MIVACRON mivacurium 10mg/5mL 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 5mL 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

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