Source: Medicines & Healthcare Products Regulatory Agency (GB) Publisher: Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE United Kingdom
ARTISS Solutions for Sealant.
Deep froze.
| Pharmaceutical Form |
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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 |
Sealer Protein Solution
Human Fibrinogen (as clottable protein) 91 mg1/ml
Aprotinin (synthetic): 3000 KIU2/ml
Thrombin Solution
Human Thrombin: 4 IU3/ml
Calcium Chloride: 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) | 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 | 20 μmol | 40 μmol | 80 μmol | 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.
| Active Ingredient | Description | |
|---|---|---|
| Aprotinin |
Aprotinin is a broad spectrum protease inhibitor which has antifibrinolytic properties. By forming reversible stoichiometric enzyme-inhibitor complexes, aprotinin acts as an inhibitor of human trypsin, plasmin, plasma kallikrein and tissue kallikrein, thus inhibiting fibrinolysis. |
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| Calcium chloride |
Calcium is the most abundant mineral in the body, and is an essential body electrolyte. Homeostasis is mainly regulated by the parathyroid hormone, by calcitonin, and by the activated form of vitamin D. Calcium is a structural component of bones and teeth. It is also required for blood clotting, neurotransmitter release, muscle contraction and normal heartbeat. |
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| Human fibrinogen |
Human fibrinogen (coagulation factor I), in the presence of thrombin, activated coagulation factor XIII (F XIIIa) and calcium ions is converted into a stable and elastic three-dimensional fibrin haemostatic clot. The administration of human fibrinogen concentrate provides an increase in plasma fibrinogen level and can temporarily correct the coagulation defect of patients with fibrinogen deficiency. |
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| Thrombin |
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| List of Excipients |
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Component 1: Sealer Protein Solution Human Albumin Solution Component 2: Thrombin Solution Human Albumin Solution |
1 ml, 2 ml, or 5 ml of sealer protein solution and 1, 2 or 5 ml of Thrombin Solution in a single-use double-chamber syringe (polypropylene) with a tip-cap in a bag, and one device set with one double syringe plunger, 2 joining pieces and 4 application cannulae.
Pack size of 1 (1 × 1 ml + 1 ml, 1 × 2 ml + 2 ml, 1 × 5 ml + 5 ml)
Both Sealer Protein Solution and Thrombin Solution are contained in a single-use double-chamber syringe made of polypropylene.
Not all pack sizes may be marketed.
Other accessories for application of the product can be obtained from BAXTER.
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
PL 00116/0634
Date of First Authorisation: 11 March 2009
Date of Last Renewal: 23 December 2013
| Drug | Countries | |
|---|---|---|
| ARTISS | Austria, Canada, Spain, Finland, France, Hong Kong, Ireland, Singapore, Turkey, United Kingdom |
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