Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Human fibrinogen; Human thrombin; Calcium chloride; Aprotinin
Baxter Healthcare Limited
B02BC; V03AK
Human fibrinogen; Human thrombin; Calcium chloride; Aprotinin
4 ml
Solution for sealant
Product subject to prescription which may not be renewed (A)
Local hemostatics; Tissue adhesives
Marketed
2009-07-03
b PACKAGE LEAFLET: INFORMATION FOR THE USER ARTISS Solutions for Sealant Deep frozen Human Fibrinogen, Human Thrombin, Aprotinin, Calcium Chloride Dihydrate. 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 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. What is in this leaflet 1. What ARTISS is and what it is used for 2. What you need to know before you use ARTISS 3. How to use ARTISS 4. Possible side effects 5. How to store ARTISS 6. Contents of the pack and other information 1. What ARTISS is and what it is used for What ARTISS is ARTISS is a two-component fibrin 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. ARTISS is prepared as two solutions (Sealer Protein Solution and Thrombin Solution), which mix when applied. What ARTISS is used for ARTISS is a tissue sealant. ARTISS is applied to glue soft tissues in plastic, reconstructive and burn surgery. For example, ARTISS may be used to glue skin grafts or skin flaps to burn wounds or to glue skin to the underlying tissue in plastic surgery. Also artificial skin may be glued to wounds with ARTISS. The clot produced by ARTISS is very similar to a natural blood clot. This means that it will dissolve naturally and leave no residue. However, aprotinin (a protein, that delays dissolution of a clot) is added to increase the longevity of the clot and to prevent its premature dissolution. 2. What you need to know before you use ARTISS Do not use ARTISS: • if you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6). • ARTISS must not be used for mass Przeczytaj cały dokument
Health Products Regulatory Authority 30 January 2019 CRN008SF0 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ARTISS Solutions for Sealant, deep frozen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1: Sealer Protein Solution Human Fibrinogen (as clottable protein) 91 mg 1 /ml Aprotinin (synthetic) 3000 KIU 2 /ml Component 2: Thrombin Solution Human Thrombin 4 IU 3 /ml Calcium Chloride Dihydrate 40 µmol/ml 1 prefilled double chamber syringe which contains Sealer Protein Solution (with Aprotinin), deep frozen <1 ml><2 ml><5 ml>, in one chamber and Thrombin Solution (with Calcium Chloride Dihydrate), deep frozen <1 ml>< 2 ml><5 ml>, in the other chamber results in <2 ml><4 ml><10 ml> total volume of product ready for use. After mixing 1 ml 2 ml 4 ml 10 ml Component 1: Sealer protein solution Human Fibrinogen (as clottable protein) 45.5 mg 91 mg 182 mg 455 mg Aprotinin (synthetic) 1,500 KIU 3,000 KIU 6,000 KIU 15,000 KIU Component 2: Thrombin Solution Human Thrombin 2 IU 4 IU 8 IU 20 IU Calcium Chloride Dihydrate 20 mmol 40 mmol 80 mmol 200 mmol 1 Contained in a total protein concentration of 96-125 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 ARTISS contains Human Factor XIII co-purified with Human Fibrinogen in a range of 0.6 - 5 IU/ml. For the full list of excipients, see section 6.1. Health Products Regulatory Authority 30 January 2019 CRN008SF0 Page 2 of 16 3 PHARMACEUTICAL FORM Solutions for Sealant Deep frozen Colourless to pale yellow and clear to slightly turbid solutions. Component 1, Sealer Protein Solution: pH 6.5 – 8.0 Component 2, Thrombin Solution: pH 6.0 – 8.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ARTISS is indicated as a tissue glue to adhere/seal subcutaneous tissue in plastic, reconstructive and burn surgery, as a replacement or an adjunct to sutures or staples (see 5.1). In addition, ARTISS is Przeczytaj cały dokument