HUMIRA Solution for Injection in Prefilled syringe 80MG0.8ML

国家: 马来西亚

语言: 英文

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

有效成分:

Adalimumab

可用日期:

ABBVIE SDN BHD

INN（国际名称）:

Adalimumab

每包单位数:

1 Pre-Filled Syringes

厂商:

ABBVIE BIOTECHNOLOGY GmbH

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
HUMIRA
®
SOLUTION FOR INJECTION
IN PRE-FILLED SYRINGE
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 doct

产品特点

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