NEOSTIGMINE JUNO neostigmine methylsulfate 2.5 mg/1 mL solution for injection ampoule
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
21-09-2021
Summary of Product characteristics
(SPC)
06-10-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
neostigmine methylsulfate, Quantity: 2.5 mg
Available from:
Juno Pharmaceuticals Pty Ltd
INN (International Name):
neostigmine methylsulfate
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections; sodium chloride
Administration route:
Intramuscular, Intravenous, Subcutaneous
Units in package:
10 ampoules, 50 ampoules
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Neostigmine is indicated for:,? Reversal of the effects of non-depolarising neuromuscular blocking agents.,? Prophylaxis and treatment of post-operative intestinal atony and urinary retention.,? Treatment of myasthenia gravis during acute exacerbations, when the condition is severe or in neonates.
Product summary:
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2015-01-27
Patient Information leaflet
_Neostigmine Juno Solution for Injection – Consumer Medicine
Information _
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_15.JU.M.1.0 _
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_Page 1 _
NEOSTIGMINE JUNO SOLUTION FOR
INJECTION
_Neostigmine Methylsulfate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
Neostigmine Juno Solution for
Injection. It does not contain all
the information that is known
about Neostigmine Juno
Solution for Injection. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you being
given Neostigmine Juno Solution
for Injection against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT THIS MEDICINE TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet. You may need
to read it again.
WHAT NEOSTIGMINE
JUNO IS USED FOR
Neostigmine Juno Solution for
Injection increases movement of
the muscles in the body.
It can be used:
•
To reverse the effects of
medicines that are used to stop
muscles moving;
•
To activate the muscles in the
bladder, stomach and
intestines following surgery
•
For myasthenia gravis.
Neostigmine is known as a
cholinesterase inhibitor. It works
by stopping a chemical called
acetylcholine, which stimulates
muscles movement, from
breaking down.
Your doctor will have explained
why you are being treated with
Neostigmine Juno Solution for
Injection.
FOLLOW ALL DIRECTIONS GIVEN TO
YOU BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this
leaflet.
Your doctor may prescribe this
medicine for another use. Ask
your doctor if you want more
information.
Neostigmine Juno Solution for
Injection is not addictive.
BEFORE YOU ARE GIVEN
NEOSTIGMINE JUNO
You may already have been
given Neostigmine Juno Solution
for Injection. Your doctor will
have considered the situation
carefully and decided to use it.
However, if any of any of the
following applies to you, tell your
doctor immediately.
_WHEN YOU MUST NOT USE IT _
YOU SHOULD NOT BE GIVEN
NEOSTIGMINE
Read the complete document
Summary of Product characteristics
Neostigmine Juno PI
Page | 1
AUSTRALIAN PRODUCT INFORMATION
NEOSTIGMINE JUNO (_NEOSTIGMINE METHYLSULFATE) _
_INJECTION_
_ _
1
NAME OF THE MEDICINE
Neostigmine methylsulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neostigmine Juno injection contains 2.5 mg neostigmine methylsulfate
in 1 mL solution.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Neostigmine Juno Solution for Injection is a clear, colourless sterile
solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Neostigmine is indicated for:
Reversal of the effects of non-depolarising neuromuscular blocking
agents.
Prophylaxis and treatment of post-operative intestinal atony and
urinary retention.
Treatment of myasthenia gravis during acute exacerbations, when the
condition is
severe or in neonates.
4.2 DOSE AND METHOD OF ADMINISTRATION
Neostigmine Juno Solution for Injection can be given as an
intramuscular (IM), intravenous
(IV) or subcutaneous (SC) injection. The following doses are
approximately equivalent in
effect: 0.5 mg IV = 1.0 - 1.5 mg IM or SC.
When Neostigmine Juno Solution for Injection is given, a syringe of
atropine sulfate or
glycopyrrolate should be available to counteract severe cholinergic
reactions, if they occur.
Do not mix atropine with other drugs in the same syringe as
compatibility data are not
available.
Neostigmine Juno Solution for Injection in ampoules contains no
antimicrobial agent. It
should be used once and any residue discarded.
ANTAGONIST TO NONDEPOLARISING NEUROMUSCULAR BLOCKADE:
Usually, reversal of neuromuscular blockade with Neostigmine Juno
Solution for Injection
should
not
be
attempted
until
spontaneous
recovery
from
paralysis
is
evident.
It
is
recommended that the patient be well ventilated and patent airway
maintained until complete
recovery of normal respiration is affirmed.
Neostigmine should be administered when the first twitch response is
substantially greater
Neostigmine Juno PI
Page | 2
than 10% of baseline, or when a second twitch is present.
Read the complete document
