Nyxoid
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
24-02-2023
Fachinformation
(SPC)
24-02-2023
Öffentlichen Beurteilungsberichts
(PAR)
12-12-2017
Wirkstoff:
Naloxone hydrochloride dihydrate
Verfügbar ab:
Mundipharma Corporation (Ireland) Limited
ATC-Code:
V03AB15
INN (Internationale Bezeichnung):
naloxone
Therapiegruppe:
All other therapeutic products
Therapiebereich:
Opioid-Related Disorders
Anwendungsgebiete:
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.
Produktbesonderheiten:
Revision: 8
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-11-09
Gebrauchsinformation
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
NYXOID 1.8 MG NASAL SPRAY, SOLUTION IN SINGLE-DOSE CONTAINER
naloxone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nyxoid is and what it is used for
2.
What you need to know before you receive Nyxoid
3.
How Nyxoid is to be given
4.
Possible side effects
5.
How to store Nyxoid
6.
Contents of the pack and other information
1.
WHAT NYXOID IS AND WHAT IT IS USED FOR
This medicine contains the active substance naloxone. Naloxone
temporarily reverses the effects of
opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine
and morphine.
Nyxoid is a nasal spray used for the emergency treatment of opioid
overdose or possible opioid
overdose in adults and adolescents over 14 years. Signs of overdose
include:
•
breathing problems
•
severe sleepiness
•
not responding to a loud noise or touch.
IF YOU ARE AT RISK OF AN OPIOID OVERDOSE YOU SHOULD ALWAYS CARRY YOUR
NYXOID WITH YOU
. Nyxoid
works for a short time only to reverse the effects of opioids while
you wait for emergency medical
attention. It is not a substitute for emergency medical care. Nyxoid
is intended for use by
appropriately trained individuals.
Always tell your friends and family that you carry Nyxoid with you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE NYXOID
_ _
DO NOT USE NYXOID
If you are allergic to naloxone or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Nyxoid will be supplied to you only
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nyxoid 1.8 mg nasal spray, solution in 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.
CLINICAL PARTICULARS
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
and healthcare settings.
Nyxoid is indicated in adults and adolescents aged 14 years and over.
Nyxoid is not a substitute for emergency medical care.
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 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 N
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