Mivacron

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Mivacurium chloride 2.14 mg/mL equivalent to 2 mg/ml mivacurium cation

Հասանելի է:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Միջազգային անվանումը):

Mivacurium chloride 2.14 mg/mL (=2 mg/ml mivacurium cation)

Դոզան:

2 mg/mL

Դեղագործական ձեւ:

Solution for injection

Կազմը:

Active: Mivacurium chloride 2.14 mg/mL equivalent to 2 mg/ml mivacurium cation Excipient: Hydrochloric acid Water for injection

Միավորները փաթեթում:

Ampoule, glass, 5x5mL, 25 mL

Դաս:

Prescription

Ռեկվիզորի տեսակը:

Prescription

Պատրաստված է:

Union Quimico Farmaceutica SA (Uquifa SA)

Թերապեւտիկ ցուցումներ:

MIVACRON is a highly selective, short-acting, non-depolarising neuromuscular blocking agent with a fast recovery profile. MIVACRON is used as an adjunct to general anaesthesia to relax skeletal muscles and to facilitate tracheal intubation and mechanical ventilation.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Ampoule, glass, 5x5mL - 25 mL - 18 months from date of manufacture stored at or below 25°C - Ampoule, glass, 5x10mL - 50 mL - 18 months from date of manufacture stored at or below 25°C

Հաստատման ամսաթիվը:

1993-02-23

Տեղեկատվական թերթիկ

MIVACRON
®
1
MIVACRON
®
_2 mg/mL Injection _
_mivacurium _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mivacron. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Mivacron
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT MIVACRON IS
USED FOR
Mivacron is a medicine that relaxes
muscles. It is used when you are
under a general anaesthetic. It allows
a tube to go down the windpipe for
your breathing while you are under a
general anaesthetic. It is not the same
as muscle relaxant tablets doctors
sometimes prescribe. It doesn’t
relieve pain.
There is no evidence that Mivacron is
addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
MIVACRON
_WHEN YOU MUST NOT BE GIVEN _
_IT _
Mivacron should not be used if:

You are allergic to mivacurium

You are known to be
homozygous for the atypical
plasma cholinesterase gene (this
affects 1 in 2500 patients)
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR IF:

You have a history of asthma,
hayfever or allergies

You have recently lost a lot of
fluids, e.g. been vomiting,
diarrhoea (frequent watery
faeces/poos), sweating
excessively, been doing high
levels of exercise, or lost a lot of
blood.

You may have salt imbalances
e.g. you have been drinking
excessive quantities of water or
have been taking large amounts
of salts, or have had diarrhoea or
have a bowel problem or no large
bowel

You have myasthenia gravis

You have any other disease of
nerves and muscles
(neuromuscular disease)

You have heart disease

You have kidney disease e.g.
kidney failure

You have liver disease

You have tetanus, tuberculosis or
any other severe or chronic
inf

Ապրանքի հատկությունները

NEW ZEALAND DATA SHEET
1.
MIVACRON
(Mivacurium 2 mg/mL Injection)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL ampoule contains 10 mg mivacurium and each 10 mL ampoule
contains 20 mg mivacurium.
This formulation contains no antimicrobial preservative and is
intended for
single patient use.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
MIVACRON injection solution is a clear, pale yellow, sterile aqueous
solution in glass ampoules containing 2 mg/mL mivacurium, present as
mivacurium chloride.
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
used as an adjunct to general anaesthesia to relax skeletal muscles
and to
facilitate tracheal intubation and mechanical ventilation.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE IN ADULTS BY INJECTION
MIVACRON is administered by intravenous injection. The mean dose
required to produce 95% suppression of the adductor pollicis single
twitch
response to ulnar nerve stimulation (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 2.0 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 block is related to the dose. Doses of
0.07,
0.15, 0.20 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 5 to 15 seconds. Higher doses should be administered
over 30 seconds in order to