PACKAGE LEAFLET: INFORMATION FOR THE USER. Active substance: enoximone

Transcription

1 PACKAGE LEAFLET 1

2 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 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. 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. - your electrolyte levels (the amounts of different chemicals in your blood). In particular your blood potassium levels will be monitored. If you have raised potassium levels you are more likely to get an irregular heartbeat (arrhythmia). This is especially likely if you are taking 2

3 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 doctor 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. Taking 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. 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 breast-feeding, 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 - you may feel faint 3

4 - 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. 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 Like all medicines, Perfan Injection can cause side effects, although not everybody gets them. 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. 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) decreased production of urine (oliguria) 4

5 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. 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 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 What Perfan 5 mg/ml Injection looks like and contents of the pack 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 Elze Germany 5

6 Phone: +49 (0) Fax: +49 (0) This leaflet was last revised in 08/ 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. In-use shelf-life 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, inuse 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. Administration Initial Therapy 6

7 Therapy should be initiated with a dose of 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 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 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. 7