ZINBRYTA daclizumab 150 mg/mL solution for injection pre-filled syringe

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Daclizumab

Saadav alates:

Biogen Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

Daclizumab

Toote omadused

ZINBRYTA PI (version 10517, supersedes 10916)
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PRODUCT INFORMATION
ZINBRYTA
®
(DACLIZUMAB)
NAME OF THE MEDICINE
ZINBRYTA (
daclizumab)
Solution for injection, in pre-filled pen
Solution for injection, in pre-filled syringe
ZINBRYTA is supplied as 150 milligrams of daclizumab per 1.0 mL.
The CAS Registry Number is 152923-56-3.
DESCRIPTION
Daclizumab is a humanized IgG1 monoclonal antibody that binds
specifically to the alpha subunit
of the interleukin-2 receptor (IL-2Rα, CD25).
Daclizumab has immunomodulatory effects by selectively blocking
signaling through high affinity
IL-2 receptors, a receptor that is up-regulated on the surface of
activated lymphocytes, while
leaving IL-2 signaling by intermediate affinity IL-2 receptors intact.
Daclizumab is produced by recombinant DNA technology and consists of
90% material from the
human IgG1 constant domains and 10% material from the
complementarity-determining region
(CDR) sequences of a murine monoclonal antibody that binds CD25.
Daclizumab is produced in a
mammalian cell line (NS0) using animal component-free medium.
Daclizumab is composed of two
humanized gamma-1 heavy chains and two humanized kappa light chains
and has a molecular
weight of approximately 144 kilodaltons (kDa).
ZINBRYTA is supplied as a sterile, preservative-free, colourless to
slightly yellow, clear to slightly
opalescent liquid. The drug product is supplied in a single-use
pre-filled pen or as a single-use pre-
filled syringe.
EXCIPIENTS
Sodium
succinate,
anhydrous
5.94 mg;
Succinic
acid
0.35 mg;
Sodium
chloride
5.84 mg;
Polysorbate 80 0.30 mg; Water for Injection; 0.14 mmol sodium per
dose.
PHARMACOLOGY
MECHANISM OF ACTION
Daclizumab is a humanized monoclonal antibody that binds to CD25
(IL-2Rα), and prevents IL-2
binding to CD25. Daclizumab modulates IL-2 signaling by blocking
CD25-dependent, high-affinity
IL-2 receptor signaling, resulting in higher levels of IL-2 available
for signalling through the
intermediate-affinity IL-2 receptor.
ZINBRYTA PI (version 10517, supersedes 10916