SUXAMETHONIUM ACCORD suxamethonium chloride dihydrate 100 mg/2 mL solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

suxamethonium chloride dihydrate, Quantity: 100 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

5 x 2 mL pre-filled syringe, 10 x 2 mL pre-filled syringe, 1 x 2 mL pre-filled syringe

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: A clear, colourless solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-08-26

Patient Information leaflet

Suxamethonium Accord - version 1
1
SUXAMETHONIUM ACCORD
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 SUXAMETHONIUM ACCORD?
Suxamethonium Accord contains the active ingredient suxamethonium.
Suxamethonium Accord is used to stop your muscles
moving during surgery or medical procedures.
For more information, see Section 1. Why am I using Suxamethonium
Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SUXAMETHONIUM ACCORD?
Do not use if you have ever had an allergic reaction to suxamethonium
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR 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
Suxamethonium Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Suxamethonium Accord 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 SUXAMETHONIUM ACCORD?
Suxamethonium Accord is an injection and will be given to you by an
anaesthetist. It will not be given to you until you are
asleep from an anaesthetic.
More instructions can be found in Section 4. How do I use
Suxamethonium Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SUXAMETHONIUM ACCORD?
THINGS YOU
SHOULD DO
•
Tell your doctor if you have any of these medical conditions: heart or
lung problems, reduced red
blood cells and iron stores (anaemia), under-active thyroid gland,
liver problems, fever, paraplegia,
severe injuries, cancer, skin diseases, broken bones.
•
Tell your doctor if you have recently been in contact with weed
killers or insecticides.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Suxamethonium Accord
affects you.
For more

Summary of Product characteristics

Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
SUXAMETHONIUM ACCORD (SUXAMETHONIUM CHLORIDE
DIHYDRATE) INJECTION
1
NAME OF THE MEDICINE
Suxamethonium chloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 syringe of 2 mL solution for injection contains 100 mg of
suxamethonium chloride dihydrate.
For the full list of excipients,
SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Injection solution. Clear, colourless solution in a pre-filled glass
syringe.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
Suxamethonium Accord is supplied in a ready-to-use pre-filled glass
syringe containing 100 mg of
suxamethonium chloride dihydrate in 2 mL water for injection.
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 Accord Injection contains no antimicrobial agent. It
should be used on one occasion
in one patient only and any residue discarded.
An initial test dose of 0.1 mg/kg may be given intravenously to
determine the patient’s 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