HEPARIN SODIUM 100 IU/ML. I.V FLUSH SOLUTION
Active substance: HEPARIN SODIUM
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B. PACKAGE LEAFLET
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Package leaflet: Information for the user Heparin sodium 100 IU/ml I.V. flush solution heparin sodium Please read all of this leaflet carefully before you start having 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 become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet Heparin sodium 10 IU/ml I.V. flush solution will be called Heparin flush. In this leaflet: 1. What Heparin flush is and what it is used for 2. Before you have Heparin flush 3. How to use Heparin flush 4. Possible side effects 5. How to store Heparin flush 6. Further information 1. WHAT HEPARIN FLUSH IS AND WHAT IT IS USED FOR Heparin flush belongs to a group of medicines called anticoagulants. It helps to stop the blood from clotting. Heparin flush is given into an intravenous (I.V.) line. This means it is injected into the tube connected to a vein to keep it clear by preventing the blood from clotting in it. It is not recommended for treatment of harmful blood clots in your body. 2. BEFORE YOU HAVE HEPARIN FLUSH Do not have Heparin flush If you are allergic (hypersensitive) to heparin or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet. If you know that you have, or have ever had, a big drop in the clotting cells (platelets) in your blood, caused by having any type of heparin (reaction called heparin-induced thrombocytopenia). Do not give this medicine to a premature baby, a newborn baby, or a baby up to a month old. Take special care with Heparin flush Before you have Heparin flush, tell your doctor: If you are pregnant or think you are pregnant. Read the section "Pregnancy and breast-feeding". If you are allergic (hypersensitive) to low molecular weight heparins, such as tinzaparin, enoxaparin or dalteparin. If this medicine is for a child who is between one month and three years old. If you know that you are sensitive to methylparahydroxybenzoate or propylparahydroxybenzoate. Read the information in the section "Important information about some of the ingredients of Heparin flush". If you have Heparin flush regularly for more than five days, your doctor may take regular blood tests. This is to check the level of platelets (a type of cell) in your blood while you have your
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medicine. Depending on the result the doctor may tell you to stop having this medicine straight away. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. Pregnancy and breast-feeding Unless your doctor has told you it is essential, you must not have Heparin flush if you are pregnant, or think you are pregnant. Read the information about benzyl alcohol in the section "Important information about some of the ingredients of Heparin flush". If you are pregnant or might be pregnant, tell your doctor before you are given Heparin flush. If you become pregnant while having this medicine, tell your doctor. If you are breast-feeding, ask your doctor for advice before having Heparin flush. Driving and using machines Usually your medicine may have little effect on your ability to drive or use machines. However, you should check with your doctor if you feel any side effect that may stop you from driving or using machines. Important information about some of the ingredients of Heparin flush This medicine contains: Benzyl alcohol. This is a preservative. It may harm a newborn baby. It must not be used in premature babies or babies under one month old. Methylparahydroxybenzoate and propylparahydroxybenzoate. These are preservatives. They may give you an allergic reaction. This may happen at any time after you have your medicine. Please read section 4 so you can spot any signs this may be happening to you. Sodium. This medicine is nearly "sodium free". Your medicine contains less than 23 milligrams (mg) of sodium in each 100 International Units (IU) dose. Please ask your doctor if you are worried about any of the ingredients in this medicine. 3. HOW TO USE HEPARIN FLUSH Heparin flush will be given to you by a doctor or nurse. Heparin flush should not be mixed with any other injection. How much Heparin flush to have Your doctor will prescribe the right dose for you. If you have more Heparin flush than you should You may start to haemorrhage (bleed severely). Please read section 4 so you can spot any signs this may be happening to you. You may be given another injection of a medicine called protamine sulphate. If you have any further questions about taking this medicine, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS When used as recommended the low dose of heparin reaching the blood is unlikely to have any effects on the body. However, information is given here on possible side effects. Important side effects to look out for You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction: You have difficulty breathing Your face or throat swell Your skin develops a severe rash
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You should tell your doctor straight away if you spot any of the following signs which mean you may be starting to bleed severely: Red or brown urine Black tarry stools Unusual bruising Bleeding from your nose, mouth or an Other possible side effects Bruising or bleeding more easily. Your blood may also form harmful clots. A big drop in clotting cells (platelets) in your blood may give you these symptoms. Your doctor can explain this more. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. 5. HOW TO STORE HEPARIN FLUSH Keep out of the reach and the sight of children. Do not use Heparin flush after the expiry date on the label. The expiry date is the last day of that month. Store below 25C. Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment. 6. FURTHER INFORMATION What Heparin flush contains The active ingredient is heparin sodium. This product contains 100 IU of heparin sodium in each millilitre (ml). The other ingredients are benzyl alcohol, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium chloride, sodium citrate and water for injections. You can find important information about some of the ingredients near the end of section 2, just before section 3. What Heparin flush looks like and contents of the pack Heparin flush is a clear, colourless or pale yellow liquid. This medicine comes in glass ampoules containing 2 ml. There are 10 ampoules in a carton. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Fannin (UK) Ltd 42-46 Booth drive, Park farm south Wellingborough northamptonshire NN8 6GT Manufacturer: LEO Pharmaceutical Products, DK 2750 Ballerup, Denmark. This leaflet was last revised in March 2008.
