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PERFAN INJECTION 100 MG/20 ML CONCENTRATE FOR SOLUTION FOR INJECTION

Active substance(s): ENOXIMONE

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The following information is intended for medical or
healthcare professionals only:
Product Summary
Trade Name of the Medicinal Product
Perfan® Injection

Qualitative and Quantitative Composition
5 mg/ml solution of enoximone presented in ampoules containing 20 ml.

Pharmaceutical Form
Solution for injection

Clinical Particulars
Therapeutic Indications
Perfan® Injection is indicated for the treatment of congestive heart failure,
typically where cardiac output is reduced and filling pressures increased, in
patients who require intravenous therapy and who can be closely monitored.
The duration of therapy should depend on the patient‘s continued positive and
beneficial response. Sustained haemodynamic and clinical effects have been
observed in patients treated for up to 48 hours.

Posology and method of administration
Perfan® Injection is for intravenous administration (slow injection or continuous
infusion) and must be diluted before use.

Dilution
Perfan® Injection must be diluted with an equal volume of 0.9% sodium chloride
injection or water for injections before administration.
Do not use more dilute solutions or other diluents, particularly dextrose injection,
as crystal formation may occur.
Use only plastic containers or syringes for dilutions. Crystal formation has been
observed within approximately 1 hour after mixing Perfan® Injection in glass
containers or syringes.
Other drugs or fluids must not be mixed in the same container or administered
concomitantly in the same infusion line as Perfan® Injection.







PACKAGE LEAFLET: INFORMATION FOR THE USER

decreased production of urine (oliguria)
fluid retention (e.g. swollen ankles)
thrombophlebitis (an inflamed blood clot in a vein) at the site of injection
irritation
muscle pain in extremities (pain in the hands or feet)

Very rare (less than 1 in 10,000 patients):
• ventricular fibrillation (when your heart contracts in an uncoordinated way).
This is a very rare but very serious side effect that will require urgent emergency
treatment. It is more likely at doses of more than 3 mg/kg body weight.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the national reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

Perfan® Injection 100 mg/20 ml
Concentrate for Solution for Injection
Active substance: enoximone
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 Perfan® Injection is and what it is used for
2. Before you use Perfan® Injection
3. How to use Perfan® Injection
4. Possible side effects
5. How to store Perfan® Injection
6. Further information

5. HOW TO STORE PERFAN® INJECTION
Store below 30°C and keep out of the reach and sight of children.
Perfan® Injection should not be given to you after the expiry date which is stated on
the label after “Exp.:”. The expiry date refers to the last day of that month.
You should not be given Perfan® Injection if there are crystals in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What Perfan® 5 mg/ml Injection contains
• The active substance is enoximone
• The other ingredients are:
– ethanol
– sodium hydroxide
– propylene glycol
– water for injections

1. WHAT PERFAN® INJECTION IS AND WHAT IT IS USED FOR
Perfan® Injection contains a drug called enoximone. Perfan® Injection makes your
heart pump more strongly.
It is used to treat congestive heart failure (CHF) in adults. CHF is when your heart
cannot pump enough blood around your body. This leads to a build up of fluid in
your limbs, lungs and other organs.

2. BEFORE YOU USE PERFAN® INJECTION
Do not use Perfan® Injection
• if you are allergic (hypersensitive) to enoximone or any of the other ingredients
of Perfan® Injection. See Section 6 for a list of other ingredients.

In-use shelf-life

What Perfan® 5 mg/ml Injection looks like and contents of the pack

Chemical and physical in-use stability has been demonstrated for 24 hours at
5°C and 25°C. From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and conditions prior
to use are the responsibility of the user and would normally not be longer than
24 hours at room temperature unless dilution has taken place in controlled and
validated aseptic conditions. After dilution, the product must be stored at room
temperature. Dilutions must not be refrigerated as crystal formation may occur.

Perfan® Injection is a clear, bright yellow solution containing 5 mg/ml enoximone.
Perfan® Injection is supplied in 20 ml glass ampoules containing 100 mg enoximone.
Cartons containing 5 or 10 ampoules are provided.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
CARINOPHARM GmbH, Bahnhofstr. 18, 31008 Elze, Germany

Contact for medical information
Professional Information Limited, Olliver, Richmond, DL10 5HX, United Kingdom
carinopharm@ professionalinformation.co.uk
Phone: 0044 (0) 1748828812
Fax: 0044 (0) 1748828801

Take special care with Perfan® Injection if you have





a thickened heart muscle (hypertrophic cardiomyopathy)
narrowed or blocked heart valves (stenotic or obstructive valvular disease)
narrowed or blocked blood vessels (outlet obstruction)
severe congestive heart failure. You may have an increased risk for irregular
heart beat.
Use in children: Perfan® Injection is not recommended for use in children.

During treatment with Perfan® Injection,
you will have extra tests to check:
• your blood pressure and heart rate. If your blood pressure becomes too low,
you will be given Perfan® Injection more slowly, or it might be stopped.
• your heart rhythm. If you have an irregular heart beat, it can become more
irregular, and your heart might stop.

This leaflet was last revised in 10/2014.
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• your electrolyte levels (the amounts of different chemicals in your blood). In
particular your blood potassium levels will be monitored. If you have raised
p­ otassium levels you are more likely to get an irregular heartbeat (arrhythmia).
This is especially likely if you are taking digoxin (another heart medicine). The
doses of other drugs you are taking might be changed to keep your heart beat
regular.
• your fluid levels and your kidney function. These will be measured by blood
tests and by how much urine you produce. If you produce more urine your
d­ octor may need to reduce the dose of any diuretics (water tablets) you are
taking. If your fluid levels fall too low Perfan® Injection will not work for you.
• your blood platelets (a type of blood cell which helps your blood to clot)
• your liver enzyme levels. If you have increases in some liver enzyme levels your
doctor may stop your Perfan® Injection.

