Adrenaline (epinephrine)

This medicinal product should be administered at the first sign of a severe Type I allergic reaction. Dosage Patients weighing 15 kg to less than 30 kg: The recommended dosage is one spray of neffy 1 mg (1 mg of adrenaline) administered into one nostril. Patients weighing 30 kg or greater: The recommended dosage is one spray of neffy 2 mg (2 mg of adrenaline) administered into one nostril. Anaphylaxis is a life-threatening emergency and self-administration of adrenaline is not intended as a substitute for immediate medical care. The patient should be advised to seek emergency medical ▼ assistance immediately following administration of neffy for close monitoring of the anaphylactic episode and in the event further treatment is required. In the absence of clinical improvement, or if deterioration occurs or symptoms reappear after 5 minutes following the initial treatment, a second dose should be administered, using a new neffy nasal spray (ideally in the same nostril). It is …

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Instructions for patients at the time of prescribing The prescribers of this medicinal product should take appropriate steps to ensure that the patient understands the indication and use of the nasal spray thoroughly. The prescriber should review the patient information leaflet and operating instructions of the nasal spray with the patient. All patients who are prescribed this medicinal product should be clearly instructed on how and when to use the product (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION). It is strongly advised that the patient’s immediate associates (e.g., parents, caregivers, teachers) are also educated on the correct use of this medicinal product in case support is needed in an emergency. For children under 12 years of age, the caregiver should administer neffy or determine that the child is properly instructed in the use of neffy and is fully capable of administration themselves. Patients with a cold or a congested nose can use this medicinal product, however, …

Central nervous system and other medicinal products The effects of adrenaline may be potentiated by tricyclic antidepressants (e.g. imipramine) and mono amine oxidase inhibitors (MAO-inhibitors) (e.g. phenelzine, selegiline, tranylcypromine) and catechol-O-methyl transferase inhibitors (COMT-inhibitors) (e.g. entacapone, opicapone), thyroid hormones, theophylline, oxytocin, anticholinergics (e.g. atropine, cyclopentolate, homatropine, hyoscine), certain antihistamines (diphenhydramine, chlorpheniramine), levodopa, and alcohol. Caution is indicated in patients receiving medicinal products that may sensitise the heart to arrhythmias, including digoxin or quinidine. Other sympathomimetic medicinal products Adrenaline should not be administered with other sympathomimetic agents because of the danger of additive effects and increased toxicity. Alpha-adrenergic blocking agents Pressor effects of adrenaline may be counteracted by rapidly acting vasodilators or alpha- adrenergic-blocking …

Summary of safety profile There were no very common adverse reactions (≥ 10%) observed in clinical trials following a single dose of neffy 2mg. The most frequently occurring adverse reactions (very common events ≥ 10%) observed in clinical studies of neffy were reported only after two 2 mg doses (4 mg total) and include throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%) and feeling jittery (10.6%). None of the adverse reactions observed in the clinical studies were serious. Tabulated list of adverse reactions Adverse reactions are summarised based on analysis of pooled safety data from primary PK/PD studies using neffy 2 mg in adult healthy volunteers, in patients with Type 1 allergies and in patients with allergic rhinitis following either one or two doses. The adverse reactions are ranked according to system organ class and frequency according to the following convention: • Very common (≥ 1/10) • Common (≥ 1/100 to < 1/10) • Uncommon (≥ 1/1,000 to < 1/100) • Rare …

Symptoms Overdose of adrenaline may cause severe headaches, chest pain, dizziness, nausea, and blurred vision. Significant overdoses or injection into a blood vessel can also cause cerebral haemorrhage resulting from a sharp rise in blood pressure. Fatalities may also result from pulmonary oedema because of peripheral vascular constriction together with cardiac stimulation. Management Pressor effects of adrenaline may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking medicinal products. If an adrenaline overdose induces pulmonary oedema that interferes with respiration, treatment consists of a rapidly acting alpha-adrenergic blocking medicinal product such as phentolamine and/or intermittent positive-pressure respiration. Adrenaline overdose can cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Treatment of arrhythmias may consist of administration of beta-adrenergic blocking medicinal …

Effects on fertility Adrenaline is an endogenous substance and blood levels after administration of neffy are within normal physiological ranges and as such it is unlikely that there would be any detrimental effects on fertility. This should not prevent the use of adrenaline under the conditions noted under Section 4.1 Therapeutic Indications. Use in pregnancy – Pregnancy Category A Adrenaline has been given to a large number of pregnant woman and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed. Adrenaline may delay the second stage of labour by inhibiting contractions of the uterus. Use with caution in pregnant women whose maternal blood pressure is in excess of 130/80 mmHg. As there are risks to the mother and fetus associated with anaphylaxis, treatment with adrenaline should not be delayed. Use in lactation There are no data on the effect of adrenaline in breast …