ANNEX III LABELLING AND PACKAGE LEAFLET

Transcription

1 ANNEX III LABELLING AND PACKAGE LEAFLET 1

2 B. PACKAGE LEAFLET 2

3 PACKAGE LEAFLET 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 further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What Refludan is and what it is used for 2. Before you use Refludan 3. How to use Refludan 4. Possible side effects 5 Storing Refludan 6. Further information Refludan 20 mg powder for solution for injection or infusion lepirudin The active substance is lepirudin, a recombinant DNA product derived from yeast cells. 1 vial of Refludan contains 20 mg lepirudin. The other ingredients are mannitol and sodium hydroxyde. Refludan is a powder for solution for injection or infusion, available in packs of 1 or 10 vials. Not all pack sizes may be marketed. The marketing authorisation holder is Schering AG D Berlin, Germany The manufacturer is Aventis Behring GmbH, Emil-von-Behring- Straße 76, D Marburg, Germany. 1. WHAT REFLUDAN IS AND WHAT IT IS USED FOR Refludan is an antithrombotic medicine. Antithrombotics are medicines to prevent formation of blood clots (thrombosis). Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines. HIT type II is an illness which can occur after you have received heparin containing medicines. It constitutes a certain kind of allergy towards heparin. It may result in a too low number of blood platelets and/or clots in your blood vessels (thrombosis). This may additionally lead to deposition of clots in organs. 2. BEFORE YOU USE REFLUDAN Do not take Refludan: - if you are hypersensitive (allergic) to lepirudin, to hirudins or any of the other ingredients of Refludan. - if you are pregnant or breast feeding. 3

4 Take special care with Refludan: If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit. Thus, please tell your doctor if you have or have had: Recent puncture of large vessels or organs Anomaly of vessels or organs Recent stroke, accident or surgery involving the brain High blood pressure Inflammation of the inner membrane of the heart Advanced kidney disease Advanced bleeding tendency Recent major surgery Recent bleeding (e.g. in brain, stomach/intestine, eye, lung) Obvious signs of bleeding Recent active peptic ulcer Age > 65 years Please inform your doctor if you suffer from reduced kidney function or liver cirrhosis (advanced disease of the liver) for he will then reduce the dosage. You should also inform your doctor if you have ever received Refludan, hirudin or a hirudin analogue. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Refludan should not be administered to pregnant women or nursing mothers. Taking other medicines: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. Medicines given to break up clots or tablets to prevent clot formation (coumarins) may increase the risk of bleeding when given at the same time. 3. HOW TO USE REFLUDAN Your doctor will determine and control the dosage and duration of your treatment with Refludan according to your clinical condition, your body weight, and certain laboratory values. If you have the impression that the effect of Refludan is too strong or too weak, talk to your doctor or pharmacist. Refludan, once reconstituted with an appropriate solvent, will be administered into a vein, by injection and then by infusion. 4. POSSIBLE SIDE EFFECTS Like all medicines, Refludan can have side effects. Very common (> 1/ 10) -Bleeding Reported bleeding events include: anaemia or drop in the haemoglobin value without obvious source of bleeding, bruising, bleeding from puncture sites, nose bleeding, blood in urine, gastrointestinal bleeding, vaginal bleeding, rectal bleeding, pulmonary haemorrhage, bleeding into chest space and around the heart following surgery, bleeding into the brain. Severe bleeding and, in particular, intracranial bleeding may be fatal. In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1 % and intracranial bleeding in 0.2 % of patients. Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae. Rare (> 1/ , <1/ 1 000) 4

5 -Allergic skin reactions (including rash), itching, hot flushes, fever, chills. -Anaphylactic/oid reactions including urticaria, difficulty in breathing (e.g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema). In severe cases these may lead to shock and death. -Injection site reactions, including pain. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. 5. STORING REFLUDAN Keep out of the reach and sight of children. Do not store above 25 C. Do not freeze. Keep the container in the outer carton Do not use after the expiry date stated on the carton and the vial. Do not use Refludan if the reconstituted solution is cloudy or contains particles. Once reconstituted Refludan is to be used immediately. Any unused solution must be discarded appropriately. 5

6 6. FURTHER INFORMATION For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien Danmark Deutschland Ελλάδα ΛΑΠΑΦΑΡΜ Α.Ε. Μενάνδρου Αθήνα Τηλ.: +30 (0) España France Ireland Luxembourg/Luxemburg Nederland Norge Österreich Portugal Suomi/Finland Sverige 6

7 Ísland United Kingdom Italia This leaflet was last approved on {date} 7

8 < The following information is intended for medical or healthcare professionals only: Instructions for use and handling: General recommendations Reconstitution and further dilution must be carried out under sterile conditions. For reconstitution water for injections or sodium chloride 9 mg/ml (0.9 %) solution are to be used. For further dilution sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solutions are suitable. For rapid, complete reconstitution, inject 0.4 ml of diluent into the vacuum vial and shake it gently. On reconstitution a clear, colourless solution is usually obtained within less than 3 minutes. Do not use solutions which are cloudy or contain particles. The reconstituted solution is to be used immediately. The preparation should be warmed to room temperature before administration. Any unused solution must be discarded appropriately. For injection only polypropylene syringes may be used. Preparation of a Refludan solution with a concentration of 5 mg/ml For intravenous. bolus injection a solution with a concentration of 5 mg/ml is needed: Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 5 ml capacity) and further dilution to a total volume of 4 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution. The final solution is to be administered in a body weight-dependent fashion. Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. The final concentration of 2 mg/ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution. The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion. The perfusor syringe must be changed at least every 12 hours after the start of the infusion. 8

