PROPOFOL 1% MCT FRESENIUS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROPOFOL

Available from:

CURE MEDICAL & TECHNICAL SUPPLY

ATC code:

N01AX10

Pharmaceutical form:

EMULSION FOR INJECTION OR INFUSION

Composition:

PROPOFOL 1 G / 100 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI DEUTSCHLAND GMBH, GERMANY

Therapeutic area:

PROPOFOL

Therapeutic indications:

Propofol 1% MCT Fresenius is a short-acting intravenous general anaesthetic for-induction and maintenance of general anaesthesia in adults and children > 1 month-sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month-sedation of ventilated patients > 16 years of age in the intensive care unit

Authorization date:

2016-06-23

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
)
_ _
_:ךיראת_
73.3.6
_םושיר רפסמו תילגנאב רישכת םש_
_:_
_ _
Propofol 1% MCT Fresenius
156-46-34397-00, 156-46-34397-01, 156-46-34397-02
םושירה לעב םש
:
Cure Medical & Technical Supply
רפל דעוימ הז ספוט
ה טו
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4. CLINICAL
PARTICULARS
4.2
POSOLOGY AND
METHOD OF
ADMINISTRATION
4.4
SPECIAL WARNINGS
AND PRECAUTIONS FOR USE
Administration of Propofol 1% MCT Fresenius by a Target
Controlled Infusion system is restricted to induction and
maintenance of general anaesthesia in adults. It is not
recommended for use in ICU sedation or sedation for surgical
and diagnostic procedures.
Delayed epileptiform attacks may occur even in non-epileptic
patients, the delay periods ranging from a few hours to several
days.
Cardiac,
circulatory
or
pulmonary
insufficiency
and
hypovolaemia should be compensated before administration
of propofol.
Propofol should not be administered in patients with advanced
cardiac failure_ _or other severe myocardial disease except with
extreme caution and intensive monitoring.
Due to a higher dosage in patients with severe overweight the
risk of haemodynamic effects on the cardiovascular system
should be taken into consideration.
Before
anaesthesia
of
an
epileptic
patient,
it
should
be
checked
that
the
patient
has
received
the
antiepileptic
treatment.
_Patients with a high intracranial pressure _
Special care should be recognised in patients with a high
intracranial pressure and a low mean arterial pressure as
there is a risk of a significant decrease of the intracerebral
perfusion pressure.
Due to the limited data available, the use of target controlle

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propofol 1% MCT Fresenius
2.
QUALITIATIVE AND QUANTITATIVE COPOSITION
Each ml emulsion contains 10 mg propofol.
Each 20 ml ampoule contains 200 mg propofol.
Each 20 ml vial contains 200 mg propofol.
Each 50 ml vial contains 500 mg propofol.
Each 100 ml vial contains 1000 mg propofol.
Excipients with known effect:
soya-bean oil
Sodium
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection or infusion.
Propofol 1% MCT Freseniusis a white, oil-in-water emulsion for
intravenous
administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Propofol 1% MCT Fresenius is a short-acting intravenous general
anaesthetic for
- induction and maintenance of general anaesthesia in adults and
children > 1
month
- sedation for diagnostic and surgical procedures, alone or in
combination with
local or regional anaesthesia in adults and children > 1 month
- sedation of ventilated patients > 16 years of age in the intensive
care unit
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Propofol 1% MCT Fresenius must only be given in hospitals or
adequately
equipped day therapy units by physicians trained in anaesthesia or in
the care of
patients in intensive care.
Circulatory and respiratory functions should be constantly monitored
(e.g. ECG,
pulse oxymetry) and facilities for maintenance of patient airways,
artificial
ventilation, and other resuscitation facilities should be immediately
available at all
times.
For sedation during surgical and diagnostic procedures Propofol 1% MCT
Fresenius should not be administered by the same person conducting the
surgical
or diagnostic procedure.
The dose of Propofol 1% MCT Fresenius should be individualised based
on the
response of the patient and premedications used.
Supplementary analgesic agents are generally required in addition to
Propofol 1%
MCT Fresenius
POSOLOGY
GENERAL ANAESTHESIA IN ADULTS
Induction of anaesthesia:
For induction of anaesthesia Propofol 1% MCT Fresenius should be
titr