Pentothal thiopental sodium 500 mg powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

thiopental sodium, Quantity: 0.5 g

Disponível em:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

DCI (Denominação Comum Internacional):

thiopental sodium

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients:

Via de administração:

Intravenous

Unidades em pacote:

0.5g X 25, 0.5g X 50

Classe:

Medicine Registered

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

INDICATIONS AS AT 08 DEC 1993 : Pentothal may be used : 1. as the sole anaesthetic agent for brief surgical procedures; 2. for the induction of anaesthesia prior to the administration of other anaesthetic agents; 3. for the short-term control of condvulsive states; 4. to supplement regional anaesthesia or low potency agents such as nitrous oxide.

Resumo do produto:

Visual Identification: White or yellow powder; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Licence status A

Data de autorização:

2000-03-21

Folheto informativo - Bula

Pentothal for Injection
v2.0
1
PENTOTHAL™ FOR INJECTION
_thiopental sodium _
CONSUMER MEDICINE INFORMATION_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pentothal for
Injection.
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 taking Pentothal 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
.
You may need to read it again.
WHAT PENTOTHAL FOR
INJECTION IS USED FOR
Pentothal 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.
BEFORE YOU ARE GIVEN
PENTOTHAL FOR INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU SHOULD NOT BE GIVEN PENTOTHAL
FOR INJECTION IF YOU HAVE AN ALLERGY
TO:
•
any other barbiturates
•
any medicine containing
thiopental sodium
•
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 difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR.
YOU SHOULD NOT BE GIVEN PENTOTHAL
FOR INJECTION IF YOU HAVE:
•
porphyria
•
a swollen jaw, mouth or neck
_BEFORE YOU ARE GIVEN IT_
_ _
TELL YOUR DOCTOR IF YOU HA

Características técnicas

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PENTOTHAL
FOR INJECTION
(thiopental sodium)
1 NAME OF THE MEDICINE
Thiopental Sodium
2 QUALITATIVE AND QUANTITAIVE COMPOSITION
Each vial contains 500 mg of thiopental sodium.
3 PHARMACEUTICAL FORM
Powder for injection.
Thiopental sodium is a yellowish hygroscopic powder stabilised with
anhydrous
sodium carbonate 60 mg/g thiopental sodium.
4. CLINICAL PARTICULARS
4.1 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.
4.2 DOSE AND ADMINISTRATION
Pentothal for Injection is administered by the intravenous route only.
Individual
response to the drug is so varied that there can be no fixed dosage.
The drug
should be titrated against patient requirements as governed by age,
sex and
bodyweight. Younger patients require relatively larger doses than
middle aged and
elderly
people;
the
latter
metabolise
the
drug
more
slowly.
Prepuberty
requirements are the same for both sexes, but adult females require
less than adult
males. Dose is usually proportional to bodyweight and obese patients
require a
larger dose than relatively lean people of the same weight.
The use of a continuous infusion increases the likelihood of
overdosage, with a
subsequent prolonged recovery period. Cloudy solutions or solutions
showing a
precipitate should not be administered.
Page 2 of 14
PREMEDICATION
Premedication usually consists of atropine or hyoscine to suppress
vagal reflexes
and inhibit secretions. Ideally, the peak effect of these medications
should be
reached shortly before the time of induction.
TEST DOSE
It is advisable to inject a small test dose of Pentothal for Injection
25 to 75 mg (1
to 3 mL of a 25 mg/mL solution) to assess tolerance or unusual
sensitivity to
Pentothal for Injection, and pause to observe patient reaction for at
least 60
secon