NORADRENALINE (NOREPINEPHRINE) Solution for infusion Ref.[7928] Active ingredients: Noradrenaline

For intravenous use only.

Noradrenaline 0.08mg/ml 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 Noradrenaline 0.08 mg/ml, solution for infusion may be commenced at a flow rate of 2 ml/hr.

Noradrenaline should only be administered as an intravenous infusion via a central venous catheter to minimize the risk of extravasation and subsequent tissue necrosis. Noradrenaline (Norepinephrine) 0.08 mg/ml, solution for infusion should be infused at a controlled rate using a syringe driver pump.

Noradrenaline (Norepinephrine) 0.08 mg/ml, solution for infusion should not be diluted before use: it is supplied ready to use. It should not be mixed with other medicines.

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

Initial dose:

The initial dose of noradrenaline base is usually between 0.05 and 0.15 micrograms/kg/min.

Maintenance dose range:

The recommended maintenance range of noradrenaline base is between 0.05 and 1.5 micrograms/kg/min.

Titration of dose:

Noradrenaline (Norepinephrine) 0.08 mg/ml, solution for infusion, should be used with a suitable syringe driver pump capable of accurately and consistently delivering the minimum specified volume at a strictly controlled rate of infusion in line with the dose titration instructions.

Once an infusion of noradrenaline has been established the dose should be titrated in steps of 0.05-0.1 micrograms/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 mm Hg – depending on the patient’s condition).

Manual bolus for priming when initiating an infusion is not recommended.

Caution is required during syringe relay to avoid haemodynamic instability. Continuous noradrenaline infusion through a double pump system and an extension set reducing dead-space volume should be encouraged.

h: hour

Duration of Treatment

Noradrenaline 0.08mg/ml, solution for infusion should be continued until high-dose vasoactive drug support is no longer indicated, at which point, the infusion should be gradually decreased, then switched to an infusion of lower concentration. Abrupt withdrawal can result in acute hypotension.

Elderly patients

See section 4.4 Special warnings and precautions for use.

Paediatric population

Noradrenaline 0.08 mg/ml, solution for infusion is indicated for adults only.

The efficacy and safety of Noradrenaline 0.08mg/ml, solution for infusion in children and adolescents has not been established.

Patients with renal and hepatic impairment.

There is no experience of treatment in patients with renal and hepatic impairment.

In the event of overdose, the following may be observed: cutaneous vasoconstriction, bed sores, circulatory collapse, and hypertension.

In the event of adverse reactions linked to an excessive dosage, it is recommended to reduce the dosage if possible.

18 months.

After the first opening, the product should be used immediately.

Do not store above 25°C. Store the vial in the outer carton to protect from light.

Clear glass vial closed with a type I bromobutyl stopper and an aluminum cap containing 50 ml of solution for infusion in pack size of 1, 10, and 25 vials.

Not all pack sizes may be marketed.

For single use only. Discard any unused contents.

Noradrenaline 0.08 mg/ml, solution for infusion is already diluted and ready to use. It should be used without prior dilution .It should be used with a suitable syringe driver pump capable of accurately and consistently delivering the minimum specified volume at a strictly controlled rate of infusion in line with the dose titration instructions specified in Section 4.2. This medicine should not be used if the solution is darker than slightly yellow or pink in colour or if it contains a precipitate.

The sterile solution should not be used if it is not clear and contains particles, or if the tamper evident sealed vial is not intact.

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