Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Milrinone 1.43 mg/mL (as lactate. Equivalent to 1mg/ml milrinone)
sanofi-aventis new zealand limited
Milrinone 1.43 mg/mL (as lactate. Equivalent to 1mg/ml milrinone)
1 mg/mL
Solution for injection
Active: Milrinone 1.43 mg/mL (as lactate. Equivalent to 1mg/ml milrinone) Excipient: Glucose monohydrate Lactic acid Sodium hydroxide Water for injection
Ampoule, 10 x 10mL, 100 mL
Prescription
Prescription
Erregierre SpA
PRIMACOR Injection is indicated for the short term intravenous therapy of severe congestive heart failure. 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.
Package - Contents - Shelf Life: Ampoule, 10 x 10mL - 100 mL - 36 months from date of manufacture stored at or below 30°C
1988-09-08
Primacor 1 PRIMACOR INJECTION 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? Effe Læs hele dokumentet
primacor-ccdsv7-dsv7-28apr21 Page 1 DATA SHEET 1 PRIMACOR 1 MG/ML SOLUTION FOR INJECTION PRIMACOR 1 mg/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose ampoule contains 1 mg/mL milrinone (as lactate) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow solution. The pH is between 3.2 and 4.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMACOR is indicated for the short term intravenous therapy of severe congestive heart failure. 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 should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines: primacor-ccdsv7-dsv7-28apr21 Page 2 LOADING DOSE 50 mcg/kg administered slowly over 10 minutes MAINTENANCE DOSE TABLE 1 INFUSION RATE TOTAL DAILY DOSE (24 HOURS) MINIMUM 0.375 mcg/kg/min 0.60 mg/kg STANDARD 0.50 mcg/kg/min 0.77 mg/kg MAXIMUM 0.75 mcg/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 closely monitored. Most patients show an improvement in haemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure. Note: See "Dosage Adjustment in Renally Impaired Patients". Dosage may be titrated to the maximum haemodynamic effect and should not exceed 1.13 mg/kg/day. Duration of therapy should depend upon patient responsiveness. Intravenous infusions of PRIMACOR should be administered as described in Table 2. TABLE 2 - PRIMACOR - RATES OF INFUSION FOR CONCENTRATIONS OF 100 MCG/ML, 150 MCG/ML AND 200 MCG/ML. INFUSION DELIVERY RATE PRIMACOR (MCG/KG/MIN) 100 MCG/ML (ML/KG/HR) 150 M Læs hele dokumentet