NYXOID Nasal spray (2025)
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Περιεχόμενα
1. Name of the medicinal product
Nyxoid 1.8 mg nasal spray, solution in a single-dose container.
2. Qualitative and quantitative composition
Each nasal spray container delivers 1.8 mg of naloxone (as hydrochloride dihydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nasal spray, solution in single-dose container (nasal spray).
Clear, colourless to pale yellow solution.
4.1. Therapeutic indications
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...
4.2. Posology and method of administration
Posology
Adults and adolescents aged 14 years and over
The recommended dose is 1.8 mg administered into one nostril (one nasal spray).
In some cases, further doses may be necessary. The appropriate...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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 circumstan...
4.5. Interaction with other medicinal products and other forms of interaction
Naloxone elicits a pharmacological response due to the interaction with opioids and opioid agonists. When administered to opioid dependent subjects, naloxone can cause acute withdrawal symptoms in ...
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of naloxone in pregnant women. Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3). The potential ...
4.7. Effects on ability to drive and use machines
Patients who have received naloxone to reverse the effects of opioids should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for ...
4.8. Undesirable effects
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...
4.9. Overdose
In view of the indication and the broad therapeutic margin, overdose is not to be expected.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Antidotes
ATC code:
V03AB15
Mechanism of action and pharmacodynamic effects
Naloxone, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opio...
5.2. Pharmacokinetic properties
Absorption
Intranasal administration of naloxone has demonstrated naloxone to be rapidly absorbed, as evidenced by very early appearance (as early as 1 minute after administration) of the active su...
5.3. Preclinical safety data
Genotoxicity and carcinogenicity
Naloxone was not mutagenic in the bacterial reverse mutation assay, but was positive in mouse lymphoma assay and was clastogenic in vitro, however, naloxone was not...
6.1. List of excipients
Trisodium citrate dihydrate (E331)
Sodium chloride
Hydrochloric acid (E507)
Sodium hydroxide (E524)
Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not freeze.
6.5. Nature and contents of container
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 stainle...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Mundipharma Corporation (Ireland) Limited, United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
8. Marketing authorization number(s)
EU/1/17/1238/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 10 November 2017
Date of latest renewal: 15 September 2022
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