Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
ALTEPLASE
Boehringer Ingelheim Limited
B01AD02
ALTEPLASE
2 Milligram
Pdr+Solv for soln for inf/inj
Product subject to prescription which may not be renewed (A)
alteplase
Marketed
2010-04-09
PACKAGE LEAFLET: INFORMATION FOR THE USER ACTILYSE ® CATHFLO ® 2 MG POWDER FOR SOLUTION FOR INJECTION AND INFUSION Alteplase READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Actilyse Cathflo is and what it is used for 2. What you need to know before you receive Actilyse Cathflo 3. How is Actilyse Cathflo administered 4. Possible side effects 5. How to store Actilyse Cathflo 6. Contents of the pack and other information 1. WHAT ACTILYSE CATHFLO IS AND WHAT IT IS USED FOR The active substance in Actilyse Cathflo is alteplase. It belongs to a group of medicines called thrombolytic agents. These medicines act by dissolving blood clots. 2. WHAT YOU NEED TO KNOW BEFORE YOU GET ACTILYSE CATHFLO YOU SHOULD NOT RECEIVE ACTILYSE CATHFLO • if you are allergic (hypersensitive) to the active substance alteplase, to gentamicin (a trace residue from the manufacturing process), to natural rubber (also called latex which is part of the packaging material) or to any of the other ingredients of this medicine (listed in section 6). YOUR DOCTOR WILL TAKE SPECIAL CARE WITH ACTILYSE CATHFLO • if you have had any allergic reaction other than a sudden life-threatening allergic reaction (severe hypersensitivity) to the active substance alteplase, to gentamicin (a trace residue from the manufacturing process), to natural rubber (also called latex which is part of the packaging material) or to any of the other ingredients of this medicine (listed in section 6). • if you have a bleeding in any part of the body • if in the past 48 hours you have had a condition that increases your risk of bleeding, including: - surgery - biopsy (a procedure for obtaining a tissue specimen) - punctur Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actilyse Cathflo 2 mg powder for solution for injection and infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial with powder contains: 2 mg alteplase (corresponding to 1,160,000 IU) Alteplase is produced by recombinant DNA technique using a Chinese hamster ovary cell-line. The specific activity of alteplase in-house reference material is 580,000 IU/mg. This has been confirmed by comparison with the second international WHO standard for t-PA. The specification for the specific activity of alteplase is 522,000 to 696,000 IU/mg. Each constituted vial will deliver 2 mg of alteplase. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection and infusion. The powder is presented as a colourless to pale yellow lyophilizate cake. The reconstituted preparation is a clear and colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Thrombolytic treatment of occluded central venous access devices including those used for haemodialysis The 2 mg vial is the only recommended presentation of alteplase for use in this indication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Actilyse Cathflo should be given as soon as possible after occlusion. The following dose guidelines apply. _Posology_ A dose of up to 2 mg alteplase administered up to two times for any one occlusion can be used to restore function of ports, single and multiple lumen catheters including those used for haemodialysis, which became dysfunctional due to thrombotic occlusion. For use in this indication reconstitution to a final concentration of 1 mg alteplase per ml is recommended. In patients with a body weight of 30 kg or more, a total dose of 2 mg alteplase in 2 ml of reconstituted solution should be instilled into the dysfunctional central venous access device. In patients with a body weight below 30 kg, the volume of reconstituted solution to be instilled into the dysfunctional central venous access devices should Lees het volledige document