NORADRENALINE (TARTRATE) AGUETTANT 2mg/ml (SULFITES FREE), concentrate for sol for infusion (8ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NORADRENALINE ACID, TARTRATE

Available from:

Laboratoire Aguettant 1 Rue Alexander Fleming, 69007 Lyon, France

ATC code:

C01CA03

INN (International Name):

NORADRENALINE ACID TARTRATE 2 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

NORADRENALINE ACID TARTRATE 2 mg/ml

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2006-08-28

Patient Information leaflet

NORADRENALINE (TARTRATE) AGUETTANT 2 MG/ML (SULFITES FREE),
CONCENTRATE FOR SOLUTION FOR INFUSION
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, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What is NORADRENALINE (TARTRATE) AGUETTANT 2 mg/ml (SULFITES FREE),
concentrate for solution for infusion and what it is used for
2. What you need to know before you use NORADRENALINE (TARTRATE)
AGUETTANT
2 mg/ml (SULFITES FREE), concentrate for solution for infusion
3. How to use NORADRENALINE (TARTRATE) AGUETTANT 2 mg/ml (SULFITES
FREE), concentrate for solution for infusion
4. Possible side effects
5. How to store NORADRENALINE (TARTRATE) AGUETTANT 2 mg/ml (SULFITES
FREE), concentrate for solution for infusion
6. Contents of the pack and other information.
1.
WHAT NORADRENALINE (TARTRATE) AGUETTANT 2 MG/ML (SULFITES
FREE), CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED
FOR
Pharmacotherapeutic class: CARDIAC STIMULANTS EXCLUDE CARDIAC
GLYCOSIDES
ATC Code: C01CA03.
This medicine is used as the emergency treatment of collapse and in
the restoration and keeping
of blood pressure.
In the local gastric irrigation, noradrenaline is used in the
treatment of digestive hemorrhages,
in addition to the usual treatments.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
USE
NORADRENALINE
(TARTRATE) AGUETTANT 2 MG/ML (SULFITES FREE), CONCENTRATE FOR SOLUTION
FOR INFUSION
NEVER USE NORADRENALINE (TARTRATE) AGUETTANT 2 MG/ML (SULFITES
FREE), CONCENTRATE FOR SOLUTION FOR INFUSION:
- if you are allergic to preparations containing noradrenaline o

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
NORADRENALINE
(TARTRATE)
AGUETTANT
2
mg/ml
(SULFITES
FREE),
concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Noradrenaline tartrate ............................. 2 mg
For 1 ml of concentrate for solution for infusion
Or 8 mg noradrenaline tartrate
(corresponding to 4 mg noradrenaline base) for one, 4-ml ampoule.
Or 16 mg noradrenaline tartrate
(corresponding to 8 mg noradrenaline base) for one, 8-ml ampoule.
Excipient with known effect: sodium.
Each ml of solution contains 3.3 mg of sodium, equivalent to 0.14 mmol
Each 4ml ampoule contains 13.2 mg of sodium, equivalent to 0.57 mmol
Each 8ml ampoule contains 26.4 mg of sodium, equivalent to 1.14 mmol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless or slightly yellow solution.
pH = 3.0 to 4.0
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
By intravenous infusion, noradrenaline is used:
-
as the emergency treatment of collapse and in the restoration and
keeping of arterial blood
pressure.
In the local gastric irrigation, noradrenaline is used in:
- the treatment of digestive haemorrhage, in addition to the usual
treatments (H2 receptors
inhibitors, proton pumps inhibitors; endoscopic sclerosis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Posology must be adapted according to the clinical state of the
patient.
Initial dose recommended are 0.1 to 0.3 µg/kg/min of tartrate
noradrenaline.
Posology reaching 3 to 5 µg/kg/min were sometimes useful in the
treatment of the septic
shock or haemorrhagic shock.
In digestive haemorrhage case, 8 to 16 mg of noradrenaline tartrate
added to very cold
physiological serum could be used for gastric washing.
METHOD OF ADMINISTRATION:
The route of administration must be necessarily the intravenous route.
Each extravasion can
induce an intense local vasoconstriction and possible tissue necrosis.
It is preferable to use a
central venous catheter.
NORADRENALINE (TARTRATE) AGUETT