Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
human fibrinogen, human thrombin
Instituto Grifols, S.A.
B02BC
human fibrinogen, human thrombin
Antihemorrhagics
Hemostasis, Surgical
Supportive treatment in adults where standard surgical techniques are insufficient:for improvement of haemostasisas suture support in vascular surgery
Revision: 7
Authorised
2017-11-10
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER VERASEAL SOLUTIONS FOR SEALANT human fibrinogen/human thrombin 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What VeraSeal is and what it is used for 2. What you need to know before you are treated with VeraSeal 3. How VeraSeal is used 4. Possible side effects 5. How VeraSeal is stored 6. Contents of the pack and other information 1. WHAT VERASEAL IS AND WHAT IT IS USED FOR VeraSeal contains human fibrinogen and human thrombin, two proteins extracted from the blood that form a clot when they are mixed together. VeraSeal is used as a sealant during surgical operations in adults. It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH VERASEAL _ _ YOUR SURGEON MUST NOT TREAT YOU WITH VERASEAL - if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this medicine (listed in section 6). VeraSeal must not be applied inside blood vessels. VeraSeal must not be used to treat severe or rapid bleeding from an artery. WARNINGS AND PRECAUTIONS Allergic reactions are possible. Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure (e.g. light-headedness, fainting, blurred vision), and anaphylaxis (a severe reaction with a rapid onset). If these symptoms occur during surgery, the use of the medicine should be stopped immediately. VeraSeal spray application should only be used if it is possible to accurately judge the spray distance. The spray device should not be used closer than the recommend Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT VeraSeal solutions for sealant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1: Human fibrinogen 80 mg/ml Component 2: Human thrombin 500 IU/ml Produced from the plasma of human donors. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solutions for sealant. Frozen solutions. After thawing, the solutions are clear or slightly opalescent and colourless or pale yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Supportive treatment in adults where standard surgical techniques are insufficient: - for improvement of haemostasis. - as suture support: in vascular surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of this medicinal product. Posology The volume of VeraSeal to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient. The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications. Application of the product must be individualised by the treating physician. In clinical trials, the individual doses have typically ranged from 0.3 to 12 ml. For other procedures, larger volumes may be required. 3 The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area. The application can be repeated, if necessary. _Paediatric population _ The safety and efficacy of VeraSeal in children aged 0 to 18 years has not yet been established. Currently available data are described in section 5.1, but no recommendation on a posology can be made. Method of administration For epilesional use. For instructions on preparation of the medicinal product before administration, see section 6.6. The product should only be admin Прочетете целия документ