PRIMACOR 1MG/ML SOLUTION FOR INJECTION

Active substance: MILRINONE

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0.375
0.400
0.500
0.600
0.700
0.750

0.11
0.12
0.15
0.18
0.21
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Solutions of different concentrations may be used according to
patient fluid requirements. The duration of therapy should
depend upon the patient’s response. In congestive cardiac
failure, patients have been maintained on the infusion for up to
5 days, although the usual period is 48 to 72 hours. In acute
states following cardiac surgery, it is unlikely that treatment
need be maintained for more than 12 hours.
Renal Impairment: Dosage adjustment required. Data obtained
from patients with severe renal impairment but without heart
failure have demonstrated that the presence of renal impairment
significantly increases the terminal elimination half-life of
milrinone. For patients with clinical evidence of renal

Creatinine Clearance
(ml/min/1.73m2)
5
10
20
30
40
50

Primacor Injection Dose Maintenance Infusion
Delivery Rate (ml/kg/hr)
(μg/kg/min)
0.20
0.23
0.28
0.33
0.38
0.43

0.06
0.07
0.08
0.10
0.11
0.13

The infusion rate should be adjusted according to haemodynamic
response.
Elderly: Experience so far suggests that no special dosage
recommendations are necessary.
Paediatric population:
In published studies selected doses for infants and children were:
• Intravenous loading dose: 50 to 75 μg/kg administered over 30
to 60 minutes.
• Intravenous continuous infusion: To be initiated on the basis
of hemodynamic response and the possible onset of
undesirable effects between 0.25 to 0.75 μg/kg/min for a
period up to 35 hours.
In clinical studies on low cardiac output syndrome in infants and
children under 6 years of age after corrective surgery for
congenital heart disease 75 μg/kg loading dose over 60 minutes
followed by a 0.75 μg/kg/min infusion for 35 hours significantly
reduced the risk of development of low cardiac output syndrome.
Results of pharmacokinetic studies (see section 5.2) have to be
taken into consideration.
Renal impairment:
Due to lack of data the use of milrinone is not recommended in
paediatric population with renal impairment (for further
information please see section 4.4).
Patent ductus arteriosus:
If the use of milrinone is desirable in preterm or term infants at
risk of/with patent ductus arteriosus, the therapeutic need must
be weighed against potential risks (see section 4.4, 4.8, 5.2, and
5.3).
4.3 Contraindications
• Hypersensitivity to milrinone or to any of the excipients
• Severe hypovolaemia.
4.4 Special warnings and special precautions for use
The use of inotropic agents such as milrinone during the acute
phase of a myocardial infarction may lead to an undesirable
increase in myocardial oxygen consumption (MVO2). Primacor
Injection is not recommended immediately following acute
myocardial infarction until safety and efficacy have been
established in this situation.
Careful monitoring should be maintained during Primacor
Injection therapy including blood pressure, heart rate, clinical
state, electro-cardiogram, fluid balance, electrolytes and renal
function (i.e. serum creatinine).
In patients with severe obstructive aortic or pulmonary valvular
disease or hypertrophic subaortic stenosis, Primacor Injection
should not be used in place of surgical relief of the obstruction.
In these conditions it is possible that a drug with inotropic /
vasodilator properties might aggravate outflow obstruction.
Supraventricular and ventricular arrhythmias have been
observed in the high risk population treated with milrinone. In
some patients an increase in ventricular ectopy including nonsustained ventricular tachycardia has been observed which did
not affect patient safety or outcome.

