Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
propofol
Pfizer Australia Pty Ltd
Propofol
Registered
Hospira TM Propofol Injection CMI Page 1 HOSPIRA™ PROPOFOL INJECTION Propofol _(pro-po-fole)_ CONSUMER MEDICINE INFORMATION _Date of dispensing_ _Consumer name_ _pharmacy name_ _Consumer address_ _pharmacy address_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hospira Propofol Injection. It does not contain all the available information. It does not take the place of talking to your doctor or anaesthetist. All medicines have risks and benefits. Your doctor or anaesthetist has weighed the risks of you being given propofol against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR ANAESTHETIST. KEEP THIS LEAFLET. You may need to read it again. WHAT HOSPIRA PROPOFOL INJECTION IS USED FOR _GENERAL ANAESTHESIA_ Hospira Propofol Injection is used as a short-acting general anaesthetic in adults, and children aged 1 month or older. A general anaesthetic is a medicine which produces general anaesthesia. This is the condition of heavy sleep needed during surgery. Propofol is short-acting, which means that patients go to sleep quickly, usually within 30 seconds of receiving propofol, but then wake up quickly as it wears off. Propofol can be used for very short operations when only one injection is needed. Propofol can be used throughout longer operations if more is given as repeated doses. Propofol can also be used to start off anaesthesia (induction anaesthesia). This means the anaesthetist may change over to another anaesthetic once sleep is induced. _SEDATION_ Propofol can be given to adults if they need to be sedated (calm) or sleepy, but do not need the heavy sleep of anaesthesia. This type of sedation may be required during certain tests or procedures. Propofol can also be used in intensive care wards for adults who are being ventilated (on a breathing machine) to keep them sedated (calm). ASK YOUR DOCTOR OR ANAESTHETIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor or anaest Read the complete document
Version 2.0 Supersedes: Version 1.0 Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION – HOSPIRA™ PROPOFOL INJECTION (PROPOFOL) 1. NAME OF THE MEDICINE Propofol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hospira™ Propofol Injection contains 10 mg propofol per 1 mL. EXCIPIENT(S) WITH KNOWN EFFECT - Egg lecithin - Soya Oil For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Hospira™ Propofol Injection is a white to slight off-white, oil in water emulsion of pH 6.0 to 8.5 for intravenous injection._ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS Hospira™ Propofol Injection is a short-acting intravenous anaesthetic agent suitable for induction of general anaesthesia in adults and children aged one month and older. MAINTENANCE OF GENERAL ANAESTHESIA IN CHILDREN AND ADULTS Hospira™ Propofol Injection is a short-acting intravenous anaesthetic agent suitable for maintenance of general anaesthesia in adults and children aged 3 years and older. Hospira™ Propofol Injection may also be used for the maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided. Hospira™ Propofol Injection has no analgesic properties. SEDATION DURING INTENSIVE CARE IN ADULTS Version 2.0 Supersedes: Version 1.0 Page 2 of 18 Hospira™ Propofol Injection may also be used in adults for sedation of ventilated patients receiving intensive care. CONSCIOUS SEDATION FOR SURGICAL AND DIAGNOSTIC PROCEDURES IN ADULTS Hospira™ Propofol Injection may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures. 4.2 DOSE AND METHOD OF ADMINISTRATION _ASEPTIC TECHNIQUE (_see also_ _SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE_) _ Strict aseptic technique must always be maintained during handling. Hospira™ Propofol Injection is for single use in one patient only. Hospira™ Propofol Injection Read the complete document