Taltz 80mg solution for injection in pre-filled pen

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IXEKIZUMAB

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

IXEKIZUMAB

Unit dalam pakej:

1 ml

Dikeluarkan oleh:

ELI LILLY AND COMPANY

Risalah maklumat

TALTZ 80 MG SOLUTION FOR INJECTION IN
PRE-FILED PEN
Ixekizumab 80 mg
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Taltz is used for
2.
How Taltz works
3.
Before you use Taltz
4.
How to use Taltz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Taltz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial number
What Taltz is used for
Plaque psoriasis
Taltz is used to treat a skin condition
called “plaque psoriasis” in adults and in
children from the age of 6 years and with
a body weight of at least 25 kg and in
adolescents
with
moderate
to
severe
disease.
Taltz
reduces
the
signs
and
symptoms of the disease.
Psoriatic arthritis in adults:
Taltz is used to treat a condition called
“psoriatic
arthritis”
in
adults,
an
inflammatory disease of the joints, often
accompanied by psoriasis. If you have
psoriatic arthritis you will first be given
other medicines. If you do not respond
well enough to these medicines, you will
be given Taltz to reduce the signs and
symptoms of the disease. Taltz can be
used
alone
or
with
another
medicine
named methotrexate.
Axial spondyloarthritis
Ankylosing
spondylitis
(radiographic
axial
spondyloarthritis)
Taltz is used to treat the adult patients
with “active ankylosing spondylitis”, a
rare type of arthritis that causes pain and
stiffness
in
your
spine
who
have
responded inadequately to conventional
therapy.
Non-radiographic axial
spondyloarthritis
Taltz is used to treat the adult patients
with
“active
non-radiographic
axial
spondyloarthritis”, a type of arthritis in
your
spine.
It
causes
inflammation,
which leads to symptoms like redness,
swelling, heat, stiffness, and pain. The
condition
affects
the
joints
and
the
entheses
tissues that connect
bones to
ligaments or tendons.
How Taltz works
Taltz
contains
the
active
substance
ixekizumab.
Ixekizumab
belongs
to
a
group
of
medicines
called
interleukin
(IL) inhibitors. This medicine works by
neutralizing
the
activity
of
a
pr

Ciri produk

Taltz pre-filled pen PI_EUSPC 17 June 2021_18 Jan 2023
1
1.
NAME OF THE MEDICINAL PRODUCT
Taltz 80 mg solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled pen contains 80 mg ixekizumab in 1 ml.
Ixekizumab is produced in CHO cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear and colourless to slightly yellow.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Plaque psoriasis
Taltz is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are candidates
for systemic therapy.
Paediatric plaque psoriasis
Taltz is indicated for the treatment of moderate to severe plaque
psoriasis in children from the age of 6
years and with a body weight of at least 25 kg and adolescents who are
candidates for systemic therapy.
Psoriatic arthritis
Taltz, alone or in combination with methotrexate, is indicated for the
treatment of active psoriatic
arthritis in adult patients who have responded inadequately to, or who
are intolerant to one or more
disease-modifying anti-rheumatic drug (DMARD) therapies (see section
5.1).
Axial spondyloarthritis
Ankylosing spondylitis (radiographic axial spondyloarthritis)
Taltz is indicated for the treatment of adult patients with active
ankylosing spondylitis who have
responded inadequately to conventional therapy.
Non-radiographic axial spondyloarthritis
Taltz is indicated for the treatment of adult patients with active
non-radiographic axial spondyloarthritis
with objective signs of inflammation as indicated by elevated
C-reactive protein (CRP) and/or magnetic
resonance imaging (MRI) who have responded inadequately to
nonsteroidal anti-inflammatory drugs
(NSAIDs).
4.2
Posology and method of administration
This medicinal product is intended for use under the guidance and
supervision of a physician
experienced in the diagnosis and treatment of conditions for which it
is indicated.
Taltz pre-filled pen PI_EUSPC 17 June 2021_