Cosentyx 150mgml solution for injection in pre-filled syringe

国家: 马来西亚

语言: 英文

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

有效成分:

Secukinumab

可用日期:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN（国际名称）:

Secukinumab

每包单位数:

1units Units; 2units Units; 1 Units; 2 Units

厂商:

NOVARTIS PHARMA STEIN AG

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
COSENTYX
®
Secukinumab
(300mg/2ml, 150 mg/mL Solution for injection in a pre-filled syringe)
WHAT IS IN THIS LEAFLET
1.
WHAT COSENTYX
® IS USED FOR
2.
HOW COSENTYX
® WORKS
3.
BEFORE YOU USE COSENTYX
®
4.
HOW TO USE COSENTYX
®
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF COSENTYX
®
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT REGISTRATION
HOLDER
10. DATE OF REVISION
WHAT COSENTYX
®
IS USED FOR
Cosentyx contains the active substance
secukinumab. Secukinumab is a fully-human
monoclonal antibody. Monoclonal antibodies
are proteins that recognise and bind specifically
to certain proteins in the body.
It belongs to a group of medicines called
interleukin (IL) inhibitors. This medicine works
by neutralising the activity of a protein called
IL-17A, which is present at increased levels in
diseases such as psoriasis, psoriatic arthritis and
axial spondyloarthritis (ankylosing spondylitis
and non-radiographic axial spondyloarthritis).
Cosentyx is used for the treatment of the
following inflammatory diseases:
_Plaque psoriasis _
Cosentyx is used to treat a skin condition called
‘plaque psoriasis’. Plaque psoriasis causes
inflammation affecting the skin. Cosentyx will
reduce the inflammation and other symptoms of
the disease.
Cosentyx is used in patients 6 years and older
with moderate to severe plaque psoriasis.
_Psoriatic arthritis _
Cosentyx is used to treat a condition called
‘psoriatic arthritis’. The condition is an
inflammatory disease of the joints, often
accompanied by psoriasis. Cosentyx is given to
you to reduce the signs and symptoms of active
psoriatic arthritis, improve physical function
and slow down the damage to the cartilage and
the bone of the joints involved in the disease.
Cosentyx is used in adults with active psoriatic
arthritis and can be used alone or with another
medicine called methotrexate.
_Axial spondyloarthritis, including ankylosing _
_spondylitis (axial spondyloarthritis with _
_radiographic damage)

产品特点

Novartis
Page 2
Malaysia Package Leaflet
20-Jan-2023
Cosentyx
®
COSENTYX
®
Interleukin inhibitors.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
SOLUTION FOR INJECTION IN A SINGLE DOSE PRE-FILLED SYRINGE
The solution is colorless to slightly yellow.
ACTIVE SUBSTANCE
Each 2 mL pre-filled syringe contains 300 mg secukinumab.
Each 1 mL pre-filled syringe contains 150 mg secukinumab.
Secukinumab is a recombinant fully human monoclonal antibody selective
for interleukin-17A.
Secukinumab is of the IgG1/κ-class produced in Chinese Hamster Ovary
(CHO) cells.
EXCIPIENTS
SOLUTION
FOR
INJECTION
(PRE-FILLED
SYRINGE):
Trehalose
dihydrate,
L-histidine/histidine
hydrochloride monohydrate, L-methionine, polysorbate 80, water for
injection.
Pharmaceutical formulations may vary between countries.
INDICATIONS
PLAQUE PSORIASIS
Cosentyx is indicated for the treatment of moderate to severe plaque
psoriasis in patients 6 years
and older who are candidates for systemic therapy or phototherapy.
PSORIATIC ARTHRITIS
Cosentyx, alone or in combination with methotrexate (MTX), is
indicated for the treatment of
active psoriatic arthritis in adult patients when the response to
previous disease-modifying anti-
rheumatic drug (DMARD) therapy has been inadequate.
AXIAL SPONDYLOARTHRITIS (AXSPA)
ANKYLOSING SPONDYLITIS (AS
, RADIOGRAPHIC
AXIAL SPONDYLOARTHRITIS)
Cosentyx is indicated for the treatment of active ankylosing
spondylitis in adults who have
responded inadequately to conventional therapy.
Novartis
Page 3
Malaysia Package Leaflet
20-Jan-2023
Cosentyx
®
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (NR-AXSPA)
Cosentyx is indicated for the treatment of active non-radiographic
axial spondyloarthritis with
objective signs of inflammation as indicated by elevated C-reactive
protein (CRP) and/or
magnetic resonance imaging (MRI) evidence in adults who have responded
inadequately to
non-steroidal anti-inflammatory drugs (NSAIDs).
JUVENILE IDIOPATHIC ARTHRITIS (JIA)
ENTHESITIS-RELATED ARTHRITIS (ERA)
Cosentyx, alone or in combination with methotr