Peringatan Keamanan

During clinical studies the most frequently reported adverse reactions included headache, nausea, rigors, and dizziness FDA Label. Alternatively, although post-marketing experience has reported the following adverse reactions, the voluntary nature of their reporting means their frequency or possibility of causal relationships to use of the medication cannot be established reliably: infusion reactions (hypersensitivity including anaphylaxis, headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomforts, nausea, vomiting, rigors, back pain, myalgia, arthralgia, changes in blood pressure), renal reactions (acute renal dysfunction or failure, osmotic nephropathy), respiratory reactions (apnea, acute respiratory distress syndrome ARDS, TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm), cardiovascular reactions (cardiac arrest, thromboembolism, vascular collapse, hypotension), neurological reactions (coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome), integumentary reactions ( Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis)), hematologic reactions (pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs’) test), gastrointestinal reactions (hepatic dysfunction, abdominal pain), and pyrexia FDA Label.

Human vaccinia virus immune globulin

DB14112

biotech approved

Deskripsi

Human vaccinia immune globulin (VIG) is a sterile solution containing the purified gamma globulin (IgG) fraction of plasma taken from healthy donors previously vaccinated with live vaccinia virus vaccine who possess high titers of anti-vaccinia virus antibody FDA Label, A33814. The IgG fraction is purified by the anion-exchange column chromatography method and the solution is solvent/detergent-treated to sterilize the compound A33814. Most compounds used currently are intravenous formulations, which contain no preservatives - unlike prior intramuscular compounds which contained thiomersal, a mercury derivative preservative that could be potentially teratogenic A33814.

Nevertheless, VIG by virtue of the way it is produced is a poorly characterized and highly variable human product that is only available in very limited quantities - all factors that may intervene with its availability and effectiveness A33798, A33814.

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean half-life was determined to be a range from approximately 26 to 30 days [FDA Label].
Volume Distribusi The volume of distribution was determined to be approximately 6630 mL [FDA Label].
Klirens (Clearance) Readily accessible information regarding the clearance of intravenous human vaccinia virus immune globulin (VIGIV) is not available.

Absorpsi

In a phase 1, double-blind study with 60 healthy subjects randomized to receive either 6000 U/kg or 9000 U/kg of intravenous human vaccinia virus immune globulin (VIGIV), the mean peak plasma concentration after intravenous administration of 6000 U/kg to 31 healthy subjects was 161 U/mL achieved within 2 hours FDA Label. Furthermore, after remaining in circulation for a prolonged period of time, maximum plasma concentrations (Cmax) of VIGIV reached levels ranging from about 160 to 232 U/mL FDA Label.

Metabolisme

Readily accessible information regarding the metabolism of intravenous human vaccinia virus immune globulin (VIGIV) is not available.

Rute Eliminasi

Readily accessible information regarding the route oof elimination of vaccinia virus immune globulin (VIGIV) is not available.

Interaksi Obat

0 Data
Tidak ada data.

Referensi & Sumber

Artikel (PubMed)
  • PMID: 21197387
    Xiao Y, Isaacs SN: Therapeutic Vaccines and Antibodies for Treatment of Orthopoxvirus Infections. Viruses. 2010 Oct;2(10):2381-2403. doi: 10.3390/v2102381.
  • PMID: 15472814
    Hopkins RJ, Lane JM: Clinical efficacy of intramuscular vaccinia immune globulin: a literature review. Clin Infect Dis. 2004 Sep 15;39(6):819-26. doi: 10.1086/422999. Epub 2004 Aug 23.
  • PMID: 16716135
    Koleba T, Ensom MH: Pharmacokinetics of intravenous immunoglobulin: a systematic review. Pharmacotherapy. 2006 Jun;26(6):813-27. doi: 10.1592/phco.26.6.813.
  • PMID: 16564720
    Wittek R: Vaccinia immune globulin: current policies, preparedness, and product safety and efficacy. Int J Infect Dis. 2006 May;10(3):193-201. doi: 10.1016/j.ijid.2005.12.001. Epub 2006 Mar 27.

Contoh Produk & Brand

Produk: 1 • International brands: 0
Produk
  • Cnj-016
    Injection • 1 [iU]/1mL • Intravenous • US • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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