PMID- 17173840
OWN - NLM
STAT- MEDLINE
DCOM- 20070308
LR  - 20191110
IS  - 0301-0546 (Print)
IS  - 0301-0546 (Linking)
VI  - 34
IP  - 6
DP  - 2006 Nov-Dec
TI  - Pharmacovigilance study of a regional intravenous immunoglobulin (II): evaluation 
      and comparison of an improved pharmaceutical form.
PG  - 242-7
AB  - INTRODUCTION: Intravenous immunoglobulin (IVIG) therapy is an effective treatment 
      in patients with different diseases. This product must comply with all the 
      regulatory requirements established by the World Health Organization and the 
      European Pharmacopoeia for clinical tolerance, therapeutic efficacy, and viral 
      safety. Although IVIG are effective and safe products, in some patients they may 
      cause adverse reactions. OBJECTIVES: The aim of this study was to assess the 
      clinical tolerance of two pharmaceutical forms (lyophilized and liquid) of 
      Imunoglobulina G Endovenosa UNC (IVIG UNC), a regional IVIG preparation, and to 
      compare the reported data. PATIENTS AND METHODS: The pharmacovigilance reports of 
      149 infusions in 51 patients treated with lyophilized IVIG UNC and of 157 
      infusions in 53 patients treated with liquid IVIG UNC were statistically 
      evaluated. Clinical tolerance was evaluated through the adverse reactions 
      reported. RESULTS: Lyophilized IVIG UNC: adverse reactions were reported in 6.7 % 
      of the total number of infusions. Of these reactions, 4.0 % were mild, 2.0 % were 
      moderate, and 0.7 % severe. Liquid IVIG UNC: adverse reactions were reported in 
      3.2 % of the total number of infusions; of these, 1.3 % were mild, 1.9 % were 
      moderate, and 0.0 % were severe. Statistical analysis showed no association 
      between tolerance and the pharmaceutical form used (p > 0.05) and indicated 
      similar tolerance for both preparations. CONCLUSIONS: Based on the results 
      obtained, the excellent clinical tolerance of both pharmaceutical forms of IVIG 
      UNC can be confirmed.
FAU - Mahieu, A C
AU  - Mahieu AC
AD  - Laboratorio de Hemoderivados, Universidad Nacional de Cordoba, Avda. Valparaiso 
      s/n, Ciudad Universitaria, X5000 HRA Cordoba, Argentina. caromah@hemo.unc.edu.ar
FAU - Sisti, A M
AU  - Sisti AM
FAU - Joekes, S
AU  - Joekes S
FAU - Manfredi, M J
AU  - Manfredi MJ
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - Singapore
TA  - Allergol Immunopathol (Madr)
JT  - Allergologia et immunopathologia
JID - 0370073
RN  - 0 (Immunoglobulins, Intravenous)
RN  - 0 (Powders)
RN  - 0 (Solutions)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Argentina
MH  - Autoimmune Diseases/therapy
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Freeze Drying
MH  - Humans
MH  - Immunoglobulins, Intravenous/administration & dosage/adverse 
      effects/chemistry/*therapeutic use
MH  - Immunologic Deficiency Syndromes/therapy
MH  - Infant
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Mucocutaneous Lymph Node Syndrome/therapy
MH  - Powders
MH  - Product Surveillance, Postmarketing
MH  - Retrospective Studies
MH  - Solutions
EDAT- 2006/12/19 09:00
MHDA- 2007/03/09 09:00
CRDT- 2006/12/19 09:00
PHST- 2006/12/19 09:00 [pubmed]
PHST- 2007/03/09 09:00 [medline]
PHST- 2006/12/19 09:00 [entrez]
AID - 13095871 [pii]
AID - 10.1157/13095871 [doi]
PST - ppublish
SO  - Allergol Immunopathol (Madr). 2006 Nov-Dec;34(6):242-7. doi: 10.1157/13095871.