Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Human fibrinogen; Aprotinin; Human factor xiii; Human thrombin; Calcium chloride
Baxter Holding B.V.
B02BC; V03AK
Human fibrinogen; Aprotinin; Human factor xiii; Human thrombin; Calcium chloride
.
Solution for sealant
Local hemostatics; Tissue adhesives
Marketed
2010-11-19
PACKAGE LEAFLET: INFORMATION FOR THE USER TISSEEL READY TO USE SOLUTIONS FOR SEALANT ACTIVE SUBSTANCES: Human fibrinogen, human thrombin, aprotinin, human factor XIII, calcium chloride PLEASE 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. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What TISSEEL is and what it is used for 2. What you need to know before you use TISSEEL 3. How to use TISSEEL 4. Possible side effects 5. How to store TISSEEL 6. Contents of the pack and other information 1. WHAT TISSEEL IS AND WHAT IT IS USED FOR WHAT TISSEEL IS The name of your medicine is TISSEEL. TISSEEL is a two-component tissue sealant, and it contains two of the proteins that make blood clot. These proteins are called fibrinogen and thrombin. When these proteins mix during application, they form a clot where the surgeon applies them. TISSEEL is prepared as two solutions (Sealer Protein Solution and Thrombin Solution), which mix when applied. WHAT TISSEEL IS USED FOR TISSEEL is a fibrin or tissue sealant. During surgery, tissues may bleed and it may not be possible for the surgeon to control this bleeding using stitches, or by applying pressure. TISSEEL is applied to the surface of tissues, either to control bleeding, or to stop (or prevent) leaks of other types of fluid, by creating a watertight seal. TISSEEL can also be applied to tension-free detached tissues to glue them together. TISSEEL can be used even if your blood does not clot properly, e.g. when you are being treated with heparin against thrombosis. The clot produced by TISSEEL is very similar to a natural blood clot and this means that it will dissolve naturally and leave no residue. However, aprotinin is added to increase the longevity of the clot and to prevent its premature dissolution. 2. WHA Lugege kogu dokumenti
Health Products Regulatory Authority 10 July 2020 CRN009TL0 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TISSEEL Ready to use Solutions for Sealant 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1: Sealer Protein Solution Human Fibrinogen (as clottable Protein) 91 mg 1 /ml Human Factor XIII 0.6 - 5 IU/ml Aprotinin 3000 KIU 2 /ml Component 2: Thrombin Solution Human Thrombin 500 IU 3 /ml Calcium Chloride 40 micromoles/ml For a full list of excipients, see section 6.1. 1 Contained in a total protein concentration of 110.5 mg/ml 2 1 EPU (European Pharmacopoeia Unit) corresponds to 1800 KIU (Kallidinogenase Inactivator Unit) 3 Thrombin activity is calculated using the current WHO International Standard for Thrombin. 1 prefilled double chamber syringe which contains Sealer Protein Solution (with Aprotinin), deep frozen 1 ml, 2 ml, or 5 ml, in one chamber and Thrombin Solution (with Calcium Chloride), deep frozen 1 ml, 2 ml, or 5 ml, in the other chamber results in 2 ml, 4 ml, or 10 ml total volume of product ready for use. 3 PHARMACEUTICAL FORM Solutions for Sealant Colourless to pale yellow and clear to slightly turbid solutions. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a coagulant producer for use as a tissue sealant and haemostatic, for surgical incisions, plastic surgical repairs, orthopaedic, traumatic, and dental surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TISSEEL is for topical (i.e., epilesional) use only, do not inject TISSEEL must not be applied intravascularly (see Section 4.3) The use of TISSEEL is restricted to experienced surgeons who have been trained in the use of TISSEEL. Posology: The amount of TISSEEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient. Health Products Regulatory Authority 10 July 2020 CRN009TL0 Page 2 of 16 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 m Lugege kogu dokumenti