Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
calcium chloride dihydrate, Quantity: 36 micromole/mL; human thrombin, Quantity: 400 IU/mL
Baxter Healthcare Pty Ltd
Aprotinin,calcium chloride dihydrate,Factor XIII,Fibrinogen,human thrombin
Solution
Excipient Ingredients: Albumin; sodium chloride; water for injections
Topical
10 mL ( 5 mL sealer protein solution + 5 mL thrombin solution), 2.0 mL (1mL sealer protein solution + 1mL thrombin solution), 4 mL (2 mL sealer protein solution + 2 mL thrombin solution)
Not Scheduled after consideration by Committee
TISSEL is indicated: - as adjunct to haemostasis during surgical procedures, when control of bleeding by conventional surgical techniques is ineffective or impractical; and - as a sealant as an adjunct for closure of colostomies. - as a sealant and/or adhesive for use in autologous chrondrocyte implantation (ACI) or matrix-induced autologous chondrocyte implantation (MACI) procedures. - for mesh fixation in non-iatrogenic abdominal wall hernia repair, as an alternative to sutures, staples or tacks.
Visual Identification: Tisseel is presented in a prefilled double-chamber syringe package with one set of sterile accessory devices (DUO SET), under deep-frozen state. The syringe is designed for simultaneous application of the Sealer protein Sol & Thrombin Sol; Container Type: Syringe; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below minus 18 degrees Celsius (deep freeze); Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2009-03-13
TISSEEL ((frozen) fibrin sealant syringe) Consumer Medicine Information _ _ TISSEEL CMI 111107 Page 1 of 4 Baxter TISSEEL WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about the TISSEEL Fibrin Sealant, Two- Component Fibrin Sealant, Deep-Frozen, Vapour Heated (VH) and Solvent Detergent (S/D) Treated [TISSEEL Fibrin Sealant]. It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks against the benefits for you of using TISSEEL. It does not take the place of talking to your doctor or pharmacist. If you have any concerns about using this medicine, ask your doctor or pharmacist. WHAT TISSEEL IS USED FOR? TISSEEL is used to help stop excessive blood loss during surgery by inducing clotting. This clot has also sealing and fixation properties. Thus, it can also be used as an aid to help in the closure of colostomies and as an aid in some cartilage repair procedures and for use in hernia repair procedures. HOW DOES TISSEEL WORK? The blood coagulation factors in the composition of TISSEEL are the same as those found in normal healthy individuals. They are isolated from healthy human plasma, except aprotinin, which is a synthetic component. The components are packed in a double-chamber syringe. One of the chamber contains Sealer Protein solution while the other contains Thrombin solution. The double-chamber syringe is stored in a deep frozen state. It will be warmed up to 33 ° C - 37 ° C just prior to use. BEFORE YOU ARE GIVEN TISSEEL _TISSEEL SHOULD NOT BE GIVEN TO YOU IF: _ • you have a tendency to allergic reactions or hypersensitivity to aprotinin. Some of the symptoms of an allergic reaction may include skin rash, swelling of the face, lips or tongue, which may cause difficulty swallowing or shortness of breath • the expiry date printed on the pack has passed _YOU MUST TELL YOUR DOCTOR IF YOU:_ • have any other illness • are taking any prescription medicine or any other medicines purchased from a pharmacy, health food Les hele dokumentet
TISSEEL (aprotinin, factor XIII, fibrinogen, thrombin, calcium chloride dihydrate) Version 1.0 1 of 18 AUSTRALIAN PRODUCT INFORMATION – TISSEEL (APROTININ, FACTOR XIII, FIBRINOGEN, THROMBIN, CALCIUM CHLORIDE DIHYDRATE) 1 NAME OF THE MEDICINE Aprotinin (synthetic), factor XIII, fibrinogen, thrombin and calcium chloride dihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredients of TISSEEL VH S/D are formulated as two sterile, deep-frozen solutions, the Sealer Protein Solution and Thrombin Solution (see Table 1 below for composition of TISSEEL). Each solution is presented in a separate preloaded chamber of one double-chamber syringe. The active ingredients are fractionated from pooled human plasma. TABLE 1: COMPOSITION OF TISSEEL SEALER PROTEIN SOLUTION THROMBIN SOLUTION Active Ingredients -Aprotinin (synthetic) -Factor XIII -Fibrinogen -Thrombin (human) -Calcium chloride dihydrate Excipients -Albumin (human) -Histidine -Nicotinamide -Polysorbate 80 -Sodium citrate -Water for Injections -Albumin (human) -Sodium chloride -Water for Injections TABLE 2: LIST OF ACTIVE INGREDIENTS AND ASSOCIATED QUANTITIES SEALER PROTEIN SOLUTION QUANTITY THROMBIN SOLUTION QUANTITY Active Ingredient Aprotinin (synth) Factor XIII Fibrinogen 2250 - 3750 KIU/mL 1.2 - 10 IU/mL 72 - 110 mg/mL Thrombin (human) Calcium chloride dihydrate 400 - 625 IU/mL 36 - 44 micromole/mL The two deep frozen solutions comprising TISSEEL must be defrosted prior to use. After thawing and warming up to 37 ºC, the two solutions are mixed during application (see DOSE AND METHOD OF ADMINISTRATION section, heading _Method of Application_ ). 3 PHARMACEUTICAL FORM Two-Component Fibrin Sealant, Deep-Frozen, Vapour Heated (VH) and Solvent Detergent (S/D) treated, TISSEEL VH S/D 1 . The 2 components of TISSEEL are colourless to pale yellow, opalescent when frozen and clear to slightly turbid solutions once defrosted. 1 The term ‘Vapour Heated (VH) and Solvent Detergent (S/D) treated’ is abbreviated as VH S/D TISSEEL (aprotinin, factor XIII, fibr Les hele dokumentet