资料单张
Humira
Version 01
15 October 2009
Page 1 of 6
HUMIRA_ _VIAL
Adalimumab (rch)
CONSUMER
MEDICINE
INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Humira.
It does not contain all the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU USE HUMIRA AND KEEP IT WITH
THE MEDICINE. You may need to
read it again.
WHAT HUMIRA IS USED FOR
Humira is intended for the
treatment of
• Rheumatoid
arthritis,
• Polyarticular
Juvenile
Idiopathic Arthritis,
• Psoriatic arthritis,
• Ankylosing spondylitis,
• Crohn’s disease and
• Psoriasis.
The active ingredient in this
medicine is adalimumab, a fully
human monoclonal antibody.
Monoclonal antibodies are proteins
that recognise and bind to other
unique proteins. Adalimumab
binds to a specific protein (tumour
necrosis factor or TNFalpha), which
is present at increased levels in
inflammatory diseases such as
rheumatoid arthritis, polyarticular
juvenile idiopathic arthritis,
psoriatic arthritis, ankylosing
spondylitis, Crohn’s disease and
psoriasis.
• Rheumatoid Arthritis
Humira is used to reduce the signs
and symptoms of moderately to
severely active rheumatoid arthritis,
a painful disease of the joints, as
well as slow down and protect
against damage to joints. Signs and
symptoms of rheumatoid arthritis
include joint pain, tenderness,
swelling and stiffness.
• Polyarticular Juvenile Idiopathic
Art
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产品特点
Humira
Version 27
16 July 2013
Page 1 of 42
PRODUCT INFORMATION
HUMIRA
®
NAME OF THE MEDICINE
Adalimumab (rch)
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 tumour necrosis factor
(TNF), and human IgG1 heavy chain and kappa light chain sequences. Humira binds with high affinity
and specificity to soluble tumour 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 solution of Humira is clear and colourless with a pH of 5.2. The drug product is supplied as either a
single-use pre-filled glass syringe, vial or as a single use, pre-filled pen (Humira Pen). Enclosed within the
pen is a single-use, pre-filled glass syringe.
All adult presentations contain 40mg adalimumab per 0.8 mL (50 mg/mL). The paediatric presentation
contains 20mg adalimumab per 0.4 mL.
Humira 40mg: 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 a
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