• you may feel faint
• you may feel sick
• your vision may become blurred
• you may feel that your heart is beating rapidly (palpitations).
If you develop any of these symptoms you must inform your doctor immediately.
Your dose of Perfan® Injection may be reduced or stopped. You will be given
treatment depending on your symptoms.

Taking other medicines

Like all medicines, Perfan® Injection can cause side effects, although not
everybody gets them.

Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
You must take special care if you are taking any of the following medicines:
• digoxin (a heart medicine)

Using Perfan® Injection with food and drink
You should ask your doctor about what you can eat or drink.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant or breast-feeding. If you are pregnant or breastfeeding, you should not be given Perfan® Injection unless it is clearly necessary.

Driving and using machines
Ask your doctor or pharmacist for advice.

Important information about some of the ingredients
of Perfan® Injection
This medicinal product contains small amounts (less than 100 mg/ml)
of ethanol (alcohol).
This medicinal product contains less than 1 mmol sodium (23 mg),
i.e. essentially ‘sodium-free’.

3. HOW TO USE PERFAN® INJECTION
You will be given Perfan® Injection by a doctor or nurse. Your doctor will decide
on how much you need and when it is to be given. The dose will depend on
the condition of your heart and your response to the drug, as well as, on the
concomitant therapies which you receive while you are on enoximone.
Perfan® Injection will be diluted before use.
Perfan® Injection will be given to you as a slow intravenous injection (injection into
a vein) or continuous infusion (drip into a vein over a longer period of time). You
will only be given Perfan® Injection if you are in hospital.
The duration of your treatment will depend on how you respond, which means
whether and how rapidly your heart condition will improve. You will normally be
given Perfan® Injection for less than 24 hours unless your heart condition requires
a longer duration of treatment.

If you think you have been given too much Perfan® Injection
If you are given too much Perfan® Injection:
• you may feel dizzy
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If you stop using Perfan® Injection
Your doctor will decide when to stop giving you this medicine.
If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS

If you have the following side effects tell your doctor immediately.
Your doctor may have to reduce your dose or stop giving you
­Perfan® Injection.
• ventricular tachycardia (rapid heart beat)
• supraventricular arrhythmia e.g. ectopia (extra heart beats) tachyarrhythmia
(disturbance of the heart rhythm also causing rapid heart beat). These are
uncommon but serious side effects and your doctor may stop your treatment.
• hypotension (low blood pressure). This is a common side effect and may cause
you to:
– feel dizzy, faint or sick
– have blurred vision
– feel that your heart is beating rapidly (palpitations)
The following side effects have also been reported with Perfan® Injection:
Common (less than 1 in 10, but more than 1 in 100 patients):
• insomnia (difficulty in sleeping)
• headache
• platelet count reduction (without symptoms)
• rise in liver enzyme levels (transaminases) and bilirubin (a bile pigment).
These can indicate liver problems.

Administration
Initial Therapy
Therapy should be initiated with a dose of 0.5–1.0 mg/kg given as a slow
intravenous injection (not faster than 12.5 mg/min); further doses of 0.5 mg/kg
may be given similarly every 30 minutes until a satisfactory response is achieved
or a total initial dose of 3.0 mg/kg is reached. Alternatively treatment may be
initiated as an infusion at a rate of 90 micrograms/kg/minute administered over
10–30 minutes until the required haemodynamic response is achieved.

Maintenance Therapy
To maintain the effects of Perfan® Injection the initial dose (not more than 3.0
mg/kg) may be repeated as required every 3–6 hours and adjusted according to
the response of the patient. Alternatively, a continuous or intermittent infusion at
a rate of 5–20 micrograms/kg/minute may be instituted.
The total dose over 24 hours should not normally exceed 24.0 mg/kg. In patients
with renal impairment the dosage or dosage frequency may need to be reduced.
Precautions should be taken to avoid venous extravasation during administration.
The pH of undiluted Perfan® Injection is approximately 12.0.
Perfan® Injection is not recommended for use in children.

Management of adverse reactions
Arrhythmias
The occurrence of severe supraventricular and ventricular arrhythmias may
require immediate discontinuation of Perfan® Injection and institution of
appropriate antiarrhythmic therapy.

Platelet count reduction
Platelet counts before and during therapy are recommended.

Gastrointestinal side effects
Severe gastrointestinal side effects may be managed by reducing dosage, or if
necessary, administration of Perfan® Injection may be temporarily interrupted.

Increases in hepatic enzyme levels
It is recommended to monitor patients for changes in hepatic enzyme levels. If
clinically significant increases in hepatic enzymes occur following the intravenous
administration of Perfan® Injection, therapy should be discontinued.

Uncommon (less than 1 in 100, but more than 1 in 1000 patients):
• dizziness
• vomiting (being sick)
• nausea (feeling sick)
• diarrhoea
• slight rise in blood glucose and alkaline phosphatase
• slight rise in leukocytes (white blood cells, particularly neutrophils and
­eosinophils)
• slight decrease in haematocrit (total volume of red blood cells) and
­haemoglobin (a red blood cell protein)
• slight rise in urea, creatinine or uric acid. These can indicate a kidney problem.
Rare (less than 1 in 1000, but more than 1 in 10,000 patients):
• fever
• chills
• inability to pass urine (urinary retention)
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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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