CRONOMIR (noradrénaline)

key points

Approval of reimbursement for CRONOMIR 10 micrograms/ml (noradrenaline tartrate), solution for injection/infusion for the restoration and maintenance of peri-operative blood pressure following hypotension induced by spinal anaesthesia or general anaesthesia in adults.

Therapeutic improvement?

No improvement over other available vasopressors.

Role in therapeutic strategy?

The management of hypotension during anaesthesia is based on the modification of anaesthetic depth according to routine monitoring data, the correction of low cardiac output by volume expansion, and/or the correction of low vascular resistance by administration of a vasopressor. These actions can be undertaken simultaneously. The different vasopressors differ in their mechanisms of action on vascular and cardiac functions according to their affinity for alpha- and beta-adrenergic receptors.

According to the recommendations of the French Anaesthesia and Intensive Care Society (SFAR), the two vasopressors used as a first-line treatment are ephedrine and noradrenaline, due to their combined α and β actions which allow for the correction of arterial hypotension with the maintenance of cardiac output despite the increase in arterial resistance. Given its short half-life, continuous intravenous administration is preferred (except for ephedrine).

Role of CRONOMIR 10 micrograms/ml (noradrenaline tartrate), solution for injection/infusion in the therapeutic strategy:

The medical use of noradrenaline as a vasopressor is a well-established option in the operating theatre for peri-operative blood pressure control.

Therefore, like the other available vasopressors, CRONOMIR 10 micrograms/ml (noradrenaline tartrate), solution for injection/for infusion is a first-line treatment for the restoration and adapted maintenance of blood pressure following  spinal anaesthesia or general anaesthesia, particularly in the latter case for patients with comorbidities undergoing major surgery.

The available clinical data do not provide a basis to reach a conclusion on the contribution of noradrenaline compared to the other available vasopressors in terms of efficacy and tolerance, nor compared to other noradrenaline-based specialities in terms of the delivery of care. As a reminder, according to the SmPC, the concentration of this presentation is not suitable for critical care situations such as the treatment of septic or cardiogenic shock and cardiac arrest, in particular.