*454022*

The following information is extracted from the SPC.
Technical information for the administration of Primacor
Injection
1 NAME OF THE MEDICINAL PRODUCT
Primacor 1mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1mg/ml of the active substance
Milrinone.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless to pale yellow liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Primacor Injection is indicated for the short-term treatment of
severe congestive heart failure unresponsive to conventional
maintenance therapy, and for the treatment of patients with
acute heart failure, including low output states following cardiac
surgery.
In paediatric population Primacor is indicated for the short-term
treatment (up to 35 hours) of severe congestive heart failure
unresponsive to conventional maintenance therapy (glycosides,
diuretics, vasodilators and/or angiotensin converting enzyme
(ACE) inhibitors), and for the short-term treatment (up to 35
hours) of paediatric patients with acute heart failure, including
low output states following cardiac surgery.
4.2 Posology and method of administration
For intravenous administration.
Adults: Primacor Injection should be given as a loading dose of
50μg/kg administered over a period of 10 minutes usually
followed by a continuous infusion at a dosage titrated between
0.375μg/kg/min and 0.75μg/kg/min according to haemodynamic
and clinical response, but should not exceed 1.13mg/kg/day
total dose.
The following provides a guide to maintenance infusion delivery
rate based upon a solution containing milrinone 200μg/ml
prepared by adding 40ml diluent per 10ml ampoule (400ml
diluent per 100ml Primacor Injection). 0.45% saline, 0.9% saline
or 5% glucose may be used as diluents.
Infusion
Primacor Injection Dose
Delivery Rate (ml/kg/hr)
(μg /kg/min)

impairment, the loading dose is not affected, but the following
maintenance infusion rates are recommended using the infusion
solution described above.

454022

Primacor 1mg/ml Solution for Injection
Milrinone

The potential for arrhythmia, present in heart failure itself, may
be increased by many drugs or a combination of drugs. Patients
receiving Primacor Injection should be closely monitored during
infusion and the infusion should be stopped if arrhythmias
develop.
As milrinone produces a slight enhancement in A-V node
conduction, there is a possibility of an increased ventricular
response rate in patients with uncontrolled atrial flutter /
fibrillation. Consideration should therefore be given to
digitalisation or treatment with other agents to prolong A-V
node conduction time prior to starting Primacor Injection
therapy, and to discontinuing the therapy if arrhythmias occur.
Milrinone may induce hypotension as a consequence of its
vasodilatory activity, therefore caution should be exercised
when Primacor Injection is administered to patients who are
hypotensive prior to treatment. The rate of infusion should be
slowed or stopped in patients showing excessive decreases in
blood pressure.
If prior vigorous diuretic therapy is suspected of having caused
significant decreases in cardiac filling pressure Primacor
Injection should be cautiously administered while monitoring
blood pressure, heart rate and clinical symptomatology.
Improvement in cardiac output with resultant diuresis may
necessitate a reduction in the dose of diuretic. Potassium loss
due to excessive diuresis may necessitate a reduction in the dose
of diuretic. Potassium loss due to excessive diuresis may
predispose digitalised patients to arrhythmias. Therefore,
hypokalaemia should be corrected by potassium
supplementation in advance of, or during, the use of Primacor
Injection.
Decrease in haemoglobin, including anaemia, often takes place
in the setting of cardiac failure. Due to the risk of
thrombocytopenia or anaemia, careful monitoring of the
corresponding laboratory parameters is required in patients
with decreased platelet count or decreased haemoglobin.
There is no experience in controlled trials with infusions of
milrinone for periods exceeding 48 hours.
Cases of infusion site reaction have been reported with Primacor
Injection (see Section 4.8, Undesirable effects). Consequently,
careful monitoring of the infusion site should be maintained so
as to avoid possible extravasation.
Use in the elderly: There are no special recommendations for
elderly patients. No age-related effects on the incidence of
adverse reactions have been observed. Controlled
pharmacokinetic studies have not shown changes in the
pharmacokinetic profile of milrinone in the elderly.
In patients with severe renal impairment dosage adjustment is
required (see section 4.2 Posology and method of
administration).
Paediatric population:
The following should be considered in addition to the warnings
and precautions described for adults:
In neonates, following open heart surgery during Primacor
therapy, monitoring should include heart rate and rhythm,
systemic arterial blood pressure via umbilical artery catheter or
peripheral catheter, central venous pressure, cardiac index,
cardiac output, systemic vascular resistance, pulmonary artery
pressure, and atrial pressure. Laboratory values that should be
followed are platelet count, serum potassium, liver function, and
renal function. Frequency of assessment is determined by
baseline values, and it is necessary to evaluate the neonate’s
response to changes in therapy.
Literature revealed that in paediatric patients with impaired
renal function, there were marked impairment of milrinone
2

