title: [Pharmacovigilance study of a regional intravenous immunoglobulin].
abstract: BACKGROUND
  Intravenous immunoglobulin preparations are an effective therapy in several processes: primary and secondary immunodeficiencies, autoimmune and inflammatory disorders, infectious diseases and allergies, among others. This biological medicine must comply with three conditions: clinical tolerance, therapeutic efficacy and viral safety.
  
  
  OBJECTIVE
  The aim of this study was to assess the therapeutic efficacy, clinical tolerance and viral safety of a regional intravenous immunoglobulin, manufactured by the Hemoderivatives Laboratory of the National University of Cordoba in Argentina (Inmunoglobulina G Endovenosa UNC), with plasma obtained from voluntary, unremunerated donors from Argentina, Chile and Uruguay.
  
  
  METHODS
  The pharmacovigilance records of 448 infusions in 111 patients with different diseases were statistically evaluated. Clinical tolerance was evaluated by recording of adverse events, therapeutic efficacy was evaluated by taking into account the specific parameters of each disease, and viral safety was evaluated by analysis of serological markers of hepatitis B, hepatitis C and human immunodeficiency viruses before and after infusion.
  
  
  RESULTS
  Adverse effects were observed in 4.6 % of total infusions, of which 3.1 % were mild, 1.3 were moderate and 0.2 % were severe. The therapeutic efficacy of the product was recorded in all diseases in which it was administered. Regarding viral safety, no seroconversions were registered in any of the records evaluated.
  
  
  CONCLUSIONS
  The results of this study indicate that Inmunoglobulina G Endovenosa UNC is well tolerated, with good therapeutic efficacy and viral safety.
authors.affiliation: Laboratorio de Hemoderivados,Universidad Nacional de Córdoba, Córdoba, Argentina. amsisti@hemo.unc.edu.ar
authors.forename: A M
authors.initials: AM
authors.lastname: Sisti
authors.forename: A C
authors.initials: AC
authors.lastname: Mahieu
authors.forename: M J
authors.initials: MJ
authors.lastname: Manfredi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000707:Anaphylaxis / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D003953:Diagnosis-Related Groups; D005260:Female; D006525:Hepatitis, Viral, Human / Q000635:transmission; D006801:Humans; D007070:Immunoglobulin A / Q000009:adverse effects; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D011358:Product Surveillance, Postmarketing; D011537:Pruritus / Q000209:etiology; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D007070:Immunoglobulin A; D016756:Immunoglobulins, Intravenous