Anectine 50mg/ml Solution for Injection or Infusion

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

SUXAMETHONIUM CHLORIDE

Verfügbar ab:

Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland

ATC-Code:

M03AB01

INN (Internationale Bezeichnung):

SUXAMETHONIUM CHLORIDE 50 mg/ml

Darreichungsform:

SOLUTION FOR INJECTION/INFUSION

Zusammensetzung:

SUXAMETHONIUM CHLORIDE 50 mg/ml

Verschreibungstyp:

POM

Therapiebereich:

MUSCLE RELAXANTS

Berechtigungsstatus:

Withdrawn

Berechtigungsdatum:

2006-09-18

Gebrauchsinformation

1
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
ANECTINE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION
(SUXAMETHONIUM CHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Anectine is and what it is used for
2.
What you need to know before you have Anectine
3.
How to have Anectine
4.
Possible side effects
5.
How to store Anectine
6.
Contents of the pack and other information
1. WHAT ANECTINE IS AND WHAT IT IS USED FOR
Anectine contains a medicine called suxamethonium chloride. This
belongs to a group of
medicines called muscle relaxants.
Anectine is used:
•
to relax muscles during operations on adults and children
•
to help insert a tube into the windpipe (endotracheal intubation), if
a person needs help to
breathe
•
to reduce how strongly your muscles contract
Ask your doctor if you would like more explanation about this
medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE ANECTINE
DO NOT USE ANECTINE IF:
•
you are allergic to suxamethonium chloride or any of the other
ingredients of Anectine injection
(listed in section 6).
•
you or a family member have reacted badly to an anaesthetic before,
such as a very high body
temperature (malignant hyperthermia) or a long pause in breathing
(prolonged apnoea).
•
you have severe liver or kidney problems.
•
you have had a major accident, operation or severe burns within the
last three months.
•
you have not been able to move for a long time such as to allow a
broken bone to mend or a
long period of bed rest.
•
you have high levels of potassium in your blood (hyperkalaemia).
•
you have recently had an eye injury.
•
you suffer from a problem caused by too much pr

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anectine 50mg/ml
Solution for
Injection
or Infusion
.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml ampoule contains 100mg Suxamethonium Chloride
For
the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
or infusion
.
A clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC I
NDICATIONS
Anectine Injection is an ultra-short acting, depolarising,
neuromuscular blocking agent. It is
used in anaesthesia as a
skeletal
muscle relaxant to facilitate tracheal intubation and
mechanical ventilation in surgical procedures.
Anectine Injection is also used to reduce the intensity of muscular
contractions associated
with pharmacologically or
electrically-induced convulsions.
4.2
POSOLOGY AND M
ETHOD OF
A
DMINISTRATION
_INSTRUCTIONS FOR USE _
The dose of Anectine Injection is dependent on
age,
body weight, the degree of muscle
relaxation required and the route of administration.
The usual method of Anectine Injection administration is by bolus
intravenous injection.
_USE BY INTRAVENOUS BOLUS INJECTION _
_Dosage in adults:_
A single intravenous dose of
suxamethonium chloride dihydrate of
approximately 1mg/kg bodyweight will usually provide profound
neuromuscular
blockade and good conditions for tracheal intubation within 30-60
seconds of its
administration. The duration of clinically useful neuromuscular
relaxation produced
by this dose is on average 2-6 minutes, although wide inter-patient
variability exists.
Larger
single doses of Anectine Injection may slightly accelerate the speed
at which
neuromuscular paralysis develops, and will produce longer durations of
clinically
useful muscle relaxation but not in a direct dose-dependent manner;
doubling the dose
of Anectine Injection does not necessarily double the duration of
relaxation.
Supplementary intravenous doses of Anectine Injection of 50-100% of
the initial dose may be
administered for the maintenance of muscle relaxation during short
surgical
or o