ROCURONIUM BAXTER rocuronium bromide 50mg/5mL injection solution vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

rocuronium bromide, Quantity: 50 mg

Tilgjengelig fra:

Baxter Healthcare Pty Ltd

INN (International Name):

Rocuronium bromide

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: sodium acetate; sodium chloride; glacial acetic acid; sodium hydroxide; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

5mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, children and infants over 1 month of age. Adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated, however, this has not been studied in infants and children. Adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

Produkt oppsummering:

Visual Identification: A clear, colourless to yellow or orange solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2011-08-16

Informasjon til brukeren

ROCURONIUM BAXTER
1
ROCURONIUM BAXTER
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ROCURONIUM BAXTER?
ROCURONIUM BAXTER contains the active ingredient rocuronium bromide.
ROCURONIUM BAXTER is one of a group of
medicines called muscle relaxants. ROCURONIUM BAXTER is 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.
For more information, see Section 1. Why am I using ROCURONIUM BAXTER?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ROCURONIUM BAXTER
Do not use if you have ever had an allergic reaction to ROCURONIUM
BAXTER or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ROCURONIUM BAXTER? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ROCURONIUM BAXTER and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW ROCURONIUM BAXTER IS GIVEN
•
ROCURONIUM BAXTER will be given by a doctor. It will not be given to
you until you are asleep from the anaesthetic.
•
It will be injected into a vein before and/or during an operation. It
will be given as a single injection or continuous infusion.
More instructions can be found in Section 4. How do I use ROCURONIUM
BAXTER? in the full CMI.
5.
WHAT SHOULD I KNOW AFTER HAVING ROCURONIUM BAXTER?
DRIVING OR USING
MACHINES
•
Your doctor will tell you when it is safe to drive and operate
potentially dangerous machinery after you
have been given ROCURONIUM BAXTER.
For more information, see Section 5. What should I know after having
ROCURONIUM BAXTER? in th

Preparatomtale

Version 2.0
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AUSTRALIAN PRODUCT INFORMATION
ROCURONIUM BAXTER (ROCURONIUM BROMIDE) INJECTION SOLUTION
1
NAME OF THE MEDICINE
Rocuronium bromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ROCURONIUM BAXTER 50 mg/5 mL: 5 mL of solution contains 50 mg
rocuronium bromide.
ROCURONIUM BAXTER 100 mg/10 mL: 10 mL of solution contains 100 mg
rocuronium bromide.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ROCURONIUM BAXTER is a clear, colourless to yellow or orange solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Adjunct to general anaesthesia to facilitate endotracheal intubation
during routine induction, to
provide muscle relaxation and to facilitate mechanical ventilation in
adults, children and infants
over 1 month of age.
Adjunct to general anaesthesia to facilitate endotracheal intubation
during rapid sequence
induction when suxamethonium is contraindicated, however, this has not
been studied in infants
and children.
Rocuronium is also indicated as an adjunct in the intensive care unit
(ICU) to facilitate mechanical
ventilation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ROCURONIUM BAXTER is administered by intravenous bolus or infusion
Like other neuromuscular blocking agents, ROCURONIUM BAXTER should
only be administered
by, or under supervision of, experienced clinicians who are familiar
with the action and use of
these drugs.
The product is for single patient use and contains no antimicrobial
agent.
As with other neuromuscular blocking agents, the dosage of rocuronium
bromide should be
individualised in each patient. The anaesthetic method used, the
duration of surgery, the method
of sedation and the expected duration of mechanical ventilation, the
possible interaction with
other drugs that are administered concomitantly and the condition of
the patient should be taken
Version 2.0
2
into account when determining the dose. The use of an appropriate
neuromuscular monitoring
technique is recommended for evaluation of the neuromuscular block and
the recovery.
I