Humira Solution for Injection in Pre-filled Pen 40mg0.4ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Adalimumab

Boleh didapati daripada:

ABBVIE SDN BHD

INN (Nama Antarabangsa):

Adalimumab

Unit dalam pakej:

1 Units; 1 Units; 1 Units; 1 Units

Dikeluarkan oleh:

ABBVIE BIOTECHNOLOGY GmbH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
HUMIRA
®
SOLUTION FOR INJECTION
IN PRE-FILLED PEN
_ _
Adalimumab
1
WHAT IS IN THIS LEAFLET
1.
What Humira

is used for
2.
How Humira

works
3.
Before you use Humira

4.
How to use Humira

5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Humira

8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT HUMIRA

IS USED FOR
Humira
®
is
intended
for
treatment
of
rheumatoid arthritis, polyarticular juvenile
idiopathic arthritis aged above 2 years old,
axial
spondyloarthritis
(ankylosing
spondylitis
and
Non-radiographic
axial
spondyloarthritis),
psoriatic
arthritis,
enthesitis-related arthritis in children aged
6 years and above,
psoriasis in adults and
children aged 4 years and above, Crohn’s
disease in adults and children aged 6 years
and above, ulcerative colitis in adults and
children
aged
6
years
and
above,
hidradenitis
suppurativa
in
adults
and
adolescents,
and
uveitis
in
adults
and
children aged 2 years and above
HOW HUMIRA

WORKS
It
is
a
medicine
that
decreases
the
inflammation process
of
these diseases.
The active ingredient,
adalimumab,
is a
human monoclonal antibody produced by
cultured cells. Monoclonal antibodies are
proteins that
recognise and bind to other
unique proteins. Adalimumab binds to a
specific protein (tumour necrosis factor or
TNFα), which is present at increased levels
in
inflammatory
diseases
such
as
rheumatoid arthritis, polyarticular juvenile
idiopathic arthritis, axial spondyloarthritis
(ankylosing
spondylitis
and
Non-
radiographic
axial
spondyloarthritis),
psoriatic
arthritis,
psoriasis,
ulcerative
colitis, hidradenitis suppurativa , Crohn’s
disease,
Uveitis
and
Enthesitis-Related
Arthritis.
BEFORE YOU USE HUMIRA

-
_When you must not use it_
•
If
you are allergic
(hypersensitive)
to
adalimumab
or
any
of
the
other
ingredients of Humira
®
.
• If you have a severe infection, including
active tuberculosis. It is important that you
tell your doctor

Ciri produk

PRODUCT INFORMATION
HUMIRA 80MG/0.8ML Solution for Injection
HUMIRA 40MG/0.4ML Solution for Injection
HUMIRA 20MG/0.2ML Solution for Injection
NAME OF THE MEDICINE
Non-proprietary Name
Adalimumab
DESCRIPTION
Humira (adalimumab) is a recombinant human immunoglobulin (IgG1)
monoclonal antibody
containing only human peptide sequences. Humira was created using
phage display technology
resulting in fully human heavy and light chain variable regions, which
confer specificity to human
tumor necrosis factor (TNF), and human IgG1 heavy chain and kappa
light chain sequences. Humira
binds with high affinity and specificity to soluble tumor necrosis
factor (TNF-alpha) but not
lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA
technology in a mammalian
cell expression system. It consists of 1330 amino acids and has a
molecular weight of approximately
148 kilodaltons.
Humira is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous
administration. The drug product is supplied as either a single-use 1
mL prefilled glass syringe, or as
a single-use prefilled Pen (Humira Pen). Enclosed within the pen is a
single-use, 1 mL prefilled glass
syringe. The solution of Humira is clear and colorless, with a pH of
about 5.2.
Inactive ingredients for Humira 80 mg per 0.8 mL (100 mg/mL) include:
33.6 mg mannitol, 0.8 mg
polysorbate 80, and water for injection.
Inactive ingredients for Humira 40 mg per 0.4 mL (100 mg/mL) include:
16.8 mg mannitol, 0.4 mg
polysorbate 80 and water for injection.
Inactive ingredients for Humira 20 mg per 0.2 mL (100 mg/mL) include:
8.4 mg mannitol, 0.2 mg
polysorbate 80, and water for injection.
CLINICAL PHARMACOLOGY
General
Adalimumab binds specifically to TNF and neutralizes the biological
function of TNF by blocking its
interaction with the p55 and p75 cell surface TNF receptors. TNF is a
naturally occurring cytokine
that is involved in normal inflammatory and immune responses. Elevated
levels of TNF are found in
the synovial fluid of rheumatoid arthritis, including j