ADCETRIS

Država: Indonezija

Jezik: indonezijščina

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Enote v paketu:

DUS, 1 VIAL @ 50 MG

Datum dovoljenje:

2022-05-27

Lastnosti izdelka

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