Sinora 0.08 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NOREPINEPHRINE BITARTRATE

Available from:

Sintetica GmbH

ATC code:

C01CA; C01CA03

INN (International Name):

NOREPINEPHRINE BITARTRATE

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Adrenergic and dopaminergic agents; norepinephrine

Authorization status:

Not marketed

Authorization date:

2020-04-24

Patient Information leaflet

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1
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, 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.
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).
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2
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE 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 b

Summary of Product characteristics

Health Products Regulatory Authority
29 November 2023
CRN00DWHY
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sinora 0.08 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 0.16 mg noradrenaline
tartrate corresponding to 0.08 mg noradrenaline base. Each 50
ml vial contains 8 mg of noradrenaline tartrate corresponding to 4 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 3.0-4.0.
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/mi