Fresofol 1% MCT/LCT Propofol 500mg/50mL Emulsion for Intravenous Injection/Infusion vial

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

propofol, Quantity: 10 g/L

から入手可能:

Fresenius Kabi Australia Pty Ltd

INN（国際名）:

Propofol

医薬品形態:

Injection, emulsion

構図:

Excipient Ingredients: medium chain triglycerides; egg lecithin; sodium hydroxide; water for injections; oleic acid; glycerol; Soya Oil

投与経路:

Intravenous

パッケージ内のユニット:

10 x 50mL vials

クラス:

Medicine Registered

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Induction of General Anaesthesia in Children and Adults,Fresofol (1 percent) MCT / LCT is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older.,Maintenance of General Anaesthesia in Children and Adults,Fresofol (1 percent) MCT / LCT is a short acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older.,Fresofol (1 percent) MCT / LCT may also be used for maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided.,Fresofol (1 percent) MCT / LCT has no analgesic properties. ,Sedation During Intensive Care in Adults,Fresofol (1 percent) MCT / LCT may also be used in adults for sedation of ventilated patients receiving intensive care.,Conscious Sedation for Surgical and Diagnostic Procedures in Adults,Fresofol (1 percent) MCT / LCT may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

製品概要:

Visual Identification: Fresofol 1% MCT/LCT is a sterile, milky white, isotonic, oil-in-water emulsion for intravenous infusion or injection.; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2012-11-23

情報リーフレット

CMI for Fresofol 1% MCT/LCT
Mar 2016
Filename: FremCMI160316-clean
Page 1 of 4
Change: Address Change
FRESOFOL
® 1% MCT/LCT
Propofol 1% w/v
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet contains some common
questions
about
Fresofol
1%
MCT/LCT.
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 or pharmacist
has weighed the risk of you taking
this medicine against the benefits
they expect it will have for you.
Keep this leaflet. You may need to
read it again.
If you have any further questions,
ask your doctor or pharmacist.
WHAT
IS
FRESOFOL
1%
MCT/LCT USED FOR
It is a short-acting sleep inducing
medicinal product used to start and
sustain a general anaesthesia.
It is used to induce sleep or lower
your level of consciousness (as a
sedative) during intensive care or
during
diagnostic
or
surgical
procedures.
BEFORE
YOU
ARE
GIVEN
FRESOFOL 1% MCT/LCT
_ _
_WHEN _
_YOU _
_MUST _
_NOT _
_BE _
_GIVEN _
_FRESOFOL 1% MCT/LCT _
Do not use Fresofol 1% MCT/LCT:

if
you
are
allergic
(hypersensitive) to Propofol or
any of the other ingredients of
Fresofol 1% MCT/LCT

if
you
are
allergic
(hypersensitive)
to
soya
or
peanut
_ _
_TAKE SPECIAL CARE WITH FRESOFOL _
_1% MCT/LCT IF: _

you have a disorder in which
your body does not handle fat
properly

you
have
any
other
health
problems
which
require
caution
in
the
use
of
fat
emulsions

you are very overweight

your blood volume is too low
(hypovolaemia)

you
are
very
weak
or
have
heart,
circulatory,
kidney
or
liver problems

you have high pressure within
the
skull
and
low
blood
pressure in the arteries

you have problems with your
breathing

you have epilepsy

you
are
undergoing
some
procedures
where
spontaneous
movements
are
particularly, undesirable.
Please tell your doctor if you have
one
of
these
diseases
or
conditions.
Do not give Fresofol 1% MCT/LCT
in children of one month of age or
younger as a general anae

製品の特徴

AUSTRALIAN PRODUCT INFORMATION- FRESOFOL® 1%
MCT/LCT (PROPOFOL)
Page 1 of 18
1 NAME OF MEDICINE
Propofol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fresofol 1% MCT/LCT is a sterile, milky white, isotonic, oil-in-water
emulsion for intravenous
infusion or injection. 1 mL of Fresofol 1% MCT/LCT contains 10 mg
propofol. It also contains
the following excipients: soya oil, medium chain triglycerides,
glycerol, egg lecithin, sodium
hydroxide, oleic acid and water for injections.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Injection for emulsion.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Induction of General Anaesthesia in Children and Adults
Fresofol 1% MCT/LCT is a short-acting intravenous anaesthetic agent
suitable for induction
of general anaesthesia in adults and children aged one month and
older.
Maintenance of General Anaesthesia in Children and Adults
Fresofol 1% MCT/LCT is a short acting intravenous anaesthetic agent
suitable for
maintenance of general anaesthesia in adults and children aged 3 years
and older.
Fresofol 1% MCT/LCT may also be used for maintenance of general
anaesthesia in children
aged from one month to 3 years for procedures not exceeding 60
minutes, unless alternative
anaesthetic agents should be avoided.
Fresofol 1% MCT/LCT has no analgesic properties.
Sedation During Intensive Care in Adults
Fresofol 1% MCT/LCT may also be used in adults for sedation of
ventilated patients
receiving intensive care.
Conscious Sedation for Surgical and Diagnostic Procedures in Adults
Fresofol 1% MCT/LCT may also be used in adults for monitored conscious
sedation for
surgical and diagnostic procedures.
4.2
DOSE AND METHOD OF ADMINISTRATION
Strict aseptic technique must always be maintained during handling. Do
not use if
contamination is suspected. Discard unused portions as directed within
the required time
limits (see also:
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Aseptic
Technique).
Adults
_Induction of General Anaesthesia _
Fresofol 1% MCT/LCT ma