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Bevacizumab sterility in multiple doses from a single use vial      
Yazarlar (5)
Prof. Dr. Kemal ÖRNEK Prof. Dr. Kemal ÖRNEK
Kırıkkale Üniversitesi, Türkiye
Zeynep Ceren Karahan
Türkiye
Ahmet Ergin
Fazıl Alper Tekeli
Türkiye
Oya Tekeli
Ankara Üniversitesi, Türkiye
Devamını Göster
Özet
BACKGROUND: Recent reports have demonstrated that refrigerated bevacizumab can be stored for up to 3 weeks at 4 degrees C without loss of efficacy. There have been no previous reports addressing bevacizumb's sterility when stored and used as multiple doses from a single-use vial.
OBJECTIVE: To evaluate the sterility of bevacizumab when used as multiple doses from a single-use vial.
METHODS: Four groups of vials were used to simulate the storage and use conditions for bevacizumab. Each group contained 11 doses of 0.2 mL of bevacizumab. One sample from each group was cultured once each day at 37 degrees C for 10 days; one sample from each group was left for 15 days. MacConkey agar, blood agar, thioglycollate broth, and Sabouraud medium were used to assess bacterial and fungal growth.
RESULTS: A total of 44 samples of bevacizumab were included in this study. Each sample was placed on 4 growth media for microbial readings. All samples were found to be negative for microbial growth. No significant differences were observed among the groups. Possible limitations of this study included the number of samples for each group and in vitro design of the study, which might have affected the growth of bacterial organisms.
CONCLUSIONS: Storage and multiple use of bevacizumab from single-use vials does not seem to result n microbial contamination.
Anahtar Kelimeler
bevacizumab | multidose | single-use vial sterility
Makale Türü Özgün Makale
Makale Alt Türü SSCI, AHCI, SCI, SCI-Exp dergilerinde yayımlanan tam makale
Dergi Adı ANNALS OF PHARMACOTHERAPY
Dergi ISSN 1060-0280 Wos Dergi Scopus Dergi
Dergi Tarandığı Indeksler SCI
Makale Dili İngilizce
Basım Tarihi 10-2008
Cilt No 42
Sayı 10
Sayfalar 1425 / 1428
Doi Numarası 10.1345/aph.1L270
BM Sürdürülebilir Kalkınma Amaçları
Atıf Sayıları
WoS 18
SCOPUS 22
Google Scholar 31
Bevacizumab sterility in multiple doses from a single use vial

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