Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
dexmedetomidine hydrochloride, Quantity: 236 microgram (Equivalent: dexmedetomidine, Qty 200 microgram)
Fresenius Kabi Australia Pty Ltd
Injection, concentrated
Excipient Ingredients: sodium chloride; water for injections
Intravenous Infusion
25, 10, 5
(S4) Prescription Only Medicine
Intensive Care Unit (ICU) Sedation,For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Kabi 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: The compound is a clear, colourless isotonic solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-11-23
Dexmedetomidine Kabi 1 DEXMEDETOMIDINE KABI CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING GIVEN DEXMEDETOMIDINE KABI? Dexmedetomidine Kabi contains the active ingredient dexmedetomidine hydrochloride. Dexmedetomidine Kabi is used for: Intensive Care Sedation Dexmedetomidine Kabi 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 Kabi 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. For more information, see Section 1. Why am I being given Dexmedetomidine Kabi? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN DEXMEDETOMIDINE KABI? Do not use if you have ever had an allergic reaction to dexmedetomidine hydrochloride or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I am given Dexmedetomidine Kabi? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Dexmedetomidine Kabi and affect how it works. These include: • medicines used to produce calmness or to help you sleep • strong pain relievers A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS DEXMEDETOMIDINE KABI GIVEN? Dexmedetomidine Kabi is diluted with another liquid in an IV bag and given as a ‘drip’ through a vein (intravenous infusion) by a doctor or nurse. Your doctor will decide how fast the infusion will be given to keep you at the right depth of sleep or calmness, and how l Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – DEXMEDETOMIDINE KABI (DEXMEDETOMIDINE (AS HYDROCHLORIDE)) CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Dexmedetomidine (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 200 microgram/ 2 mL: Each 2 mL vial of DEXMEDETOMIDINE KABI contains 236 micrograms of dexmedetomidine hydrochloride (equivalent to 200 micrograms dexmedetomidine base). 400 microgram/ 4 mL: Each 4 mL vial of DEXMEDETOMIDINE KABI contains 472 micrograms of dexmedetomidine hydrochloride (equivalent to 400 micrograms dexmedetomidine base). 1000 microgram/ 10 mL: Each 10 mL vial of DEXMEDETOMIDINE KABI contains 1180 micrograms of dexmedetomidine hydrochloride (equivalent to 1000 micrograms dexmedetomidine base). For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) concentrated injection is a sterile, non-pyrogenic solution suitable for intravenous (IV) infusion. DEXMEDETOMIDINE KABI concentrated injection is supplied as a clear, colourless isotonic solution with a pH of 4.5 – 7.0. It is presented in 2 mL, 4 mL or 10 mL vials, 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 DEXMEDETOMIDINE KABI 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 administration in young, healthy volunteers with high vagal tone or with different routes of a Read the complete document