Noradrenaline concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

noradrenaline (noradrenaline tartrate)

Available from:

Kalceks JSC

ATC code:

C01CA03

INN (International Name):

noradrenaline (noradrenaline tartrate)

Dosage:

1mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

(5/1x5/) ampoules 2ml in plastic liner, (10/2x5/) ampoules 2ml in plastic liner

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NORADRENALINE (NOREPINEPHRINE) 1 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
noradrenaline
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 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 is and what it is used for
2.
What you need to know before you are given Noradrenaline
3.
How Noradrenaline will be given
4.
Possible side effects
5.
How to store Noradrenaline
6.
Contents of the pack and other information
1.
WHAT NORADRENALINE IS AND WHAT IT IS USED FOR
Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for
infusion contains the active
substance noradrenaline and act as a vasoconstrictor (causes narrowing
of blood vessels).
Noradrenaline is used in adults in an emergency to increase blood
pressure to normal levels.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NORADRENALINE
YOU SHOULD NOT BE GIVEN NORADRENALINE
•
if you are allergic to noradrenaline or any of the other ingredients
of this medicine (listed in
section 6)
•
if you have low blood pressure that has been caused by low blood
volume
•
if you receive some anaesthetics such as halothane or cyclopropane
(this may increase the risk
of irregular heart beat).
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given noradrenaline if
you:
•
have diabetes
•
have liver failure
•
have severe kidney disorders
•
suffer from high blood pressure
•
have an over-active thyroid gland
•
have low levels of oxygen in the blood
•
have high levels of carbon dioxide in the blood
•
have elevated pressure inside the skull (intracranial pressure)
•
have clots or obstructions in the blood vessels supplying the heart,
intestines, or other parts of
the bod

Summary of Product characteristics

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
Each 1 ml of concentrate for solution for infusion contains
noradrenaline tartrate equivalent to 1 mg
noradrenaline.
Each ampoule containing 2 ml of concentrate for solution for infusion
contains noradrenaline tartrate
equivalent to 2 mg noradrenaline.
Each ampoule containing 4 ml of concentrate for solution for infusion
contains noradrenaline tartrate
equivalent to 4 mg noradrenaline.
Each ampoule containing 5 ml of concentrate for solution for infusion
contains noradrenaline tartrate
equivalent to 5 mg noradrenaline.
Each ampoule containing 8 ml of concentrate for solution for infusion
contains noradrenaline tartrate
equivalent to 8 mg noradrenaline.
Each ampoule containing 10 ml of concentrate for solution for infusion
contains noradrenaline tartrate
equivalent to 10 mg noradrenaline.
When diluted as recommended, each ml contains noradrenaline tartrate
equivalent to 40 micrograms
noradrenaline.
Excipient with known effect
8 ml of concentrate for solution for infusion contains 26.4 mg (or
1.12 mmol) sodium.
10 ml of concentrate for solution for infusion contains 33 mg (or 1.40
mmol) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless or yellowish solution, practically free from visible
particles.
pH ranges between 3.0 and 4.0.
Osmolality 260-310 mOsm/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for
infusion is recommended in
adults 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 _
Add 2 ml of Noradrenaline (Norepinephrine) 1 mg/ml concentrate for
solution for infusion to 48 ml
50 mg/ml (5%) glucose (or other in section 6.6 mentioned solution