Propofol-Lipuro 10 mg/ml emulsion for injection or infusion (10ml ampoule)

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

PROPOFOL

Prieinama:

B Braun Melsungen AG Carl-Braun-Strasse 1, D34212 Melsungen, Germany

ATC kodas:

N01AX10

INN (Tarptautinis Pavadinimas):

PROPOFOL 10 mg/ml

Vaisto forma:

EMULSION FOR INFUSION OR INJECTION

Sudėtis:

PROPOFOL 10 mg/ml

Recepto tipas:

POM

Gydymo sritis:

ANESTHETICS

Autorizacija statusas:

Authorised

Leidimo data:

2017-03-24

Pakuotės lapelis

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL-LIPURO 10 MG/ML EMULSION FOR INJECTION OR INFUSION
Propofol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
●
Keep this leaflet. You may need to read it again.
●
If you have any further questions, ask your doctor or pharmacist.
●
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Propofol-Lipuro is and what it is used for
2.
What you need to know before you use Propofol-Lipuro
3.
How to use Propofol-Lipuro
4.
Possible side effects
5.
How to store Propofol-Lipuro
6.
Contents of the pack and other information
1.
WHAT PROPOFOL-LIPURO IS AND WHAT IT IS USED FOR
Propofol-Lipuro belongs to a group of medicines called general
anaesthetics. General anaesthetics are used to
cause unconsciousness (sleep) so that surgical operations or other
procedures can be performed. They can also
be used to sedate you (so that you are sleepy but not completely
asleep).
Propofol Lipuro is used to:
●
induce and maintain general anaesthesia in adults and children > 1
month
●
sedate patients > 16 years of age receiving artificial respiration in
intensive care
●
sedate adults and children > 1 month during diagnostic and surgical
procedures, alone or in combination
with local or regional anaesthesia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROPOFOL-LIPURO
DO NOT USE PROPOFOL-LIPURO:
●
if you are allergic to propofol, soya, peanut or any of the other
ingredients of this medicine (listed in
section 6).
It must not be used in patients of 16 years of age or younger for
sedation during intensive care. Safety and
efficacy for these age groups have not been demonstrated.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before receiving Propofol.
Special care has to be taken
●
if you have serious head injuries,
●
if you have a mitochondrial disease,
Page 2 of 7

Prekės savybės

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propofol-Lipuro 10 mg/ml emulsion for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propofol-Lipuro 10 mg/ml contains
per 1 ml
per 10 ml ampoule
per 20 ml ampoule
or vial
per 50 ml vial
per 100 ml vial
Propofol
10 mg
100 mg
200 mg
500 mg
1000 mg
Excipients with known effect
1 ml emulsion for injection or infusion contains
Soya-bean oil, refined
50 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection or infusion
White milky oil-in-water emulsion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Propofol-Lipuro 10 mg/ml 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
GENERAL INSTRUCTIONS
Propofol-Lipuro 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 oximeter) and facilities for
maintenance of patent airways, artificial
ventilation, and other resuscitation facilities should be immediately
available at all times. For sedation during
surgical or diagnostic procedures Propofol-Lipuro should not be given
by the same person that carries out the
surgical or diagnostic procedure.
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Supplementary analgesic medicinal products are generally required in
addition to Propofol-Lipuro.
_POSOLOGY _
Propofol-Lipuro is given intravenously. The dosage is adjusted
individually according to the patient’s
response.
●
_General anaesthesia in adults _
Induction of anaesthesia:
For induction of anaesthesia Propofol-Lipuro should be ti