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

Authorization date:

2014-05-12

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_
.3.3.3
_םושיר רפסמו תילגנאב רישכת םש_
_:_
_ _
1g100
ml emulsion for injection or infusion
Propofol 1% Fresenius
121-62-30136-00, 121-62-30136-01, 121-62-30136-02
םושירה לעב םש
:
Cure Medical & Technical Supply
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4. CLINICAL
PARTICULARS
4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE
epileptic
-
Delayed epileptiform attacks may occur even in non
patients, the delay period 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.
4.5 INTERACTION WITH
OTHER MEDICINAL
PRODUCTS AND OTHER
FORMS OF INTERACTION
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.
Concomitant use of benzodiazepines, parasympatholytic
agents or inhalational anaesthetics has been reported to
prolong the anaesthesia and to reduce the respiratory rate.
After additional premedication with opioids, the sedative
effects of propofo

Summary of Product characteristics

1
The content of this leaflet has been determined by the Israeli MOH and
has been checked and
approved in March 2017.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propofol 1% Fresenius
_emulsion for injection or infusion _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml emulsion contains 10 mg propofol.
Each 20 ml ampoule contains 200 mg propofol.
Each 50 ml vial contains 500 mg propofol.
Each 100 ml vial contains 1000 mg propofol.
Excipients:
1 ml emulsion contains:
soya-bean oil
100 mg
sodium
max. 0.06 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection or infusion
White oil-in-water emulsion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Propofol 1% 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% 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.
2
Circulatory
and
respiratory
functions
should
be
constantly
monitored
(e.g.
ECG,
pulse
oximetry) 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%
Fresenius should not be
administered by the same person conducting the surgical or diagnostic
procedure.
The dose of Propofol 1% Fresenius emulsion should be individualised
based on the response
of the patient and premedications used.
Supplementary analgesic agents are generally required in addition to
Propofol 1% Fresenius.
_ _
_ _
POSOLOGY
_ _
GENERAL ANAESTHESIA IN ADULTS
Induction of anaesthesia:
F