Farklı sevofluran ürünleri ne kadar farklıdır?

Sevoşuran 1990 yılından bu yana anestezi pratiğinde, özellikle pediatrik hasta grubunda, sıklıkla kullanılan halojenli bir inhalasyon anesteziğidir. Ülkemizde kullanıma sunulmuş, iki ayrı firma tarafından üretilen iki farklı sevoşuran bulunmaktadır. Bunlar arasında hazırlama, paketleme ve sunum açısından belirgin farklılıklar vardır. Anestezi uzmanları preparatlar arasında seçim yaparken bilgi bombardımanı altında kalmakta ve zorluklar yaşamaktadır. Bu nedenle farklı preparat kullanımında dikkatli olunmalı, beklenmeyen bir etki görülmesi halinde hasta güvenliği ön planda tutulmalı ve otoritelere bildirilmelidir. Bu derlemede farklı sevoşuran preparatları hakkındaki literatür gözden geçirilmiş olup avantaj ve dezavantajlarının değerlendirilmesi amaçlanmıştır.

What is the difference between different sevoflurane products?

Sevoflurane is a halogenated inhalation anesthetic which is commonly used in anesthesia practice since 1990, especially in pediatric patient group. In our country there are two different sevoflurane in use, produced by two different companies. They have clear differences in terms of preparation, packaging and presentation. Anesthesiologists remain under information overload and have difficulties when choosing between preparations. Therefore, caution must be exercised in the use of different preparations, if an unexpected effect is found patient safety should be kept at the forefront and must be reported to the authorities. In this review the literature on the different preparations of sevoflurane is revised to evaluate the advantages and disadvantages.

___

  • 1. Kharasch ED, Subbarao GN, Cromack KR, Stephens DA, Saltarelli MD. Sevoflurane formulation water content influences degradation by Lewis acids in vaporizers. Anesth Analg 2009;108(6):1796-802.
  • 2. SEVORANE Likid %100 Ürün Kullanma Talimat›, Onaylama tarihi 08.01.2010, Abbott Laboratuarlar›, ‹stanbul, Türkiye.
  • 3. SOJOURN 250 mL Ürün Kullanma Talimat›, ADEKA ‹laç Sanayii, Samsun, Türkiye, Ruhsat Numaras› 23.01.2008-124/2
  • 4. Baker MT. Sevoflurane: are there differences in products? Anesth Analg 2007;104(6):1447-51.
  • 5. McLeskey CH. The science and art behind the enhanced stabilization of sevoflurane. Bull HK Coll Anaesthesiol 2006;15: 11-3.
  • 6. Dalbey W, Dunn B, Bannister R, et al. Acute effets of 10-minute exposure to hydrogen fluoride in rats and derivation of a short term exposure limit for humans. Regul Toxicol Pharmacol 1998; 27(3):207-16.
  • 7. Callan CM. Maker follows up on sevoflurane problem. J Clin Monit 1997;13(5):335.
  • 8. McLeskey CH. Anesthesiologist Executive Reports How Abbott Made Sevoflurane Safer Water Stops Formation of Highly Toxic Acid. Anesthesia Patient Safety Foundation Newsletter, Fall 2000, http://www.apsf.org/newsletters/html/2000/fall/09LtrHowSevoSafer. htm
  • 9. Abbott Laboratories, et al vs Baxter Pharmaceutical Products, Inc, et al. In the United States District court for the Northern district of Illinois Eastern Division. Case 1:01-cv- 01867, Document 244, Filed Sept 22, 2005.
  • 10. Baxter says wins Sevoflurane patent dispute with Abbott. http://articles.marketwatch.com /2005-09-23/news/30976273_1_ baxter-international-sevoflurane-patent
  • 11. McNeirney JC. The Mythology of Lewis acids, the need for water in Sevoflurane and the suitability of USP Type III amber glass as a container. Primal Critical Care information booklet page 3-6.
  • 12. O’Neill B, Hafiz MA, De Beer DA. Corrosion of Penlon sevoflurane vaporizers. Anaesthesia 2007;62(4):421.
  • 13. Gupta A, Ely J. Faulty sevoflurane vaporizer. Anaesthesia 2007; 62(4): 421
  • 14. Kharasch ED. Sevoflurane: The challenges of safe formulation. APSF Newsletter Fall 2007; 22: 48
  • 15. Lebel F. Baxter shares perspective on sevofluran safety. APSF Newsletter Winter 2008; 22: www.apsf.org/newsletters/html/ 2008/winter/index.htm
  • 16. McNeirney JC, Terrell RC. Minrad provides packaging perspective. APSF Newsletter Winter 2008; 22. www.apsf.org/newsletters/ html/2008/winter/index.htm
  • 17. Saltarelli M. Abbott addresses sevoflurane formulation. APSF Newsletter Winter 2008; 22: www.apsf.org/newsletters/html/ 2008/winter/index.htm
  • 18. Baker MT. Sevoflurane-Lewis Acid Stability. Anesth Analg 2009;108(6):1725-26.
  • 19. Mychaskiw G 2nd, Mayhew JF. "Dry" Sevoflurane and the Falling Sky (or Lack Thereof) Anesth Analg 2010;110(1): 254.
  • 20. Kharach ED, Subbaroa GN, Cromack KR, Stephens DA, Saltarelli MD. In response. Anesth Analg 2010;110(1):254-5.
  • 21. Shafer SL. In response Anesth Analg 2010;110(1):255-6.
  • 22. Urgent production information notice. Penlon sigma delta sevoflurane vaporizer, distributed by Baxter. 07/09/2006 http://www.mhra.gov.uk/home/groups/dts-iac/documents/fieldsafe tynotice/con2024731.pdf.
  • 23. Watkins A. Penlon clarifies vaporizer modifications. APSF Newsletter Winter 2008; 22: www.apsf.org/newsletters/html/ 2008/winter/index.htm .
  • 24. United States Patent # 6,074,668. Date of Patent Jun 13, 2000. Container for an Inhalation anesthetic.http://www.docstoc. com/docs/46525654/Container-For-An-Inhalation-Anesthetic--- Patent-6074668 son eriflim 09.09.2012
  • 25. U.S. Department Of Health And Human Services Food And Drug Administration Center For Drug Evaluation And Research Office Of Pharmaceutical Science Office Of Generic Drugs. Approved Drug Products With Therapeutic Equivalence Evaluations. 30th edition. 2010;s:13.
  • 26. U.S. Department Of Health And Human Services Food And Drug Administration Center For Drug Evaluation And Research Office Of Pharmaceutical Science Office Of Generic Drugs. Approved Drug Products With Therapeutic Equivalence Evaluations. 30th edition. 2010;s: 344.
  • 27. McNeirney JC. The Mythology of Lewis acids, the need for water in Sevoflurane and the suitability of USP Type III amber glass as a container. Primal Critical Care information booklet page 9-15.
  • 28. Lattas H, Plante M, Fortier LP, et al. Statement of Principles on Choosing inhalation anesthetics agents: An important occupational health and safety issue. Canadian Journal of Respiratory Therapy 2012;48:17-21.
  • 29. Heijbel H, Bjurstöm R, Jakobsson JG. Personnel breathing zone sevoflurane concentration adherence to occupational exposure limits in conjunction with filling of vaporisers. Acta Anesthesiol Scand 2010;54(9):1117-20.
Anestezi Dergisi-Cover
  • ISSN: 1300-0578
  • Yayın Aralığı: Yılda 4 Sayı
  • Başlangıç: 1993
  • Yayıncı: Betül Kartal
Sayıdaki Diğer Makaleler

