ANESIA propofol 1000mg/100mL emulsion for injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

propofol, Quantity: 1000 mg

Saadav alates:

Baxter Healthcare Pty Ltd

INN (Rahvusvaheline Nimetus):

Propofol

Ravimvorm:

Injection, emulsion

Koostis:

Excipient Ingredients: Soya Oil; glycerol; egg lecithin; sodium oleate; sodium hydroxide; water for injections

Manustamisviis:

Intravenous

Ühikuid pakis:

1 vial

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. Anesia 1% has no analgesic properties. Although the safety and efficacy of propofol in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. Anesia 1% may also be used in adults for sedation of ventilated patients receiving intensive care. Anesia1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

Toote kokkuvõte:

Visual Identification: White oil-in-water emulsion in a clear glass vial.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2009-05-22

Infovoldik

ANESIA 1 %
[Propofol]
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about this medicine.
It does not contain all the available information. It does not take
the place of talking to
your doctor or anaesthetist.
All medicines have risks and benefits. Your doctor or anaesthetist has
weighed the risks
of you being given Anesia against the benefits it is expected to have
for you.
If you have any concerns about being given this medicine, ask your
doctor or anaesthetist.
Keep this leaflet. You may need to read it again.
What Anesia is used for
General anaesthesia
Anesia contains propofol, which is used as a short-acting general
anaesthetic in adults,
and children aged 3 years or older.
A general anaesthetic is a medicine which produces general
anaesthesia. Anesia is short-
acting, which means that patients go to sleep quickly, usually within
30 seconds of
receiving the medication, but then wake up quickly as it wears off.
Anesia can be used for very short operations when only one injection
is needed. Anesia
can be used throughout longer operations if more is given as repeated
doses. Anesia can
also be used to start off anaesthesia (induction anaesthesia). This
means the
anaesthetist may change over to another anaesthetic once sleep is
induced.
Sedation
Anesia can be given to adults and adolescents over 16 years of age in
lower doses if they
need to be sedated or sleepy, but do not need the heavy sleep of
anaesthesia. This type
of sedation may be required during certain tests or procedures.
Anesia can also be used in intensive care wards for adults and
adolescents over 16 years
of age who are being ventilated (on a breathing machine) to keep them
sedated.
Ask your doctor or anaesthetist if you have any questions about why
this medicine has
been prescribed for you. Your doctor or anaesthetist may have
prescribed it for another
reason.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
There is not enough information to recommend

Toote omadused

PRODUCT INFORMATION
Anesia
Name of the drug
Anesia is composed of:-
Active:
Propofol (10 mg/mL).
Excipients:
Soya oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL),
sodium
oleate (0.3 mg/mL).
Description
Chemical name: 2,6-diisopropylphenol.
Chemical structure:
CAS: 2078-54-8.
Molecular formula: C
12
H
18
O
Molecular Weight: 178
Anesia is a white, oil in water emulsion in a clear glass vial.
Pharmacology
Pharmacodynamics:
Propofol is a short acting general anaesthetic agent with a rapid
onset of
action of approximately 30 seconds. Recovery from anaesthesia is
usually rapid. The
mechanism of action, as for other general anaesthetics, is poorly
understood. The majority of
pharmacodynamic properties exhibited by propofol are proportional to
the dose or concentration
in the blood. These dose or dose rate dependent properties include the
desired therapeutic
effects of mild sedation through to anaesthesia, but also include the
increasing incidence of
cardiac and respiratory depression seen with increasing dose.
The cardiovascular effects of propofol range from a minimal reduction
in blood pressure through
to arterial hypotension, and a decrease in heart rate. However, the
haemodynamic parameters
normally remain relatively stable during maintenance and the incidence
of untoward
haemodynamic changes is low.
Although ventilatory depression can occur following administration of
propofol, any effects are
qualitatively similar to those of other intravenous anaesthetic agents
and are readily manageable
in clinical practice.
It has been reported that in patients with normal intraocular pressure
that propofol anaesthesia
produces a decrease in intraocular pressure, which may be associated
with a concomitant
decrease in systemic vascular resistance.
In combination with hypocarbia, propofol increases cerebrovascular
resistance, decreases
cerebral blood flow, cerebral metabolic oxygen consumption and
intracranial pressure, but
does not affect cerebrovascular reactivity to changes in arterial
carbon dioxide tension.
I