SUXAMETHONIUM JUNO suxamethonium chloride dihydrate 100 mg/2 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

suxamethonium chloride dihydrate, Quantity: 100 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; hydrochloric acid

Administration route:

Intramuscular, Intravenous

Units in package:

50 x 2 mL ampoules, 10 x 2 mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the production of skeletal muscle relaxation in anaesthesia. Suited for procedures requiring only brief relaxation such as endotracheal intubation, endoscopic examinations, orthopaedic manipulations, short surgical procedures and electro-convulsive therapy.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-01-17

Patient Information leaflet

SUXAMETHONIUM JUNO
_Suxamethonium chloride dihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Suxamethonium Juno. It does not
contain all the information that is
known about Suxamethonium Juno.
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 your being given
Suxamethonium Juno against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SUXAMETHONIUM
JUNO IS FOR
Suxamethonium Juno is used to stop
your muscles moving during surgery
or medical procedures.
It belongs to a group of medicines
called neuromuscular blockers which
work by stopping messages being
sent from the nerves to the muscles.
Your doctor will have explained why
you will be given Suxamethonium
Juno.
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.
Suxamethonium Juno is not
addictive.
BEFORE YOU ARE GIVEN
SUXAMETHONIUM JUNO
You may already have been given
Suxamethonium Juno. Your doctor
will have considered the situation
carefully and decided to use it.
However, if any of the following
applies to you, tell your doctor
immediately.
_WHEN YOU MUST NOT USE IT _
YOU SHOULD NOT BE GIVEN
SUXAMETHONIUM JUNO IF YOU ARE
PREGNANT OR BREASTFEEDING UNLESS
YOUR DOCTOR SAYS SO. ASK YOUR
DOCTOR ABOUT THE RISKS AND BENEFITS
INVOLVED.
We do not know if it is safe for you
to be given it while you are pregnant.
It may affect your baby if you are
given it early in pregnancy or in the
last weeks before your baby is due.
Your baby may take in
Suxamethonium Juno from breast
milk if you are breastfeeding.
YOU MUST NOT BE GIVEN
SUXAMETHONIUM JUNO IF YOU:
•
ARE SENSITIVE TO SUXAMETH

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
SUXAMETHONIUM JUNO
(SUXAMETHONIUM CHLORIDE DIHYDRATE) INJECTION
1
NAME OF THE MEDICINE
Suxamethonium chloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mL sterile solution of pH 3.0 – 5.0 containing 100 mg of
suxamethonium chloride dihydrate.
Suxamethonium chloride dihydrate is a white or almost white,
crystalline powder.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Injection solution. Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the production of skeletal muscle relaxation in anaesthesia.
Suited for procedures requiring
only brief relaxation such as endotracheal intubation, endoscopic
examinations, orthopaedic
manipulations, short surgical procedures and electro-convulsive
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage is individualised and its administration should be determined
after careful assessment of the
patient. The dose of suxamethonium is dependent on bodyweight, the
degree of muscle relaxation
required and the response of individual patients. Suxamethonium causes
paralysis of the respiratory
muscles, therefore after administration, respiration must be
controlled. It should not be
administered to a conscious patient.
Suxamethonium should not be mixed with any neuromuscular blocking
agent, nor with general
anaesthetics such as short acting barbiturates, nor any other
therapeutic agent in the same syringe.
Suxamethonium Chloride Injection contains no antimicrobial agent. It
should be used only once
and any residue discarded.
An initial test dose of 0.1 mg/kg may be given intravenously to
determine the patients response.
ADULT
For short procedures, such as endotracheal intubation the usual adult
dose is
0.6 mg/kg (range 0.3 - 1.1 mg/kg) administered IV over 10 to 30
seconds. This dose produces
muscle relaxation in about 60 seconds and has a duration of
approximately 4 to 6 minutes. Larger
doses produce more prolonged muscle relaxation.
For more prolonged surgical procedures in an adult, s