País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Dexmedetomidine hydrochloride 118 µg/mL equivalent to equivalent to 100 micrograms/mL Dexmedetomidine
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
200 mcg/2mL
Concentrate for injection
Active: Dexmedetomidine hydrochloride 118 µg/mL equivalent to equivalent to 100 micrograms/mL Dexmedetomidine Excipient: Sodium chloride Water for injection
Prescription
ICU Sedation: For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Accord 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.
Package - Contents - Shelf Life: Vial, glass, Type I glass vial closed with rubber stopper and Al seal - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)
2020-05-08
Dexmedetomidine Accord – version 2.0 1 DEXMEDETOMIDINE ACCORD 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 ACCORD? Dexmedetomidine Accord contains the active ingredient dexmedetomidine (as hydrochloride). Dexmedetomidine Accord belongs to a group of medicines called alpha-2-receptor agonists. It is 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). Dexmedetomidine Accord can be given to adults prior to an operation if they are not on a ventilator if it is required for the procedure or surgery that they be sleepy and calm. It works by its actions on brain chemicals. For more information, see Section 1. Why am I using Dexmedetomidine Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN DEXMEDETOMIDINE ACCORD? Do not use if you have ever had an allergic reaction to any medicine containing 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 Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Dexmedetomidine Accord and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW WILL I BE GIVEN DEXMEDETOMIDINE ACCORD? Dexmedetomidine Accord will be given to you by a doctor or a nurse. More instructions can be found in Section 4. How will I be given Dexmedetomidine Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN DEXMEDETOMIDINE ACCORD? THINGS YOU SHOULD DO • If you are about to have any blood tests, tell your doctor that you are being g Leer el documento completo
Page 1 of 17 NEW ZEALAND DATA SHEET DEXMEDETOMIDINE ACCORD (DEXMEDETOMIDINE) CONCENTRATE FOR INFUSION 1 PRODUCT NAME Dexmedetomidine Accord 200 micrograms/2 mL Concentrate for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in Dexmedetomidine Accord is dexmedetomidine hydrochloride. Each 1 mL of Dexmedetomidine Accord Concentrate for infusion contains 118 micrograms of dexmedetomidine hydrochloride (equivalent to 100 micrograms dexmedetomidine base) and 9 mg of sodium chloride in water for injections. The solution is preservative-free and contains no additives or chemical stabilisers. Dexmedetomidine Accord is presented in a 2 mL vial, containing 236 micrograms of dexmedetomidine hydrochloride (equivalent to 200 micrograms dexmedetomidine base), and must be diluted prior to use. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Concentrate for infusion. Dexmedetomidine Accord is a sterile, non-pyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine Accord (dexmedetomidine (as hydrochloride)) 100 micrograms/mL is supplied as clear, colourless, isotonic solutions with a pH of 4.5 to 7.0. Dexmedetomidine Accord is presented in a 2 mL vial and must be diluted prior to use. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ICU SEDATION For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Accord 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 D OSE AND METHOD OF ADMINISTRATION _NOTE:_ Dexmedetomidine hydrochloride 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 dexmedeto Leer el documento completo