MILRINONE-BAXTERmilrinone (as lactate) 10 mg/10 mL concentrated injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

milrinone, Quantity: 10 mg

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

Milrinone

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: glucose; water for injections; sodium hydroxide; lactic acid

Administration route:

Intravenous

Units in package:

10 mL ampoules, 10 ampoules per pack, 10 mL ampoules, 5 ampoules per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MILRINONE-BAXTER 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 (e.g. digoxin, diuretics, vasodilators, including ACE inhibitors). The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. ,MILRINONE-BAXTER is also indicated for low output states following cardiac surgery, including weaning from cardio-pulmonary bypass pump.

Product summary:

Visual Identification: Sterile, clear, colourless to pale yellow solution, practically free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-04-17

Patient Information leaflet

MILRINONE-CLARIS
_Milrinone lactate, Concentrated Solution for injection _
_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
Milrinone-Claris. It does not
contain all the information that is known about Milrinone-Claris. It
does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking
Milrinone-Claris against the benefits they expect it will have for
you.
This medicine is likely to be used while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine is given to you. In some cases
this leaflet may be given to you
after the medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT MILRINONE-CLARIS IS USED FOR
Milrinone-Claris 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-Claris also helps to maintain the output of blood from the
heart in patients following heart
surgery.
Milrinone-Claris helps improve the efficiency with which your heart
pumps blood around your body.
Milrinone-Claris works by increasing the force by which your heart
muscles work and opening up
your blood vessels to allow blood to flow more freely.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT: _
YOU SHOULD NOT USE MILRINONE-CLARIS 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 a rash,
asthma attack or hay fever.
YOU SHOULD NOT USE MILRINONE-CLARIS IF YOU HAVE CERTAIN SEVERE
PROBLEMS (OBSTRUCTIVE AORTIC OR
PULMONARY VALVULAR DISEASE).
MILRINONE-CLARI

Summary of Product characteristics

Milrinone-Baxter (Milrinone lactate)
Version 1.0
1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
MILRINONE-
BAXTER
(MILRINONE
LACTATE)
CONCENTRATED
SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Milrinone (as lactate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Milrinone-Baxter is a sterile, clear, colourless to pale yellow
aqueous solution, practically free
from visible particles, containing milrinone lactate equivalent to
milrinone 10 mg/10 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrated Solution for Infusion
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Milrinone-Baxter 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 (e.g. digoxin, diuretics, vasodilators, including ACE
inhibitors). The majority of
experience with intravenous milrinone has been in patients receiving
digoxin and diuretics.
Milrinone-Baxter 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-Baxter requires dilution prior to administration to patients
intravenously.
Milrinone-Baxter should be administered with a loading dose followed
by a continuous infusion
(maintenance dose) according to the following guidelines:
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.
Milrinone-Baxter (Milrinone lactate)
Version 1.0
2 of 11
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