Tracrium 250mg/25ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atracurium besilate

Available from:

Aspen Pharma Trading Ltd

ATC code:

M03AC04

INN (International Name):

Atracurium besilate

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010500; GTIN: 5010706003569

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRACRIUM
10 MG/ML INJECTION
ATRACURIUM BESILATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING 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.
WHAT IS IN THIS LEAFLET:
1. What Tracrium is and what it is used for
2. What you need to know before you have Tracrium
3. How to have 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
•
to relax the muscles of adults in intensive care.
Ask your doctor if you would like more explanation about this
medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE TRACRIUM
DO NOT HAVE TRACRIUM IF:
•
you are allergic to atracurium besilate, any other muscle relaxant or
any of the other
ingredients in Tracrium (listed in section 6)
•
you have reacted badly to an anaesthetic before.
Do not have Tracrium if any of the above apply to you. If you are not
sure, talk to your
doctor, nurse or pharmacist before you have Tracrium.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before having Tracrium if:
•
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
•
you have a lower than normal volume

Summary of Product characteristics

OBJECT 1
TRACRIUM INJECTION
Summary of Product Characteristics Updated 03-Aug-2017 | Aspen
1. Name of the medicinal product
Tracrium Injection
2. Qualitative and quantitative composition
Atracurium Besilate HSE 10 mg/ml
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Injection
4. Clinical particulars
4.1 Therapeutic indications
Tracrium is a highly selective, competitive or non-depolarising
neuromuscular blocking agent. It is used
as an adjunct to general anaesthesia or sedation in the intensive care
unit (ICU), to relax skeletal muscles,
and to facilitate tracheal intubation and mechanical ventilation.
4.2 Posology and method of administration
Route of administration: Intravenous injection or continuous infusion.
_Used by injection in adults_: Tracrium is administered by intravenous
injection.
The dosage range recommended for adults is 0.3 to 0.6 mg/kg (depending
on the duration of full block
required) and will provide adequate relaxation for about 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.
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 evidence of recurarisation.
_Use as an infusion in adults_: After an initial bolus dose of 0.3 to
0.6 mg/kg, Tracrium can be used to
maintain neuromuscular block during long surgical procedures by
administration as a continuous infusion
at rates of 0.3 to 0.6mg/kg/hour.
Tracrium can be administered by infusion during cardiopulmonary bypass
surgery at the recomme