Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
dexmedetomidine hydrochloride, Quantity: 118 microgram/mL
Sandoz Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: water for injections; sodium chloride
Intravenous Infusion
25 vials
(S4) Prescription Only Medicine
ICU Sedation,For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Sandoz 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: A clear, colorless solution in 2 mL clear glass vials, sealed with 13 mm coated stoppers, and secured with orange aluminum flip-off seals; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-10-11
210609-Dexmedetomidine Sandoz 1 DEXMEDETOMIDINE SANDOZ ® _Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dexmedetomidine Sandoz. 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 Sandoz 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 DEXMEDETOMIDINE SANDOZ IS USED FOR _INTENSIVE CARE SEDATION _ Dexmedetomidine Sandoz can be used as a sedative (calming agent) if adults need to 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 Sandoz 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 action 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 Sandoz is only available with a doctor’s prescription. BEFORE YOU ARE GIVEN DEXMEDETOMIDINE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DEXMEDETOMIDINE SANDOZ 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 GIVE THIS MEDICINE TO A CHI Baca dokumen lengkap
210609-Dexmedetomidine Sandoz-pi Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION DEXMEDETOMIDINE SANDOZ (DEXMEDETOMIDINE HYDROCHLORIDE) CONCENTRATED INJECTION 1. NAME OF THE MEDICINE Dexmedetomidine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in DEXMEDETOMIDINE SANDOZ is dexmedetomidine (as dexmedetomidine hydrochloride). DEXMEDETOMIDINE SANDOZ is a sterile, non-pyrogenic solution suitable for intravenous infusion. Each 2 mL of DEXMEDETOMIDINE SANDOZ contains 236 microgram of dexmedetomidine hydrochloride (equivalent to 200 microgram dexmedetomidine base) and 18 mg of sodium chloride in water for injections. 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 SANDOZ dexmedetomidine hydrochloride 100 microgram/mL is supplied as clear, colourless, isotonic solutions with a pH of 4.5 to 7.0. DEXMEDETOMIDINE SANDOZ 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 SANDOZ 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 DOSAGE _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 bolus administration of dexmedetomidine hydrochloride. 210609-Dexmed Baca dokumen lengkap