Hyrimoz 40mg0.8ml Solution for Injection in Pre-Filled Pen

Country: Malaysia

Language: English

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

Active ingredient:

Adalimumab

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

Adalimumab

Units in package:

1 Capsules; 1 Units; 2 Units

Manufactured by:

Sandoz GmbH, Biochemiestrasse

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
HYRIMOZ SOLUTION FOR INJECTION IN
PRE-FILLED PEN
Adalimumab (40mg/0.8ml)
_ _
_ _
_1 _
_ _
WHAT IS IN THIS LEAFLET
1.
What Hyrimoz is used for
2.
How Hyrimoz works
3.
Before you use Hyrimoz
4.
How to use Hyrimoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Hyrimoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HYRIMOZ
IS USED FOR
Hyrimoz
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 HYRIMOZ
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 HYRIMOZ
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to adalimumab or any of the other
ingredients of Hyrimoz.
•
If you have a
severe
infection,
including active tuberculosis. It is
important that you tell

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Hyrimoz 40mg/0.8ml Solution for Injection in Pre-Filled Pen
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 to slightly opalescent, colourless to slightly yellowish
solution.
Hyrimoz
is
a
biosimilar
medicinal
product
of
Humira.
Hyrimoz
is
not
interchangeable
or
automatically substitutable with Humira.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RHEUMATOID ARTHRITIS
Hyrimoz 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.
Hyrimoz can be used alone or in combination with methotrexate or other
disease modifying
antirheumatic drugs (DMARDs).
PSORIATIC ARTHRITIS
Hyrimoz 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.
Hyrimoz can be used alone or in combination with disease modifying
anti-rheumatic drugs.
AXIAL SPONDYLOARTHRITIS
ANKYLOSING SPONDYLITIS
Hyrimoz
is
indicated
for
reducing
signs
and
symptoms
in
patients
with
active
ankylosing
spondylitis.
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (AXIAL SPONDYLOARTHRITIS
WITHOUT RADIOGRAPHIC
EVIDENCE OF AS)
Hyrimoz 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 CRP and/or MRI,
who have had an inadequate response to, or are intolerant to
nonsteroidal anti-inflammatory drugs.
PLAQUE PSORIASIS
Hyrimoz is indicated for the treatment of adult patients with moderat