DIPROFOL 1 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROPOFOL

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

N01AX10

Pharmaceutical form:

EMULSION FOR INJECTION OR INFUSION

Composition:

PROPOFOL 10 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SYNTHON HISPANIA S.L., SPAIN

Therapeutic group:

PROPOFOL

Therapeutic area:

PROPOFOL

Therapeutic indications:

Diprofol 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:

2020-01-31

Patient Information leaflet

ורת
לנוישנרטניא
מ"עב
רוטיקה
14
,
.ד.ת
10347
הפיח ץרפמ ,
2624761
:לט
04-8475700
:סקפ
04-8727165
רבמבונ
2018
ה/דבכנ ה/אפור
ת/דבכנ ת/חקור יכ םכעידוהל תשקבמ ורת תרבח
אפורל םינולעה לש
רישכתה
םי DIPROFOL 1% AMP AND VIALS AND
DIPROFOL 2% VIALS
כדוע
ונ
.
םהב םיפיעסה קר םיניוצמ וז העדוהב
םייתוהמ םייוניש ושענ
אפורל םינולעב
עבצב ונמוס תופסות .
םודא
,
לוחכ עבצב ונמוס תוקיחמה
ב
הקיחמ וק
.
ולעה
ן
כדועמה
ן
מוסרפ ךרוצל תואירבה דרשמל חלשנ
ו
:תואירבה דרשמ רתאבש תופורתה רגאמב
www.health.gov.il
לבקל ןתינו
ו
:םושירה לעבל היינפ ידי לע ספדומ
ורת
לנוישנרטניא
רוטיקה בוחר ,מ"עב
14
ד.ת ,
10347
הפיח ץרפמ
2624761
.
,הכרבב
ןמדלוג הנירמ
הנוממ תחקור
DIPROFOL 1%, AMPOULES AND VIALS
ליעפ ביכרמ
:
Propofol 10mg/ml
היוותהה :רישכתל תרשואמה
Diprofol 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.
םינוכדע
ל ןולעב
אפור
:
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The benefits and risks of the proposed procedure should be considered
prior to proceeding with
repeated or prolonged use (>3 hours) of propofol in young children (<
3 years) and in pregnant
women as there have been reports of neurotoxicity in preclinical
studies, see Section 5.3.
_ _
5.3
_ _
PRECLINICAL SAFETY DATA
_ _
Published studies in animals demonstrate that the use of anaesthetic
agents during the period of
rapid brain growth or synaptogenesis res

Summary of Product characteristics

DIPROFOL
®
1%
Propofol 1%
For IV Administration
1. NAME OF THE MEDICINAL PRODUCT
Diprofol 1% (propofol 10 mg/ml).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Diprofol 10 mg/ml, emulsion for injection or infusion,
contains 10 mg/ml propofol.
The solution contains as excipients soybean oil and
egg lecithin, which are also used in intravenous
feeding. It contains no preservatives.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection or infusion.
Diprofol is a white, aqueous isotonic oil-in-water
emulsion
for
intravenous
administration.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diprofol 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Propofol
must
be
used
only
in
well
equipped
hospitals or medical centers by doctors trained
in anaesthesia or the treatment of intensive care
patients. Continual monitoring of the circulation
and
the
respiration
(for
example,
ECG
pulse
oxymeter) is necessary. Provisions for prevention
of
airway
obstruction,
artificial
respiration
and
other resuscitation provisions must be immediately
available at all times. As regards sedation during
surgical or diagnostic operations propofol must not
be administered by the same person who performs
the surgical or diagnostic operation.
Additional
analgesics
are
generally
necessary
in
combination
with
propofol.
4.2.1 INDUCTION OF GENERAL ANAESTHESIA
ADULTS
In unpremedicated and premedicated patients, it is
recommended that Diprofol 1% should be titrated
(approximately 4 ml [40 mg] every 10 seconds
in an average healthy adult by bolus injection or
infusion) against the response of the patient until
the clinical signs show the onset of