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Human vaccinia virus immune globulin

Generic Name
Human vaccinia virus immune globulin
Brand Names
Cnj-016
Drug Type
Biotech
Unique Ingredient Identifier
7UB4J759TD

Overview

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 . The IgG fraction is purified by the anion-exchange column chromatography method and the solution is solvent/detergent-treated to sterilize the compound . 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 . 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 .

Indication

CNJ-016 Vaccinia Immune Globulin Intravenous Human (VIGIV) is indicated for the treatment and/or modification of: (a) eczema vaccinatum, (b) progressive vaccinia, (c) severe generalized vaccinia, (d) vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions, or (e) aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard .

Associated Conditions

  • Eczema Vaccinatum
  • Generalized vaccinia

Clinical Trials

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No clinical trials found for this drug

FDA Drug Approvals

Approved Product
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NDC Code
Route
Strength
Effective Date
Emergent BioSolutions Canada Inc.
60492-0173
INTRAVENOUS
1 [iU] in 1 mL
5/17/2019

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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No UK EMC drug information found for this drug.

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