Propofol 10mg/ml (1%) Emulsion for Injection / Infusion

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

PROPOFOL

Prieinama:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, 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:

Withdrawn

Leidimo data:

2015-07-02

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROPOFOL 10 MG/ML (1%) EMULSION FOR INJECTION/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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Propofol is and what it is used for
2.
What you need to know before you receive Propofol
3.
How to use Propofol
4.
Possible side effects
5.
How to store Propofol
6.
Contents of the pack and other
information
1.
WHAT PROPOFOL IS AND WHAT IT IS USED FOR
Propofol 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 will be given to you as an injection by a doctor.
Propofol 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 RECEIVE PROPOFOL
DO NOT USE PROPOFOL
-
in patients allergic (hypersensitive) to propofol or any of the other
ingredients of
Propofol
-
in patients allergic to peanut or soya. This is because Propofol
contains soya-bean oil.
-
in patients of 16 years of age or younger for sedation in intensive
care.
WARNINGS AND PRECAUTIONS
The use of Propofol is not recommended in newborn infants.
-

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml emulsion for injection/infusion contains 10 mg propofol.
Each 20 ml ampoule/vial contains 200 mg propofol.
Each 50 ml vial contains 500 mg propofol.
Each 100 ml vial contains 1000 mg propofol.
Excipients:
1 ml emulsion for injection/infusion contains 100 mg soya-bean oil,
refined and 0.0018 mmol
(0.04 mg) sodium.
Each 20 ml ampoule/vial contains 2 g soya-bean oil, refined and 0.036
mmol (0.8 mg)
sodium.
Each 50 ml vial contains 5 g soya-bean oil, refined and 0.09 mmol (2
mg) sodium.
Each 100 ml vial contains 10 g soya-bean oil, refined and 0.18 mmol (4
mg) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Emulsion for injection/infusion.
White aqueous isotonic oil-in-water emulsion.
Osmolality: 285 - 320 mOsm/Kg.
pH is in the range of 6.0 – 8.5.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Propofol 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 must only be administered 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 a patient airways,
artificial ventilation, and other
resuscitation facilities should be immediately available at all times.
For sedation during surgical and diagnostic procedures Propofol should
not be administered
by the same person conducting the surgical or diagnostic procedure.
Propofol has no analgesic properties and t