국가: 이스라엘
언어: 영어
출처: 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% MCT 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
2016-06-23
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_ 73.3.6 _םושיר רפסמו תילגנאב רישכת םש_ _:_ _ _ Propofol 1% MCT Fresenius 156-46-34397-00, 156-46-34397-01, 156-46-34397-02 םושירה לעב םש : Cure Medical & Technical Supply רפל דעוימ הז ספוט ה טו דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 4. CLINICAL PARTICULARS 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Administration of Propofol 1% MCT Fresenius by a Target Controlled Infusion system is restricted to induction and maintenance of general anaesthesia in adults. It is not recommended for use in ICU sedation or sedation for surgical and diagnostic procedures. Delayed epileptiform attacks may occur even in non-epileptic patients, the delay periods 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. 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. Due to the limited data available, the use of target controlle 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propofol 1% MCT Fresenius 2. QUALITIATIVE AND QUANTITATIVE COPOSITION Each ml emulsion contains 10 mg propofol. Each 20 ml ampoule contains 200 mg propofol. Each 20 ml vial contains 200 mg propofol. Each 50 ml vial contains 500 mg propofol. Each 100 ml vial contains 1000 mg propofol. Excipients with known effect: soya-bean oil Sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection or infusion. Propofol 1% MCT Freseniusis a white, oil-in-water emulsion for intravenous administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propofol 1% MCT 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% MCT 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. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse oxymetry) 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% MCT Fresenius should not be administered by the same person conducting the surgical or diagnostic procedure. The dose of Propofol 1% MCT Fresenius should be individualised based on the response of the patient and premedications used. Supplementary analgesic agents are generally required in addition to Propofol 1% MCT Fresenius POSOLOGY GENERAL ANAESTHESIA IN ADULTS Induction of anaesthesia: For induction of anaesthesia Propofol 1% MCT Fresenius should be titr 전체 문서 읽기