Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
dexmedetomidine hydrochloride
Interpharma Pty Ltd
dexmedetomidine hydrochloride
Registered
InterPharma Pty Ltd Version 2.1 1 DEXMEDETOMIDINE EVER PHARMA_ _ DEXMEDETOMIDINE (DEX-MED-E-TOH-MED-EEN) (AS HYDROCHLORIDE)_ _ CONCENTRATED INJECTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DEXMEDETOMIDINE EVER PHARMA. 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 EVER PHARMA 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 IS DEXMEDETOMIDINE EVER PHARMA USED FOR _INTENSIVE CARE SEDATION _ DEXMEDETOMIDINE EVER PHARMA 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 EVER PHARMA 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 EVER PHARMA is only available with a doctor's prescription. BEFORE YOU ARE GIVEN DEXMEDETOMIDINE EVER PHARMA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DEXMEDETOMIDINE EVER PHARMA 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 t Aqra d-dokument sħiħ
1 Version 3.6 AUSTRALIAN PRODUCT INFORMATION – DEXMEDETOMIDINE EVER PHARMA DEXMEDETOMIDINE (AS HYDROCHLORIDE) 100 MICROGRAM/ML CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Dexmedetomidine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. DEXMEDETOMIDINE EVER PHARMA is a clear, colourless, sterile and isotonic concentrated solution with a pH of 4.5 to 7.0. DEXMEDETOMIDINE EVER PHARMA is a concentrated sterile, non-pyrogenic solution suitable for intravenous infusion after dilution. Each 1 mL of DEXMEDETOMIDINE EVER PHARMA contains 118 microgram of dexmedetomidine hydrochloride (equivalent to 100 microgram dexmedetomidine base). The solution is preservative- free and contains no additives or chemical stabilisers. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM DEXMEDETOMIDINE EVER PHARMA is presented in a 2 mL, 4 mL and 10 mL vials or 2 mL, 4 mL and 10 mL ampoules, 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 EVER PHARMA 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 tone or with different routes of administration including rapid intravenous or bol Aqra d-dokument sħiħ