Mivacron 10 mg Solution for Injection

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Prieinama:

Alfred Gera & Sons Limited 10 Triq il-Masgar, Qormi QRM3217, Malta

ATC kodas:

M03AC10

INN (Tarptautinis Pavadinimas):

MIVACURIUM 2 mg/ml

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

MIVACURIUM 2 mg/ml

Recepto tipas:

POM

Gydymo sritis:

MUSCLE RELAXANTS

Produkto santrauka:

Licence number in the source country: Germany - 31178.00.00

Autorizacija statusas:

Authorised

Leidimo data:

2024-01-11

Pakuotės lapelis

Package Leaflet: Information for the User
MIVACRON 10 MG 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 relax

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mivacron 10mg 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)
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
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and 0.25 mg/kg produce clinically effective block for approximately
13, 16, 20 and
23 minutes, respectively.
Doses of up to 0.15 mg/kg may be administered over