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Precut by dotted line

clearance and clinically significant side effects, but the specific
creatinine clearance at which doses must be adjusted in
paediatric patients is still not clear, therefore the use of
milrinone is not recommended in this population (see section
4.2).
In paediatric patients milrinone should be initiated only if the
patient is hemodynamically stable.
Caution should be exercised in neonates with risk factors of
intraventricular haemorrhage (i.e. preterm infant, low birth
weight) since milrinone may induce thrombocytopenia. In
clinical studies in paediatric patients, risk of thrombocytopenia
increased significantly with duration of infusion. Clinical data
suggest that milrinone-related thrombocytopenia is more
common in children than in adults (see section 4.8).
In clinical studies milrinone appeared to slow the closure of the
ductus arteriosus in paediatric population. Therefore, if the use
of milrinone is desirable in preterm or term infants at risk
of/with patent ductus arteriosus, the therapeutic need must be
weighed against potential risks (see section 4.2, 4.8, 5.2, and
5.3).
4.5 Interaction with other medicinal products and other forms
of interactions
Furosemide or bumetanide should not be administered in
intravenous lines containing milrinone lactate in order to avoid
precipitation.
Milrinone should not be diluted in sodium bicarbonate
intravenous infusion.
Whilst there is a theoretical potential interaction with calcium
channel blockers, there has been no evidence of a clinically
significant interaction to date.
Milrinone has a favourable inotropic effect in fully digitalised
patients without causing signs of glycoside toxicity.
Fluid and electrolyte changes, as well as serum creatinine levels
should be carefully monitored during treatment with milrinone.
Improvement in cardiac output and consequently, diuresis, may
require reduction in the dose of a diuretic agent. Potassium loss
due to excessive diuresis may predispose digitalised patients to
arrhythmias. Therefore, hypokalaemia should be corrected by
potassium supplementation in advance of, or during milrinone
use.
4.6 Fertility, pregnancy and lactation
Use in Pregnancy
Although animal studies have not revealed evidence of drug-induced
foetal damage or other deleterious effects on reproductive
function, the safety of milrinone in human pregnancy has not
yet been established. It should be used during pregnancy only if
the potential benefit justifies the potential risk to the foetus.
Use in Lactation
There is insufficient information on the excretion of milrinone in
human milk. A decision must be made whether to discontinue
breast-feeding or discontinue milrinone therapy taking into
account the benefit of breast-feeding for a child and the benefit
of therapy for the woman.
4.7 Effects on ability to drive and to use machines
No studies on the effect on the ability to drive and use machinery
have been performed.
4.8 Undesirable effects
Adverse reactions have been ranked under heading of system-organ
class and frequency using the following convention: very
common (≥1/10); common (≥1/100, ≤1/10); uncommon
(≥1/1,000, ≤ 1/100); rare (≥1/10,000, ≤1/1,000); very rare
(≤1/10,000); not known (cannot be estimated from the
available data).

Blood and the lymphatic system disorders:
• Uncommon: Thrombocytopenia*
• Not known: reduction of red blood count and/or haemoglobin
concentration
*In infants and children, risk of thrombocytopenia increased
significantly with duration of infusion. Clinical data suggest that
milrinone-related thrombocytopenia is more common in
children than in adults (see section 4.4).
Immune system disorders:
• Very rare: Anaphylactic shock
Metabolism and nutrition disorders:
• Uncommon: Hypokalaemia
Nervous system disorders:
• Common: Headaches, usually mild to moderate in severity
• Uncommon: Tremor
Cardiac disorders:
• Common:
- Ventricular ectopic activity
- Non sustained or sustained ventricular tachycardia (see
section 4.4)
- Supraventricular arrhythmias
- Hypotension
• Uncommon:
- Ventricular fibrillation
- Angina/chest pain
• Very rare: Torsades de pointes
The incidence of arrhythmias has not been related to dose or
plasma levels of milrinone. These arrhythmias are rarely life
threatening. If present, they are often associated with certain
underlying factors such as pre-existing arrhythmias, metabolic
abnormalities (e.g. hypokalaemia) abnormal digoxin levels and
catheter insertion. Clinical data suggest that milrinone-related
arrhythmias are less common in children than in adults.
Respiratory, thoracic and mediastinal disorders:
• Very rare: Bronchospasm
Hepato-biliary disorders:
• Uncommon: Liver function tests abnormal
Skin and subcutaneous tissue disorders:
• Very rare: Skin reactions such as rash
General disorders and administration site conditions:
• Not known: Infusion site reaction
Paediatric population:
Nervous system disorders:
• Not known: Intraventricular haemorrhage (see section 4.4)
Congenital, familial, and genetic disorders:
• Not known: Patent ductus arteriosus*** (see section 4.2, 4.4,
5.2, and 5.3)
***The critical consequences of the patent ductus arteriosus are
related to a combination of pulmonary overcirculation with
consecutive pulmonary oedema and haemorrhage and of
reduced organ perfusion with consecutive intraventricular
haemorrhage and necrotizing enterocolitis with possible fatal
outcome as described in literature.
Long-term safety data for paediatric population are not yet
available.
4.9 Overdose
Overdose of intravenous Primacor may produce hypotension
(because of its vasodilatory effect) and cardiac arrhythmia. If this
occurs, Primacor injection administration should be reduced or
temporarily discontinued until the patient’s condition stabilises.
No specific antidote is known, but general measures for
circulatory support should be taken.

