País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Dexmedetomidine hydrochloride 118 µg/mL (equiv 100 µg/mL dexmedetomidine)
Teva Pharma (New Zealand) Limited
100 mcg/mL
Concentrate for infusion
Active: Dexmedetomidine hydrochloride 118 µg/mL (equiv 100 µg/mL dexmedetomidine) Excipient: Sodium chloride Water for injection
Prescription
For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine-Teva by continuous intubation in these patents should not exceed 24 hours. For sedation of non-intubated patients prior to and/or during surgical and other procedures.
Package - Contents - Shelf Life: Vial, glass, clear type 1, 2 mL fill in cardboard carton - 5 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, clear type 1, 2 mL fill in cardboard carton - 25 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2017-08-16
DEXMEDETOMIDINE-TEVA ® V3.0 1 DEXMEDETOMIDINE- TEVA® _Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride _ CONSUMER MEDICINE INFORMATION Consumer Name: Pharmacist Name: Consumer Address: Pharmacist Address: Date of Dispensing: 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 WITH THE MEDICINE. 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 available only 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 Leer el documento completo
Data Sheet: Dexmedetomidine-Teva 1 Version 3.1 DATA SHEET 1. PRODUCT NAME Dexmedetomidine-Teva (Dexmedetomidine hydrochloride) (100 micrograms/mL) concentrate for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dexmedetomidine-Teva is a sterile, non-pyrogenic solution suitable for intravenous infusion. The active ingredient in Dexmedetomidine-Teva is dexmedetomidine as hydrochloride. Each 2 mL of Dexmedetomidine-Teva contains 236 micrograms of dexmedetomidine hydrochloride (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. Dexmedetomidine-Teva is presented in a 2 mL vial, and must be diluted prior to use. For a full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Concentrate for infusion. Dexmedetomidine-Teva (dexmedetomidine hydrochloride) 100 micrograms/mL is supplied clear, colourless isotonic solution with a pH 4.5 – 7.0. Dexmedetomidine-Teva is presented in 2 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-Teva 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 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. Data Sheet: Dexmedetomidine-Teva 2 Version 3.1 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 administration including rapid intravenous or bolus administration o Leer el documento completo