国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
dobutamine hydrochloride, Quantity: 14 mg/mL (Equivalent: dobutamine, Qty 12.5 mg/mL)
Sandoz Pty Ltd
Injection, concentrated
Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium metabisulfite
Intravenous Infusion
5 vials, 1 vial, 10 vials
(S4) Prescription Only Medicine
Adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.
Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2003-01-07
______________________________________________________________________________ Dobutamine Sandoz ® 1 DOBUTAMINE SANDOZ® _Dobutamine hydrochloride Injection _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Dobutamine 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 using Dobutamine Sandoz 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. You may need to read it again. WHAT DOBUTAMINE SANDOZ IS USED FOR The name of your medicine is Dobutamine Sandoz. It contains the active ingredient dobutamine hydrochloride. This medicine belongs to a group of medicines called adrenergic stimulants. This medicine is used to treat heart failure following a heart attack or heart surgery_. _Dobutamine Sandoz works by helping the heart to beat more strongly._ _ 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. This medicine is not addictive. This medicine is available only with a doctor’s prescription. DOBUTAMINE SANDOZ IS NOT RECOMMENDED FOR USE IN CHILDREN. The safety and effectiveness of Dobutamine Sandoz in children have not been established._ _ BEFORE YOU ARE GIVEN DOBUTAMINE SANDOZ _WHEN YOU MUST NOT BE GIVEN IT _ DO NOT USE DOBUTAMINE SANDOZ IF YOU HAVE AN ALLERGY TO DOBUTAMINE OR 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 DOBUTAMINE SANDOZ IF YOU HAVE A HEART CONDITION KNOWN AS IDIOPATHIC HYPERTROPHIC SUBAORTIC STENOSIS_._ THIS MEDICINE SHOULD NOT BE USED AFTER THE EXPIRY 完全なドキュメントを読む
191120-Dobutamine Sandoz-pi Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION DOBUTAMINE SANDOZ ® (DOBUTAMINE HYDROCHLORIDE) CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Dobutamine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of DOBUTAMINE SANDOZ ® 250 mg/20 mL (as hydrochloride) concentrated injection is Dobutamine hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Dobutamine Sandoz 250 mg/20 mL Concentrated Injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The rate of infusion needed to increase cardiac output usually ranges from 2.5 to 10 microgram/kg/minute (see Table 1). On rare occasions, infusion rates up to 40 microgram/kg/minute have been required to obtain the desired effect. However, the possibility of intensifying myocardial ischaemia should be borne in mind and the lowest effective dose infused. TABLE 1. RATES OF INFUSION FOR CONCENTRATIONS OF 250, 500 AND 1000 µ G/ML DRUG DELIVERY RATE ( µ G/KG/MIN) INFUSION DELIVERY RATE 250 µ G/ML* (ML/KG/MIN) 500 µ G/ML** (ML/KG/MIN) 1000 µ G/ML*** (ML/KG/MIN) 2.5 0.01 0.005 0.0025 5.0 0.02 0.010 0.0050 7.5 0.03 0.015 0.0075 10.0 0.04 0.020 0.0100 12.5 0.05 0.025 0.0125 15.0 0.06 0.030 0.0150 * 250 mg/L of diluent ** 500 mg/L or 250 mg/500 mL of diluent *** 1000 mg/L or 250 mg/250 mL of diluent The rate of administration and the duration of therapy should be adjusted according to the patient's response, as determined by the following clinical indicators: haemodynamic parameters such as heart rate and rhythm, arterial pressure, and, whenever possible, cardiac output and measurements of ventricular filling pressures (central venous, pulmonary artery 191120-Dobutamine Sandoz-pi Page 2 of 10 wedge and left atrial), and signs of pulmonary congestion and organ perfusion (urine flow, skin temperature and 完全なドキュメントを読む