MIVACRON mivacurium 20mg/10mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mivacurium chloride, Quantity: 2.14 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: hydrochloric acid; water for injections

Administration route:

Intravenous

Units in package:

5 x 10mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MIVACRON is a highly selective, non-depolarising neuromuscular blocking agent with a fast recovery profile and a short duration of action. MIVACRON is used as an adjunct to general anaesthesia to relax skeletal muscles and to facilitate tracheal intubation and mechanical ventilation. This formulation contains no antimicrobial preservative and is intended for single patient use.

Product summary:

Visual Identification: A clear, pale yellow aqueous solution practically free from particles.; Container Type: Ampoule; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-05-16

Patient Information leaflet

1
MIVACRON
®
_MIVACURIUM CHLORIDE_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about MIVACRON. It does not
contain all of the available information.
Reading
this
leaflet
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist.
Taking any medicine involves some risk. It
is possible that all risks associated with
this
medicine
might
not
have
been
detected,
despite
proper
testing.
Only
your doctor or pharmacist is able to weigh
up all of the relevant facts, and you should
consult them if you have any queries.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
MIVACRON
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP THIS INFORMATION.
You may want to read it again.
This
leaflet
provides
information
about
MIVACRON.
The
statements
that
are
made in this leaflet cannot be applied to
any other medicine, even those that are
similar
or
appear
to
contain
the
same
ingredients.
WHAT MIVACRON IS USED FOR
MIVACRON
is
used
together
with
anaesthetic medicines to relax the body's
muscles. It will be given to you when you
are asleep during surgery.
_ _
_HOW DOES MIVACRON WORK? _
Mivacurium chloride (the active ingredient
in
MIVACRON)
belongs
to
a
group
of
medicines
called
"neuromuscular
blockers".
MIVACRON works by blocking the effects
of one of the body's chemical messengers
called
acetylcholine.
Acetylcholine
is
involved in muscle contraction.
Your
doctor
may,
however,
have
prescribed MIVACRON for a different use
to that described above.
IF YOU HAVE ANY QUESTIONS ABOUT WHY
YOU HAVE BEEN PRESCRIBED MIVACRON
ASK YOUR DOCTOR OR PHARMACIST.
Your doctor or pharmacist will be able to
provide you with more information.
MIVACRON
IS
NOT
SUITABLE
FOR
EVERYONE.
BE SURE THAT YOUR DOCTOR KNOWS ABOUT
THE
FOLLOWING
BEFORE
YOU
ARE
GIVEN
MIVACRON:
1.
IF YOU ARE ALLERGIC TO:
•
mivacurium
chloride
(the
active
ingredient in MIVACRON).
•
any other ingredient listed at the end
of this leaflet.
2.
IF
YOU
ARE
PREGNANT
OR
BREASTFEEDING.
3.
IF
YOU
SUFFER
FROM
ASTHMA
OR
ALLERGIES.
4.
IF
YOU
SUFFER
FROM
OR
HAVE
HAD
HEA

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
MIVACRON (MIVACURIUM CHLORIDE)
INJECTION
1
NAME OF THE MEDICINE
Mivacurium chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MIVACRON injection is a sterile, non-pyrogenic solution (pH 3.5 to
6.5) containing
mivacurium chloride equivalent to 2 mg/mL mivacurium.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
MIVACRON injection is a clear, pale yellow sterile aqueous solution
practically free from
particles.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
MIVACRON is a highly selective, non-depolarising neuromuscular
blocking agent with a fast
recovery profile, and a short duration of action. MIVACRON is used as
an adjunct to general
anaesthesia to relax skeletal muscles and to facilitate tracheal
intubation and mechanical
ventilation.
This formulation contains no antimicrobial preservative and is
intended for single patient use.
4.2
D
OSE AND METHOD OF ADMINISTRATION
PHARMACEUTICAL PRECAUTIONS
Since no antimicrobial preservative is included, MIVACRON injection
must be used under full
aseptic conditions and any dilution carried out immediately before
use. Any unused solution
in open ampoules should be discarded.
To
avoid
distress
to
the
patient,
MIVACRON
should
not
be
administered
before
unconsciousness has been induced.
The dosage information provided below is intended as a guide only.
Doses of MIVACRON
should be individualised (see section 5, PHARMACOLOGICAL PROPERTIES).
Factors that
may warrant dosage adjustment include but may not be limited to: The
presence of significant
kidney, liver, or cardiovascular disease, obesity (patients weighing
≥
30% more than ideal
body weight for height), asthma, reduction in plasma cholinesterase
activity, and the presence
of inhalational anaesthetic agents.
2
The onset of conditions suitable for tracheal intubation occurs
earlier after a conventional
intubation dose of suxamethonium than after recommended doses of
MIVACRON.
USE BY INJECTION IN ADULTS
MIVACRON is administered by intravenous inj