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Package leaflet: Information for the user Heparin sodium 100 IU/ml I.V. flush solution heparin sodium Please read all of this leaflet carefully before you start having 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 become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet Heparin sodium 10 IU/ml I.V. flush solution will be called Heparin flush. In this leaflet: 1. What Heparin flush is and what it is used for 2. Before you have Heparin flush 3. How to use Heparin flush 4. Possible side effects 5. How to store Heparin flush 6. Further information 1. WHAT HEPARIN FLUSH IS AND WHAT IT IS USED FOR Heparin flush belongs to a group of medicines called anticoagulants. It helps to stop the blood from clotting. Heparin flush is given into an intravenous (I.V.) line. This means it is injected into the tube connected to a vein to keep it clear by preventing the blood from clotting in it. It is not recommended for treatment of harmful blood clots in your body. 2. BEFORE YOU HAVE HEPARIN FLUSH Do not have Heparin flush If you are allergic (hypersensitive) to heparin or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet. If you know that you have, or have ever had, a big drop in the clotting cells (platelets) in your blood, caused by having any type of heparin (reaction called heparin-induced thrombocytopenia). Do not give this medicine to a premature baby, a newborn baby, or a baby up to a month old. Take special care with Heparin flush Before you have Heparin flush, tell your doctor: If you are pregnant or think you are pregnant. Read the section "Pregnancy and breast-feeding". If you are allergic (hypersensitive) to low molecular weight heparins, such as tinzaparin, enoxaparin or dalteparin. If this medicine is for a child who is between one month and three years old. If you know that you are sensitive to methylparahydroxybenzoate or propylparahydroxybenzoate. Read the information in the section "Important information about some of the ingredients of Heparin flush". If you have Heparin flush regularly for more than five days, your doctor may take regular blood tests. This is to check the level of platelets (a type of cell) in your blood while you have your
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medicine. Depending on the result the doctor may tell you to stop having this medicine straight away. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. Pregnancy and breast-feeding Unless your doctor has told you it is essential, you must not have Heparin flush if you are pregnant, or think you are pregnant. Read the information about benzyl alcohol in the section "Important information about some of the ingredients of Heparin flush". If you are pregnant or might be pregnant, tell your doctor before you are given Heparin flush. If you become pregnant while having this medicine, tell your doctor. If you are breast-feeding, ask your doctor for advice before having Heparin flush. Driving and using machines Usually your medicine may have little effect on your ability to drive or use machines. However, you should check with your doctor if you feel any side effect that may stop you from driving or using machines. Important information about some of the ingredients of Heparin flush This medicine contains: Benzyl alcohol. This is a preservative. It may harm a newborn baby. It must not be used in premature babies or babies under one month old. Methylparahydroxybenzoate and propylparahydroxybenzoate. These are preservatives. They may give you an allergic reaction. This may happen at any time after you have your medicine. Please read section 4 so you can spot any signs this may be happening to you. Sodium. This medicine is nearly "sodium free". Your medicine contains less than 23 milligrams (mg) of sodium in each 100 International Units (IU) dose. Please ask your doctor if you are worried about any of the ingredients in this medicine. 3. HOW TO USE HEPARIN FLUSH Heparin flush will be given to you by a doctor or nurse. Heparin flush should not be mixed with any other injection. How much Heparin flush to have Your doctor will prescribe the right dose for you. If you have more Heparin flush than you should You may start to haemorrhage (bleed severely). Please read section 4 so you can spot any signs this may be happening to you. You may be given another injection of a medicine called protamine sulphate. If you have any further questions about taking this medicine, please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS When used as recommended the low dose of heparin reaching the blood is unlikely to have any effects on the body. However, information is given here on possible side effects. Important side effects to look out for You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction: You have difficulty breathing Your face or throat swell Your skin develops a severe rash
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You should tell your doctor straight away if you spot any of the following signs which mean you may be starting to bleed severely: Red or brown urine Black tarry stools Unusual bruising Bleeding from your nose, mouth or an Other possible side effects Bruising or bleeding more easily. Your blood may also form harmful clots. A big drop in clotting cells (platelets) in your blood may give you these symptoms. Your doctor can explain this more. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. 5. HOW TO STORE HEPARIN FLUSH Keep out of the reach and the sight of children. Do not use Heparin flush after the expiry date on the label. The expiry date is the last day of that month. Store below 25C. Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment. 6. FURTHER INFORMATION What Heparin flush contains The active ingredient is heparin sodium. This product contains 100 IU of heparin sodium in each millilitre (ml). The other ingredients are benzyl alcohol, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium chloride, sodium citrate and water for injections. You can find important information about some of the ingredients near the end of section 2, just before section 3. What Heparin flush looks like and contents of the pack Heparin flush is a clear, colourless or pale yellow liquid. This medicine comes in glass ampoules containing 2 ml. There are 10 ampoules in a carton. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Fannin (UK) Ltd 42-46 Booth drive, Park farm south Wellingborough northamptonshire NN8 6GT Manufacturer: LEO Pharmaceutical Products, DK 2750 Ballerup, Denmark. This leaflet was last revised in March 2008.
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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
