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MILRINONE 1 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance(s): MILRINONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MILRINONE 1 MG/ML SOLUTION
FOR INJECTION/INFUSION
Milrinone
(Referred to Milrinone in this leaflet)
Read all of this leaflet carefully before you start using
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Milrinone is and what it is used for
2. Before you use Milrinone
3. How to use Milrinone
4. Possible side effects
5. How to store Milrinone
6. Further information
1. WHAT MILRINONE IS AND WHAT IT IS USED
FOR
Milrinone is a medicine used to increase cardiac output
(heart performance). The active substance is called milrinone. It is a substance with properties that increase
the strength of heart contractions and dilate the blood
vessels.
Milrinone can be used in adults for:
- Short-term treatment of severe congestive heart failure (where the heart cannot pump enough blood to

PB Milrinone_UK.indd 1

the rest of the body) when other medicines have not
worked
Milrinone can be used in children for:
- Short-term treatment (up to 35 hours) of severe congestive heart failure (where the heart cannot pump
enough blood to the rest of the body) when other
medicines have not worked.
- Short-term treatment (up to 35 hours) of acute heart
failure after a heart operation i.e. when your heart is
having difficulty pumping blood around your body.
Whilst using Milrinone, constant monitoring of heart
function and blood pressure must be ensured.
2. BEFORE YOU USE MILRINONE
Do not use Milrinone
- if you are allergic (hypersensitive) to milrinone (active
substance) or any of the other ingredients of Milrinone,
- if your heart failure is due to abnormal enlargement of
the heart muscle cells (hypertrophic obstructive cardiomyopathy),
- if you have been diagnosed with ventricular aneurysm
(localised expansion of the heart’s ventricle wall),
- if you are suffering from severe, as-yet untreated dehydration (hypovolaemia),
- if you have suffered an acute heart attack (myocardial
infarction).
In addition, do not use Milrinone
if your heart failure is due to
- an overactive thyroid (hyperthyroidism),
- acute heart muscle inflammation (myocarditis) or
- a certain type of heart muscle disease (amyloid cardiomyopathy),
due to the lack of sufficient therapeutic experience available.

Take special care with Milrinone
- if you have severe narrowing of the heart valves (obstructive aortic or pulmonary valve disease),
- if you have been, or if you are expected to be diagnosed
with certain forms of heart rhythm disorders (e.g. atrial
flutter, atrial fibrillation or certain other types of heart
rhythm disorders originating from the lower chamber
(ventricle) of the heart), as Milrinone may promote certain heart rhythm disorders. Your doctor will therefore
check whether additional antiarrhythmic treatment, a
dose adjustment or electrocardiogram monitoring is
required.
- if your heart is suspected of having low filling pressures
(e.g. due to previous treatment with water tablets).
Before use, your doctor will check your filling pressures and correct them if necessary.
- if you suffer from a kidney disorder or low blood pressure. Before and during treatment, your doctor will
carry out appropriate checks and take these into account during treatment, as well as when determining
the dose of Milrinone and other medicines.
- if you have been diagnosed with a reduced number
of blood platelets (thrombocytes) or red blood cells
(erythrocytes) or a low haemoglobin level, Milrinone
may only be used with careful blood platelet monitoring, as this might lead to a further decrease in these
blood components.
Cases of reactions at the infusion site have been reported. Whilst using Milrinone, careful monitoring is therefore required at the puncture site, in order to prevent extravascular administration of the infusion (i.e. accidental
administration outside the vein).
Children and adolescents
The following should be considered in addition to warnings and precautions described for adults: Before giving
Milrinone infusion, your doctor will check a lot of param-

eters such as heart rhythm and blood pressure. He/she
will order blood tests as well.
The infusion will not start if your child´s heart rhythm
and blood pressure is not stable.
Please tell your doctor if:
- Your child has kidney problems
- Your child is a preterm infant or has a low birth weight
Your child has a certain heart problem named Patent
Ductus Arterisus: a connection between 2 major blood
vessels (aorta and pulmonary artery) which persists
though it should be closed.
Elderly patients
There are special dosage recommendations for elderly
patients. Controlled pharmacokinetic studies have so far
shown no age-dependent effect on the distribution and/or
excretion of milrinone, the active substance of Milrinone.

Pregnancy and breast-feeding
For milrinone, no clinical data are available regarding
use in pregnant women. Animal studies do not indicate
direct or indirect harmful effects with respect to pregnancy, prenatal development (i.e. before the birth), delivery or postnatal development (i.e. after the birth).
Caution should be exercised during use in pregnancy.
As it is unknown whether milrinone is excreted in human milk, breast-feeding must be discontinued in the
event of treatment.
Ask your doctor or pharmacist for advice before taking
any medicine.

