Milrinone GH 10mg/10 mL Concentrated Injection milrinone (as lactate)10mg/10 mL ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

milrinone, Quantity: 10 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Milrinone

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous

Units in package:

10 ampoules, 1 ampoule

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2013-11-29

Patient Information leaflet

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

Summary of Product characteristics

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