This brand name is authorized in Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Malta, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States
The drug TISSEEL contains a combination of these active pharmaceutical ingredients (APIs):
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1
Human fibrinogen
UNII N94833051K - FIBRINOGEN HUMAN
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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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2
Aprotinin
UNII 04XPW8C0FL - APROTININ
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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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3
Thrombin
UNII 6K15ABL77G - HUMAN THROMBIN
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4
Calcium chloride dihydrate
UNII M4I0D6VV5M - CALCIUM CHLORIDE
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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. |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| B02BC | Local hemostatics | B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics |
| V03AK | Tissue adhesives | V Various → V03 All other therapeutic products → V03A All other therapeutic products |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 503215110023603, 503215110023703, 503215110023803, 503215110023903, 503215110024003, 503215110024103 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02326132, 02326175 |
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 172-MBE-1220 |
| Country: EE | Ravimiamet | Identifier(s): 1494660 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 78896 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 094485, 477970, 494352, 592362 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 67121475 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 222623, 222625, 222627 |
| Country: HK | Department of Health Drug Office | Identifier(s): 62819, 62820, 62821, 63006, 63007, 63008 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8965, 8974 |
| Country: MT | Medicines Authority | Identifier(s): AA1277/02001, AA565/89001, MA1277/01401, MA1277/01402, MA1277/01403 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 11582 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100219853, 100219920 |
| Country: SG | Health Sciences Authority | Identifier(s): 14707P |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8681413880919, 8681413880926, 8681413880933, 8681413880940, 8681413880957 |
| Country: US | FDA, National Drug Code | Identifier(s): 0338-8402, 0338-9560, 0338-9564, 0338-9568 |
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