PROPOFOL 2 % MCT FRESENIUS

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

PROPOFOL

Disponible des:

CURE MEDICAL & TECHNICAL SUPPLY

Codi ATC:

N01AX10

formulario farmacéutico:

EMULSION FOR INJECTION OR INFUSION

Composición:

PROPOFOL 2 G / 100 ML

Vía de administración:

I.V

tipo de receta:

Required

Fabricat per:

FRESENIUS KABI DEUTSCHLAND GMBH, GERMANY

Área terapéutica:

PROPOFOL

indicaciones terapéuticas:

Propofol 2% MCT Fresenius is a short-acting intravenous general anaesthetic for-induction and maintenance of general anaesthesia in adults and children > 3 years-sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 3 years-sedation of ventilated patients > 16 years of age in the intensive care unit

Data d'autorització:

2016-06-23

Informació per a l'usuari

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(
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)
)
_ _
_:ךיראת_
33.3.31
_םושיר רפסמו תילגנאב רישכת םש_
_:_
_ _
Propofol 2% MCT Fresenius
156-47-34414-00, 156-47-34414-01 156-47-34414-02
םושירה לעב םש
:
Cure Medical & Technical Supply
ל דעוימ הז ספוט
ה טורפ
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 2% 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.
4.5 INTERACTION WITH
OTHER MEDICINAL
PRODUCTS AND OTHER
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.
Pain o

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propofol 2% MCT Fresenius
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml emulsion contains 20 mg propofol.
Each 50 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 2% MCT Fresenius is a white, oil-in-water emulsion for
intravenous administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Propofol 2% MCT Fresenius is a short-acting intravenous general
anaesthetic
for
-induction and maintenance of general anaesthesia in adults and
children > 3
years
-sedation for diagnostic and surgical procedures, alone or in
combination with
local or regional anaesthesia in adults and children > 3 years
-sedation of ventilated patients > 16 years of age in the intensive
care unit
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Propofol 2% 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 2% MCT
Fresenius should not be administered by the same person conducting the
surgical or diagnostic procedure.
The dose of Propofol 2% 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
2% MCT Fresenius.
POSOLOGY
GENERAL ANAESTHESIA IN ADULTS
Induction of anaesthesia:
For induction of anaesthesia Propofol 2% MCT Fresenius should be
titrated
(approximately 20 - 40 mg propofol every 10 seconds) against the
response
of the patient until clinical signs show the onset o