Using other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
If you are taking water tablets (diuretics) at the same
time as Milrinone, their effect may be enhanced in terms
of increasing urine output and lowering potassium. The
resulting potassium loss may promote the onset of
heart rhythm disorders, especially if you are taking concomitantly digoxin (used for heart problems). The effect
of Milrinone may also be stronger.
When given at the same time as cardiotonic medicines
(i.e. that increase the strength of heart contractions, e.g.
dobutamine), Milrinone can enhance the cardiotonic
(positive inotropic) effects of these medications and
vice versa.
Please note that all this information may also apply to
recently-used medicines.

Important information about some of the ingredients
of Milrinone
This medicine contains glucose. If you have been told
that you have an intolerance to some sugars, you should
tell your doctor before Milrinone is used.

Driving and using machines
There is no available experience regarding adverse effects on the ability to drive and use machines.

3. HOW TO USE MILRINONE
Your doctor will determine the dosage and how to administer Milrinone. In general, he/she will be guided by
the following dosage recommendations:
Dosage
Starting dosage:
Milrinone should be administered at a loading dose of
50 micrograms of milrinone/kg body weight (BW) over a
10-minute period; this is normally followed by a continuous maintenance infusion.
Maintenance dosage:
In general, the continuous maintenance infusion is 0.5 mi-

crograms of milrinone/kg BW/min; however, it can range
between 0.375 micrograms of milrinone/kg BW/min and
0.75 micrograms of milrinone/kg BW/min, depending on
the effects on the cardiovascular system.
The total dose should not exceed 1.13 mg milrinone/kg
BW/day.
For administering the maintenance dose, a solution for
infusion is prepared at a concentration of 200 micrograms of milrinone/ml. It is made by adding 40 ml of a
carrier solution to 10 ml undiluted solution for injection/
infusion. As carrier solutions, 0.9% saline solution or 5%
glucose solution can be used.
Depending on the required maintenance dose (in micrograms per kg BW per minute), this gives the following infusion rates (in millilitres per kg BW per hour) for
the prepared solution for infusion, at a concentration of
200 micrograms/ml (see Table 1).
Table 1: Converting the maintenance dose to the equivalent infusion rate
Maintenance
dose
(micrograms/kg
BW per minute)

Maintenance
dose
(micrograms/kg
BW per hour)

0.375

22.5

0.11

0.400

24.0

0.12

Infusion rate*
(millilitres/kg
BW per hour)

0.500

30.0

0.15

0.600

36.0

0.18

0.700

42.0

0.21

0.750

45.0

0.22

Children and adolescents
Your doctor should give your child a first dose ranging
between 50 and 75 micrograms for every kilogram of his
weight, over a period of 30 to 60 minutes.
This is then followed by a dose ranging from 0.25 to 0.75
micrograms for every kilogram of his/her weight per
minute according to your child´s response to the treatment and occurrence of side effects.
Milrinone can be given for up to 35 hours.
During infusion, your child will be closely monitored:
your doctor will check a lot of parameters such as heart
rhythm and blood pressure and blood will be taken to
evaluate the response to therapy and occurrence of side
effects.
Elderly patients
Based on the current state of knowledge, it is assumed
that no special dosage recommendations are necessary
for this patient group if kidney function is normal.
Patients with impaired kidney function
If your kidney function is severely impaired, the excretion of milrinone will be reduced. The maintenance dose
should therefore be reduced, depending on the extent
of kidney dysfunction (see Table 2).

* calculated for a solution for infusion with 200 micrograms of milrinone per millilitre

21.05.13 08:47

Table 2: Converting the reduced maintenance dose to
the equivalent infusion rate in patients with renal insufficiency
Maintenance
dose
(micrograms/
kg BW per
minute)

Maintenance
dose
(microgram/
kg BW per
hour)

Infusion rate*
(millilitres/
kg BW
per hour)

5

0.20

12.0

0.06

10

0.23

13.8

0.07

Creatinine
clearance
(ml/
min/1.73 m²)

20

0.28

16.8

0.08

30

0.33

19.8

0.10

40

0.38

22.8

0.11

50

0.43

25.8

0.13

* calculated for a solution for infusion with 200 micrograms of milrinone per millilitre
Method of administration:
Milrinone is administered by slow intravenous injection
or by intravenous infusion.
Milrinone must not be mixed with carrier solutions other than those mentioned above (5% glucose solution or
0.9% saline solution).
Furosemide is chemically incompatible with a range of
substances including milrinone. If Milrinone is administered at the same time as furosemide or bumetanide, different intravenous accesses should therefore be selected
or furosemide should be taken as a tablet, for example.
Milrinone must not be mixed with sodium bicarbonate
solutions for infusion.
Depending on fluid requirements, solutions for infusion
with various concentrations can be used.

