Monographie - Trastuzumab

Última actualización :
28/04/2024

Trastuzumab

Factores que influyen sobre la estabilidad

Nombre comercial

Los nombres comerciales son orientativos y los excipientes de la formulación pueden ser distintos dependiendo del país y del laboratorio fabricante.

Herceptin	Alemania, Arabia Saudita, Argentina, Australia, Austria, Bélgica, Brasil, Canadá, Chile, Colombia, Dinamarca, Ecuador, Egipto, Emiratos Árabes Unidos, España, Estados Unidos de América, Finlandia, Francia, Gran Bretaña, Grecia, Hungría, Irán, Irlanda, Islandia, Italia, Japón, Luxemburgo, Malasia, Marruecos, Marruecos, México, Noruega, Nueva Zelanda, Países Bajos, Polonia, Portugal, Rumania, Suecia, Suiza, Turquía
Herclon	Marruecos
Hertraz	Chile
Herzuma	Alemania, Bélgica, España, Estados Unidos de América, Francia, Gran Bretaña
Kanjinti	Alemania, Bélgica, España, Gran Bretaña
Trastuzumab Baxter	Nueva Zelanda
Trazimera	Gran Bretaña

Bibliografía : Trastuzumab

	Tipo	Publicación
2296	Laboratorio	Témocilline (Negaban®) - Résumé des caractéristiques du produit Eumedica 2017
2975	Póster	Nalenz H, Schoenhammer K, Dietel E, Heynen S.R, Grauschopf U, Mahler H.C. In-Use stability of herceptin for subcutaneous injection with different administration materials. ESCP 2014 2014
3077	Laboratorio	Trastuzumab (Herceptin®) – Summary of Product Characteristics Roche 2019
3113	Libro	Herceptin Compendium Suisse des m?dicaments 2010
3258	Periódico	Kaiser J, Krämer I. Physicochemical Stability of Diluted Trastuzumab Infusion Solutions in Polypropylene Infusion Bags. Int J Pharm Compound 2011 ; 15, 6 : 515-520.
3343	Póster	Vieillard V, da Silva R, Astier A, Paul M. Physicochemical stability of diluted trastuzumab solutions stored 6 months at 4°C. ECOP Congress, Budapest, Hungary 2012
3366	Periódico	Kwong Glover Z.W, Gennaro L, Yadav S, Demeule B, Wong P.Y, Sreedhara A. Compatibility and stability of pertuzumab and trastuzumab admixtures in i.v. infusion bags for coadministration. J Pharm Sci 2012 ; DOI 10.1002 / jps.23403
3386	Periódico	Paul M, Vieillard V, Da Silva Lemos R, Escalup L, Astier A. Long-term physico-chemical stability of diluted trastuzumab. Int J Pharm 2013 ; 448: 101-104.
3647	Laboratorio	Trastuzumab (Herceptin® 600 mg for subcutaneous injection) - Summary of Product Characteristics Roche 2019
3849	Periódico	Pabari R.M, Ryan B, Ahmad W, Ramtoola Z. Physical and structural stability of the monoclonal antibody, trastuzumab (Herceptin®), intravenous solutions. Curr Pharm Biotech 2013 ; 14, 2: 220-225.
4163	Periódico	Nalenz H, K?pf E, Dietel E. Prolonged In-Use Stability of Reconstituted Herceptin in Commercial Intravenous Bags. Int J Pharm Compound 2018 22;5:417-423
4191	Periódico	Vieillard V, Astier A, Paul M. Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at varioustemperatures. GaBI Journal 2018
4194	Periódico	Kim S.J, Lee J.W, Kang H.Y, Kim S.Y, Shin Y.K, Kim K.W, Oh J.S, Lim K.J, Kim J.Y. In-Use Physichochemical and Biological Stability of the Trastuzumab Biosimilar CT-P6 Upon Preparation for Intravenous Infusion. Bio Drugs 2018 32;619-625
4271	Periódico	Yun J, Kim J, Chung J, Hwang S-J, Park S-J. Extended Stability of Reconstituted and Diluted SB3 (Trastuzumab Biosimilar) Assessed by Physicochemical and Biological Properties Adv Ther 2019
4396	Periódico	Lueras A, Polozova A, Asbury D, Hippenmeyer J, Litowski J, Goss M, Breslin P, Crampton S. Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions. GaBI Journal 2020 ; 9, 1:
4477	Periódico	Crampton S, Polozoxa A, Asbury D, Lueras A, Breslin P, Hippenmeyer J, Litkowski J,,Goss M. Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentration and stress conditions. GaBI Journal 2020 ; 9, 1: 5-13.
4493	Periódico	Le Guyader G, Vieillard V, Paul M. Physicochemical stability study of MYL-1401O, a biosimilar of trastuzumab, following a transient temperature excursion. J Oncol Pharm Practice 2020
4649	Periódico	Davies L, Milligan K, Corris M, Clarke I, Dwyer P, Lee S-E, Teraoka J, Crouse-Zeineddini J, Hippenmeyer J. Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices. GaBI Journal 2021 ; 10, 4
4754	Periódico	Weiser S, Burns C, Zartler E Physicochemical stability of PF-05280014 (trastuzumab-qyyp; TrazimeraTM), a trastuzumab biosimilar, under extended in-use conditions. J Oncol Pharm Practice 2023 ;29,3:

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