Tracrium 10mg/ml, Solution for Injection or Infusion (5ml ampoule)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATRACURIUM BESILATE

Available from:

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

ATC code:

M03AC04

INN (International Name):

ATRACURIUM BESILATE 10 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION/INFUSION

Composition:

ATRACURIUM BESILATE 10 mg/ml

Prescription type:

POM

Therapeutic area:

MUSCLE RELAXANTS

Authorization status:

Authorised

Authorization date:

2005-11-25

Patient Information leaflet

Package leaflet: Information for the patient
TRACRIUM 10 MG/ML SOLUTION FOR INJECTION OR INFUSION
ATRACURIUM BESILATE
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, nurse or
pharmacist.
•
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Tracrium is and what it is used for
2.
What you need to know before you use Tracrium
3.
How to use Tracrium
4.
Possible side effects
5.
How to store Tracrium
6.
Contents of the pack and other information
1. WHAT TRACRIUM IS AND WHAT IT IS USED FOR
Tracrium contains a medicine called atracurium besilate. This belongs
to a group of
medicines called muscle relaxants.
Tracrium is used:
•
to relax muscles during operations
on adults and children over 1 month of age
•
to help insert a tube into the windpipe (tracheal intubation), if a
person needs help to
breathe.
Ask your doctor if you would like more explanation about this
medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRACRIUM
DO NOT USE TRACRIUM IF:
•
you are allergic to atracurium besilate, cisatracurium (another muscle
relaxant) or
any of the other ingredients in Tracrium (listed in Section 6)
•
you have reacted badly to an anaesthetic before.
Do not use Tracrium if any of the above apply to you. If you are not
sure, talk to your
doctor, nurse or pharmacist before you use Tracrium.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using this medicine
if:
•
you are allergic to any other muscle relaxant
•
you have muscle weakness, tiredness or difficulty in co-ordinating
your movements
(myasthenia gravis)
•
you have a neuromuscular disease, such as a muscle wasting disease,
paralysis,
motor neurone disease or cerebral palsy
•
you have a severe electrolyte imbalance
•
yo

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tracrium 10 mg/ml, Solution for Injection or Infusion, ampoules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg of atracurium besilate.
_ _
Each 2.5 ml ampoule contains 25 mg of atracurium besilate.
Each 5 ml ampoule contains 50 mg of atracurium besilate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion.
A clear, colorless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Tracrium is a highly selective, competitive or non-depolarising
neuromuscular blocking agent,
which is used as an adjunct to general anaesthesia to enable tracheal
intubation to be performed
and to relax skeletal muscles during surgery or controlled
ventilation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Injection: _
Tracrium is administered by intravenous injection.The dosage range for
adults is 0.3 to 0.6
mg/kg (depending on the duration of full block required) and will
provide adequate relaxation
for 15 to 35 minutes.
Endotracheal intubation can usually be accomplished within 90 seconds
from the intravenous
injection of 0.5 to 0.6 mg/kg.
Full block can be prolonged with supplementary doses of 0.1 to 0.2
mg/kg as required. Successive
supplementary dosing does not give rise to accumulation of
neuromuscular blocking effect.
_Caesarean Section_
:
Tracrium is suitable for maintenance of muscle relaxation during
Caesarean section as it does not
cross the placenta in clinically significant amounts following
recommended doses (0.3-0.6 mg/kg).
Spontaneous recovery from the end of full block occurs in about 35
minutes as measured by the
restoration of the tetanic response to 95% of normal neuromuscular
function.
2
The neuromuscular block produced by Tracrium can be rapidly reversed
by standard doses of
anticholinesterase agents, such as neostigmine and edrophonium,
accompanied or preceded by
atropine, with no evidence of recurarisation.
_Continuous infusion_
:
Normothermia: Af