NYXOID naloxone hydrochloride dihydrate 2.2 mg/actuation nasal spray vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

naloxone hydrochloride dihydrate, Quantity: 2.2 mg/actuation

Disponible depuis:

Mundipharma Pty Ltd

forme pharmaceutique:

Spray, nasal

Composition:

Excipient Ingredients: sodium chloride; hydrochloric acid; sodium citrate dihydrate; nitrogen; sodium hydroxide; purified water

Mode d'administration:

Nasal

Unités en paquet:

2

Type d'ordonnance:

(S3) Pharmacist Only Medicine

indications thérapeutiques:

Nyxoid is intended as part of the emergency treatment for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in:,? the home or other non medical setting,? a health facility setting,For this reason, Nyxoid should be carried by persons at risk of, or likely to witness such events.,Nyxoid is indicated in adults and children.

Descriptif du produit:

Visual Identification: A unit dose device containing a vial held tightly within a vial holder. The vial is a clear glass vial containing liquid and a black stopper. All components show no visible signs of damage.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2018-09-18

Notice patient

NYXOID
1
NYXOID® nasal spray
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1. Why am I using NYXOID?
NYXOID contains the active ingredient Naloxone. NYXOID is a nasal
spray used as part of the emergency treatment of opioid
overdose or possible opioid overdose.
For more information, see Section 1. Why am I using NYXOID? in the
full CMI.
2. What should I know before I use NYXOID?
Do not use if you have ever had an allergic reaction to Naloxone or
any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical
conditions, take any other medicines, or are pregnant or
plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
NYXOID? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with NYXOID and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4. How do I use NYXOID?
•
One spray of NYXOID is given into one nostril.
•
Each NYXOID nasal spray contains one single dose of naloxone and
cannot be reused. Do not prime or test the device
before you give it.
•
Call for an ambulance before giving NYXOID.
More instructions can be found in Section 4. How do I use NYXOID? in
the full CMI.
5. What should I know while using NYXOID?
Things you
should do
•
Remind any doctor, dentist or pharmacist you visit that you are using
NYXOID.
Driving or using
machines
•
Do not drive or operate machinery after you have been given NYXOID
nasal spray for at least 24
hours (1 day), since the effects of opioids may recur.
Drinking
alcohol
•
If alcohol has been taken in addition to opioids there may be a delay
in the action of naloxone.
Looking after
your medicine
•
Store below 30°C. Do not freeze
For more information, see Section 5. What should I know while using
NYXOID? in the full CMI.
6. Are

Résumé des caractéristiques du produit

NYXOID
®
Nasal Spray
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION -
NYXOID
®
(NALOXONE HYDROCHLORIDE DIHYDRATE) NASAL SPRAY
1
NAME OF THE MEDICINE
Naloxone hydrochloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 100 microlitre contains 2.2 mg naloxone hydrochloride
dihydrate. For the full list
of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
NYXOID nasal spray is a clear, colourless to pale yellow solution in
glass vials in a single dose
nasal spray device.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC
I
NDICATIONS
Nyxoid is intended as part of the emergency treatment for known or
suspected opioid overdose
as manifested by respiratory and/or central nervous system depression
in:

the home or other non-medical setting

a health facility setting
For this reason, Nyxoid should be carried by persons at risk of, or
likely to witness such events.
Nyxoid is indicated in adults and children.
4.2
D
OSE AND
M
ETHOD OF ADMINISTRATION
Nyxoid is administered as a part of a resuscitation intervention in
emergency settings, including
the home or other non-medical settings in suspected overdose
casualties, where opioids may be
involved or suspected.
The prescriber should review in detail, the indications, the
instructions and operation of the
nasal spray with the patient or any other person who might be in a
position to administer this
product to a patient experiencing a known or suspected opioid overdose
event.
How to identify an opioid overdose (symptoms of respiratory
depression)

Breathing problems

Severe sleepiness

Not responding to a loud noise or touch.
NYXOID
®
Nasal Spray
Page 2 of 11
Dosage
One spray of Nyxoid into a nostril. Re-administer Nyxoid, using a new
Nyxoid container, into
the other nostril after 2 to 3 minutes if the patient does not respond
or responds and then
relapses into respiratory depression. Further doses may be given every
2 to 3 minutes if
needed until further assistance is available.
Method of administration
Nasal use only.
The device is