Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium chloride; Thrombin; Aprotinin; Fibrinogen
Baxter Healthcare Ltd
B02BC30
Calcium chloride; Thrombin; Aprotinin; Fibrinogen
20micromol/1ml ; 2unit/1ml ; 1500Kallikrein inactivator unit/1ml ; 45.5mg/1ml
Solution for sealant
Epilesional
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 05413760362472
OBJECT 1 ARTISS SOLUTIONS FOR SEALANT Summary of Product Characteristics Updated 18-Nov-2015 | Baxter Healthcare Ltd 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) Aprotinin (synthetic) 91 mg 1 /ml 3000 KIU 2 /ml Component 2: Thrombin Solution Human Thrombin Calcium Chloride 4 IU 3 /ml 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), 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) Aprotinin (synthetic) 45.5 mg 1,500 KIU 91 mg 3,000 KIU 182 mg 6,000 KIU 455 mg 15,000 KIU Component 2: Thrombin Solution Human Thrombin Calcium Chloride 2 IU 20 μmol 4 IU 40 μmol 8 IU 80 μmol 20 IU 200 μmol 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. 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. 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 indicated as an adjunct to hemostasis on subcutaneous tissue surfaces. 4.2 Posology and meth Przeczytaj cały dokument