Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PROPOFOL
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N01AX10
PROPOFOL
Emulsie voor infusie, Emulsie voor injectie
EI FOSFATIDEN, GEZUIVERD ; GLYCEROL (E 422) ; NATRIUMHYDROXIDE (E 524) ; SOJAOLIE, GEZUIVERD ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,
Intraveneus gebruik
Propofol
Hulpstoffen: EI FOSFATIDEN, GEZUIVERD; GLYCEROL (E 422); NATRIUMHYDROXIDE (E 524); SOJAOLIE, GEZUIVERD; STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;
2012-07-06
Sandoz B.V. Page 1/11 Propofol Sandoz ® 10/20 mg/ml, emulsie voor injectie of infusie RVG 109287 - 109292 1313-V8 1.3.1.3 Bijsluiter Februari 2021 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPOFOL SANDOZ ® 10 MG/ML, EMULSIE VOOR INJECTIE OF INFUSIE PROPOFOL SANDOZ ® 20 MG/ML, EMULSIE VOOR INJECTIE OF INFUSIE 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. - 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 [nationally completed name] is and what it is used for 2. What you need to know before you use [nationally completed name] 3. How to use [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [nationally completed name] 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). [nationally completed name] will be given to you as an injection by a doctor. [nationally completed name 10 mg/ml emulsion for injection/infusion] 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 [nationally completed name 20 mg/ml emulsion for injection/infusion] is used to: - Induce and maintain general anaesthesia in adults and children > 3 years of age - Sedat Perskaitykite visą dokumentą
Sandoz B.V. Page 1/19 Propofol Sandoz 10/20 mg/ml, emulsie voor injectie/infusie RVG 109287-92 1311-V11 1.3.1.1 Samenvatting van de Productkenmerken Februari 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propofol Sandoz 10 mg/ml, emulsie voor injectie of infusie Propofol Sandoz 20 mg/ml, emulsie voor injectie of infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [nationally completed name] 10 mg/ml emulsion for injection/infusion Each ml emulsion for injection/infusion contains 10 mg of propofol. Each 20 ml ampoule/vial contains 200 mg of propofol. Each 50 ml vial contains 500 mg of propofol. Each 100 ml vial contains 1000 mg of propofol. [nationally completed name] 20 mg/ml emulsion for injection/infusion Each ml emulsion for injection/infusion contains 20 mg of propofol. Each 50 ml vial contains 1000 mg of propofol. Excipients with known effect: [nationally completed name] 10 mg/ml emulsion for injection/infusion Each ml emulsion for injection/infusion contains 100 mg of soya-bean oil, refined. Each 20 ml ampoule/vial contains 2 g of soya-bean oil, refined. Each 50 ml vial contains 5 g of soya-bean oil, refined. Each 100 ml vial contains 10 g of soya-bean oil, refined. [nationally completed name] 20 mg/ml emulsion for injection/infusion Each ml emulsion for injection/infusion contains 100 mg of soya-bean oil, refined. Each 50 ml vial contains 5 g of soya-bean oil, refined. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection/infusion. White or almost white, homogeneous aqueous isotonic oil-in-water emulsion, practically free of extraneous particulate contamination and large oil droplets. Slight creaming may be visible on prolonged standing. Osmolality: 285 - 320 mOsm/Kg pH is in the range of 6.0 – 8.5. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS [nationally completed name 10 mg/ml emulsion for injection/infusion] Sandoz B.V. Page 2/19 Propofol Sandoz 10/20 mg/ml, emulsie voor injectie/infusie RVG 109287-92 1311-V11 1.3.1.1 Samenva Perskaitykite visą dokumentą