Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
dobutamine hydrochloride, Quantity: 14.01 mg/mL (Equivalent: dobutamine, Qty 12.5 mg/mL)
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium metabisulfite; water for injections
Intravenous
1 x 250mg/20mL
(S4) Prescription Only Medicine
Dobutamine Hydrochloride Injection is indicated in adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery.
Visual Identification: A clear, colourless or slightly tinged yellow solution, free from visible particulates.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1993-11-30
DBL™ DOBUTAMINE HYDROCHLORIDE INJECTION _Dobutamine Hydrochloride (do-BEWT-a-meen)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Dobutamine Hydrochloride Injection. 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 being given DBL Dobutamine Hydrochloride Injection against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT DBL DOBUTAMINE HYDROCHLORIDE INJECTION IS USED FOR DBL Dobutamine Hydrochloride Injection is used in patients who require short-term treatment of heart failure following a heart attack or heart surgery. DBL Dobutamine Hydrochloride Injection acts directly on the heart muscle to increase the force of each contraction. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DBL DOBUTAMINE HYDROCHLORIDE INJECTION HAS BEEN PRESCRIBED FOR YOU. There is no evidence that DBL Dobutamine Hydrochloride Injection is addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL DOBUTAMINE HYDROCHLORIDE INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN DBL DOBUTAMINE HYDROCHLORIDE INJECTION IF YOU HAVE AN ALLERGY TO DOBUTAMINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction to DBL Dobutamine Hydrochloride Injection 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. YOU SHOULD NOT BE GIVEN DBL DOBUTAMINE HYDROCHLORIDE INJECTION IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • a heart condition called idiopathic hypertrophic sub aortic stenosis (a narrowing Leggi il documento completo
Version pfpdobui10722 Supercedes: pfpdobui11020 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION – DBL ™ DOBUTAMINE HYDROCHLORIDE INJECTION (DOBUTAMINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Dobutamine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial of DBL Dobutamine Hydrochloride Injection contains dobutamine hydrochloride 280.2 mg (250 mg dobutamine equivalent) and sodium metabisulfite 4.4 mg. Dobutamine hydrochloride is a white to practically white, crystalline powder. It is sparingly soluble in water and methyl alcohol; soluble in alcohol. EXCIPIENT WITH KNOWN EFFECT: • Sodium Metabisulfite For the full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Solution for injection. DBL Dobutamine Hydrochloride Injection is a sterile solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Dobutamine Hydrochloride Injection is indicated in adults who require short-term treatment of cardiac failure secondary to acute myocardial infarction, or cardiac surgery. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The rate of infusion needed to increase cardiac output usually ranges from 2.5 to 10 micrograms/kg/min (see table). On rare occasions, infusion rates up to 40 micrograms/kg/min 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. RATES OF INFUSION FOR CONCENTRATIONS OF 250, 500 AND 1,000 MICROGRAMS/ML Version pfpdobui10722 Supercedes: pfpdobui11020 Page 2 of 10 Drug Delivery Rate (microgram/kg/min) Infusion Delivery Rate 250 microgram/mL 1 (mL/kg/min) 500 microgram/m L 2 (mL/kg/min) 1000 microgram/m L 3 (mL/kg/min) 2.5 0.01 0.005 0.0025 5 0.02 0.01 0.005 7.5 0.03 0.015 0.0075 10 0.04 0.02 0.01 12.5 0.05 0.025 0.0125 15 0.06 0.03 0.015 1. 250 mg per litre of diluent 2. 500 mg per litre or 250 mg per 500 mL of diluent 3. 1000 mg per litre or 250 mg per 250 mL of diluent. The rate of administration and the duration of therapy should be ad Leggi il documento completo