Skyrizi solution for injection in pre-filled pen 150MGML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RISANKIZUMAB

Boleh didapati daripada:

ABBVIE SDN BHD

INN (Nama Antarabangsa):

RISANKIZUMAB

Unit dalam pakej:

1 Units

Dikeluarkan oleh:

Abbvie Deutschland GmbH & Co.KG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SKYRIZI SOLUTION FOR INJECTION IN PRE-
FILLED PEN 150MG/ML
Risankizumab
1
WHAT IS IN THIS LEAFLET
1.
What Skyrizi is used for
2.
How Skyrizi works
3.
Before you use Skyrizi
4.
How to use Skyrizi
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Skyrizi
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SKYRIZI IS USED FOR
Skyrizi contains the active substance
risankizumab.
Skyrizi is used to treat adults with
moderate to severe plaque psoriasis and
active psoriatic arthritis.
HOW SKYRIZI WORKS
This medicine works by stopping a
protein in the body called ‘IL-23’, which
causes inflammation.
PLAQUE PSORIASIS
SKYRIZI reduces inflammation and can
therefore help to improve skin clearance
and the appearance of nails. It also
reduces symptoms of plaque psoriasis
such as burning, itching, pain, redness,
and scaling.
PSORIATIC ARTHRITIS
SKYRIZI reduces the inflammation and
can therefore help to reduce pain,
stiffness, and swelling in and around
your joints, pain and stiffness in your
spine, psoriatic skin rash, psoriatic nail
damage, and it may limit damage to the
bone and cartilage in your joints. These
effects can ease your normal daily
activities, reduce tiredness, and improve
your quality of life.
BEFORE YOU USE SKYRIZI
-
_When you must not use it_

if you are allergic to risankizumab or
any of the other ingredients of this
medicine.

if you have an infection, including
active tuberculosis, which your
doctor thinks is important.
CHILDREN AND ADOLESCENTS
Skyrizi is not recommended for children
and adolescents under 18 years of age.
This is because Skyrizi has not been
studied in this age group.
_Pregnancy and lactation_
If you are pregnant, think you may be
pregnant or are planning to have a baby,
ask your doctor for advice before using
this medicine. This is because it is not
known how this medicine will affect the
baby.
If you are a woman who can become
pregnant, you should use

Ciri produk

1
NAME OF THE MEDICINAL PRODUCT
Skyrizi 150 mg solution for injection in pre-filled pen
Skyrizi 150 mg solution for injection in pre-filled syringe
Skyrizi 75 mg solution for injection in pre-filled syringe
QUALITATIVE AND QUANTITATIVE COMPOSITION
Skyrizi 150 mg solution for injection in pre-filled pen
Each pre-filled pen contains 150 mg risankizumab in 1 mL solution.
Skyrizi 150 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 150 mg risankizumab in 1 mL solution.
Skyrizi 75 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml
solution.
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal
antibody selective to the
interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells
using recombinant DNA
technology.
Information about certain excipients
SKYRIZI 150 mg/mL and SKYRIZI 75 mg/0.83 mL contain less than 1 mmol
sodium (23 mg) per
150 mg dose, i.e., essentially ‘sodium-free’.
SKYRIZI 75 mg/0.83 mL contains 68 mg sorbitol per 150 mg dose.
For the full list of excipients, see PHARMACEUTICAL PARTICULARS
section.
PHARMACEUTICAL FORM
Solution for injection (injection).
Skyrizi 150 mg solution for injection in pre-filled pen and pre-filled
syringe
The solution is colourless to yellow and clear to slightly opalescent.
Skyrizi 75 mg solution for injection in pre-filled syringe
The solution is colourless to slightly yellow and clear to slightly
opalescent.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
PLAQUE PSORIASIS
Skyrizi is indicated for the treatment of moderate to severe plaque
psoriasis in adults who are
candidates for systemic therapy.
PSORIATIC ARTHRITIS
2
Skyrizi, alone or in combination with methotrexate (MTX), is indicated
for the treatment of active
psoriatic arthritis in adults who have had an inadequate response or
who have been intolerant to one or
more disease-modifying antirheumatic drugs (DMARDs).
POSOLOGY AND METHOD OF ADMINISTRATION
Skyrizi is intended for use under the guidance and supervis