HereS a breakdown of the provided text, focusing on the key data about EURneffy:
What is EURneffy?
EURneffy is a nasal spray that delivers adrenaline for the emergency treatment of anaphylaxis.
it is indeed the first approved nasal spray alternative to customary adrenaline auto-injector pens.
Key Features and Benefits:
Delivery Method: Nasal spray.
Dosage: Delivers a single dose of 2 mg of adrenaline with one activation.
Suitability: for adults and children weighing 30 kg (approx. 66 lbs) or more.
Effectiveness: Works even with nasal congestion.
Indications: Emergency treatment of allergic reactions caused by insect stings/bites, foods, medicinal products, and other allergens. Also for idiopathic or exercise-induced anaphylaxis. Shelf Life: 30 months.
Temperature Stability: Better than traditional adrenaline auto-injectors.
Regulatory Approvals:
European Union: Approved in August 2023.
United Kingdom: Approved by the MHRA (Medicines and Healthcare products Regulatory Agency) in January 2024, using the International Recognition Procedure.
Vital Patient Advice:
Carry Two Doses: Always carry two doses in case a second dose is needed.
Second Dose governance: If symptoms persist or recur, administer a second dose in the same nostril after 10 minutes.
Inform Others: Inform friends or family about the condition.
Seek Medical Attention: Always seek immediate medical attention after any severe allergic reaction, even if symptoms resolve, due to the risk of biphasic anaphylaxis (delayed recurrence of symptoms).
Correct Usage: The spray’s plunger must not be pressed before insertion into the nostril to avoid premature dose release.
Efficacy and Tolerability:
Clinical data: Trials involving over 700 participants showed EURneffy produced a pharmacological response comparable to intramuscular adrenaline auto-injectors.
Real-World Data: Also supports its effectiveness in acute situations. Adverse Reactions: No serious adverse events reported in studies. Most frequent reactions (after a second 2 mg dose) included throat irritation, headache, nasal discomfort, and feeling jittery.
Ongoing Monitoring:
The MHRA will continue to monitor the safety and effectiveness of EURneffy.
Healthcare professionals and patients are encouraged to report suspected side effects via the Yellow Card scheme.
Where to Find More Information:
Patient Information Leaflet and Summary of Product Characteristics will be available on the MHRA website within seven days of approval.