Fraizeron 150mgml solution for injection in pre-filled pen

国: マレーシア

言語: 英語

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

有効成分:

Secukinumab

から入手可能:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN（国際名）:

Secukinumab

パッケージ内のユニット:

1units Units; 2units Units

製:

NOVARTIS PHARMA STEIN AG

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FRAIZERON
®
Secukinumab
(300mg/2ml, 150 mg/mL Solution for injection in a pre-filled pen)
WHAT IS IN THIS LEAFLET
1.
WHAT FRAIZERON
® IS USED FOR
2.
HOW FRAIZERON
® WORKS
3.
BEFORE YOU USE FRAIZERON
®
4.
HOW TO USE FRAIZERON
®
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF FRAIZERON
®
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT REGISTRATION
HOLDER
10. DATE OF REVISION
WHAT FRAIZERON
®
IS USED FOR
Fraizeron 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).
Fraizeron is used for the treatment of the
following inflammatory diseases:
_Plaque psoriasis _
Fraizeron is used to treat a skin condition called
‘plaque psoriasis’. Plaque psoriasis causes
inflammation affecting the skin. Fraizeron will
reduce the inflammation and other symptoms of
the disease.
Fraizeron is used in patients 6 years and older
with moderate to severe plaque psoriasis.
_Psoriatic arthritis _
Fraizeron is used to treat a condition called
‘psoriatic arthritis’. The condition is an
inflammatory disease of the joints, often
accompanied by psoriasis. Fraizeron 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.
Fraizeron 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 _
_radiograp

製品の特徴

Novartis
Page 2
Malaysia Package Leaflet
20-Jan-2023
Fraizeron
FRAIZERON
®
Interleukin inhibitors.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
POWDER FOR SOLUTION FOR INJECTION
The powder is a white solid lyophilisate in a 6 mL glass vial.
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
The solution is colorless to slightly yellow.
Certain dosage strengths and dosage forms may not be available in all
countries.
ACTIVE SUBSTANCE
Each vial of powder for solution for subcutaneous injection contains
150 mg of secukinumab
when reconstituted with 1 mL water for injection.
Each 2 mL pre-filled pen contains 300 mg secukinumab.
Each 1 mL pre-filled pen 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
POWDER
FOR
SOLUTION
FOR
SUBCUTANEOUS
INJECTION:
Sucrose,
L-histidine,
L-histidine
hydrochloride monohydrate, polysorbate 80, water for injection.
SOLUTION
FOR
INJECTION
(PRE-FILLED
PEN):
Trehalose
dihydrate,
L-histidine/histidine
hydrochloride monohydrate, L-methionine, polysorbate 80, water for
injection.
Pharmaceutical formulations may vary between countries.
INDICATIONS
PLAQUE PSORIASIS
Fraizeron 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
Fraizeron, 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.
Novartis
Page 3
Malaysia Package Leaflet
20-Jan-2023
Fraizeron
AXIAL SPONDYLOARTHRITIS (AXSPA)
ANKYLOSING SPONDYLITIS (AS, RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS)
Fraizeron is indicated for the treatment of active ankylosing
spondylitis in adults who have
responded inadequately to conventional therapy.
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (NR-AXSPA)
F