Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom
Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.
Nyxoid is indicated in adults and adolescents aged 14 years and over.
Nyxoid is not a substitute for emergency medical care.
The recommended dose is 1.8 mg administered into one nostril (one nasal spray).
In some cases, further doses may be necessary. The appropriate maximum dose of Nyxoid is situation specific. If the patient does not respond, the second dose should be administered after 2-3 minutes. If the patient responds to the first administration but then relapses again into respiratory depression, the second dose should be administered immediately. Further doses (if available) should be administered in alternate nostrils and the patient should be monitored whilst awaiting arrival of the emergency services. Emergency services may administer further doses according to local guidelines.
The safety and efficacy of Nyxoid in children below 14 years has not been established. No data are available.
Nasal use.
Nyxoid should be administered as soon as possible to avoid damage to the central nervous system or death.
Nyxoid contains only one dose and therefore it must not be primed or tested prior to administration.
Detailed instructions on how to use Nyxoid are provided in the Package Leaflet and a Quick Start Guide is printed on the back of each blister. In addition, training is provided via a video and a Patient Information Card.
In view of the indication and the broad therapeutic margin, overdose is not to be expected.
3 years.
Do not freeze.
The immediate container consists of a type I glass vial with siliconised chlorobutyl stopper containing 0.1 ml solution. The secondary packaging (actuator) is comprised of polypropylene and stainless steel.
Each pack contains two single-dose nasal sprays.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