PB Milrinone_UK.indd 2

For the injection, as large a vein as possible should be
chosen to avoid local irritation.
Injections that miss the intended blood vessel must be
avoided.
Duration of treatment:
The duration of treatment should not exceed 48 hours,
as no controlled studies have been conducted with a
treatment period of more than 48 hours.
If you are given more Milrinone than you should
A drop in blood pressure and rapid heart rhythm disorders may occur.
In the event of an overdose, your doctor will stop the infusion or reduce the infusion rate and may initiate other
appropriate procedures. There is no known specific antidote.
If you forget to use Milrinone
Your doctor or nurse will have instructions on when to
give you this medicine. It is unlikely that you will not be
given the medicine as it has been prescribed. However,
if you think you have missed a dose, tell your doctor or
nurse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Milrinone can cause side effects, although not everybody gets them.
The following categories are used for stating the frequency of side effects:

Very common: more than 1 in 10 patients treated
Common:

1 to 10 out of 100 patients treated

Uncommon:

1 to 10 out of 1,000 patients treated

Rare:

1 to 10 out of 10,000 patients treated

Very rare:

less than 1 in 10,000 patients treated

Not known:

cannot be estimated from the
available data

Common (1 to 10 out of 100 patients treated)
– mild to moderately severe headache,
– irregular heartbeat caused by extra beats,
– racing heart,
– heart rhythm disorders,
– low blood pressure (hypotension).
Uncommon (1 to 10 out of 1,000 patients treated)
– reduction in the number of blood platelets,
– low potassium levels,
– trembling,
– ventricular fibrillation,
– severe chest pain, often with tight-chestedness and
shortness of breath,
– increased liver values as a result of impaired liver
function.
Rare (1 to 10 out of 10,000 patients treated)
– reduction in the number of red blood cells,
– reduced haemoglobin concentration (blood pigment),
Very rare (less than 1 in 10,000 patients treated)
– allergic (anaphylactic) shock,
– a particularly dangerous form of racing heart (torsade
de pointes),
– spasmodic constriction of the bronchial tubes,
– skin reactions, e.g. skin rash.
Not known (cannot be estimated from the available data)
– irritation at the infusion site

– reduction of red blood count and/or haemoglobin concentration.
Life-threatening heart rhythm disorders have occurred
particularly in patients with pre-existing heartbeat irregularities and/or metabolic abnormalities (e.g. low
potassium level) and/or high digitalis levels.
Additional side effects in children
In addition to side effects observed in adults, the following were reported in children:
Not known (cannot be estimated from the available
data)
– bleeding into the fluid-filled areas (ventricles) surrounded by the brain (intraventricular haemorrhage)
– a heart problem known as Patent Ductus arteriosus: a
connection between 2 major blood vessels (aorta and
pulmonary artery) which persists though it should be
closed. This can cause excess fluid in the lungs, bleedings, destruction of the bowel or part of the bowel and
possibly be fatal.
Moreover, compared to adults, decrease in the number
of platelets in the blood seems to occur more often in
children and the risk of this side effect in increased with
the duration of the Milrinone infusion. Heart rhythm
troubles seem to occur less often in children than in
adults.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE MILRINONE
Keep out of the sight and reach of children.
Do not use Milrinone after the expiry date which is stated on the label and outer carton. The expiry date refers
to the last day of that month.

Storage conditions:
This medicinal product does not require any special
storage conditions.
Notes on shelf life after opening or dilution with
isotonic sodium chloride or glucose 5 % solution
The chemical and physical stability of the ready-to-use
preparation has been demonstrated for 24 hours at
25°C. From a microbiological point of view, the readyto-use preparation should be used immediately.
If the ready-to-use preparation is not used immediately,
storage times and conditions are the responsibility of
the user.
After opening, discard any unused portion.
Any unused product or waste material should be disposed of in accordance with local requirements.

Marketing Authorisation Holder
CARINOPHARM GmbH
Bahnhofstr. 18
D-31008 Elze
GERMANY
Tel.: +49 (0)180 2 1234-01
Fax: +49 (0)180 2 1234-02
E-mail: info@carinopharm.de
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstr. 18
D-31028 Gronau
GERMANY
This leaflet was last revised in 05/2013

6. CONTENT OF THE PACK AND OTHER
INFORMATION
What Milrinone contains
· The active substance is milrinone.
Each ml solution for injection/infusion contains 1 mg
milrinone. Each ampoule of 10 ml solution for injection/infusion contains 10 mg milrinone.
· The other ingredients are glucose, lactic acid, sodium
hydroxide and water for injections.
What Milrinone looks like and contents of the pack
Milrinone is a clear, colourless to pale yellow solution
for injection/infusion.
Milrinone is available in the following pack sizes:
· Pack of 5 or 10 clear glass ampoules of 10 ml.
Not all pack sizes may be marketed.

21.05.13 08:47

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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