5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Cardiac therapy; phosphodiesterase
inhibitor, ATC code: C01CE02
Milrinone is a positive inotrope and vasodilator, with little
chronotropic activity. It also improves left ventricular diastolic
relaxation. It differs in structure and mode of action from the
digitalis glycosides, catecholamines or angiotensin converting
enzyme inhibitors. It is a selective inhibitor of peak III
phosphodiesterase isoenzyme in cardiac and vascular muscle. It
produces slight enhancement of A-V node conduction, but no
other significant electro-physiological effects.
In clinical studies Primacor Injection has been shown to produce
prompt improvements in the haemodynamic indices of
congestive heart failure, including cardiac output, pulmonary
capillary wedge pressure and vascular resistance, without
clinically significant effect on heart rate or myocardial oxygen
consumption. Haemodynamic improvement during intravenous
Primacor therapy is accompanied by clinical symptomatic
improvement in congestive cardiac failure, as measured by
change in New York Heart Association classification.
Paediatric population:
Literature review identified clinical studies with patients treated
for low cardiac output syndrome following cardiac surgery,
septic shock or pulmonary hypertension. The usual dosages were
a loading dose of 50 to 75 μg/kg administered over 30 to 60
minutes followed by an intravenous continuous infusion of 0.25
to 0.75 μg/kg/min for a period up to 35 hours. In these studies,
milrinone demonstrated an increase of cardiac output, a
decrease in cardiac filling pressure, a decrease in systemic and
pulmonary vascular resistance, with minimal changes in heart
rate and in myocardial oxygen consumption.
Studies of a longer use of milrinone are not sufficient to
recommend an administration of milrinone during a period of
more than 35 hours.
Some studies explored the paediatric use of milrinone in
patients with nonhyperdynamic septic shock (Barton et al., 1996;
Lindsay et al., 1998); the effect of milrinone on postbypass
pulmonary hypertension after tetralogy of Fallot repair (Chu et
al., 2000); the combined effect of nitric oxide and milrinone on
pulmonary circulation after Fontan-type procedure (Cai et al.,
2008).
The results of these studies were inconclusive. Therefore, the use
of milrinone in these indications cannot be recommended.
5.2 Pharmacokinetic properties
Following intravenous injections of 12.5 to 125mcg/kg to
congestive heart failure patients, Primacor Injection had a
volume of distribution of 0.38 l/kg/hr, a mean terminal
elimination half-life of 2.3 hours, and a clearance of 0.13
l/kg/hr. Following intravenous infusions of 0.2 to
0.7mcg/kg/min to congestive heart failure patients, the drug
had a volume of distribution of about 0.45 l/kg, a mean terminal
elimination half-life of 2.4 hours, and a clearance of 0.14
l/kg/hr. These pharmacokinetic parameters were not dosedependent, and the area under the plasma concentration versus
time curve following injection was significantly dose-dependent.
The primary route of excretion of milrinone in man is via the
urine. Elimination in normal subjects via the urine is rapid, with
approximately 60% recovered within the first two hours
following dosing, and approximately 90% recovered within the
first eight hours following dosing. The mean renal clearance of
milrinone is approximately 0.3 l/min, indicative of active
secretion.

