Sinora 1 mg/ml concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Noradrenaline tartrate

Available from:

Sintetica GmbH

ATC code:

C01CA; C01CA03

INN (International Name):

Noradrenaline tartrate

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Adrenergic and dopaminergic agents; norepinephrine

Authorization status:

Not marketed

Authorization date:

2020-08-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINORA
1 mg/ml Concentrate for solution for infusion
Noradrenaline (as noradrenaline tartrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 pharmacist.
-
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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What SINORA is and what it is used for
2.
What you need to know before SINORA is given to you
3.
How to use SINORA
4.
Possible side effects
5.
How to store SINORA
6.
Contents of the pack and other information
1.
WHAT SINORA IS AND WHAT IT IS USED FOR
SINORA contains the active substance noradrenaline and act as a
vasoconstrictor.
SINORA is used for the emergency restoration of blood pressure in
cases of suddenly decreased blood pressure
(acute hypotension).
2.
WHAT YOU NEED TO KNOW BEFORE SINORA IS GIVEN TO YOU
DO NOT USE SINORA:
-
if you are allergic (hypersensitive) to noradrenaline preparations or
to any of the other ingredients of this
medicine (listed in section 6).
_ _
-
if you are hypotensive (have low blood pressure) that has been caused
by hypovolaemia (low blood
volume).
-
if you are taking some anaesthetics such as halothane or cyclopropane
(this may increase the risk of
irregular heart beat)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING SINORA
• if you have diabetes
• if you suffer from high blood pressure
• if you have an over-active thyroid
• if you have low levels of oxygen in the blood
• if you have high levels of carbon dioxide in the blood
• if you have clots or obstructions in the blood vessels supplying
the heart, intestines or other parts of the body
• if yo

Summary of Product characteristics

Health Products Regulatory Authority
09 September 2022
CRN00D3GY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sinora 1 mg/ml concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml concentrate for solution for infusion contains 2 mg noradrenaline
(norepinephrine) tartrate corresponding to 1 mg
noradrenaline (norepinephrine) base.
Each ampoule containing 1 ml of concentrate for solution for infusion
contains 2 mg of noradrenaline (norepinephrine) tartrate
corresponding to 1 mg of noradrenaline (norepinephrine) base.
Each ampoule containing 4 ml of concentrate for solution for infusion
contains 8 mg of noradrenaline (norepinephrine) tartrate
corresponding to 4 mg of noradrenaline (norepinephrine) base.
Each ampoule containing 5 ml of concentrate for solution for infusion
contains 10 mg of noradrenaline (norepinephrine)
tartrate corresponding to 5 mg of noradrenaline (norepinephrine) base.
Each ampoule containing 10 ml of concentrate for solution for infusion
contains 20 mg of noradrenaline (norepinephrine)
tartrate corresponding to 10 mg of noradrenaline (norepinephrine)
base.
When diluted as recommended, each ml contains 80 micrograms
noradrenaline (norepinephrine) tartrate equivalent to 40
micrograms noradrenaline (norepinephrine) base.
Excipients:
Each ampoule containing 1 ml of concentrate for solution for infusion
contains 0.14 mmol (or 3.3 mg) sodium.
Each ampoule containing 4 ml of concentrate for solution for infusion
contains 0.57 mmol (or 13.2 mg) sodium.
Each ampoule containing 5 ml of concentrate for solution for infusion
contains 0.72 mmol (or 16.5 mg) sodium.
Each ampoule containing 10 ml of concentrate for solution for infusion
contains 1.44 mmol (or 33 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear colourless solution.
pH 3.0-4.5.
Osmolarity: 275 – 305 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated in adults for use as an emergenc