藥品參考
Ex vivo expanded autologous human corneal epithelial cells containing stem cells
Ex vivo expanded autologous human corneal epithelial cells containing stem cells is a medicine in the class miscellaneous.
- 藥物類別: Miscellaneous
最後更新 來源: EMA SmPC
僅供醫療專業人員參考。本頁為簡要摘要,並非醫療建議,亦不能取代官方仿單或臨床判斷。開立處方或調劑前請務必核實。
本頁的臨床內容僅提供英文版。
重點資訊
- 藥物類別
- Miscellaneous
- ATC 代碼
- S01XA19
- 已知交互作用
- 2 (嚴重: 2)
- 商品名
- 1
- 國家與市場
- 1
作用方式
Replaces corneal epithelium and lost limbal stem cells in patients whose limbus has been destroyed by ocular burns. The administered stem cells multiply, differentiate and migrate to regenerate corneal epithelium and maintain a stem cell reservoir.
成人常用劑量(仿單摘要)
Moderate to severe limbal stem cell deficiency due to ocular burns: 79,000 - 316,000 cells/ cm², corresponding to 1 cm² of product/cm² of defect, by implantation, single treatment; may be repeated if the treating physician considers it indicated
懷孕與哺乳
- 懷孕
- Unknown Corneal implant of the patient's own stem cells (Holoclar), applied to one eye. No data in pregnancy and no animal studies; little or no systemic exposure is expected. EU label: as a precaution, avoid implantation during pregnancy.
- 哺乳
- Unknown No data. Little or no exposure of the infant is expected from an eye implant. EU label: not recommended to implant while breastfeeding, as a precaution; the eye medicines given after surgery should also be checked.
已通報的副作用
- Eye pain
- Corneal epithelium defect
- Conjunctival haemorrhage
- Glaucoma / increased intraocular pressure
- Corneal perforation
- Ulcerative keratitis
禁忌症
- Hypersensitivity to any of the excipients or to bovine serum and murine 3T3-J2 cells
哪些人需要特別留意
- For autologous use only; must never be given to other patients or if labels and lot number do not match the patient's identity
- Risk of transmission of infectious agents; monitor patients for signs and symptoms of infection after treatment
- Contains lethally-irradiated murine 3T3 fibroblast cells and may contain traces of foetal bovine serum; do not treat patients with known hypersensitivity to mice or foetal bovine serum
請告知藥師或醫師您是否懷孕或哺乳、是否患有腎臟或肝臟疾病、是否有過敏,以及您正在使用的所有其他藥物或保健品。
重要交互作用 (2)
Pro+ 會員專屬
解鎖完整頁面
建立帳號並開始 Pro+ 試用,即可開啟 Ex vivo expanded autologous human corneal epithelial cells containing stem cells 的完整藥品專論:劑量、懷孕與哺乳、副作用、警示及所有交互作用。
- Dosing by age, kidney and liver function, and further dose lines
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
在網頁版免費試用 Pro+ 14 天,無需信用卡。
常見問題
What is Ex vivo expanded autologous human corneal epithelial cells containing stem cells used for?
Ex vivo expanded autologous human corneal epithelial cells containing stem cells is a medicine in the class miscellaneous.
What side effects have been reported with Ex vivo expanded autologous human corneal epithelial cells containing stem cells?
Eye pain, Corneal epithelium defect, Conjunctival haemorrhage, Glaucoma / increased intraocular pressure, Corneal perforation, Ulcerative keratitis.
Can Ex vivo expanded autologous human corneal epithelial cells containing stem cells be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Corneal implant of the patient's own stem cells (Holoclar), applied to one eye. No data in pregnancy and no animal studies; little or no systemic exposure is expected. EU label: as a precaution, avoid implantation during pregnancy. Breastfeeding: Unknown. No data. Little or no exposure of the infant is expected from an eye implant. EU label: not recommended to implant while breastfeeding, as a precaution; the eye medicines given after surgery should also be checked.
What does Ex vivo expanded autologous human corneal epithelial cells containing stem cells interact with?
MediHelp lists 2 known interactions for Ex vivo expanded autologous human corneal epithelial cells containing stem cells. Major: 2. The most serious include Epinephrine, Lidocaine.
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