a pack 5 ampoules of 4 ml in a pack 5 vials of 20 ml in a pack

Tipo di ricetta:

POM - Prescription Only Medicine

Prodotto da:

NOVOCAT FARMA, S.A

Gruppo terapeutico:

Adrenergic and dopaminergic agents

Indicazioni terapeutiche:

Noradrenaline (Norepinephrine) Concentrate is indicated for the emergency restoration of blood pressure in cases of acute hypotension.

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2015-03-31

Foglio illustrativo

PATIENT INFORMATION LEAFLET 

NORADRENALINE (NOREPINEPHRINE) 1 MG/ML  
CONCENTRATE FOR SOLUTION FOR INFUSION  
NORADRENALINE (AS NORADRENALINE TARTRATE) 

IN THIS LEAFLET: 

1. What NORADRENALINE (NOREPINEPHRINE) CONCENTRATE is and what it
is used for 
2. Things to consider before you start to
use NORADRENALINE (NOREPINEPHRINE) CONCENTRATE  
3. How to use NORADRENALINE (NOREPINEPHRINE) CONCENTRATE 
4. Possible side effects 
5. How to store NORADRENALINE (NOREPINEPHRINE) CONCENTRATE  
6. Further information 

1. WHAT NORADRENALINE (NOREPINEPHRINE) CONCENTRATE IS AND WHAT IT 
IS USED FOR 

Noradrenaline  (Norepinephrine)  Concentrate  is  used  in  an  emergency  to  increase  blood 
pressure to normal levels. 

2.  THINGS  TO  CONSIDER  BEFORE  YOU  START  TO  USE  NORADRENALINE 
(NOREPINEPHRINE) CONCENTRATE  

YOU WILL NOT BE GIVEN
NORADRENALINE (NOREPINEPHRINE) CONCENTRATE IF  


You are allergic (hypersensitive) to Noradrenaline preparations or
to any of the other 
ingredients of this medicine (see section 6).  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE EVEN IF YOU HAVE 
ALREADY USED NORADRENALINE OR A SIMILAR MEDICINE BEFORE, WE ADVISE YOU TO READ THIS 
TEXT CAREFULLY.  THE INFORMATION MAY HAVE BEEN CHANGED. 
- Keep this leaflet. You may need to read it again. . 
- If you have any further questions, 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 symptoms are the same as yours. 
- If any of the side effects gets serious, or if you
notice any side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

- 
The  name  of  this  medicinal  product  is  Noradrenaline  (Norepinephrine)

Scheda tecnica

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 
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.  

1 vial of 20
ml contains 40 mg noradrenaline tartrate equivalent to 20 mg 
noradrenaline base.  

When diluted as recommended, each ml contains 80
micrograms noradrenaline 
tartrate equivalent to 40 micrograms noradrenaline base.  
Excipients:  
1 ampoule of 2 ml contains 0.29 mmol (or 6.6 mg) sodium.  
1 ampoule of 4 ml contains 0.58 mmol (or 13.2 mg) sodium.  
1 vial of 20 ml contains 2.90 mmol (or 66.1 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 – 4.5 
Osmolality: 280 – 320 mosmol/Kg 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Noradrenaline (Norepinephrine) Concentrate is indicated for the
emergency 
restoration of blood pressure in cases of acute hypotension. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

_Route of Administration: _ 
For intravenous use only.  
_Method of administration: _ 
Administer as a diluted solution 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 dilution instructions see section 6.6.  
_Dosage: _ 
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
m