STELARA 45MG0.5ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE

Pajjiż: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

USTEKINUMAB

Disponibbli minn:

JOHNSON & JOHNSON SDN BHD

INN (Isem Internazzjonali):

USTEKINUMAB

Unitajiet fil-pakkett:

1Pieces Pieces

Manifatturat minn:

CILAG AG

Fuljett ta 'informazzjoni

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
STELARA
® SOLUTION FOR INJECTION IN
PREFILLED SYRINGE
Ustekinumab (45mg/0.5ml, 90mg/1ml)
WHAT IS IN THIS LEAFLET
1.
What Stelara
®
is used for
2.
How Stelara
®
works
3.
Before you use Stelara
®
4.
How to use Stelara
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Stelara
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT STELARA
® IS USED FOR
Stelara is a prescription medicine that
is approved for the treatment of:
•
Adults with moderate to severe
plaque psoriasis that is chronic
(doesn’t go away)
•
Adults with active psoriatic arthritis,
an inflammatory disease of the joints
that is usually accompanied by
psoriasis
•
Adults with moderately to severely
active Crohn’s disease or ulcerative
colitis
HOW STELARA
® WORKS
Stelara blocks the action of two proteins in
your body called interleukin 12 (IL-12)
and interleukin 23 (IL-23). IL-12 and IL-
23 are made by your body's immune
system. In people with psoriasis, psoriatic
arthritis or Crohn’s disease, IL-12 and IL-
23 can cause their immune system to
attack normal healthy parts of their body.
Stelara can block the IL-12 and IL-23
from causing the immune system to attack
the skin, nails, joints or the digestive tract.
BEFORE YOU USE STELARA
®
_-_
_ _
_When you must not use it_
You should not receive Stelara if you
have:
•
had an allergic reaction to Stelara,
or any of the other ingredients in
Stelara. See the end of this labeling
for a complete list of ingredients in
Stelara.
_-_
_ _
_Before you start to use it _
Your doctor will assess your health before
each treatment.
Tell your doctor about all of your medical
conditions before each treatment,
including if you:
•
ever had an allergic reaction to
Stelara. Ask your doctor if you are
not sure.
•
have any kind of infection, even if it
is very minor
•
have an infection that won't go
away or a history of infection that
keeps coming back.
•
have had TB (tuberculosis), or

Karatteristiċi tal-prodott

1
PRODUCT NAME
STELARA
®
Solution for Injection in Pre-filled Syringe
STELARA
®
130mg/26mL Concentrate for Solution for Infusion
STELARA
®
Solution for Injection in Single-use Vial
DOSAGE FORMS AND STRENGTHS
Ustekinumab is a fully human IgG1κ monoclonal antibody with an
approximate molecular weight
of 148600 daltons. Ustekinumab is produced by a recombinant cell line
cultured by continuous
perfusion and is purified by a series of steps that includes measures
to inactivate and remove
viruses.
STELARA is available in the following presentations:
_SOLUTION FOR INJECTION FOR SUBCUTANEOUS ADMINISTRATION _
_Pre-filled Syringe _
•
45 mg / 0.5 mL
•
90 mg / 1.0 mL
_SINGLE-USE VIAL_
•
45 mg / 0.5 mL
_CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION (only for
intravenous induction dose for the _
_treatment of Crohn’s disease and ulcerative colitis) _
_Single-use Vial _
•
130 mg / 26 mL
For excipients, see
_List of Excipients._
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
PLAQUE PSORIASIS
_(VIA SUBCUTANEOUS ADMINISTRATION ONLY) _
STELARA is indicated for the treatment of moderate to severe plaque
psoriasis in adults who
failed to respond to, or who have a contraindication to, or are
intolerant to other systemic therapies
including
ciclosporin,
methotrexate
(MTX)
or
PUVA
(psoralen
and
ultraviolet
A)
(see
_Pharmacodynamic Properties_
).
PEDIATRIC PLAQUE PSORIASIS
_(VIA SUBCUTANEOUS ADMINISTRATION ONLY WITH SINGLE-USE VIAL)_
STELARA is indicated for the treatment of moderate to severe plaque
psoriasis in children and
adolescent patients from the age of 6 years and older, who are
inadequately controlled by, or are
intolerant to, other systemic therapies or phototherapies (see
_Pharmacodynamic Properties_
).
PSORIATIC ARTHRITIS (PSA)
_(VIA SUBCUTANEOUS ADMINISTRATION ONLY) _
STELARA
alone or in combination with MTX, is indicated for the treatment of
active
psoriatic
arthritis in adult patients when the response to previous
non-biological disease-modifying anti-
rheumatic drug (DMARD) therapy has been inadequate (se