AMGEVITA 20 mg0.4 ml solution for injection in pre-filled syringe

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Adalimumab

Boleh didapati daripada:

Amgen Biopharmaceuticals Malaysia Sdn Bhd

INN (Nama Antarabangsa):

Adalimumab

Unit dalam pakej:

20mg/0.4ml Pre-Filled Syringes

Dikeluarkan oleh:

Amgen manufactuirng ,Ltd

Risalah maklumat

AMGEVITA® SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
Adalimumab 50 mg/mL
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET?
1.
What AMGEVITA is used for
2.
How AMGEVITA works
3.
Before you use AMGEVITA
4.
How to use AMGEVITA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
AMGEVITA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT AMGEVITA IS USED FOR
AMGEVITA contains the active
substance adalimumab, a selective
immune-suppressive agent.
AMGEVITA 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 AMGEVITA 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 AMGEVITA
-
_When you must not use it _
•
If you are allergic
(hypersensitive)
to AMGEVITA or any of the other
ingredients of AMGEVITA.
•
If you have a severe infec

Ciri produk

1
PRODUCT INFORMATION
NAME OF THE MEDICINE
AMGEVITA
®
20 mg/0.4 mL solution for injection in pre-filled syringe.
AMGEVITA
®
40 mg/0.8 mL solution for injection in pre-filled syringe.
AMGEVITA
®
40 mg/0.8 mL solution for injection in pre-filled autoinjector.
NON-PROPRIETARY NAME
Adalimumab
DESCRIPTION
AMGEVITA
®
(adalimumab) is a biosimilar medicine to the reference product HUMIRA
®
(Adalimumab). The comparability of
AMGEVITA with HUMIRA
®
has been demonstrated with regard to physicochemical characteristics
and efficacy and safety
outcomes (see CLINICAL PHARMACOLOGY, CLINICAL TRIALS AND ADVERSE
EFFECTS). The evidence for comparability
supports the use of AMGEVITA for the listed indications.
AMGEVITA (adalimumab) is a recombinant human immunoglobulin (IgG1)
monoclonal antibody containing only human peptide
sequences. AMGEVITA 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. AMGEVITA 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.
AMGEVITA is supplied as a sterile, preservative-free solution of
adalimumab for subcutaneous administration. The solution of
AMGEVITA is clear and colourless to slightly solution.
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 arthritis,
psoriatic arthritis and ankylosing spondylitis patients and play an