3

Paediatric population:
Milrinone is cleared more rapidly in children than in adults, but
infants have significantly lower clearance than children, and
preterm infants have even lower clearance. As a consequence of
this more rapid clearance compared to adults, steady-state
plasma concentrations of milrinone were lower in children than
in adults. In paediatric population with normal renal function
steady-state milrinone plasma concentrations after 6 to 12 hours
continuous infusion of 0.5 to 0.75 μg/kg/min were about of 100
to 300 ng/ml.
Following intravenous infusion of 0.5 to 0.75 μg/kg/min to
neonates, infants and children after open heart surgery,
milrinone has a volume of distribution ranging from 0.35 to 0.9
litres/kg with no significant difference across age groups.
Following intravenous infusion of 0.5 μg/kg/min to very
preterm infants to prevent low systemic outflow after birth,
milrinone has a volume of distribution of about 0.5 litres/kg.
Several pharmacokinetic studies showed that, in paediatric
population, clearance increases with increasing age. Infants have
significantly lower clearance than children (3.4 to 3.8 ml/kg/min
versus 5.9 to 6.7 ml/kg/min). In neonates milrinone clearance
was about 1.64 ml/kg/min and preterm infants have even lower
clearance (0.64 ml/kg/min).
Milrinone has a mean terminal half-life of 2 to 4 hours in infants
and children and a mean terminal elimination half-life of 10
hours in preterm infants.
It was concluded that the optimal dose of milrinone in paediatric
patients in order to obtain plasma levels above the threshold of
pharmacodynamic efficacy appeared higher than in adults, but
that optimal dose in preterms in order to obtain plasma levels
above the threshold of pharmacodynamic efficacy appeared
lower than in children.
Patent ductus arteriosus:
Milrinone is cleared by renal excretion and has a volume of
distribution that is restricted to extracellular space which
suggests that the fluid overload and hemodynamic changes
associated with patent ductus arteriosus may have an effect on
distribution and excretion of milrinone (see section 4.2, 4.4, 4.8,
and 5.3).
5.3 Preclinical safety data
Juvenile animals:
A preclinical study was performed to clarify the ductus-dilating
effects of PDE 3 inhibitors in near-term rat pups and their
differential effects in near-term and preterm foetal rats.
Postnatal ductus arteriosus dilatation by milrinone was studied
with three doses (10, 1 and 0.1 mg/kg). The dilating effects of
milrinone in the foetal ductus constricted by indomethacin were
studied by simultaneous administration of milrinone (10, 1 and
0.1 mg/kg) and indomethacin (10 mg/kg) to the mother rat at
D21 (near-term) and D19 (preterm). This in vivo study has shown
that milrinone induces dose-dependent dilation of the foetal
and the postnatal constricted ductus arteriosus. Dilating effects
were more potent with injection immediately after birth than at
1 hour after birth. In addition, the study showed that the
premature ductus arteriosus is more sensitive to milrinone than
the mature ductus arteriosus (see section 4.2, 4.4, 4.8, and 5.2).
6 PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Lactic Acid
Glucose Anhydrous
Water for Injection
Sodium Hydroxide (for pH adjustment)

6.2 Incompatibilities
Furosemide or bumetanide should not be administered in
intravenous lines containing Primacor Injection since
precipitation occurs on admixture. Sodium Bicarbonate
Intravenous infusion should not be used for dilution.
Other drugs should not be mixed with Primacor Injection until
further compatibility data are available.
6.3 Shelf life
48 months when unopened. A diluted solution of Primacor
Injection should be used within 24 hours.
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
6.5 Nature and contents of container
Type I colourless, glass ampoules 10ml or 20ml packed in lots of
10.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Infusion solutions diluted as recommended with 0.45% saline,
0.9% saline or 5% glucose should be freshly prepared before use.
Parenteral drug products should be examined visually and
should not be used if particulate matter or discolouration are
present.
7 MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
50 Kings Hill Avenue
Kings Hill
West Malling
Kent
ME19 4AH
UK
or trading as:
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8 MARKETING AUTHORISATION NUMBER
PL 04425/0646
9 Date of First Authorisation / Renewal of the Authorisation
Date of first authorisation: 11 October 1989
Date of latest renewal: 7 April 2004
10 Date of Revision of Text
Jan 2012
LEGAL STATUS
POM

