Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
PROPOFOL
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom
N01AX10
PROPOFOL 1000 mg
EMULSION FOR INFUSION OR INJECTION
PROPOFOL 1000 mg
POM
ANESTHETICS
Withdrawn
2014-09-22
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPOFOL 10 MG/ML (1%) EMULSION FOR INJECTION/INFUSION propofol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Propofol 10 mg/ml (1%) is and what it is used for 2. What you need to know before you are given Propofol 10 mg/ml (1%) 3. How you will be given Propofol 10 mg/ml (1%) 4. Possible side effects 5. How to store Propofol 10 mg/ml (1%) 6. Contents of the pack and other information 1. WHAT PROPOFOL 10 MG/ML (1%) IS AND WHAT IT IS USED FOR Propofol 10 mg/ml (1%) contains the active substance propofol. It 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 10 mg/ml (1%) will be given to you as an injection by a doctor. IN ADULTS AND CHILDREN OVER 1 MONTH OF AGE IT IS USED TO: - Help put you to sleep BEFORE an operation or other procedure. - Keep you asleep DURING an operation or other procedure. - Sedate you during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia. IN PEOPLE OVER 16 YEARS OF AGE IT IS ALSO USED TO: - Sedate you when receiving artificial respiration in an Intensive Care Unit (ICU). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PROPOFOL 10 MG/ML (1%) YOU WILL NOT BE GIVEN PROPOFOL 10 MG/ML (1%) IF: - you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6). - you are allergic to peanut or soya. This is because Propofol 10 mg/ml (1%) contains soya oil. - you are 16 years of Leggi il documento completo
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Propofol 10 mg/ml (1%) Emulsion for Injection /Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of emulsion for injection/infusion contains 10 mg of propofol. Each 20 ml vial contains 200 mg of propofol. Each 50 ml vial contains 500 mg of propofol. Each 100 ml vial contains 1000 mg of propofol. Excipient with known effect Each ml of emulsion for injection/infusion contains 100 mg of soya-bean oil and approximately 0.016 mmol (0.4 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for Injection /Infusion. White or slightly off- white emulsion, having a milk-like appearance with no evidence of oiling-out of the emulsion and free from visible particulate. pH: 6.0 - 8.5 Osmolality: 300-330 mOsm/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Propofol 10mg/ml (1%) is a short-acting intravenous general anaesthetic for: Induction and maintenance of general anaesthesia in adults and children over 1 month. Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children over 1 month. Sedation of ventilated patients over 16 years of age in the intensive care unit. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lower doses of propofol may be necessary when general anaesthesia is used in addition to regional anaesthesia. Posology ADULTS Page 2 of 14 _Induction of General Anaesthesia _ In un-premedicated and premedicated patients, it is recommended that propofol should be titrated (approximately 4 ml [40 mg] every 10 seconds in an average healthy adult by bolus injection or infusion) against the response of the patient until the clinical signs show the onset of anaesthesia. Most adult patients aged less than 55 years are likely to require 1.5–2.5 mg/kg of propofol. The total dose required can be reduced by lower rates of administration (2–5 ml/min [20–50 mg/min]). Over this age, the requirement will gener Leggi il documento completo