Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
dexmedetomidine hydrochloride, Quantity: 236 microgram (Equivalent: dexmedetomidine, Qty 200 microgram)
Pfizer Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: water for injections; sodium chloride
Intravenous
5 x 2mL vials, 25 x 2mL vials
(S4) Prescription Only Medicine
Intensive Care Unit (ICU) Sedation: For sedation of initially intubated adult patients during treatment in an intensive care setting. The use of PRECEDEX by continuous infusion in these patients should not exceed 24 hours.,Procedural Sedation: For sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2002-04-04
PRECEDEX® PRECEDEX® READY TO USE _Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PRECEDEX and PRECEDEX READY TO USE (collectively referred to as PRECEDEX in this leaflet unless stated otherwise). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PRECEDEX against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PRECEDEX IS USED FOR _INTENSIVE CARE SEDATION_ PRECEDEX can be used as a sedative (calming agent) if adults need to be calm or sleepy in the Intensive Care Unit whilst they are being ventilated (on a breathing machine). It may be given as an infusion up to 24 hours. _PROCEDURAL SEDATION_ PRECEDEX can be given to adults prior to an operation if they are not on a ventilator (breathing machine) if it is required for the procedure or surgery that they be sleepy and calm. This medicine belongs to a group of medicines called alpha-2-receptor agonists. This medicine works by its actions on brain chemicals. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. PRECEDEX is available only with a doctor's prescription. BEFORE YOU ARE GIVEN PRECEDEX _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE PRECEDEX IF YOU HAVE AN ALLERGY TO: • any medicine containing dexmedetomidine hydrochloride • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT GIVE THIS MEDICINE TO A CHILD UNDER THE A Прочитајте комплетан документ
______________________________________________________________________________________________________________ Version: pfppreci10921 Supercedes: pfppreci10421 1 AUSTRALIAN PRODUCT INFORMATION – PRECEDEX ® (DEXMEDETOMIDINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Dexmedetomidine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PRECEDEX concentrated injection is a sterile, non-pyrogenic solution suitable for intravenous (IV) infusion. Each 2 mL of PRECEDEX contains 236 micrograms of dexmedetomidine HCl (equivalent to 200 micrograms dexmedetomidine base) and 18 mg of sodium chloride in water for injections. The solution is preservative-free and contains no additives or chemical stabilisers. 3. PHARMACEUTICAL FORM PRECEDEX (dexmedetomidine hydrochloride) 100 micrograms/mL is supplied as clear, colourless, isotonic solutions with a pH of 4.5 to 7.0. PRECEDEX is presented in 2 mL vial and must be diluted prior to use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intensive Care Unit (ICU) Sedation For sedation of initially intubated patients during treatment in an intensive care setting. The use of PRECEDEX by continuous infusion in these patients should not exceed 24 hours. Procedural Sedation For sedation of non-intubated patients prior to and/or during surgical and other procedures . 4.2 DOSE AND METHOD OF ADMINISTRATION _NOTE:_ Dexmedetomidine should be administered only by persons skilled in anaesthetics or in the management of patients in the intensive care setting. Due to the known pharmacological effects, patients should be continuously monitored. Clinically significant events of bradycardia and sinus arrest have been associated with dexmedetomidine hydrochloride administration in young, healthy volunteers with high vagal ______________________________________________________________________________________________________________ Version: pfppreci10921 Supercedes: pfppreci10421 2 tone or with different routes of administration including rapid intravenous or bolus administration of dexmedetomid Прочитајте комплетан документ