Actemra 162mg Solution for Injection in Pre-filled Syringe 162mg0.9ml

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Tocilizumab

Disponível em:

ROCHE SINGAPORE PTE. LTD.

Código ATC:

L04AC07

Forma farmacêutica:

INJECTION, SOLUTION

Composição:

Tocilizumab 162 mg/0.9 mL

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

Vetter Pharma-Fertigung GmbH & Co KG

Status de autorização:

ACTIVE

Data de autorização:

2015-08-28

Características técnicas

1
Please visit www.roche.com.sg/pharma/actemra for a printable version
of this leaflet.
INF/PFS-ACT-2023 07
ACTEMRA ®
Tocilizumab
_____________________________________________________
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6)
receptor monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass.
ATC Code : L04AC07.
1.2
TYPE OF DOSAGE FORM
Intravenous (IV) formulation: Concentrate solution for infusion.
Subcutaneous (SC) formulation: Solution for injection (injection).
1.3
ROUTE OF ADMINISTRATION
Intravenous (IV) infusion.
Subcutaneous (SC) injection.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: tocilizumab.
Tocilizumab solution for intravenous (IV) infusion is a clear to
opalescent,
colourless to pale yellow liquid, supplied in preservative-free,
non-pyrogenic
single-use vials.
Tocilizumab is supplied in 10 ml and 20 ml vials containing 4 ml, 10
ml or
20 ml of tocilizumab (20 mg/ml).
Excipients: Polysorbate 80, sucrose, disodium phosphate dodecahydrate,
sodium dihydrogen phosphate dihydrate and water for injections.
Tocilizumab
solution
for
subcutaneous
(SC)
injection
is
a
yellowish,
preservative-free liquid supplied in a ready-to-use, single-use
pre-filled
syringe with needle safety device (PFS+NSD). Each pre-filled syringe
delivers 0.9 mL (162 mg) of tocilizumab.
Excipients: L-histidine, L-histidine hydrochloride monohydrate,
L-arginine
hydrochloride, L-methionine, polysorbate 80 and water for injection.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
RHEUMATOID ARTHRITIS [IV AND SC FORMULATIONS]
Actemra,
in
combination
with
methotrexate
(MTX)
or
other
disease-
modifying anti-rheumatic drugs (DMARDs), is indicated for:
•
the
treatment
of
severe,
active
and
progressive
rheumatoid
arthritis (RA) in adults not previously treated with MTX [IV
formulation only]
•
the treatment of moderate to severe active rheumatoid arthritis
(RA) in adult patients who h