4

PACKAGE LEAFLET: INFORMATION FOR THE USER

Primacor 1mg/ml Solution for Injection
Milrinone

Is this leaflet hard to see or read?
Phone 01483 505515 for help

Read all of this leaflet carefully before you start taking this
medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse 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, nurse or pharmacist.
In this leaflet:
1. What Primacor is and what it is used for
2. Before you are given Primacor
3. How Primacor is given
4. Possible side effects
5. How to store Primacor
6. Further information
1. What Primacor is and what it is used for
The name of your medicine is Primacor 1mg/ml Solution for
Injection (called Primacor in this leaflet). Primacor contains a
medicine called milrinone. This belongs to a group of medicines
called phosphodiesterase inhibitors.
It works by making your heart muscle contract more strongly and
your blood vessels become wider. This means blood can flow
more easily making your heart pump blood more successfully.
Primacor can be used for:
• Short-term treatment of severe congestive heart failure
(where the heart cannot pump enough blood to the rest of the
body) when other medicines have not worked
• Treatment after a heart operation for when your heart is
having difficulty pumping blood around your body
Primacor 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.
2. Before you are given Primacor
Do not have this medicine and tell your doctor, nurse or
pharmacist if:
× You are allergic (hypersensitive) to milrinone or any of the other
ingredients of Primacor (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
× You have lost body fluids and are severely dehydrated.
Do not have this medicine if any of the above apply to you. If you
are not sure, talk to your doctor, nurse or pharmacist before
having Primacor.
Take special care with Primacor
Check with your doctor, nurse or pharmacist before you have
this medicine if:
s You are having or have just had a heart attack
s You have severe heart valve problems such as narrowing,
thickening or blockage of your heart valves
s You have uneven or uncontrolled fast heartbeats. You may also
be experiencing pounding in your chest, light-headedness,
fainting and shortness of breath
s You have low blood pressure which may make you feel dizzy,
light-headed or faint
s You have previously taken water tablets (diuretics) which
caused you to have heart problems
s You have low levels of potassium in your blood. Your doctor
may do blood tests to check this
s You have kidney problems

