OMEGAPHARM THIOPENTAL SODIUM 470 mg thiopental sodium 470 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

thiopental sodium, Quantity: 470 mg

Available from:

Omegapharm

INN (International Name):

thiopental sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

100 vials, 1 vial, 50 vials, 10 vials, 25 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? As the sole anaesthetic agent for brief surgical procedures.,? Induction of anaesthesia prior to the administration of other anaesthetic agents.,? Short-term control of convulsive states.,? Supplement to regional anaesthesia or low potency agents such as nitrous oxide.

Product summary:

Visual Identification: Yellowish, white powder; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-11-10

Patient Information leaflet

Omegapharm Thiopental sodium powder for injection
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CMI v1.1 Oct 19
OMEGAPHARM THIOPENTAL SODIUM 470 MG POWDER FOR INJECTION
thiopental sodium _(thye-oh-PEN-tal)_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Omegapharm Thiopental
sodium powder for
injection
It does not contain all the available information.
It does not take the place of talking with your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of your treatment using
Omegapharm Thiopental sodium powder for injection against the benefits
they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OMEGAPHARM THIOPENTAL SODIUM POWDER FOR INJECTION IS USED FOR
Omegapharm Thiopental sodium powder for injection is used as a general
anaesthetic, or to
make you sleepy before using another anaesthetic agent, or to control
seizures.
This medicine belongs to a group of medicines called barbiturates.
This medicine works as a short acting depressant of the nervous
system, which is composed of
the brain and spinal cord. It creates a sleep like state and loss of
consciousness to prevent pain
and discomfort during surgery.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it for another reason.
THIOPENTAL IS ADDICTIVE.
This medicine is available only with a doctor's prescription.
BEFORE OMEGAPHARM THIOPENTAL SODIUM POWDER FOR INJECTION IS GIVEN
_WHEN OMEGAPHARM THIOPENTAL SODIUM POWDER FOR INJECTION SHOULD NOT BE
USED _
_ _
YOU SHOULD NOT BE GIVEN OMEGAPHARM THIOPENTAL SODIUM POWDER FOR
INJECTION IF YOU HAVE
AN ALLERGY TO:
•
any other barbiturates;
•
any medicine containing thiopental sodium; or
•
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
•
shortness of breath;
•
wheezing or difficulty b

Summary of Product characteristics

Omegapharm Thiopental Sodium 470 mg powder for Injection
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PRODUCT INFORMATION
OMEGAPHARM THIOPENTAL SODIUM 470 MG POWDER FOR INJECTION
NAME OF THE MEDICINE
Thiopental sodium
Chemical name: sodium 5-ethyl-5-(1-methylbutyl)-2- thiobarbiturate.
Thiopental sodium
is a thiobarbiturate, the sulfur analogue of pentobarbitone sodium.
It has a pKa of 7.4.
The empirical formula of thiopental sodium is C11H17N2NaO2S and its
molecular weight
is 264.32.
CAS Number: 71-73-8.
ATC Code: N01AF03
DESCRIPTION
Thiopental sodium is a yellowish hygroscopic powder stabilised with 30
mg anhydrous
sodium carbonate per 470 mg of thiopental sodium
_, equivalent to 500mg of thiopental _
_sodium and sodium carbonate._
The product is presented as a sterile powder for injection.
There are no excipients in the product.
PHARMACOLOGY
Thiopental sodium is an ultra short-acting depressant of the central
nervous system, which
induces hypnosis and anaesthesia, but not analgesia. It produces
hypnosis within 30 to 40
seconds of intravenous injection. Consciousness returns after 20 to 30
minutes of a single
induction dose. Recovery after a small dose is rapid, with some
somnolence and retrograde
amnesia. The mechanism by which barbiturate anaesthetics produce
general anaesthesia is
not completely understood. It has been proposed that they act by
enhancing responses to
gamma-aminobutyric
acid
(GABA),
diminishing
glutamate
responses,
and
directly
OMEGAPHARM THIOPENTAL SODIUM 470 MG POWDER FOR INJECTION PRODUCT
INFORMATION
Omegapharm Thiopental sodium 470 mg powder for Injection
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depressing excitability by increasing membrane conductance, thereby
producing a net
decrease in neuronal excitability to provide anaesthetic action.
As sedative hypnotics, the barbiturates appear to act at the level of
the thalamus where they
inhibit
ascending
conduction
in
the
reticular
formation,
thus
interfering
with
the
transmission of impulses to the cortex. Thiopental sodium reduces
intracranial pressure. It
has a dose related depression of respiratory and laryngeal