Tracrium 10mg/ml, solution for injection or infusion, ampoules

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Atracurium besilate

זמין מ:

Aspen Pharma Trading Limited

קוד ATC:

M03AC; M03AC04

INN (שם בינלאומי):

Atracurium besilate

כמות:

10 milligram(s)/millilitre

טופס פרצבטיות:

Solution for injection/infusion

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Other quaternary ammonium compounds; atracurium

מצב אישור:

Marketed

תאריך אישור:

1983-09-28

עלון מידע

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

מאפייני מוצר

Health Products Regulatory Authority
30 November 2023
CRN00DZLC
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tracrium 10mg/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 50mg 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.
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 evidenc