医薬品リファレンス
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.
- 薬効分類: Miscellaneous
最終更新日 出典: EMA SmPC
医療従事者向け・参照専用。このページは簡潔な要約であり、医学的助言ではなく、公式の添付文書や臨床判断に代わるものではありません。処方・調剤の前に必ず確認してください。
このページの臨床コンテンツは英語でのみ提供されています。
要点
- 薬効分類
- Miscellaneous
- ATCコード
- S01XA19
- 既知の相互作用
- 2 (重大: 2)
- 商品名
- 1
- 国・市場
- 1
作用のしくみ
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.
成人の通常用量（添付文書の要約）
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
妊娠と授乳
- 妊娠
- 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.
- 授乳
- 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.
報告されている副作用
- Eye pain
- Corneal epithelium defect
- Conjunctival haemorrhage
- Glaucoma / increased intraocular pressure
- Corneal perforation
- Ulcerative keratitis
禁忌
- Hypersensitivity to any of the excipients or to bovine serum and murine 3T3-J2 cells
注意が必要な方
- 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
妊娠中または授乳中であること、腎臓や肝臓の病気、アレルギー、ほかに使用しているすべての薬やサプリメントについて、薬剤師または医師にお伝えください。
主な相互作用 (2)
Pro+会員向け
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アカウントを作成してPro+トライアルを始めると、Ex vivo expanded autologous human corneal epithelial cells containing stem cellsの完全なモノグラフ（用量、妊娠・授乳、副作用、警告、すべての相互作用）を表示できます。
- Dosing by age, kidney and liver function, and further dose lines
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
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よくある質問
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.
完全なモノグラフ、用量、相互作用チェッカーはMediHelpアプリで
MediHelpアプリで、完全なリファレンスを開き、複数薬剤の相互作用をチェックし、用量ツールを利用できます。
