Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Royal Jelly fresh
Astragrace Corp Pty Ltd
Medicine Listed
PRIMACOR INJECTION P r i m a c o r CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING PRIMACOR? Primacor contains the active ingredient Milrinone Lactate. Primacor is used for the short term treatment of severe congestive heart failure. For more information, see Section 1. Why am I using Primacor? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PRIMACOR? Do not use if you have ever had an allergic reaction to Primacor or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Primacor? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Primacor and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE PRIMACOR? Primacor is usually given to you in hospital. It is given to you as a series of injections. More instructions can be found in Section 4. How do I use Primacor? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PRIMACOR? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Primacor. THINGS YOU SHOULD NOT DO • You should not use Primacor if you are allergic to milrinone, similar medicines, or any of the ingredients listed at the end of this leaflet. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how Primacor affects you. DRINKING ALCOHOL • NA LOOKING AFTER YOUR MEDICINE • If you need to store Primacor make sure it is in a cool dry place where the temperature does not exceed 30°C. • Do not refrigerate. For more information, see Section 5. What should I know while using Primacor? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? Eff Lire le document complet
primacor-ccdsv7-piv8-28may21 Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION – PRIMACOR ® (MILRINONE LACTATE) 1 NAME OF THE MEDICINE Milrinone lactate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION STERILE, SINGLE DOSE AMPOULES Single-dose ampoules of 10 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone, and 47 mg glucose monohydrate, 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. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Sterile aqueous solution of the lactate salt of milrinone for injection or infusion intravenously. Colourless to pale yellow in solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primacor 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 Primacor has been in patients receiving digoxin and diuretics. Primacor is also indicated for low output states following cardiac surgery, including weaning from cardio-pulmonary bypass pump. 4.2 DOSE AND METHOD OF ADMINISTRATION Primacor Injection should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines: primacor-ccdsv7-piv8-28may21 Page 2 of 12 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 Note: Administer as a continuous intravenous infusion. The infusion rate should be adjusted according to haemodynamic and clinical response. Patients should be clo Lire le document complet