MYKRONOR Solution for injection / infusion Ref.[50949] Active ingredients: Noradrenaline

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 experienced with its use and have appropriate facilities to adequately monitor the patient.

Initial rate

The initial dose of infusion is between 0.02 microgram/kg/min and 0.05 microgram/kg/min of noradrenaline (equivalent to 0.04 microgram/kg/min and 0.1 microgram/kg/min of noradrenaline tartrate). An initial intravenous bolus of 5 micrograms to 10 micrograms of noradrenaline (10 micrograms to 20 microgams noradrenaline tartrate) may be administered before the start of the infusion, following spinal anesthesia, or the induction of general anesthesia.

Titration of dose

Once an infusion of noradrenaline has been established the dose can be increased or decreased at the discretion of the attending physician to maintain an adequate target blood pressure during the peri-operative period. The dose should be adjusted according to age, weight and clinical condition of the patient.

Intravenous bolus of 5 micrograms to 10 micrograms noradrenaline (10 micrograms to 20 micrograms noradrenaline tartrate) can be administered if the blood pressure needs to be increased rapidly.

Duration of treatment and monitoring

Noradrenaline should be continued throughout the peri-operative period as long as considered necessary to maintain adequate blood pressure and tissue perfusion.

Withdrawal of therapy

Infusions should be reduced gradually, avoiding abrupt withdrawal which can result in acute hypotension.

Hepatic/renal impairment

There is no experience in treatment of hepatically or renally impaired patients.

Elderly patients

In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range as to reflect the greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy.

Paediatric population

This medicinal product is indicated for adults only.

The safety and efficacy of noradrenaline in children aged less than 18 years old has not yet been established. No data are available.

Method of administration

For intravenous use.

This medicinal product is a ready to use solution for single use only, which should not be diluted before use.

It can be administered as a continuous infusion or bolus injection through a peripheral venous line. The infusion can be administered at a controlled rate using either a syringe pump or an infusion pump or a drip counter.

Site of infusion

This medicinal product should be infused through a peripheral or a central venous catheter.

Symptoms

Overdosage may result in headache, severe hypertension, reflex bradycardia, marked increase in peripheral resistance, and decreased cardiac output. These may be accompanied by violent headache, cerebral haemorrhage, photophobia, retrosternal pain, pallor, fever, intense sweating, pulmonary oedema and vomiting.

Management

In case of accidental overdose, as evidenced by excessive blood pressure elevation, reduce the rate of infusion, or discontinue this medicinal product until the condition of the patient stabilizes.

2 years.

Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C in a polypropylene syringe. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless manipulation has taken place in controlled and validated aseptic conditions.

Store below 25°C.

Store the vial in the outer carton to protect from light. Do not freeze.

20 ml or 50 ml clear type II glass vial closed with a chlorobutyl stopper and an aluminium cap. Box of 1 or 10 vials.

Not all pack sizes may be marketed.

For single use only. Discard any unused contents.

This medicinal product is already diluted and ready to use. It should be used without prior dilution. It can be administered using either a syringe pump, or an infusion pump, or a drip counter capable of accurately and consistently delivering the minimum specified volume at a strictly controlled rate of infusion in line with the dose instructions specified in Section 4.2. This medicinal product is a clear and colourless solution, practically free from visible particles. The solution should not be used if the solution appears slightly yellow or pink, or is brown in colour, or if it contains particles or a precipitate.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.