Country: Israel
Language: English
Source: Ministry of Health
PROPOFOL
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
N01AX10
EMULSION FOR INJECTION OR INFUSION
PROPOFOL 10 MG/ML
I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
PROPOFOL
PROPOFOL
Propofol-Lipuro 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.
2013-03-31
אפורל ןולעב )תוחיטב עדימ( הרמחה לע העדוה ןכדועמ( .102.50 ) :ךיראת _13/03/17_ םושירה רפסמו תילגנאב רישכת םש : 01 - 21603 - 70 - 001030 - 21603 - 70 - 030 PROPOFOL LIPURO 1% םושירה לעב םש : LAPIDOT MEDICAL IMPORT AND MARKETING LTD ! דבלב תורמחהה טרפמ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD AND DURATION OF ADMINISTRATION _ ● _Method of administration _ Intravenous use Propofol-Lipuro 1% is administered intravenously by injection or continuous infusion either undiluted or diluted with 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution as well as in a 0.18 % w/v sodium chloride and 4 % w/v glucose (see also section 6.6). Containers should be shaken before use. Before use, the neck of the ampoule or the surface of the rubber stopper of the vial should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded. Infusion of undiluted Propofol-Lipuro 1% When administering Propofol-Lipuro 1% by continuous infusion, it is recommended that burettes, drop counters, syringe pumps or volumetric infusion pumps, should always be used to control the infusion rates. _METHOD AND DURATION OF ADMINISTRATION _ ● _Method of administration _ Intravenous use Propofol-Lipuro 1% is administered intravenously by injection or continuous infusion either undiluted or diluted with 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution as well as in a 0.18 % w/v sodium chloride and 4 % w/v glucose (see also section 6.6). Containers should be shaken before use. Before use, the neck of the ampoule or the surface of the rubber stopper of the vial should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded. Propofol-Lipuro 10 mg/ml contains no antimicrobial preservatives and supports growth of microorganisms. Therefore, Propofol-Lipuro 10 mg/ Read the complete document
The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in February 2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propofol-Lipuro 1% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Propofol-Lipuro 1 % contains _ _ _ _ _Excipients with known effect: _ 1 ml of emulsion for injection or infusion contains Soya-bean oil, refined 50 mg Sodium oleate 0.03 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 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 GENERAL INSTRUCTIONS Propofol-Lipuro 1% must only be given in hospitals or adequately equipped day therapy units by phy- sicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse-oxymeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should be immediately avail- able at all times. For sedation during surgical or diagnostic procedures Propofol-Lipuro 1% should not be given by the same person that carries out the surgical or diagnostic procedure. Supplementary analgesic medicinal products are generally required in addition to Propofol-Lipuro 1% per 1 ml per 20 ml ampoule per 50 ml vial per 100 ml vial Propofol 10 mg 200 mg 500 mg 1000 mg _ _ _POSOLOGY _ Propofol-Lipuro 1% is given intravenously. The dosage is adjusted individually according to the pa- tient’s response. ● _General anaesthesia in adults _ Induction o Read the complete document