Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
dexmedetomidine hydrochloride, Quantity: 236 microgram (Equivalent: dexmedetomidine, Qty 200 microgram)
Teva Pharma Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: sodium chloride; water for injections
Intravenous Infusion
25 vials, 5 vials
(S4) Prescription Only Medicine
ICU Sedation,For sedation of initially intubated patients during treatment in an intensive care setting.,The use of dexmedetomidine 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.
Visual Identification: Clear, colourless solution in 3 mL glass vials with grey teflon coated chlorobutyl rubber stoppers and Al caps fitted with green-blue flip off cover.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-10-23
DEXMEDETOMIDINE- TEVA ® _Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dexmedetomidine. 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 Dexmedetomidine 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. You may need to read it again. WHAT DEXMEDETOMIDINE IS USED FOR _INTENSIVE CARE SEDATION_ Dexmedetomidine 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_ Dexmedetomidine 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. Dexmedetomidine is only available with a doctor's prescription. BEFORE YOU ARE GIVEN DEXMEDETOMIDINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DEXMEDETOMIDINE 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 TAKE THIS MEDICINE IF YOU ARE PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT BRE Læs hele dokumentet
DEXMEDETOMIDINE-TEVA ® 200 µg/2 mL concentrated injection Page 1 of 22 Teva Pharma Australia Pty Ltd Version 2.0 2019-04-18 AUSTRALIAN PI – DEXMEDETOMIDINE-TEVA ® (DEXMEDETOMIDINE HYDROCHLORIDE) CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Dexmedetomidine hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dexmedetomidine-Teva is a sterile, non-pyrogenic solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is a white or almost white powder, freely soluble in water and its pKa is 7.1. The partition coefficient in octanol: water at pH 7.84 is 2.89. Each 2 mL of Dexmedetomidine-Teva 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 Dexmedetomidine-Teva dexmedetomidine (as hydrochloride) concentrated injection 200 micrograms/2 mL is supplied as clear, colourless, isotonic solution with a pH of 4.5 to 7.0. Dexmedetomidine-Teva is presented in a 3 mL vial, and must be diluted prior to use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ICU Sedation For sedation of initially intubated patients during treatment in an intensive care setting. The use of dexmedetomidine 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. Contains no antimicrobial agent. For single use in one patient only. Discard any residue after use. Clinically significant events of bradycardia and sinus arrest have been associated with dexmedetomidine hydrochloride administration in young, healthy volunteers wi Læs hele dokumentet