IDACIO solution for Injection for paediatric use 40mg0.8ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Adalimumab

Boleh didapati daripada:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Nama Antarabangsa):

Adalimumab

Unit dalam pakej:

0.8 ml

Dikeluarkan oleh:

FRESENIUS KABI AUSTRIA GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
IDACIO
® SOLUTION FOR INJECTION
FOR PAEDIATRIC USE
Adalimumab (40mg)
WHAT IS IN THIS LEAFLET
1.
What Idacio®
is used for
2.
How Idacio®
works
3.
Before you use Idacio®
4.
How to use Idacio®
5.
While you are using Idacio®
6.
Possible side effects
7.
Storage and Disposal of Idacio®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
-
If you have a severe infection, including
active tuberculosis.
-
If you have moderate or severe heart
failure.
-
It is important to tell your doctor
if you
have had or have any of the above.
_ _
_ _
-
_Pregnancy and lactation _
Do not take Idacio® if you are pregnant,
trying to get pregnant or think you may
be pregnant.
_Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy,
supermarket
or
health
food
shop.
You
should
not
take
Idacio®
with
medicines
containing
the
active
substance, anakinra or abatacept. If you
have questions, please ask your doctor.
WHAT IDACIO®
IS USED FOR
In adult, Idacio® is intended for treatment
of
rheumatoid arthritis, psoriatic arthritis,
ankylosing
spondylitis, Crohn’s
disease,
ulcerative
colitis,
plaque
psoriasis,
hidradenitis suppurativa and uveitis.
In
children,
Idacio®
is
prescribed
for
polyarticular
juvenile idiopathic arthritis,
enthesitis-related
arthritis,
Crohn’s
disease,
plaque
psoriasis,
hidradenitis
suppurativa, uveitis and ulcerative colitis.
HOW IDACIO®
WORKS
It
is
a
medicine
that
decreases
the
inflammation
process of certain 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
TNF),
which
is
present
at
increased
levels in inflammatory diseases such as
rheumatoid
arthritis,
polyarticular
juvenile
idiopathic
arthritis,
ankylosing
spondylitis,
psoriatic

Ciri produk

1
IDACIO
®
Adalimumab
PRODUCT NAME
IDACIO solution for injection in pre-filled syringe 40mg/0.8ml
IDACIO solution for injection in pre-filled pen 40mg/0.8ml
IDACIO solution for injection for paediatric use 40mg/0.8ml
TRADE NAME
IDACIO
®
IDACIO (adalimumab) is a biosimilar medicine to the reference product
Humira
®
.
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
important role in both the pathologic inflammation and the joint
destruction that are hallmarks of these diseases. Increased levels of
TNF are also found in hidradenitis suppurativa (HS) lesions.
The relationship between these pharmacodynamic activities and the
mechanism(s) by which adalimumab exerts its clinical effects
is unknown.
Adalimumab also modulates biological responses that are induced or
regulated by TNF, including changes in the levels of adhesion
molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and
ICAM-1 with an IC
50
of 1-2 X 10
-10
M).
PHARMACODYNAMICS
After treatment with adalimumab, a rapid decrease in levels of acute
phase reactants of inflammation (C-reactive protein (CRP)
and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6)
was observed compared to baseline in patients with RA. A
decrease in CRP levels was also observed in patients with JIA,
Crohn’s disease, ulcerative colitis and hidradenitis suppurativa as
well as a significant reduction in the expression of the TNF and
inflammatory markers such as human leucocyte antigen (HLA-DR)
and myeloperoxidase (MPO) in the colon of patients with Crohn’s
disease. Serum levels of matrix metalloproteinases (MMP-1 and
MMP-3) that pr