Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to dexmedetomidine 0.100 mg/1 mL
Medsurge Pharma Limited
Concentrate for infusion
Active: Dexmedetomidine hydrochloride 0.118 mg/mL equivalent to dexmedetomidine 0.100 mg/1 mL 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 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 1 glass vial (filled with 4 mL) closed with rubber stopper - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Type 1 glass vial (filled with 4 mL) closed with rubber stopper - 4 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Type 1 glass vial (filled with 4 mL) closed with rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C
2022-02-17
Dexmedetomidine Medsurge Edition-02 July 2023 1 DEXMEDETOMIDINE _DEXMEDETOMIDINE (DEX-MED-E-TOH-MED-EEN) HYDROCHLORIDE _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dexmedetomidine Mesurge. 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 using dexmedetomidine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DEXMEDETOMIDINE MEDSURGE 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 Medsurge is available only with a doctor's prescription. BEFORE YOU ARE GIVEN DEXMEDETOMIDINE MEDSURGE _WHEN YOU MUST NOT USE IT _ DO NOT USE DEXMEDETOMIDINE MEDSURGE 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 USE THIS MEDI Lestu allt skjalið
Dexmedetomidine Medsurge-data-sheet-v2.0 Page 1 of 21 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Dexmedetomidine Medsurge ( Dexmedetomidine hydrochloride 118 mcg/mL equivalent to dexmedetomidine 100 mcg/mL ) concentrate for IV infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in Dexmedetomidine Medsurge is dexmedetomidine as hydrochloride. Each 1 mL of dexmedetomidine (as hydrochloride) injection contains 118 micrograms of dexmedetomidine hydrochloride (equivalent to 100 micrograms of dexmedetomidine base) and 8.83 mg of sodium chloride in Water for Injections. Each 2 mL of dexmedetomidine (as hydrochloride) injection contains 236 micrograms of dexmedetomidine hydrochloride (equivalent to 200 micrograms of dexmedetomidine base) and 17.66 mg of sodium chloride in Water for Injections. Each 4 mL of dexmedetomidine (as hydrochloride) injection contains 472 micrograms of dexmedetomidine hydrochloride (equivalent to 400 micrograms of dexmedetomidine base) and 35.32 mg of sodium chloride in Water for Injections. Each 10 mL of dexmedetomidine (as hydrochloride) injection contains 1180 micrograms of dexmedetomidine hydrochloride (equivalent to 1000 micrograms of dexmedetomidine base) and 88.30 mg of sodium chloride in Water for Injections. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrated Injection. Dexmedetomidine Medsurge is a sterile, non-pyrogenic solution suitable for intravenous (IV) infusion following dilution. Dexmedetomidine Medsurge (dexmedetomidine hydrochloride) 100 microgram/mL is supplied as a sterile, clear and colourless or yellowish, isotonic solution with a pH of 4.5 to 7.0. Dexmedetomidine Medsurge is presented in a 2 mL ampoule, 4 mL vial or 10 mL vial and must be diluted prior to use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ICU (INTENSIVE CARE UNIT) 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 Lestu allt skjalið