If you are not sure if any of the above apply to you, talk to your
doctor, nurse or pharmacist before having Primacor.
The following should be considered in addition to warnings and
precautions described for adults:
Take special care with Primacor:
Using Primacor in Children:
Before giving Primacor infusion, your doctor will check a lot of
parameters 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:
s Your child has kidney problems
s Your child is a preterm infant or has a low birth weight
s Your child has a certain heart problem named Patent Ductus
Arteriosus: a connection between 2 major blood vessels (aorta
and pulmonary artery) which persists though it should be closed.
In these cases, your doctor will decide if your child will be
treated with Primacor.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including herbal
medicines. This is because Primacor can affect the way some
other medicines work. Also some medicines can affect the way
Primacor works.
In particular, tell your doctor, nurse or pharmacist if you are taking:
• Digoxin – used for heart problems
• Water tablets (diuretics)
• Medicines used to treat high blood pressure or angina (chest
pain) such as amlodipine, nifedipine or felodipine
Pregnancy and breast-feeding
Talk to your doctor, nurse or pharmacist before having this
medicine if you are pregnant, might become pregnant, or think
you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your
doctor or pharmacist before taking any medicine.
3. How Primacor is given
Primacor will normally be given by your doctor or nurse. This is
because it needs to be given as an injection.
Having this medicine
• This medicine is usually given in a ‘drip’ after being diluted
using either a sugar or salt solution
• If you feel the effect of your medicine is too weak or too strong,
tell your doctor or nurse
How much will be given to you
• Your doctor will decide how much medicine you should have
based on your body weight
• If you have problems with your kidneys, you may be given a
lower dose
Adults and the elderly
• Your doctor should give you a first dose of 50 micrograms for
every kilogram of your weight over 10 minutes
• This is then followed by a smaller dose between 0.375 and 0.75
micrograms for every kilogram of body weight per minute as
needed
• The medicine is usually given for 2 to 3 days, but it may be
given for up to 5 days
• If you are having this medicine after a heart operation, it will
usually only be given for up to 12 hours
Use in Children
• 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.
1 Primacor 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.
If you have more Primacor than you should
It is unlikely that your doctor or nurse will give you too much of
this medicine. Your doctor and nurse will check your progress
and the medicine that you are given. Always ask if you are not
sure why you are getting a dose of medicine. The following
effects may happen if you have too much Primacor: feeling dizzy,
light-headedness and fainting (due to low blood pressure) and
an uneven heartbeat.
If you forget to have Primacor
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 do think you
have missed a dose, tell your doctor or nurse.
If you stop having Primacor
Keep having Primacor until your doctor tells you to stop. Do not
stop having Primacor just because you feel better. If you stop,
your illness may get worse.
Tests
Your doctor or nurse will use an electrocardiogram (ECG) to
check how well your heart works. They will also carry out blood
tests and check your blood pressure and pulse rate.
If you have any further questions on the use of this product,
ask your doctor or nurse.
4. Possible side effects
Like all medicines, Primacor can cause side effects, although not
everybody gets them.
Stop having Primacor and tell you doctor straight away if:
• You have an allergic reaction. The signs may include: a rash,
swallowing or breathing problems, swelling of your lips, face,
throat or tongue, fainting or losing consciousness. The chances
of this happening are very rare
Tell a doctor or nurse straight away if you notice any of the
following side effects:
Common (affects less than 1 in 10 people)
• Uneven, increased or fast heartbeats. You may also experience
pounding in your chest, feel light-headed, faint or short of breath
Uncommon (affects less than 1 in 100 people)
• Ventricular fibrillation – a serious hearth rhythm problem. Signs
of this include very fast, uneven or forceful heartbeat
(palpitations), dizziness and loss of consciousness. You may also
feel sick, have cold sweats, shortness of breath and chest pain
• Thrombocytopenia – a blood problem. Signs of this are that
you may bruise more easily than usual
• Chest pain
Very rare (affects less than 1 in 10,000 people)
• Torsades de Pointes – a serious heart rhythm problem. Signs of
this include very fast, uneven or forceful heartbeat
(palpitations), dizziness and loss of consciousness. You may
also feel sick, have cold sweats, shortness of breath, unusual
pale complexion and chest pain
• Difficulty breathing, wheezing or tightness in the chest
Tell a doctor or nurse as soon as possible if you notice any of the
following side effects:
Common (affects less than 1 in 10 people)
• Low blood pressure. Signs of this include feeling dizzy, lightheaded or fainting. If you also notice signs like a fast or uneven
heartbeat or chest pain this could be a more serious side effect
(see above)
• Headache
Uncommon (affects less than 1 in 100 people)
• Feeling shaky
• Low levels of potassium in your blood. Signs of this are
tiredness, confusion, muscle weakness and muscle cramps.
This may be due to low levels of potassium in your body

Tell a doctor or nurse if any of the following side effects gets
serious or lasts longer than a few days
Very Rare (affects less than 1 in 10,000 people)
• Skin rashes including at the site of the injection
Uncommon (affects less than 1 in 100 people)
• A blood test may show changes in the way the liver is working
Talk to your doctor, nurse or pharmacist if any of the side effects
gets serious or lasts longer than a few days, or if you notice any
side effects not listed in this leaflet.
In addition to side effects observed in adults, the following were
reported in children:
Frequency not known:
• 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 is increased with the duration of the
Primacor infusion. Heart rhythm troubles seem to occur less
often in children than in adults.
5. How to store Primacor
This medicine will be kept by your doctor or pharmacist in a safe
place where children cannot see or reach it.
Do not use Primacor after the expiry date, which is stated on the
ampoule and the carton. The expiry date refers to the last day of
the month.
Primacor should be stored below 25°C. Do not freeze.
Medicines should not be disposed of via wastewater or
household waste. Your doctor or nurse will dispose of medicines
no longer required.
These measures will help to protect the environment.
6. Further Information
What Primacor contains
• Each 1 ml of injection contains 1 mg of the active substance,
milrinone
• The other ingredients are lactic acid, glucose anhydrous, water
for injection and sodium hydroxide (for pH adjustment)
What Primacor looks like and contents of the pack
Primacor is a clear, colourless to pale yellow liquid and is
available as 10 ml or 20 ml glass ampoules in boxes of 10.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie, 6 Boulevard
de l'Europe, 21800 Quetigny, France
This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in 04/2012
© Sanofi, 1989 – 2012

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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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