ACTEMRA 20 MGML CONCENTRATE FOR SOLUTION FOR INFUSION.

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

TOCILIZUMAB

Tilgængelig fra:

ROCHE (MALAYSIA) SDN. BHD.

INN (International Name):

TOCILIZUMAB

Enheder i pakken:

200gm10ml1Units mL; 400gm20ml1Units mL; 80gm4ml1Units mL; 80mg / 4ml 1 unit Vials; 200mg / 10ml 1 unit Vials; 400mg / 20ml 1 unit Vials

Fremstillet af:

CHUGAI PHARMA MANUFACTURING CO., LTD

Produktets egenskaber

PACK INSERT FOR MALAYSIA
Actemra
®
20mg/ml
Concentrate for solution for infusion
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
Concentrate solution for infusion.
1.3
Route of Administration
Intravenous (IV) infusion.
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, 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 (RA)
Tocilizumab is indicated for the treatment of moderate to severe
active rheumatoid arthritis (RA) in adult patients. Tocilizumab can
be used alone or in combination with methotrexate (MTX) and/or other
disease-modifying anti-rheumatic drugs (DMARDs).
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 (MTX).
Coronavirus disease 2019 (COVID-19)
Tocilizumab is indicated for the treatment of coronavirus disease 2019
(COVID-19) in hospitalized adults who are receiving
systemic corticosteroids and require supplemental oxygen or mechanical
ventilation.
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Tocilizumab in combination with methotrexate (MTX) is indicated for
the treatment of juvenile idiopathic polyarthritis (rheumatoid
factor positive or negative and extended oligoarthritis) in patients 2
years of age and older, who have responded inadequately to
previous therapy with MTX.