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Eurneffy is a brand name for Epinephrine (also known as Adrenaline). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EURneffy is indicated in the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise induced anaphylaxis. Treatment is indicated for adults and children aged 4 years and over with a body weight of 15 kg or…
Verbatim from this product's EMA label. Tap a section to expand.
Posology This medicinal product should be administered at the first sign of a severe Type I allergic reaction. The recommended initial dose in children aged 4 years and over weighing 15 kg to less than 30 kg is a single nasal administration of 1 mg adrenaline.
The recommended initial dose in adults and children aged 4 years and over weighing 30 kg or more is a single nasal administration of 2 mg adrenaline. The patient should be advised to immediately seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
3 In the absence of clinical improvement after approximately 10 minutes, or if deterioration occurs or symptoms reappear after the initial treatment, a second dose should be administered in the same nostril together with emergency medical help.
A maximum of 4 mg (two doses of 2 mg adrenaline) for adults and children aged 4 years and over weighing 30 kg or more may be given unless instructed by a medical professional to give additional doses. A maximum of 2 mg (two doses of 1 mg adrenaline) for children aged 4 years or more weighing 15 kg to less than 30 kg may be given unless instructed by a medical professional to give additional doses.
It is recommended that patients should always carry two nasal sprays to treat an allergy emergency. Elderly No pharmacokinetic (PK) data are available after nasal administration of adrenaline in patients aged 65 years or older. No dose adjustment is required.
Paediatric population The safety and efficacy of EURneffy in children below 4 years of age and weighing less than 15 kg have not been established. No data are available. Method of administration For nasal use only. This medicinal product is a ready-to-use, nasal spray, solution in single-dose container.
It delivers its entire dose upon activation. The nasal spray should not be primed and should not be sprayed in the eyes or mouth. This medicinal product is for single use only and must be discarded and replaced immediately after use as it delivers only one dose.
4). The patient/caregiver should be informed to seek emergency medical assistance immediately to have close monitoring of the anaphylactic episode and in the event further treatment is required. • If symptoms get worse or reoccur after approximately 10 minutes, or if any error in dosing is suspected, a new nasal spray should be used to give a second dose in the same nostril.
Summary of safety profile The most frequently occurring adverse reactions following EURneffy administration are throat irritation, headache, nasal discomfort and feeling jittery, all categorised as very common and reported by more than 1 out of 10 patients.
Tabulated list of adverse reactions Adverse reactions are summarised based on analysis of pooled safety data from primary PK/ pharmacodynamic (PD) studies using EURneffy 1 mg and 2 mg in paediatric and adult healthy volunteers, in patients with Type 1 allergies and in patients with allergic rhinitis.
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 (≥ 1/10 000 to < 1/1 000) • Very rare (< 1/10 000) • Not known (frequency cannot be estimated from the available data) Table 1: Adverse reactions identified with EURneffy System organ class Frequency Adverse reaction Psychiatric disorders Common Anxiety Uncommon Euphoric mood Nervousness 7 System organ class Frequency Adverse reaction Not known Disorientation1 Memory impairment1 Panic reaction1 Nervous system disorders Very common Headache Common Tremor Paraesthesia Uncommon Dizziness Head discomfort Presyncope Not known Psychomotor hyperactivity1 Somnolence1 Eye disorders Uncommon Lacrimation increased Cardiac disorders Common Palpitations Not known Angina1 Cardiac arrhythmias1,2 Stress cardiomyopathy1 Tachyarrhythmia1 Tachycardia1Ventricular ectopy1 Vascular disorders Not known Hypertension1 Vasoconstriction1 Respiratory, thoracic and mediastinal disorders Very common Nasal discomfort Throat irritation Common Rhinorrhoea Nasal oedema Rhinalgia Nasal congestion Nasal pruritus Uncommon Oropharyngeal pain Sneezing Intranasal paraesthesia Paranasal sinus discomfort Epistaxis Nasal dryness Dry throat Upper respiratory tract congestion Nasal mucosal disorder Gastrointestinal disorders Uncommon Nausea Paraesthesia oral Salivary hypersecretion Toothache Gingival discomfort Skin and subcutaneous tissue disorders Uncommon Pruritus Not known Paraesthesia1 General disorders and administration site conditions Very common Feeling jittery Uncommon Chest discomfort Energy increased Fatigue Feeling hot Investigations Common Blood pressure increased Heart rate increased Uncommon Body temperature increased 8 1 Adverse reactions that have not been observed in clinical studies with EURneffy, but are known to occur with other adrenaline formulations including intravenous, intramuscular, and subcutaneous administrations.
