医薬品リファレンス
Prademagene zamikeracel
Prademagene zamikeracel is a medicine in the class miscellaneous.
- 薬効分類: Miscellaneous
最終更新日 出典: US FDA label
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
- 商品名
- 1
- 国・市場
- 1
作用のしくみ
Autologous cells gene-modified through RVV transduction to express COL7A1 and produce C7 protein, formed into cellular sheets for topical application onto wounds. This addresses the absent or low C7 protein and anchoring fibrils in RDEB.
成人の通常用量（添付文書の要約）
RDEB wounds: dose based on wound surface area, topical application to wounds only (autologous); one sheet covers 41.25 cm2; up to twelve sheets supplied; apply all selected sheets in a single surgical session
妊娠と授乳
- 妊娠
- Unknown Gene-corrected skin sheets applied to wounds in dystrophic epidermolysis bullosa. No human data and no animal reproduction studies. Women who could become pregnant should use effective contraception at the time of treatment.
- 授乳
- Unknown No information on passage into milk or infant effects; no animal studies. LactMed: not necessarily a reason to stop breastfeeding, but weigh the theoretical risk of retroviral-vector insertional oncogenesis against the benefits.
報告されている副作用
- Procedural pain
- Pruritus
注意が必要な方
- Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur; monitor and treat per standard practice.
- Retroviral vector-mediated insertional oncogenesis may potentially occur; monitor patients lifelong for malignancies.
- Transmission of infectious agents may occur because human and bovine-derived reagents are used in manufacture.
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。
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、Prademagene zamikeracel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
- Paediatric dosing
- How to give it
- Patient counselling points
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同じ分類のほかの薬剤
よくある質問
What is Prademagene zamikeracel used for?
Prademagene zamikeracel is a medicine in the class miscellaneous.
What side effects have been reported with Prademagene zamikeracel?
Procedural pain, Pruritus.
Can Prademagene zamikeracel be taken in pregnancy or while breastfeeding?
Pregnancy: Unknown. Gene-corrected skin sheets applied to wounds in dystrophic epidermolysis bullosa. No human data and no animal reproduction studies. Women who could become pregnant should use effective contraception at the time of treatment. Breastfeeding: Unknown. No information on passage into milk or infant effects; no animal studies. LactMed: not necessarily a reason to stop breastfeeding, but weigh the theoretical risk of retroviral-vector insertional oncogenesis against the benefits.
What does Prademagene zamikeracel interact with?
MediHelp does not list a checked interaction for Prademagene zamikeracel yet. Always tell your pharmacist about every medicine you take.
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。
