NALOXONE JUNO NEONATAL naloxone hydrochloride (as dihydrate) 40 micrograms/2 mL solution for injection, ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

naloxone hydrochloride dihydrate, Quantity: 22 microgram/mL (Equivalent: naloxone hydrochloride?, Qty 20 microgram/mL)

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

naloxone hydrochloride dihydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid

Administration route:

Intramuscular, Intravenous, Subcutaneous

Units in package:

5, 10, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by opioids including natural and synthetic opioids, propoxyphene, methadone and the narcotic-antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride injection is also indicated for the diagnosis of suspected acute opioid overdosage.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-03-10

Patient Information leaflet

_ _
_Page 1 of 3_
NALOXONE JUNO
NALOXONE JUNO NEONATAL
_Naloxone Hydrochloride Dihydrate Solution for Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
NALOXONE
JUNO
and
NALOXONE JUNO NEONATAL
(referred to as Naloxone. It does
not
contain
all
the
available
information and it does not take
the place of talking to your doctor
or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you being
treated with this medicine against
the benefits it is expected to have
for you.
Please read this leaflet carefully
and follow the instructions given
to you by your doctor and the
advice contained in this leaflet.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT BEING TREATED WITH THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT NALOXONE JUNO
AND
NALOXONE
JUNO
NEONATAL IS USED FOR
Naloxone
hydrochloride
dihydrate belongs to a group of
medicines
called
opioid
antagonists.
Naloxone
hydrochloride
dihydrate works by reversing the
effects of opium-like substances
such as morphine, heroin and
codeine.
Your doctor may have prescribed
this medicine for another reason.
Ask your doctor if you have any
questions
about
why
this
medicine has been prescribed for
you.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
NALOXONE JUNO OR
NALOXONE JUNO
NEONATAL
_WHEN NALOXONE JUNO AND _
_NALOXONE JUNO _
_NEONATAL MUST NOT BE _
_GIVEN_
YOU SHOULD NOT BE GIVEN THIS
MEDICINE
IF
YOU
HAVE
AN
ALLERGY TO:
•
Any
medicine
containing
naloxone
hydrochloride
dihydrate
•
Any of the ingredients listed
at the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
•
Shortness of breath
•
Wheezing
or
difficulty
breathing
•
Swelling of the face, lips,
tongue or other parts of the
body
•
Rash, itching or hives on
the skin.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE
IF
THE
SOLUTION
IS
DISCOLOURED OR CLOUDY, TURBID
OR A PRECIPITATE IS PRESENT.
The injection is normally a cle

Summary of Product characteristics

Australian Product Information
PI v 3.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
NALOXONE JUNO
NALOXONE JUNO NEONATAL
_ _
_ _
_ _
_(NALOXONE HYDROCHLORIDE (AS DIHYDRATE) INJECTION) _
1 NAME OF THE MEDICINE
The name of this medicine is naloxone hydrochloride dihydrate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NALOXONE JUNO and NALOXONE JUNO NEONATAL are available as sterile
solutions for
intravenous, intramuscular and subcutaneous administration at a
concentration of 400
micrograms of naloxone hydrochloride (as dihydrate) in 1 mL of water
for injections, and 40
micrograms of naloxone hydrochloride (as dihydrate) in 2 mL water for
injections. The pH is
adjusted to 3.0 – 3.3 with hydrochloric acid.
NALOXONE JUNO and NALOXONE JUNO NEONATAL, opioid antagonists, are
synthetic
congeners of oxymorphone. In structure they differ from oxymorphone in
that the methyl group
on the nitrogen atom is replaced by an allyl group.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Solution for injection.
NALOXONE JUNO and NALOXONE JUNO NEONATAL are clear, colourless
solutions.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Naloxone hydrochloride dihydrate injection is indicated for the
complete or partial reversal of
opioid depression, including respiratory depression, induced by
opioids including natural and
synthetic
opioids,
propoxyphene,
methadone
and
the
narcotic-antagonist
analgesics:
nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride
dihydrate injection is also
indicated for the diagnosis of suspected acute opioid overdosage.
4.2 DOSE AND METHOD OF ADMINISTRATION
NALOXONE JUNO and NALOXONE JUNO NEONATAL may be administered
intravenously,
intramuscularly,
or
subcutaneously.
The
most
rapid
onset
of
action
is
achieved
by
intravenous administration and it is recommended in emergency
situations.
Since the duration of action of some opioids may exceed that of
naloxone hydrochloride
dihydrate the patient should be kept under continued surveillance, and
repeated doses of
n