Sinora 0.16 mg/ml solution for infusion

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

NOREPINEPHRINE BITARTRATE

MAH:

Sintetica Ireland Limited

ATC_code:

C01CA; C01CA03

INN:

NOREPINEPHRINE BITARTRATE

dosage:

0.16 milligram(s)/millilitre

pharmaceutical_form:

Solution for infusion

therapeutic_area:

Adrenergic and dopaminergic agents; norepinephrine

authorization_date:

2020-04-24

PIL

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Sinora
0.08 mg/ml solution for infusion
0.16 mg/ml 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 is a medicine that
belongs to the group of
adrenergic and dopaminergic
agents.
Sinora is indicated in adults
weighing over 50 kg for
the on-going treatment of
hypotensive emergencies with
escalating noradrenaline dose
requirements.
The product is for adults only.
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).
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 you have low blood pre

SPC

Health Products Regulatory Authority
09 December 2020
CRN00C1KC
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sinora 0.16 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 0.32 mg noradrenaline
tartrate corresponding to 0.16 mg noradrenaline base. Each 50
ml vial contains 16 mg of noradrenaline tartrate corresponding to 8 mg
of noradrenaline base.
Excipient with known effect:
Each ml of solution for infusion contains 0.14 mmol (or 3.3 mg)
sodium.
Each 50 ml vial contains 7.19 mmol (or 165.3 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear colourless solution.
pH 3.0-4.5.
Osmolarity: 250 – 350 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sinora solution for infusion is indicated in adults weighing over 50kg
for the on-going treatment of hypotensive emergencies
with escalating noradrenaline dose requirements.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route of Administration: _
For intravenous use only.
_Blood pressure control:_
Blood pressure should be monitored carefully for the duration of
therapy, and preferably controlled by arterial blood pressure
monitoring. The patient should be monitored carefully for the duration
of noradrenaline therapy.
_Posology:_
Sinora solution for infusion should not be used for initiating
vasopressor treatment. It may be considered for use in patients
already established on noradrenaline therapy whose dose requirements
are clinically confirmed to be escalating, such that
Sinora 0.08 mg/ml, solution for infusion may be commenced at a flow
rate of 1.5 ml/h and Sinora 0.16 mg/ml, solution for
infusion may be commenced at a flow rate of 0.75 ml/h.
Adults
_Initial dose: _
The initial dose of noradrenaline base is usually between 0.05 and
0.15 micrograms/kg/min. This initial posology should be
administered using a less concentrated noradrenaline solution that
permits better titration by 0.05 and 0.1 micrograms/kg