Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
human thrombin, Quantity: 3.2 IU/mL; calcium chloride dihydrate, Quantity: 36 micromole/mL
Baxter Healthcare Pty Ltd
Aprotinin,calcium chloride dihydrate,Factor XIII,Fibrinogen,Thrombin
Solution
Excipient Ingredients: sodium chloride; Albumin; water for injections
Topical
4 mL (2 mL sealer protein solution + 2 mL thrombin solution), 10 mL (5 mL sealer protein solution + 5 mL thrombin solution), 2 mL (1 mL sealer protein solution + 1 mL thrombin solution)
Not Scheduled after consideration by Committee
ARTISS is indicated to adhere autologous skin grafts in burn patients. ARTISS is indicated to adhere tissue flaps during rhytidectomy (face-lift). Artiss is not indicated for haemostasis
Visual Identification: ARTISS 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 Solution & Thrombin Solution.; 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
Registered
2010-08-19
ARTISS ((frozen) fibrin sealant syringe) Consumer Medicine Information ARTISS CMI 130624 Page 1 of 4 Baxter ARTISS WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about the ARTISS FIBRIN SEALANT, TWO- COMPONENT FIBRIN SEALANT, DEEP-FROZEN. 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 having ARTISS. It does not take the place of talking to your doctor or pharmacist. If you have any concerns about having this medicine, ask your doctor or pharmacist. WHAT ARTISS IS USED FOR? ARTISS is used as a tissue glue to join skin surfaces in burns surgery. ARTISS is also used to join skin surfaces in face-lift surgery. HOW DOES ARTISS WORK? The blood coagulation factors in the composition of ARTISS are the same as those found in normal healthy individuals. They are isolated from healthy human plasma, except aprotinin, which is synthetically made. The components are packed in a double-chamber syringe. One of the chambers 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 between 33°C -37°C just prior to use. BEFORE YOU ARE GIVEN ARTISS _ARTISS SHOULD NOT BE GIVEN TO YOU IF: _ you have a tendency to allergic reactions or hypersensitivity to aprotinin or any of the ingredients in this medicine (listed under _What is in ARTISS?)_ . 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 store or supermarket have previously received aprotinin or fibrin sealant, whether you are allergic or not to it _ _ _YOU MUST TELL YOUR DOCTOR IF YOU ARE PREGNANT, PLANNING TO Prečítajte si celý dokument
ARTISS (aprotinin, factor XIII, fibrinogen, thrombin, calcium chloride dihydrate) Version 1.0 1 of 16 AUSTRALIAN PRODUCT INFORMATION – ARTISS (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 ARTISS is a two-component fibrin sealant made from pooled human plasma. Each solution is presented in a separate preloaded chamber of one double-chamber syringe: chamber one [1] contains Sealer Protein Solution (with aprotinin), deep frozen (1 mL, 2 mL or 5 mL), chamber two [2] contains Thrombin Solution (with calcium chloride), deep frozen (1 mL, 2 mL or 5 mL), resulting in 2 mL, 4 mL or 10 mL total volume of product ready for use. Composition of the active ingredients of ARTISS: (1) SEALER PROTEIN SOLUTION: 1 mL of the solution contains: ACTIVE INGREDIENTS QUANTITY As total protein 96 – 125 mg Fibrinogen (Clottable Protein) 72 – 110 mg Factor XIII (human) 1.2 – 10 IU Aprotinin, synthetic (Fibrinolysis Inhibitor) 2250 – 3750 KIU 1 ARTISS contains Human Factor XIII co-purified with Human Fibrinogen in a range of 1.2 - 10.0 IU/mL. (2) THROMBIN SOLUTION: 1 mL of the solution contains: ACTIVE INGREDIENTS QUANTITY Thrombin (human) 3.2 – 5 IU 2 Calcium chloride dihydrate 36 – 44 µmol LIST OF EXCIPIENTS: Composition of the excipients of ARTISS: (1) SEALER PROTEIN SOLUTION : 1 mL of the solution contains human albumin (10 – 20 mg), histidine (10 – 25 mg), sodium citrate (4.8 – 9.7 mg), polysorbate 80 (0.6 – 1.9 mg), nicotinamide (3 – 9 mg) and Water for Injections q.s. to 1 mL. (2) THROMBIN SOLUTION : 1 mL of the solution contains human albumin (45 – 55 mg), sodium chloride (3.5 – 5.5 mg) and Water for Injections q.s to 1 mL. 1 KIU = Kallidinogenase Inactivator Unit 2 Thrombin activity is calculated using the current WHO International Standard for thrombin. ARTISS (aprotinin, factor XIII, fibrinogen, thrombin, calcium chloride Prečítajte si celý dokument