Sinora 0.1 mg/ml solution for infusion

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Noradrenaline tartrate

Beszerezhető a:

Sintetica Ireland Limited

ATC-kód:

C01CA; C01CA03

INN (nemzetközi neve):

Noradrenaline tartrate

Adagolás:

0.1 milligram(s)/millilitre

Gyógyszerészeti forma:

Solution for infusion

Terápiás terület:

Adrenergic and dopaminergic agents; norepinephrine

Engedélyezési státusz:

Marketed

Engedély dátuma:

2020-08-14

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SINORA
0.1 mg/ml solution for infusion
0.2 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 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 th

Termékjellemzők

Health Products Regulatory Authority
03 December 2021
CRN009TF1
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sinora 0.1 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 0.2 mg noradrenaline
(norepinephrine) tartrate corresponding to 0.1 mg
noradrenaline (norepinephrine) base. Each 50 ml vial contains 10 mg of
noradrenaline (norepinephrine) tartrate corresponding
to 5 mg of noradrenaline (norepinephrine) 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
Indicated 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
_Route of Administration: _
For intravenous use.
_Posology:_
Adults
_Initial dose: _
The initial dose, at a body weight of 70 kg, should be between 0.4
mg/hour to 0.8 mg/hour noradrenaline base (0.8 mg/hour to
1.6 mg/hour noradrenaline tartrate). Some clinicians may wish to start
at a lower dose of 0.2 mg/hour noradrenaline base (0.4
mg/hour noradrenaline tartrate).
_Titration of dose: _
Once an infusion of noradrenaline has been established the dose should
be titrated in steps of 0.05 -0.1 µg/kg/min of
noradrenaline base according to the pressor effect observed. There is
great individual variation in the dose required to attain
and maintain normotension. The aim should be to establish a low normal
systolic blood pressure (100 - 120 mm Hg) or to
achieve an adequate mean arterial blood pressure (greater than 65 - 80
mm Hg - depending on the patient's condition). NORADRENALINE 0.1 MG/ML SOLUTION FOR INFUSION 50 ML VIAL CONTAINING 5 MG OF NORADRENALINE BASE
PATIENT’S WEIGHT
POSOLOGY
(Μ