Peringatan Keamanan

Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa L2079. Data regarding overdosage are not available. The predominant adverse reaction associated with thrombin alfa is the possibility of thrombosis or other thromboembolic events occurring FDA Label.

Thrombin alfa

DB11572

biotech approved

Deskripsi

Thrombin Alfa is a human coagulation protein produced via recombinant DNA technology from a genetically modified CHO cell line. Thrombin Alfa is identical in amino acid sequence and structurally similar to naturally occurring human thrombin. Thrombin Alfa precursor is secreted to culture medium as single chain form that is proteolytically converted to a two-chain active form (using a protein derived from snakes) and is purified by a chromatographic process that yields a product having hemostatic activities similar to native human thrombin. The cell line used to manufacture Thrombin Alfa has been tested and shown to be free of known infectious agents. The cell culture process used in the manufacture of Thrombin Alfa employs no additives of human or animal origin. The purification process includes solvent-detergent treatment and nano-filtration steps dedicated to viral clearance. The thrombin alfa product ultimate comes from recombinant human prethrombin-1 L2079.

Nevertheless, because the incidence of hemostasis within a timely manner is relatively comparable between the use of thrombin alfa and the placebo treatment in patient subjects, thrombin alfa is not currently approved by certain organizations like the European Medicines Agency L2079.

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) Following intravenous administration, thrombin alfa exhibited an initial half-life of 0.17 hours (10.2 min) [L2079]. Following either intravenous or subcutaneous administration, the agent demonstrated a terminal half-life of about 15 hours [L2079]. This data follows administration of thrombin alfa to cynomolgus monkeys.
Volume Distribusi Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa [L2079]. Volume of distribution data is subsequently not readily available.
Klirens (Clearance) Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa [L2079]. Regardless, thrombin alfa, like natural thrombin, is known to be rapidly neutralized by naturally circulating plasma inhibitors limiting its duration of action and preventing the active form from diffusing into the general circulation [L2079].

Absorpsi

Traditional absorption, distribution, metabolism, and excretion studies were not/have not been performed for thrombin alfa L2079. Nevertheless, observations of a subcutaneous administration of 350 U rhThrombin/kg resulted in a bioavailability of approximately 95% in male cynomolgus monkeys L2079.

Metabolisme

Much like endogenous thrombin, thrombin alfa does not circulate in the blood as a free, active molecule for very long FDA Label. After performing its function it is rapidly inactivated after formation of complexes with various circulating endogenous plasma inhibitors (like antithrombin III) FDA Label, L2079. This rapid inactivation prevents the active agent from diffusing into the general circulation. The complexes formed are then generally cleared and eliminated by the liver FDA Label, L2079.

Rute Eliminasi

Thrombin alfa, like endogenous thrombin, is cleared by two primary separate pathways: (1) through rapid formation of thrombin inhibitor complexes, which are recognized by hepatic receptors and degraded, and (2) via direct binding to thrombomodulin on the endothelium, followed by internalization and degradation L2079. Specific thrombin inhibitors include ATIII, alpha-2M and heparin cofactor II L2079.

Interaksi Obat

0 Data
Tidak ada data.

Target Protein

Coagulation factor V F5
Coagulation factor VIII F8
Fibrinogen alpha chain FGA
Fibrinogen beta chain FGB
Fibrinogen gamma chain FGG

Referensi & Sumber

Artikel (PubMed)
  • PMID: 17635715
    Crawley JT, Zanardelli S, Chion CK, Lane DA: The central role of thrombin in hemostasis. J Thromb Haemost. 2007 Jul;5 Suppl 1:95-101. doi: 10.1111/j.1538-7836.2007.02500.x.

Contoh Produk & Brand

Produk: 11 • International brands: 0
Produk
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    Kit • 1000 [iU]/1mL • Topical • US • Approved
  • Recothrom
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  • Recothrom
    Kit; Powder, for solution • 1000 [iU]/1mL • Topical • US • Approved
  • Recothrom
    Kit; Powder, for solution • 1000 [iU]/1mL • Topical • US • Approved
  • Recothrom
    Kit; Powder, for solution • 1000 [iU]/1mL • Topical • US • Approved
  • Recothrom
    Kit • 1000 [iU]/1mL • Topical • US • Approved
Menampilkan 8 dari 11 produk.

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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