Actemra Concentrate for Solution for Infusion 20mgml

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Tocilizumab

Saatavilla:

ROCHE SINGAPORE PTE. LTD.

ATC-koodi:

L04AC07

Annos:

20mg/ml

Lääkemuoto:

INFUSION, SOLUTION CONCENTRATE

Koostumus:

Tocilizumab 20mg/ml

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

Prescription Only

Valmistaja:

Chugai Pharma Manufacturing Co., Ltd

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2009-11-03

Pakkausseloste

1 
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) IgG
1

subclass. 
ATC Code:  L04AC07. 
1.2 
TYPE OF DOSAGE FORM 
Concentrate solution for infusion. 
1.3 
ROUTE OF ADMINISTRATION 
Intravenous (i.v.) infusion. 
1.4 
STERILE / RADIOACTIVE STATEMENT 
Sterile. 
1.5 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active ingredient: tocilizumab. 
Tocilizumab 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.  
2. 
CLINICAL

PARTICULARS 
2.1 
THERAPEUTIC INDICATION(S) 
Rheumatoid Arthritis 
Tocilizumab, in combination with methotrexate (MTX) or other
disease-modifying anti-rheumatic drugs (DMARDs), is indicated for
the 
treatment of moderate to severe active rheumatoid arthritis (RA) in
adult patients who have either responded inadequately to, or who
were 
intolerant to, previous therapy with one or more
disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis
factor (TNF) 
antagonists. 
In these patients, tocilizumab can be used alone in case of
intolerance to MTX or where continued treatment with MTX is
inappropriate. 
Tocilizumab has been shown to reduce the rate of progression of joint
damage as measured by X-ray and to improve physical function when 
given in combination with methotrexate. 

POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) 
Tocilizumab is indic

Valmisteyhteenveto

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