Nyxoid

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. Paediatric population The safety and efficacy of Nyxoid in children below 14 years has not been established. No data are available. Method of administration Nasal use.

Nyxoid should be administered as soon as possible to avoid damage to the central nervous system or death. 3 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.

Summary of the safety profile The most common adverse reaction (AR) seen with naloxone administration is nausea (frequency very common). Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them.

Tabulated list of adverse reactions The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing medicinal products during clinical studies and post marketing experience. ARs are listed below by system organ class and frequency.

Frequency categories are assigned to those adverse reactions considered to be at least possibly causally related to naloxone and are defined as very common: (≥ 1/10); common: (≥ 1/100, < 1/10); uncommon: (≥ 1/1,000, < 1/100); rare: (≥ 1/10,000, < 1/1,000) very rare: (< 1/10,000); not known (cannot be estimated from the available data).

Immune system disorders Very rare:

Hypersensitivity, Anaphylactic shock Nervous system disorders Common Dizziness, Headache Uncommon Tremor Cardiac disorders Common Tachycardia Uncommon Arrhythmia, Bradycardia Very rare Cardiac fibrillation, Cardiac arrest Vascular disorders Common Hypotension, Hypertension Respiratory, thoracic and mediastinal disorders Uncommon Hyperventilation Very rare Pulmonary oedema Gastrointestinal disorders Very common Nausea 6 Common Vomiting Uncommon Diarrhoea, Dry mouth Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis Very rare Erythema multiforme General disorders and administration site conditions Uncommon Drug withdrawal syndrome (in patients dependent on opioids) Description of selected adverse reactions Drug withdrawal syndrome Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia.

Instructing patients / users on the proper use of Nyxoid Nyxoid should only be made available once the suitability and competence of an individual to administer naloxone in the appropriate circumstances has been established. Patients or any other person who might be in a position to administer Nyxoid must be instructed in its proper use and the importance of seeking medical assistance.

Nyxoid is not a substitute for emergency medical care and may be used instead of intravenous injection, when intravenous access is not immediately available. Nyxoid is intended to be administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected, likely in a non-medical setting.

Therefore, the prescriber should take appropriate steps to ensure that the patient and/or any other person who might be in a position to administer Nyxoid thoroughly understands the indications and use of Nyxoid. The prescriber should describe the symptoms which allow presumptive diagnosis of central nervous system (CNS) / respiratory depression, the indication and the instructions for use with the patient and / or person who might be in a position to administer this product to a patient experiencing a known or suspected opioid overdose event.

This should be performed in accordance with the educational guidance for Nyxoid. Monitoring of the patient for a response Patients who respond satisfactorily to Nyxoid must be closely monitored. The effect of some opioids can be longer than the effect of naloxone, which could lead to reoccurrence of respiratory depression and therefore further doses of naloxone may be required.

8). Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when Nyxoid is administered. Effectiveness of naloxone Reversal of buprenorphine-induced respiratory depression may be incomplete.

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