VECURONIUM SUN vecuronium bromide 10mg powder for injection glass vial

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

vecuronium bromide, Quantity: 10 mg

Disponible des:

Sun Pharma ANZ Pty Ltd

Designació comuna internacional (DCI):

Vecuronium bromide

formulario farmacéutico:

Injection, powder for

Composición:

Excipient Ingredients: citric acid; sodium hydroxide; mannitol; dibasic sodium phosphate; phosphoric acid

Vía de administración:

Intravenous

Unidades en paquete:

1, 4, 10 and 20 vials

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

VECURONIUM SUN is a skeletal muscle relaxant for use as an adjunct to general anaesthesia in adults and children for all surgical procedures.

Resumen del producto:

Visual Identification: White to off-white lyophilized cake in 10 ml colorless tubular glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2015-04-28

Informació per a l'usuari

1
VECURONIUM SUN CMI V2
VECURONIUM SUN
_Vecuronium bromide _
_ _
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet is a summary of some of
the information about the drug
Vecuronium SUN
It does not contain all the available
information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Vecuronium
SUN against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT VECURONIUM SUN IS
USED FOR
Vecuronium SUN is one of a group
of medicines called muscle relaxants.
Muscle relaxants are used during an
operation as part of the general
anaesthetic. When you have an
operation, your muscles must be
completely relaxed. This makes it
easier for the surgeon to perform the
operation.
Normally the nerves send messages
to the muscles by impulses.
Vecuronium SUN acts by blocking
these impulses so the muscles are
relaxed. Because the muscles needed
for breathing also become relaxed
you will need help with your
breathing (artificial respiration)
during and after your operation until
you can breathe on your own. During
the operation the effect of the muscle
relaxants is constantly checked and if
necessary some more drug is given.
At the end of the operation the
effects of Vecuronium SUN are
allowed to wear off and you can start
breathing on your own. Sometimes
another drug is given to help speed
this up. Vecuronium SUN can also
be used in Intensive Care to keep your
muscles relaxed.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT THIS MEDICINE.
Vecuronium SUN is not addictive.
BEFORE YOU ARE GIVEN
VECURONIUM SUN
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN VECURONIUM
SUN IF YOU HAVE AN ALLERGY TO:
• any medicine containing
vecuronium bromide
• any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or di

Fitxa tècnica

Page 1 of 12
VECURONIUM SUN PI V3.1
AUSTRALIAN PRODUCT INFORMATION
VECURONIUM SUN
_(vecuronium bromide)_
1 NAME OF THE MEDICINE
Vecuronium bromide
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vecuronium SUN 10mg: 10mL vials each containing 10.0 mg sterile
lyophilised vecuronium
bromide.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Powder for injection.
It is an odourless, bitter tasting white to creamy white,
microcrystalline powder. At 25
o
C (pH 3), its
solubility is 16 mg/mL, and pKa is 8.97. Because vecuronium bromide
hydrolyses rapidly in water, a
ready-for-use aqueous solution form is not available.
Following reconstitution with solvent (Water for Injections) the
resultant solution is isotonic and has a
pH of 4.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vecuronium SUN is a skeletal muscle relaxant for use as an adjunct to
general anaesthesia in adults
and children for all surgical procedures.
4.2 DOSE AND METHOD OF ADMINISTRATION
Vecuronium SUN should be administered in carefully adjusted dosage by
or under the supervision of
experienced clinicians who are familiar with the action and use of
these drugs. The drug should not
be administered unless facilities for intubation, artificial
respiration, oxygen therapy, suction and
reversal agents are immediately available.
To avoid microbial contamination, Vecuronium SUN should be used
without delay once reconstituted
and any residue should be discarded.
RECONSTITUTION
Vecuronium SUN 10mg: The contents of each vial should be dissolved in
5mL water for injections.
After reconstitution, Vecuronium SUN is administered intravenously
either as a bolus injection or as a
continuous infusion.
When calculating the dose of neuromuscular blocking agents the
following factors must be taken into
account:
• The anaesthetic technique used, potential interactions with the
drugs used before and during
anaesthesia, and the condition of the individual patient.
The use of an appropriate neuromuscular monitoring technique is
recom