Država: Izrael
Jezik: angleščina
Source: Ministry of Health
PROPOFOL
CURE MEDICAL & TECHNICAL SUPPLY
N01AX10
EMULSION FOR INJECTION OR INFUSION
PROPOFOL 1 G / 100 ML
I.V
Required
FRESENIUS KABI DEUTSCHLAND GMBH, GERMANY
PROPOFOL
Propofol 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.
2014-05-12
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( .102.50 .102.50 .102.50 ) ) ) _ _ _:ךיראת_ .3.3.3 _םושיר רפסמו תילגנאב רישכת םש_ _:_ _ _ 1g100 ml emulsion for injection or infusion Propofol 1% Fresenius 121-62-30136-00, 121-62-30136-01, 121-62-30136-02 םושירה לעב םש : Cure Medical & Technical Supply ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 4. CLINICAL PARTICULARS 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE epileptic - Delayed epileptiform attacks may occur even in non patients, the delay period ranging from a few hours to several days. 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. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 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. Concomitant use of benzodiazepines, parasympatholytic agents or inhalational anaesthetics has been reported to prolong the anaesthesia and to reduce the respiratory rate. After additional premedication with opioids, the sedative effects of propofo Preberite celoten dokument
1 The content of this leaflet has been determined by the Israeli MOH and has been checked and approved in March 2017. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propofol 1% Fresenius _emulsion for injection or infusion _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml emulsion contains 10 mg propofol. Each 20 ml ampoule contains 200 mg propofol. Each 50 ml vial contains 500 mg propofol. Each 100 ml vial contains 1000 mg propofol. Excipients: 1 ml emulsion contains: soya-bean oil 100 mg sodium max. 0.06 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection or infusion White oil-in-water emulsion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propofol 1% Fresenius 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 1% 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. 2 Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse oximetry) 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 1% Fresenius should not be administered by the same person conducting the surgical or diagnostic procedure. The dose of Propofol 1% Fresenius emulsion should be individualised based on the response of the patient and premedications used. Supplementary analgesic agents are generally required in addition to Propofol 1% Fresenius. _ _ _ _ POSOLOGY _ _ GENERAL ANAESTHESIA IN ADULTS Induction of anaesthesia: F Preberite celoten dokument