Mivacron 2mg/ml Solution for Injection

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

MIVACURIUM

Pieejams no:

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

ATĶ kods:

M03AC10

SNN (starptautisko nepatentēto nosaukumu):

MIVACURIUM 2 mg/ml

Zāļu forma:

SOLUTION FOR INJECTION

Kompozīcija:

MIVACURIUM 2 mg/ml

Receptes veids:

POM

Ārstniecības joma:

MUSCLE RELAXANTS

Autorizācija statuss:

Authorised

Autorizācija datums:

2006-11-23

Lietošanas instrukcija

Package Leaflet: Information for the User
MIVACRON 2 MG/ML SOLUTION FOR INJECTION
mivacurium (as mivacurium chloride)
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, 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.
IN THIS LEAFLET:
1.
What Mivacron is and what it is used for
2.
What you need to know before you have Mivacron
3.
How to have Mivacron
4.
Possible side effects
5.
How to store Mivacron
6.
Contents of the pack and other information
1. WHAT MIVACRON IS AND WHAT IT IS USED FOR
Mivacron contains a medicine called mivacurium. This belongs to a
group of medicines
called muscle relaxants.
Mivacron is used:
•
to relax muscles during operations
on adults and children 2 months of age and over,
including heart surgery
•
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 HAVE MIVACRON
DO NOT HAVE MIVACRON IF:
•
you are allergic to mivacurium or any of the other ingredients in
Mivacron (listed in
Section 6)
•
you have been diagnosed as having a genetically determined abnormal
cholinesterase
•
you or your family have reacted badly to an anaesthetic before
Do not have Mivacron if any of the above apply to you. If you are not
sure, talk to your
doctor, nurse or pharmacist before you have Mivacron.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before having this medicine
if:
•
you have muscle weakness, tiredness or difficulty in co-ordinating
your movements
(myasthenia gravis) or other form of neuromuscular disease
•
you have a burn which requires medical treatment
•
you have ever had an allergic reaction to any muscle rel

Produkta apraksts

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mivacron 2mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2mg mivacurium (as mivacurium chloride)
Each 5ml ampoule contains 10mg mivacurium. (As mivacurium chloride)
Each 10ml ampoule contains 20mg mivacurium. (As mivacurium chloride)
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection. (Short term: Injection)
A clear, pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mivacron
is
a
highly
selective,
short-acting,
non-depolarising
neuromuscular
blocking agent with a fast recovery profile.
Mivacron is indicated as an adjunct to general anaesthesia to relax
skeletal muscles
and to facilitate tracheal intubation and mechanical ventilation in
adults, children and
infants 2 months and over.
This formulation contains no antimicrobial preservative and is
intended for single
patient use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Use by injection in adults:_
Mivacron is administered by intravenous injection. The mean dose
required to
produce 95% suppression of the adductor pollicis single twitch
response to ulnar
nerve stimulations (ED
95
) is 0.07 mg/kg (range 0.06 to 0.09) in adults receiving
narcotic anaesthesia.
The following dose regimens are recommended for tracheal intubation:-
i._ _
A dose of 0.2 mg/kg, administered over 30 seconds, produces good to
excellent conditions for tracheal intubation within 2 to 2.5 minutes.
ii._ _
A dose of 0.25 mg/kg administered as a divided dose (0.15 mg/kg
followed
30 seconds later by 0.1 mg/kg), produces good to excellent conditions
for
tracheal intubation within 1.5 to 2.0 minutes of completion of
administration
of the first dose portion.
The recommended bolus dose range for healthy adults is 0.07 to 0.25_
_mg/kg. The
duration of neuromuscular blockade is related to the_ _dose. Doses of
0.07, 0.15, 0.20
Page 2 of 12
and 0.25 mg/kg produce clinically effective block for approximately
13, 16, 20 a