Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BRENTUXIMAB VEDOTIN
TAKEDA INDONESIA - Indonesia
BRENTUXIMAB VEDOTIN
50 MG/VIAL
SERBUK INJEKSI
DUS, 1 VIAL @ 50 MG
TAKEDA AUSTRIA Gmbh - Austria
2017-11-23
Page 1 of 47 ADCETRIS ® (BRENTUXIMAB VEDOTIN) DISETUJUI OLEH BPOM 15 AGUSTUS 2023 EREG10023512300031 Page 2 of 47 1 NAME OF THE MEDICINAL PRODUCT & PHARMACEUTICAL FORM ADCETRIS 50 mg powder for concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Brentuximab vedotin is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 (IgG1), produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE). Each single-use vial contains 50 mg of brentuximab vedotin. Each mL contains 5 mg of brentuximab vedotin, after reconstitution. Powder for concentrate for solution for infusion. White to off-white lyophilized cake or powder. Excipients (weight per 50 mg vial; concentration after reconstitution): Citric acid monohydrate Sodium citrate dihydrate α,α-Trehalose dihydrate, Polysorbate 80 3 PHARMACEUTICAL PARTICULARS _3.1 _ _INCOMPATIBILITIES_ _ _ In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. _3.2 _ _SPECIAL PRECAUTIONS FOR STORAGE AND TRANSPORTATION_ Store at 2 – 8˚C. Keep the container in the original carton. Unopened vial: 4 years Reconstituted ADCETRIS Vial: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 – 8˚C. From a mi crobiological point of view, the product must be used within 24 hours after vial reconstitution. Infusion Bag with Diluted ADCETRIS: The chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 2 –8˚C when the dilution occurs immediately after reconstitution. From a microbiological point of view, the product must be used within 24 hours after vial reconstitution. DISETUJUI OLEH BPOM 15 AGUSTUS 2023 EREG10023512300031 Page 3 of 47 _3.3 _ _INSTRUCTIONS FOR USE AND HANDLING AND DISPOSAL_ _ _ Procedures for proper handling and disposal of anticancer drugs should be considered. Seve Olvassa el a teljes dokumentumot