Instructions for patients at the time of prescribing A physician who prescribes this medicinal product should take appropriate steps to ensure that the patient understands the indication and use of the nasal spray thoroughly. The physician should review the patient information leaflet and operating instructions of the nasal spray with the patient.
2). g. parents, caregivers, teachers) 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 EURneffy or determine that the child is properly instructed in the use of EURneffy and is fully capable of administration themselves.
2). Warnings for patients about anaphylaxis Patients should be instructed to recognise symptoms of systemic allergic reactions and anaphylaxis that may occur within minutes after exposure and which may consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhoea and abdominal cramps, involuntary voiding, wheezing, dyspnoea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.
Patients with concomitant asthma may be at increased risk of severe anaphylactic reaction. In young children, symptoms of systemic allergic reactions and anaphylaxis resemble symptoms of anaphylaxis in other age groups. The caregiver should be instructed to recognise symptoms of systemic allergic reactions and anaphylaxis that often consist of skin and/or gastrointestinal symptoms.
g. tongue thrusting, ear pulling, clinging to caregiver, cessation of playing, crying, spitting up/regurgitation after foods, increased secretions, loose stools, sleepiness/drowsiness after feeds, flushing with fever or crying spells, scratching, irritability) leading to misdiagnosis of anaphylaxis if inappropriately interpreted.
Adrenaline is recommended for use at first signs or symptoms of severe allergy reactions leading to anaphylaxis. Patients should be instructed to always carry adrenaline in situations of potential risks. The patient/caregiver should be informed about the possibility of biphasic anaphylaxis which is characterised by initial resolution followed by recurrence of symptoms some hours later.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• If a second dose is needed but not available, seek emergency medical assistance immediately. • Patients should preferably lie flat with feet elevated but sit up if they have breathing difficulties. Unconscious patients should be placed on their side in a recovery position.
6.
4). Paediatric population In a clinical study of paediatric subjects, 80 subjects between 4 and 17 years of age weighing 15 kg or more were treated with EURneffy. 5 %). 7 %). 5 %). There were no clinically relevant differences in the safety between the paediatric and adult populations treated with EURneffy.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
The patient should be advised to always seek medical assistance immediately after any severe allergic reaction. Populations at increased risks with the use of adrenaline Extreme caution should be taken when administering adrenaline to patients who have a heart disease.
g. 5). Anginal pain may be induced by adrenaline in patients with coronary insufficiency. There is a risk of adverse reactions following adrenaline administration in patients with high intraocular pressure, severe renal impairment, prostatic adenoma leading to residual urine, hypercalcaemia, and hypokalaemia.
In patients with Parkinson’s disease, adrenaline may be associated with a transient worsening of Parkinson’s symptoms such as rigidity and tremor. 8). Patients with these conditions, and/or any other persons who might be in a position to administer this medicinal product to a patient experiencing a severe allergic reaction or anaphylaxis should be carefully instructed in regard to the circumstances under which this life-saving medicinal product should be used.
5 Excipients with known effect Benzalkonium chloride This medicinal product contains benzalkonium chloride that may cause irritation or swelling inside the nose, especially if used for a long time. Sodium metabisulphite This medicinal product contains metabisulphite that may rarely cause severe hypersensitivity reactions and bronchospasm.