Suxamethonium Chloride 50 mg/ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Suxamethonium chloride

Available from:

Ethypharm

ATC code:

M03AB01

INN (International Name):

Suxamethonium chloride

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

suxamethonium

Authorization status:

Not marketed

Authorization date:

2019-05-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUXAMETHONIUM CHLORIDE 50 MG/ML SOLUTION FOR INJECTION / INFUSION
SUXAMETHONIUM CHLORIDE DIHYDRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
member of the operating theatre staff
• If you get any side effects, talk to your doctor, nurse, or member
of the operating theatre staff.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1
. What Suxamethonium Chloride 50 mg/ml Solution for Injection /
Infusion is and what it is used for
2. What you need to know before you are given Suxamethonium Chloride
50 mg/ml Solution for
Injection /Infusion
3. How Suxamethonium Chloride 50 mg/ml Solution for Injection /
Infusion is given
4. Possible side effects
5. How to store Suxamethonium Chloride 50 mg/ml Solution for Injection
/ Infusion
6. Contents of the pack and other information
1. WHAT SUXAMETHONIUM CHLORIDE 50 MG/ML SOLUTION FOR INJECTION /
INFUSION IS AND WHAT IT IS USED
FOR
Suxamethonium Chloride Injection / Infusion contains a medicine called
suxamethonium chloride.
This belongs to a group of medicines called muscle relaxants.
Suxamethonium Chloride is used:
• to relax muscles during operations on adults and children
Ask your doctor if you would like more explanation about this
medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SUXAMETHONIUM CHLORIDE 50
MG/ML SOLUTION FOR
INJECTION / INFUSION
YOU SHOULD NOT BE GIVEN SUXAMETHONIUM CHLORIDE 50 MG/ML SOLUTION FOR
INJECTION / INFUSION IF:
• you are allergic to suxamethonium chloride, or any of the other
ingredients of this medicine (listed
in section 6)
• your doctor has told you that you suffer from abnormal
cholinesterase activity (cholinesterase is
an enzyme that breaks down acetylcholine)
• you or any of your family have a history of abnormally high body
temperat

Summary of Product characteristics

Health Products Regulatory Authority
22 April 2020
CRN009C5M
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suxamethonium Chloride 50 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Suxamethonium Chloride 50 mg/ml (100 mg/2 ml).
Each ml of solution for injection or infusion contains 50 mg of
suxamethonium chloride (equivalent to 40.2 mg of
suxamethonium). Each 2 ml ampoule contains 100 mg suxamethonium
chloride (equivalent to 80.4 mg of suxamethonium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear, colourless solution.
pH of the solution 3.0-4.2.
Osmolality of the product is 300-365 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Used _FOR MUSCLE RELAXATION DURING _general anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Use by intravenous injection _
_Adults and Children over 12 years_
The dose is dependent on body weight, the degree of muscular
relaxation required, the route of administration, and the
response of individual patients.
To achieve endotracheal intubation Suxamethonium Chloride is usually
administered intravenously in a dose of 1 mg/kg. This
dose will usually produce muscular relaxation in about 30 to 60
seconds and has a duration of action of about 2 to 6 minutes.
Larger doses will produce more prolonged muscular relaxation, but
doubling the dose does not necessarily double the
duration of relaxation. Supplementary doses of Suxamethonium Chloride
of 50% to 100% of the initial dose administered at 5
to 10 minute intervals will maintain muscle relaxation during short
surgical procedures performed under general anaesthesia.
The total dose of Suxamethonium Chloride should not exceed 500 mg.
_Infants and young children are more resistant to suxamethonium
compared with adults._
_Children 1 to 12 years _
1-2 mg/kg by intravenous injection.
A total dose of 150 mg should not be exceeded.
_ _
_Infants, under 1 year_
2 mg/kg by intravenous injection.
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