HUMIRA SOLUTION FOR INJECTION

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:

000 mcg/mL; gm ml 2 mL; 0 gm 0 ml 1 mL

Dikeluarkan oleh:

ABBVIE BIOTECHNOLOGY GmbH

Risalah maklumat

Adalimumab(40mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
HUMIRA SOLUTION FOR INJECTION
_ _
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,
ankylosing
spondylitis,
psoriatic
arthritis,
psoriasis,
Crohn’s
disease
in
adults
and
children
aged
6
years
and
above,
ulcerative
colitis,
hidradenitis suppurativa and uveitis.
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,
ankylosing
spondylitis,
psoriatic
arthritis,
psoriasis,
ulcerative
colitis,
hidradenitis
suppurativa, Crohn’s disease and uveitis.
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 (see “Take special
care with Humira”). It is important that
you tell your doctor if you have
symptoms of infections, e.g. fever,
wounds, feeling tired, dental problems.
• If you have moderate or severe heart
failure. It is important to tell your doctor
if you have had or have a serious heart
condition (see“Take special care with
Humira”).
_ _
_Pregnancy and lactation _
Do not take Humira

if you are pregnant,
trying to get pregnant or think you may
b

Ciri produk

HUMIRA Product Package Insert
PRODUCT NAME
Adalimumab solution for injection
Adalimumab solution for injection in pre-filled syringe
Adalimumab pen
Trade Name
Humira
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, 1 mL single-use glass vial 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. Each single use pre-filled Pen, syringe, or vial of Humira contains
40 mg adalimumab per 0.8 mL (50mg/mL).
Inactive ingredients include: 4.93 mg sodium chloride, 0.69 mg monobasic sodium phosphate dihydrate, 1.22 mg
dibasic sodium phosphate dihydrate, 0.24 mg sodium citrate, 1.04 mg citric acid monohydrate, 9.6 mg mannitol, 0.8 mg
polysorbate 80 and water for injection per 0.8 mL.
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 juvenile idiopathic arthr