Plesenta previa ve ablasyo plesenta olan iki gebede sezaryen için spinal anestezi

Özden DAŞ, Berrin GÜNAYDIN, NURAY BOZKURT, DEMET COŞKUN, Hakan DAYANIR

Dandy Walker sendromlu hastada genel anestezi uygulaması

Rüveyda İrem DEMİRCİOĞLU, Azra ÖZANBARCI, Safinaz KARABAYIRLI, Burhanettin USTA, Fatih ANDIRAN

Farklı sevofluran ürünleri ne kadar farklıdır?

Zekeriya ALANOĞLU, ÇİĞDEM YILDIRIM GÜÇLÜ, AHMET ONAT BERMEDE, NESLİHAN ALKIŞ

İnguinal herni operasyonlarında spinal anestezi ile paravertebral bvlok uygulamalarının Karşılaştırılması

Can BAHAR, Gülten ÜTEBEY, Onur ÖZLÜ

Çocuklarda üst ekstremite Tendon transfer cerrahisinde uygulanan interskalen bloğun postoperatif analjezik etkinliği

Yücel YÜCE, Banu AYHAN, Fatma SARICAOĞLU, Seda B. AKINCI, Gürsel LEBLEBİCİOĞLU, Ülkü AYPAR

Plesenta akreta vakalarında perioperatif anestezi yaklaşımı (Retrospektif analiz)

TÜLAY ÖZKAN SEYHAN, Mukadder ORHAN SUNGUR, Fatma DEMİRCAN, İbrahim KALELİOĞLU, Ahmet Cem İYİBOZKURT, Mert ŞENTÜRK

Sistemik lupus eritematozus hastalığına bağlı dördüncü dereceden nefropatisi olan bir gebede sezaryen anestezi yönetimi

AYÇA TAŞ TUNA, Berrin GÜNAYDIN, NURAY BOZKURT, Hakan DAYANIR, DEMET COŞKUN

Posttorakotomi ağrı yönetimi

Tarık PURTULOĞLU, Ali SIZLAN, Abdülkadir ATIM

İkiz gebede posterior reversible ensefalopati sendromu ve anestezi yönetimi

Mesut ERBAİ, Burhan DOST, Ömür ÖZTÜRK, Abdulkadir İSKENDER, YAVUZ DEMİRARAN

Ameliyathane ve servis çalışanlarında hepatit B, hepatit C ve HIV seroprevlalansının karşılaştırılması

Ümit Yaşar TEKELİOĞLU, MÜCAHİDE ESRA KOÇOĞLU, Akcan AKKAYA, Abdullah DEMİRHAN, İSMAİL NECATİ HAKYEMEZ, Tekin TAŞ, Hakan BAYIR, HASAN KOÇOĞLU