Abrilada Solution for Injection in Pre-filled Pen 40mg0.8mL

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Adalimumab

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Adalimumab

Unit dalam pakej:

1 Units; 2 Units

Dikeluarkan oleh:

Catalent Indiana, LLC

Risalah maklumat

Pfizer confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ABRILADA SOLUTION FOR INJECTION IN PRE-FILLED PEN
40MG/0.8ML
Adalimumab (40 mg)
PLD Title
: Adalimumab (Abrilada)
PLD Date
: 28 December 2021
Country
: Malaysia
Reference Document
: Malaysia CLD dated 27 December 2021; EU SPC dated 23 October 2020;
Reason for change
: PfLEET Number - 2020-0065024 (D) New PLD creation
: PfLEET Number - 2021-0072909 (S2) - To update as per BOH request
: PfLEET number 2021-0072485 (O): To update pack size
: To update as per BOH request
Pfizer confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ABRILADA SOLUTION FOR INJECTION IN PRE-FILLED PEN
40MG/0.8ML
Adalimumab (40 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Abrilada is used for
2.
How Abrilada works
3.
Before you use Abrilada
4.
How to use Abrilada
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Abrilada
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ABRILADA IS USED FOR
Abrilada contains the active substance
adalimumab, a medicine that acts on
your body’s immune (defence) system.
Abrilada is intended for the treatment of
the following inflammatory diseases:
-
_In Adults _
•
Rheumatoid arthritis, psoriatic arthritis
and axial spondyloarthritis,
•
Plaque psoriasis,
•
Crohn’s disease,
•
Ulcerative colitis,
•
Hidradenitis suppurativa,
•
Uveitis.
HOW ABRILADA WORKS
The active ingredient in Abrilada,
adalimumab, is a monoclonal antibody.
Monoclonal antibodies are proteins that
attach to a specific target in the body.
The target of adalimumab is another
protein called tumour necrosis factor
(TNFα), which is involved in the
immune (defence) system and is present
at increased levels in the inflammatory
diseases listed above. By attaching to
TNFα, Abrilada blocks its action and
reduces the inflammation in these
diseases.
BEFORE YOU USE ABRILADA
-
_When you must not use it _
•
if you are allergic to adalimumab or
any of the other ingredients of thi

Ciri produk

Pfizer Confidential
ADALIMUMAB
ABRILADA
1.
NAME OF THE MEDICINAL PRODUCT
Abrilada Solution for Injection in Pre-filled Pen 40mg/0.8mL.
ABRILADA is a biosimilar medicine to HUMIRA. The evidence for
comparability supports
the use of ABRILADA for the listed indications.
Abrilada is not interchangeable or
automatically substitutable with Humira.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in
Chinese hamster
ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to very light brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS
Abrilada is indicated for reducing signs and symptoms, inducing major
clinical response and
clinical remission, inhibiting the progression of structural damage
and improving physical
function in adult patients with moderately to severely active
rheumatoid arthritis.
Abrilada can be used alone or in combination with methotrexate or
other disease modifying
antirheumatic drugs (DMARDs).
PSORIATIC ARTHRITIS
Abrilada is indicated for reducing the signs and symptoms of active
arthritis in patients with
psoriatic arthritis, inhibiting the progression of structural damage,
and improving physical
function in patients with psoriatic arthritis.
Abrilada can be used alone or in combination with disease modifying
anti-rheumatic drugs.
Pfizer Confidential
1
AXIAL SPONDYLOARTHRITIS
_ANKYLOSING SPONDYLITIS (AS) _
Abrilada is indicated for reducing signs and symptoms in patients with
active ankylosing
spondylitis.
_NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (AXIAL SPONDYLOARTHRITIS
WITHOUT RADIOGRAPHIC _
_EVIDENCE OF AS) _
Abrilada is indicated for reducing signs and symptoms in patients with
active non-
radiographic axial spondyloarthritis (nr-axSpA) but with objective
signs of inflammation by
elevated C-Reactive Protein (CRP) and/or Magnetic Resonance Imaging
(MR