ROCURONIUM BROMIDE MEDSURGE rocuronium bromide 50 mg/ 5 mL solution for injection vial

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

rocuronium bromide, Quantity: 50 mg

Tersedia dari:

Medsurge Pharma Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

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

Rute administrasi :

Intravenous Bolus, Intravenous Infusion

Unit dalam paket:

10 vials

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Rocuronium is indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during routine induction, to provide muscle relaxation and to facilitate mechanical ventilation in adults, and paediatric patients from term newborn infants to adolescents. ,In adults, rocuronium is also indicated as an adjunct to general anaesthesia to facilitate endotracheal intubation during rapid sequence induction when suxamethonium is contraindicated. ,In adults, rocuronium is also indicated as an adjunct in the intensive care unit (ICU) to facilitate mechanical ventilation.

Ringkasan produk:

Visual Identification: A clear colorless to pale yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status otorisasi:

Registered

Tanggal Otorisasi:

2021-11-01

Selebaran informasi

Rocuronium Bromide Medsurge CMI v2 Jul 2022
1
ROCURONIUM BROMIDE
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 BROMIDE?
Rocuronium Bromide contains the active ingredient rocuronium bromide.
Rocuronium Bromide is one of a group of medicines
called muscle relaxants.
Rocuronium Bromide 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
Bromide?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ROCURONIUM BROMIDE?
Do not use if you have ever had an allergic reaction to rocuronium
bromide 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 Bromide?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rocuronium Bromide 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 DO I USE ROCURONIUM BROMIDE?
•
Rocuronium bromide 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
Bromide?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ROCURONIUM BROMIDE?
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 bromide.
For more information, see Section 5. What should I

Karakteristik produk

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ROCURONIUM BROMIDE
PRODUCT INFORMATION
AUSTRALIAN PRODUCT INFORMATION
ROCURONIUM BROMIDE MEDSURGE (ROCURONIUM BROMIDE)
SOLUTION FOR INJECTION
1 NAME OF THE MEDICINE
Rocuronium bromide
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ROCURONIUM BROMIDE MEDSURGE 50 mg in 5 mL solution for injection
contains
10
mg/mL of rocuronium bromide.
For the full list of excipients, see Section 6.1 List of Excipients.
3 PHARMACEUTICAL FORM
ROCURONIUM BROMIDE MEDSURGE is a clear, colourless to pale yellow
solution for
injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rocuronium is indicated as an adjunct to general anaesthesia to
facilitate endotracheal
intubation during routine induction, to provide muscle relaxation and
to facilitate mechanical
ventilation in adults, and paediatric patients from term newborn
infants to adolescents.
In adults, rocuronium is also indicated as an adjunct to general
anaesthesia to facilitate
endotracheal intubation during rapid sequence induction when
suxamethonium is
contraindicated.
In adults, rocuronium is also indicated as an adjunct in the intensive
care unit (ICU) to
facilitate mechanical ventilation.
4.2 DOSE AND METHOD OF ADMINISTRATION
Like other neuromuscular blocking agents, Rocuronium bromide should
only be administered
by, or under supervision of, experienced clinicians who are familiar
with the action and use
of these drugs.
Rocuronium bromide is administered by intravenous bolus or infusion.
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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 into account when determining the dose. The
use of an appropriate
neuromuscular monitoring technique is recommended