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References & Adverse Incidents Reporting

References

  1. GelX Oral Spray Instructions for Use.
  2. Singh V, Singh AK. Oral mucositis. Natl J Maxillofac Surg. 2020 Jul-Dec;11(2):159-168. doi: 10.4103/njms.NJMS_10_20. Epub 2020 Dec 16. PMID: 33897175; PMCID: PMC8051654. [Available from https://pubmed.ncbi.nlm.nih.gov/33897175/ ] Accessed June 2024
  3. S.S. Shetty, M. Maruthi and V. Dhara et al. Oral Mucositis: Current knowledge and future directions [Available from: https://pubmed.ncbi.nlm.nih.gov/34758917] Accessed June 2024
  4. Biswal BM. Current trends in the management of oral mucositis related to cancer treatment. Malaysian J Med Sci. 2008; 15(3):4-13. Ld.
  5. Niculita O. et al. The efficacy of polyvinylpyrrolidone-Zn Gluconate and Taurine in the prevention of Oral Mucositis in Haematological Patients. Rev. Chim., 71 (8), 2020, 195-205
  6. Colita, A. et al. Single-center, open-label safety and efficacy. The efficacy of PVP-zinc gluconate and taurine gel (GelX) in prophylaxis and treatment of oral mucositis in children treated with chemotherapy. 15 patients GelX Oral Spray Poster at EHA, June 2015. Vienna.
  7. Dragomir, M. Single-center, open-label safety and efficacy ongoing study. Prevention and treatment of chemotherapy-induced oral mucositis in children with cancer. 15 patients treated with GelX Oral Spray. Poster presented at the ECCO Congress, Sep 2015. Vienna.
  8. Oral Cancer Foundation. Online [Available from: https://oralcancerfoundation.org/complications/mucositis/] Accessed June 2024
  9. Oral mucositis. The American Academy of Oral Medicine. [Available from: https://www.aaom.com/index.php?option=com_content&view=article&id=149:oral-mucositis&catid=22:patient-condition-information&Itemid=120. January 22, 2015.] Accessed June 2024
  10. Bell A, Kasi A. Oral Mucositis. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. [Available from: https://www.ncbi.nlm.nih.gov/books/NBK565848/  Accessed June 2024
  11. Lalla, R. et al. “Management of oral mucositis in patients with cancer.” Dental clinics of North America vol. 52,1 (2008): 61-77, doi:10.1016/j.cden.2007.10.002 Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2266835 Accessed June 2024
  12. Data on File. Galen Ltd.
  13. Data on File 01. Galen Ltd
  14. Oral mucositis. The American Academy of Oral Medicine. [Available from: https://www.aaom.com/index.php?option=com_content&view=article&id=149:oral-mucositis&catid=22:patient-condition-information&Itemid=120. January 22, 2015.] Accessed June 2024
  15. Dm+d Online. Accessed June 2024
  16. Zannier F et al. Effects of three products in the prevention and treatment of chemotherapy and radiation therapy-induced oral mucositis. Annals of Oncology annual conference. Submitted Abstracts Basic Science. Volume 30, Supplement 5, v20, October 01, 2019.
  17. Harris, DJ. et al. Putting evidence into practice: evidence-based interventions for the management of oral mucositis. Clin J Oncol Nurs. 2008 Feb;12(1):141-52. doi: 10.1188/08.CJON.141-152. Update in: Clin J Oncol Nurs. 2014;18 Suppl:80-96_ PMID: 18258584. [Available from: https://pubmed.ncbi.nlm.nih.gov/18258584/] Accessed June 2024
  18. Steinmann D, et al. Nursing Procedures for the Prevention and Treatment of Mucositis Induced by Cancer Therapies: Clinical Practice Guideline Based on an Interdisciplinary Consensus Process and a Systematic Literature Search. lntegr Cancer Ther. 2021 Jan­Dec;20: 1534735420940412. doi: 10_ 1177/1534735420940412. PMID: 33467951; PMCID: PMC7960907. [Available from: https://www.ncbi.nlm.nih.gov/pmdarticles/PMC7960907/] Accessed June 2024
  19. Brown, T J., Gupta, A. Management of Cancer Therapy-Associated Oral Mucositis. JCO Oncology Practice 2020 16:3, 103-109_ [Available from: https://ascoQubs_org/doi/10.1200/JOP.19.00652] Accessed June 2024
  20. Data on File 02. Galen Ltd

Adverse Incidents Reporting

Adverse incidents should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard.

Adverse incidents should also be reported to Galen Limited on 028 3833 4974, and select the customer services option, or e-mail customer.services@galen-pharma.com.

Medical information enquiries should also be directed to Galen Limited.