IDACIO solution for injection in pre-filled pen 40mg0.8ml

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

Adalimumab

Dostępny od:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International Nazwa):

Adalimumab

Sztuk w opakowaniu:

0.8 ml; 0.8 ml

Wyprodukowano przez:

FRESENIUS KABI AUSTRIA GMBH

Ulotka dla pacjenta

_Figure A_
EXP: MM/YYYY
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_Figure F_
30
minutes
_Figure E_
_Figure B_
Product Name:
Territory:
IDACIO 40MG AI
MY
Type of Packaging:
Dosage:
LEAFL ET
40 MG
Material number:
2-D-Matrix Code:
M081843/00 MY
M081843/00 MY
Pharma-Code (Laetus):
EAN-Code:
-
Dimension:
Font:
Size:
151,5 X 90 MM
INTERSTATE
7
Colours:
1. Draft
23.12.2021, 13:00
●
CYAN
1. Corr
10.01.2022, 20:15
●
MAGENTA
2. Corr
●
YELLOW
3. Corr
●
BLACK
●
DIE CUT
Operator:
CLAUDIA KOSCHAK
Technical layout ref:
IFU_03_454.5X540 MM V01
READ CAREFULLY THESE ENTIRE INSTRUCTIONS BEFORE USING YOUR IDACIO
PRE-FILLED PEN.
IMPORTANT INFORMATION
•
Only use Idacio pre-filled pen if your healthcare professional has
trained you how to use it
correctly.
•
The Idacio pre-filled pen comes as a ready to use single use
pre-filled pen to give a full
dose of adalimumab.
•
Always inject using the technique your healthcare professional taught
you.
•
Children under 12 years of age are not allowed to inject themselves
and injection must be
done by a trained adult.
•
Keep the Idacio pre-filled pen out of the reach of children.
•
DO NOT insert your fingers into the opening of the safety guard.
•
DO NOT use an Idacio pre-filled pen that has been frozen or left in
direct sunlight.
•
Talk to your healthcare professional if you have any questions or
concerns.
STORAGE INFORMATION
•
Store the pre-filled pen in its original box to protect it from light.
•
Store the pre-filled pen in a refrigerator between 2°C to 8°C.
•
If needed, for example when traveling, a single pre-filled pen can be
stored at room
temperature for up to 14 days.
GET FAMILIAR WITH YOUR IDACIO PRE-FILLED PEN
Injection
button
Syringe plunger
Injector body
Transparent syringe housing
Label area
(Idacio, dose, expiration date)
Needle cap
Before Use
Needle
Syringe plunger
final position
After Use
Safety guard
extended
Needle cap
STEP 1
PREPARE FOR YOUR INJECTION
Each box of Idacio pre-filled pen comes with
two pre-filled pens.
1.1
Prepare a clean flat surface, such as a t

Charakterystyka produktu

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