Mykronor 5 micrograms/ml, solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Noradrenaline tartrate

Available from:

Laboratoire AGUETTANT

ATC code:

C01CA03

INN (International Name):

Noradrenaline tartrate

Dosage:

5 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

norepinephrine

Authorization status:

Not marketed

Authorization date:

2021-08-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYKRONOR 5 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION
noradrenaline (norepinephrine)
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.
-
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 Mykronor is and what it is used for
2.
What you need to know before you are given Mykronor
3.
How Mykronor is given
4.
Possible side effects
5.
How to store Mykronor
6.
Contents of the pack and other information
1.
WHAT MYKRONOR IS AND WHAT IT IS USED FOR
This medicine contains the active substance noradrenaline (as
noradrenaline tartrate) and acts as a
vasoconstrictor (narrowing of the blood vessels).
This medicine is for adults only.
This medicine is used during surgery to restore and maintain blood
pressure, following a drop induced by
anaesthesia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MYKRONOR
YOU MUST NOT BE GIVEN MYKRONOR:
-
if you are allergic to noradrenaline or any of the other ingredients
of this medicine (listed in section 6),
-
during anaesthesia with cyclopropane or halothane.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
Mykronor:
-
if you have an ischemic heart disease (disease caused by narrowing or
blockage of blood vessels supplying
the heart muscle),
-
if you have angina (chest pain),
-
if you have recently had myocardial infarction (a heart attack),
-
if you have clots or obstructions in the blood vessels supplying the
heart, intestines or other parts of the
body (vascular condition),
-
if you are hypertensive (have high blood pressure),
-
if you are hypotensive (have low blood pressure) that has been caused
by hypovolaemia (low blood
volume),
-
if you have hyperthyroidism (your thyroid gland is o

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2022
CRN00CXPF
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mykronor 5 micrograms/ml, solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection/infusion contains 10 micrograms of
noradrenaline (norepinephrine) tartrate monohydrate,
equivalent to 5 micrograms noradrenaline (norepinephrine) anhydrous.
Each 20 ml vial contains 200 micrograms of noradrenaline
(norepinephrine) tartrate monohydrate, equivalent to 100
micrograms of noradrenaline (norepinephrine) anhydrous.
Each 50 ml vial contains 500 micrograms of noradrenaline
(norepinephrine) tartrate monohydrate, equivalent to 250
micrograms of noradrenaline (norepinephrine) anhydrous.
Excipient with known effect
This medicinal product contains sodium.
Each ml of solution for injection/infusion contains 3.54 mg equivalent
to 0.15 mmol of sodium. Each 20 ml vial contains
approximately 71 mg equivalent to 3 mmol of sodium.
Each 50 ml vial contains approximately 177 mg equivalent to 7.5 mmol
of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clearand colourless solution, practically free from visible particles.
pH: 3.7 to 4.1
Osmolality: 260-320 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Restoration and maintenance of peri-operative blood pressure following
hypotension induced by spinal or general anesthesia
in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This presentation is suitable for perioperative setting, the
concentration is not adapted to critical care setting.
Posology
This medicinal product
should not be diluted before use: it is supplied ready to use and must
not be mixed with other
medicines. It is suitable for injection or continuous infusion through
a peripheral venous line.
The patient should be monitored carefully for the duration of
noradrenaline therapy.
Noradrenaline should only be administered by healthcare professionals
who are exp