ACTEMRA 162MG0.9ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TOCILIZUMAB; TOCILIZUMAB

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TOCILIZUMAB; TOCILIZUMAB

Unit dalam pakej:

4units Units; 1units Units

Dikeluarkan oleh:

F.HOFFMANN-LA ROCHE LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET_
ACTEMRA ®
Tocilizumab (162mg/0.9ml solution for injection in a pre-filled
syringe)
WHAT IS IN THIS LEAFLET
1.
What Actemra is used for
2.
How Actemra works
3.
Before you use Actemra
4.
How to use Actemra
5.
While you are using Actemra
6.
Side effects
7.
Storage and Disposal of Actemra
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ACTEMRA IS USED FOR

Moderate to severe active rheumatoid
arthritis (RA) in adults.

Treatment of giant cell arteritis (GCA)
in adult patients.

Treatment of active polyarticular
juvenile idiopathic arthritis in patients
2 years of age and older, in
combination with methotrexate.

Treatment of active systemic juvenile
idiopathic arthritis in patients 2 years
of age and older, to be given alone or
in combination with MTX.
HOW ACTEMRA WORKS
Actemra contains the active substance
tocilizumab. It is a protein made from
specific immune cells (monoclonal
antibody), that blocks the action of a
specific protein (cytokine) called
interleukin-6. Interleukin-6 is involved in
inflammatory processes of the body, and
blocking it can reduce the inflammation
in your body.
Actemra helps to reduce symptoms such
as pain and swelling in your joints and
can also improve your performance of
daily tasks. Actemra has been shown to
slow the damage to the cartilage and
bone of the joints caused by the disease
and to improve your ability to do normal
daily activities.
Actemra is usually given in combination
with methotrexate. However, Actemra
can be given alone if your doctor
determines that methotrexate is
inappropriate.
Before you use Actemra
When you must not use it
Do not use Actemra if:

You have had an allergic reaction to
tocilizumab or any of the other
ingredients of this medicine listed at
the end of this leaflet.

Some symptoms of an allergic
reaction:
-
hives or skin rash
-
swelling of the face, lips or tongue
-
wheezing or trouble breathing
-
faintness

You have an active, severe infection.

Ciri produk

PACK INSERT FOR MALAYSIA
Actemra
®
162mg/0.9ml
Solution for injection in a pre-filled syringe
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
Subcutaneous (SC) formulation: Ready-to-use sterile liquid solution in
a single-use pre-filled syringe (PFS) with needle
safety device (NSD).
1.3
Route of Administration
Subcutaneous (SC) injection.
1.4
Sterile / Radioactive Statement
Sterile.
1.5
Qualitative and Quantitative Composition
Active ingredient: tocilizumab.
Excipients:
L-histidine,
L-histidine
monohydrochloride
monohydrate,
L-arginine
hydrochloride,
L-methionine,
polysorbate 80 and water for injection.
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 device delivers 0.9 mL (162 mg) of
tocilizumab.
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 MTX.
Giant Cell Arteritis (GCA)
Tocilizumab is indicated for the treatment of Giant Cell Arteritis
(GCA) in adult patients.
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.
Tocilizumab can be given a