Generated Narrative: Composition trastazumabjpi Language: ja Profile: Composition (ePI) identifier: https://spor.ema.europa.eu/rmswi//fcats34placeholder status: Final type: Package Leaflet date: 2002-08-01 13:28:17+0000 author: Organization Chugai Pharmaceutical Co., Ltd. title: Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use Attesters - Mode Time * Official 2002-08-01 13:28:17+0000
Herceptin (trastazumab) Package Leaflet - 150 mg for Intravenous Use
アロマターゼ阻害剤/閉経後乳癌治療剤
unavailable
2. 禁忌(次の患者には投与しないこと)
禁忌(次の患者には投与しないこと)
9. 特定の背景を有する患者に関する注意
特定の背景を有する患者に関する注意
16.6.1 腎機能障害患者における体内動態
16.6.2 肝機能障害患者における体内動態
17.1.4 海外大規模比較試験(第III相試験 術後補助療法)
17.1.6 非盲検無作為化比較試験(第II/III相試験 転移性乳癌に対する第一次 ホルモン療法)
Generated Narrative: Organization orgchugai Profile: Organization (ePI) identifier: https://pmda-org-id/672212 (use: official, ) active: true type: Marketing authorisation holder name: Chugai Pharmaceutical Co., Ltd. Contacts - Address * Medical Information Department 2-1-1 Nihonbashi Muromachi, Chuo-ku, Tokyo 103-8324(work)
Medical Information Department 2-1-1 Nihonbashi Muromachi, Chuo-ku, Tokyo 103-8324
Generated Narrative: RegulatedAuthorization authherceptin150 Profile: RegulatedAuthorization (ePI) identifier: https://pmda-approvalandlicenseno//21300AMY00128 (use: official, ) subject: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation region: Japan status: Active statusDate: 2002-08-01 13:28:17+0000 holder: Organization Chugai Pharmaceutical Co., Ltd.
Generated Narrative: MedicinalProductDefinition medprodherceptin150 Profile: MedicinalProductDefinition (ePI) identifier: http://iyaku.info/medicine/4291447D2024 type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Herceptin (trastazumab) 150 mg type: Full name part part: Herceptin type: Invented name part part part: trastazumab type: Scientific name part part part: 150 mg type: Strength part part part: Intravenous infusion type: Pharmaceutical dose form part Usages - Country Jurisdiction Language * Japan Japan Japanese (Region=Japan)
Medicinal product subject to medical prescription
Generated Narrative: PackagedProductDefinition packherceptinvial Profile: PackagedProductDefinition (ePI) identifier: https://pmda-packinsertno//4291012F1022 (use: official, ) name: Herceptin (trastazumab) 150 mg for Intravenous Use type: Chemical Medininal Prodcut packageFor: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2002-08-01 13:28:17+0000 containedItemQuantity: 150 mg manufacturer: Organization Chugai Pharmaceutical Co., Ltd. Packagings - Identifier Type Quantity Material * https://spor.ema.europa.eu/pmswi/123456 Vial 28 Glass type I
Herceptin (trastazumab) 150 mg for Intravenous Use
Generated Narrative: AdministrableProductDefinition adminprodherceptin150 Profile: AdministrableProductDefinition (ePI) identifier: https://www.who-umc.org/phpid/7532F47F36A3585D1F348BBDDA057862 status: Active formOf: MedicinalProductDefinition: identifier = http://iyaku.info/medicine#4291447D2024; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Tablet unitOfPresentation: 15054000 producedFrom: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 RouteOfAdministrations - Code * 20053000
Generated Narrative: ManufacturedItemDefinition manitemherceptin150 Profile: ManufacturedItemDefinition (ePI) identifier: https://pmda-sccj/874291 (use: official, ) status: Active manufacturedDoseForm: Tablet unitOfPresentation: 15054000 manufacturer: Organization Chugai Pharmaceutical Co., Ltd.
Generated Narrative: Ingredient trastazumab Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//P188ANX8CK (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Active Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * trastazumab Strengths - Presentation[x] Basis * 150 mg active ingredient - basis of strength
Generated Narrative: Ingredient carnubawax Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//R12CBM0EIZ (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * Carnauba wax
Generated Narrative: Ingredient crystallinecellulose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//OP1R32D61U (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * crystalline cellulose
Generated Narrative: Ingredient mannitol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//3OWL53L36A (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * MANNITOL
Generated Narrative: Ingredient hypromelose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//3NXW29V3WO (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * HYPROMELLOSE, UNSPECIFIED
Generated Narrative: Ingredient lightanhydroussilicicacid Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//ETJ7Z6XBU4 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * light anhydrous silicic acid
Generated Narrative: Ingredient magnesiumcarbonate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//0E53J927NA (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * MAGNESIUM CARBONATE
Generated Narrative: Ingredient magnesiumstearate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//70097M6I30 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * MAGNESIUM STEARATE
Generated Narrative: Ingredient methylparaben Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//A2I8C7HI9T (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * METHYLPARABEN
Generated Narrative: Ingredient polyethyleneglycol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//30IQX730WE (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * POLYETHYLENE GLYCOL 6000
Generated Narrative: Ingredient polysorbate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//6OZP39ZG8H (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * POLYSORBATE 80
Generated Narrative: Ingredient polyvinylalcohol Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//532B59J990 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * POLYVINYL ALCOHOL, UNSPECIFIED
Generated Narrative: Ingredient sucrose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//C151H8M554 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * SUCROSE
Generated Narrative: Ingredient silicondioxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//ETJ7Z6XBU4 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * SILICON DIOXIDE
Generated Narrative: Ingredient sodiumstarch Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//5856J3G2A2 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * SODIUM STARCH GLYCOLATE TYPE A POTATO
Generated Narrative: Ingredient syntehticwax Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//5M631N9V0S (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * synthetic wax
Generated Narrative: Ingredient talc Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//7SEV7J4R1U (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * talc
Generated Narrative: Ingredient titaniumdioxide2 Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//15FIX9V2JP (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://pmda-sccj#874291 (use: official, ); status = active; manufacturedDoseForm = 10219000; unitOfPresentation = 15054000 role: Excipient Manufacturers - Manufacturer * Organization Chugai Pharmaceutical Co., Ltd. substance Codes - Concept * TITANIUM DIOXIDE
Generated Narrative: SubstanceDefinition subherceptin150 Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//P188ANX8CK (use: official, ) version: 39 status: Validated (UNII) description: White to pale yellow manufacturer: Organization Chugai Pharmaceutical Co., Ltd. Structures - MolecularFormula * C20H24O2 Names - Name Type * trastazumab Chemical Name