9 PACKAGE LEAFLET 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 further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What Refludan is and what it is used for 2. Before you use Refludan 3. How to use Refludan 4. Possible side effects 5 Storing Refludan 6. Further information Refludan 50 mg powder for solution for injection or infusion lepirudin The active substance is lepirudin, a recombinant DNA product derived from yeast cells. 1 vial of Refludan contains 50 mg lepirudin. The other ingredients are mannitol and sodium hydroxyde. Refludan is a powder for solution for injection or infusion, available in packs of 1 or 10 vials. Not all pack sizes may be marketed. The marketing authorisation holder is Schering AG D Berlin, Germany The manufacturer is Aventis Behring GmbH, Emil-von-Behring- Straße 76, D Marburg, Germany. 1. WHAT REFLUDAN IS AND WHAT IT IS USED FOR Refludan is an antithrombotic medicine. Antithrombotics are medicines to prevent formation of blood clots (thrombosis). Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines. HIT type II is an illness which can occur after you have received heparin containing medicines. It constitutes a certain kind of allergy towards heparin. It may result in a too low number of blood platelets and/or clots in your blood vessels (thrombosis). This may additionally lead to deposition of clots in organs. 2. BEFORE YOU USE REFLUDAN Do not take Refludan: - if you are hypersensitive (allergic) to lepirudin, to hirudins or any of the other ingredients of Refludan. - if you are pregnant or breast feeding. Take special care with Refludan: 9

10 If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit. Thus, please tell your doctor if you have or have had: Recent puncture of large vessels or organs Anomaly of vessels or organs Recent stroke, accident or surgery involving the brain High blood pressure Inflammation of the inner membrane of the heart Advanced kidney disease Advanced bleeding tendency Recent major surgery Recent bleeding (e.g. in brain, stomach/intestine, eye, lung) Obvious signs of bleeding Recent active peptic ulcer Age > 65 years Please inform your doctor if you suffer from reduced kidney function or liver cirrhosis (advanced disease of the liver) for he will then reduce the dosage. You should also inform your doctor if you have ever received Refludan, hirudin or a hirudin analogue Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Refludan should not be administered to pregnant women or nursing mothers. Taking other medicines: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. Medicines given to break up clots or tablets to prevent clot formation (coumarins) may increase the risk of bleeding when given at the same time. 3. HOW TO USE REFLUDAN Your doctor will determine and control the dosage and duration of your treatment with Refludan according to your clinical condition, your body weight, and certain laboratory values. If you have the impression that the effect of Refludan is too strong or too weak, talk to your doctor or pharmacist. Refludan, once reconstituted with an appropriate solvent, will be administered into a vein, by injection and then by infusion. 4. POSSIBLE SIDE EFFECTS Like all medicines, Refludan can have side effects. Very common (> 1/ 10) -Bleeding Reported bleeding events include: anaemia or drop in the haemoglobin value without obvious source of bleeding, bruising, bleeding from puncture sites, nose bleeding, blood in urine, gastrointestinal bleeding, vaginal bleeding, rectal bleeding, pulmonary haemorrhage, bleeding into chest space and around the heart following surgery, bleeding into the brain. Severe bleeding and, in particular, intracranial bleeding may be fatal. In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1 % and intracranial bleeding in 0.2 % of patients. Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae. Rare (> 1/ , <1/ 1 000) -Allergic skin reactions (including rash), itching, hot flushes, fever, chills. 10

11 -Anaphylactic/oid reactions including urticaria, difficulty in breathing (e.g. consisting of spasms), cough, sharp sound when breathing, build-up of water in the body and in the inner wall of a vessel (including: face oedema, tongue oedema, throat oedema). In severe cases these may lead to shock and death. -Injection site reactions, including pain. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. 5. STORING REFLUDAN Keep out of the reach and sight of children. Do not store above 25 C. Do not freeze. Keep the container in the outer carton Do not use after the expiry date stated on the carton and the vial. Do not use Refludan if the reconstituted solution is cloudy or contains particles. Once reconstituted Refludan is to be used immediately. Any unused solution must be discarded appropriately. 11

12 6. FURTHER INFORMATION For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien Danmark Deutschland Ελλάδα ΛΑΠΑΦΑΡΜ Α.Ε. Μενάνδρου Αθήνα Τηλ.: +30 (0) España France Ireland Luxembourg/Luxemburg Nederland Norge Österreich Portugal Suomi/Finland Sverige 12

13 Ísland United Kingdom Italia This leaflet was last approved on {date} 13

14 < The following information is intended for medical or healthcare professionals only: Instructions for use and handling : General recommendations Reconstitution and further dilution must be carried out under sterile conditions. For reconstitution water for injections or sodium chloride 9 mg/ml (0.9 %) solution are to be used. For further dilution sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solutions are suitable. For rapid, complete reconstitution, inject 1 ml of diluent into the vacuum vial and shake it gently. On reconstitution a clear, colourless solution is usually obtained within less than 3 minutes. Do not use solutions which are cloudy or contain particles. The reconstituted solution is to be used immediately. The preparation should be warmed to room temperature before administration. Any unused solution must be discarded appropriately. For injection only polypropylene syringes may be used. Preparation of a Refludan solution with a concentration of 5 mg/ml For intravenous bolus injection a solution with a concentration of 5 mg/ml is needed: Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution. The final solution is to be administered in a body weight-dependent fashion. Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. The final concentration of 2 mg/ml is obtained by transfer of both solutions into one sterile, single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution. The infusion speed of the perfusor automate is to be set in a body weight-dependent fashion. The perfusor syringe must be changed at least every 12 hours after the start of the infusion. 14