octagam® - Intravenous Human Immunoglobulin
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octagam® is a liquid, ready-to-use intravenous immunoglobulin (IVIg), first launched in 1995 as the initial solvent/detergent (S/D)-treated immunoglobulin developed by Octapharma.
Today, octagam® is available in two optimised concentrations and is produced using a consistent formulation and a robust manufacturing process. This results in a well-tolerated immunoglobulin therapy that is now available in over 80 countries worldwide..1-7
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The efficacy and tolerability of octagam® across multiple indications have been demonstrated in numerous clinical studies. Its quality and safety are ensured through a robust and well-established manufacturing process.3,4
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The efficacy and tolerability of octagam® in its indications are supported by numerous clinical studies.1,3,4,6,7 while its solid and reliable manufacturing guarantees quality and safety in every dose.3,4
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octagam® offers tailored immunoglobulin therapy with various vial sizes, two concentrations, and easy handling.3,4
Referencias
Frenzel W, Wietek S, Svae TE, Debes A, Svorc D. Tolerability and safety of Octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials . Int J Clin Pharmacol Ther. 2016 Nov;54(11):847-855. doi: 10.5414/CP202782. PMID: 27719744; PMCID: PMC5095453. [PubMed]
Debes A, Bauer M, Kremer S. Tolerability and safety of the intravenous immunoglobulin Octagam: a 10-year prospective observational study. Pharmacoepidemiol Drug Saf. 2007 Sep;16(9):1038-47. doi: 10.1002/pds.1449. PMID: 17636556. [PubMed]
octagam®5% - SPC (25.10.2023)
octagam®10% - SPC (30.05 2023)
Robak T, Mainau C, Pyringer B, Chojnowski K, Warzocha K, Dmoszynska A, Straub J, Imbach P. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam® 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9. doi: 10.1179/102453310X12719010991867. PMID: 20863431. [PubMed]
Ochs HD, Pinciaro PJ; Octagam Study Group. Octagam 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004 May;24(3):309-14. doi: 10.1023/B:JOCI.0000025453.23817.3f. PMID: 15114062. [PubMed]
Wietek S, Svorc D, Debes A, Svae TE. Tolerability and safety of the intravenous immunoglobulin octagam® 10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials. Hematology. 2018 May;23(4):242-247. doi: 10.1080/10245332.2017.1385892. Epub 2017 Oct 11. PMID: 29020871. [PubMed]
