Referência de medicamentos
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.
- Classe do medicamento: Miscellaneous
Última atualização Fontes: EMA SmPC
Para profissionais de saúde — apenas referência. Esta página é um resumo breve, não é aconselhamento médico nem substitui a bula oficial ou o julgamento clínico. Verifique sempre antes de prescrever ou dispensar.
O conteúdo clínico desta página está disponível apenas em inglês.
Pontos-chave
- Classe do medicamento
- Miscellaneous
- Código ATC
- S01XA19
- Interações conhecidas
- 2 (Grave: 2)
- Nomes comerciais
- 1
- Países e mercados
- 1
Como funciona
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.
Dose habitual em adultos (resumo da bula)
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
Gravidez e amamentação
- Gravidez
- 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.
- Amamentação
- 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.
Efeitos adversos relatados
- Eye pain
- Corneal epithelium defect
- Conjunctival haemorrhage
- Glaucoma / increased intraocular pressure
- Corneal perforation
- Ulcerative keratitis
Contraindicações
- Hypersensitivity to any of the excipients or to bovine serum and murine 3T3-J2 cells
Quem deve ter cuidado
- 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
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Principais interações (2)
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- Dosing in older adults
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Perguntas frequentes
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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