Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
milrinone, Quantity: 10 mg
Generic Health Pty Ltd
Milrinone
Injection, concentrated
Excipient Ingredients: water for injections; glucose; lactic acid; sodium hydroxide
Intravenous
10 ampoules, 1 ampoule
(S4) Prescription Only Medicine
Milrinone GH Concentrated Injection is indicated for the short term (48 hours) intravenous therapy of severe congestive heart failure patients in intensive care and coronary care units not responding to other therapy (eg. digoxin, diuretics, vasodilators, including ACE inhibitors). The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. - Milrinone GH Concentrated Injection is also indicated for low output states following cardiac surgery, including weaning from cardio-pulmonary bypass pump.
Visual Identification: Clear, colourless to pale yellow sterile solution, practically free from visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-11-29
CONSUMER MEDICINE INFORMATION MILRINONE GH (MILRINONE LACTATE) CONCENTRATED INJECTION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE. This leaflet answers some common questions about Milrinone GH. 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 your treatment using Milrinone GH 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 MILRINONE GH IS USED FOR The name of your medicine is Milrinone GH. It contains the active ingredient called milrinone. Milrinone GH is used for the short-term treatment of severe congestive heart failure. This is a condition where the heart fails to pump enough blood around the body. The symptoms of this condition include weakness, breathlessness, fluid build-up in the tissues and a blue discolouration of the skin. Milrinone GH also helps to maintain the output of blood from the heart in patients following heart surgery. Milrinone GH helps improve the efficiency with which your heart pumps blood around your body. Milrinone GH works by increasing the force by which your heart muscles work and opening up your blood vessels to allow blood to flow more freely. Your doctor may have prescribed Milrinone GH for another reason. Ask your doctor if you have any questions about why Milrinone GH has been prescribed for you. This medicine is available only with a doctor's prescription. BEFORE MILRINONE GH IS GIVEN _WHEN YOU MUST NOT USE IT _ YOU SHOULD NOT USE MILRINONE GH IF YOU ARE ALLERGIC TO MILRINONE, SIMILAR MEDICINES, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. The symptoms of an allergic reaction may include rash, asthma attack or hay fever. YOU SHOULD NOT USE MILRINONE GH IF YOU HAVE CERTAIN SEVERE PROBLEMS (OBSTRUCTIVE AORTIC OR PULM Read the complete document
AUSTRALIAN PRODUCT INFORMATION – MILRINONE GH (MILRINONE (AS LACTATE)) CONCENTRATED INJECTION 1 NAME OF THE MEDICINE Milrinone (as lactate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ampoules of 10 mL contain in each mL, 1 mg milrinone (as lactate) and 47 mg glucose, in water for injections. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These ampoules require preparation of dilutions prior to administration to patients intravenously. 3 PHARMACEUTICAL FORM Milrinone GH 10 mg/10 mL: Clear, colourless to pale yellow sterile solution, practically free from visible particles. Milrinone GH concentrated injection is available as a sterile aqueous solution for intravenous injection or infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Milrinone GH concentrated injection is indicated for the short term (48 hours) intravenous therapy of severe congestive heart failure patients in intensive care and coronary care units not responding to other therapy (eg. digoxin, diuretics, vasodilators, including ACE inhibitors). The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. Milrinone GH concentrated injection is also indicated for low output states following cardiac surgery, including weaning from cardio-pulmonary bypass pump. 4.2 DOSE AND METHOD OF ADMINISTRATION Milrinone GH concentrated injection should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines (see TABLE 1): TABLE 1: LOADING DOSE: 50 μg/kg Administer slowly over 10 minutes MAINTENANCE DOSE: INFUSION RATE TOTAL DAILY DOSE (24 HOURS) MINIMUM 0.375 μg/kg/min 0.60 mg/kg STANDARD 0.50 μg/kg/min 0.77 mg/kg MAXIMUM 0.75 μg/kg/min 1.13 mg/kg Milrinone GH v6 Page 2 of 11 (milrinone (as lactate)) concentrated injection NOTE: Administer as a continuous intravenous infusion. The infusion rate should be adjusted accordin Read the complete document