Primacor

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Milrinone 1.43 mg/mL (as lactate. Equivalent to 1mg/ml milrinone)

Inapatikana kutoka:

sanofi-aventis new zealand limited

INN (Jina la Kimataifa):

Milrinone 1.43 mg/mL (as lactate. Equivalent to 1mg/ml milrinone)

Kipimo:

1 mg/mL

Dawa fomu:

Solution for injection

Tungo:

Active: Milrinone 1.43 mg/mL (as lactate. Equivalent to 1mg/ml milrinone) Excipient: Glucose monohydrate Lactic acid Sodium hydroxide Water for injection

Vitengo katika mfuko:

Ampoule, 10 x 10mL, 100 mL

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Erregierre SpA

Matibabu dalili:

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.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Ampoule, 10 x 10mL - 100 mL - 36 months from date of manufacture stored at or below 30°C

Idhini ya tarehe:

1988-09-08

Taarifa za kipeperushi

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

Tabia za bidhaa

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