Stelara Solution for Injection 45mg0.5 ml

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Ustekinumab

Tilgjengelig fra:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC-kode:

L04AC05

Dosering :

45mg/vial

Legemiddelform:

INJECTION, SOLUTION

Sammensetning:

Ustekinumab 45mg/vial

Administreringsrute:

SUBCUTANEOUS

Resept typen:

Prescription Only

Produsert av:

Cilag AG

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2009-09-29

Informasjon til brukeren

1
STELARA
® (
stel-ahr-uh
)
(USTEKINUMAB)
Review this patient information before you start taking STELARA
®
and each time you get a refill.
There may be new information. This information does not take the place
of talking with your
healthcare provider about your medical condition or treatment. It is
important to remain under a
healthcare provider’s care while using STELARA
®
.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT STELARA
®
?
STELARA
®
is a medicine that may decrease the activity of your immune system. It
can increase your
chances of getting serious side effects including:
SERIOUS INFECTIONS
•
STELARA
®
may lower your ability to fight infections. Some infections could
become serious
and lead to hospitalization. If you have an infection or have any open
cuts, tell your healthcare
provider before you start using STELARA
®
. If you get an infection, have any sign of an
infection such as fever, feel very tired, cough, flu-like symptoms, or
warm, red or painful skin
or sores on your body, tell your healthcare provider right away. These
may be signs of
infections such as chest infections, or skin infections or shingles
that could have serious
complications.
•
Your doctor will examine you for tuberculosis (TB) and perform a test
to see if you have TB.
If your doctor feels that you are at risk for TB, you may be treated
with medicine for TB before
you begin treatment with STELARA
®
and during treatment with STELARA
®
.
SERIOUS SKIN CONDITIONS
•
Shedding of Skin – Increase in redness and shedding of skin over a
larger area of the body may
be symptoms of erythrodermic psoriasis or exfoliative dermatitis,
which are serious skin
conditions. You should contact your doctor straight away if you notice
any of these signs.
CANCERS
Many drugs such as STELARA
®
that may decrease the activity of the immune system, may
increase the risk of cancer. Tell your doctor if you have ever had any
type of cancer, or notice any
changes
to
your
health
status
(including
unusual
changes
to
your
skin)
while

Preparatomtale

1
PRODUCT NAME
STELARA
®
(ustekinumab)
DOSAGE FORMS AND STRENGTHS
Ustekinumab is a fully human IgG1қ monoclonal antibody with an
approximate molecular
weight of 148,600 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
SINGLE-USE VIAL:

130 mg / 26 mL
Not all presentations may be available locally.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
PLAQUE PSORIASIS:
STELARA
®
is indicated for the treatment of adult patients (18 years or older)
with moderate to
severe plaque psoriasis who failed to respond to, or who have a
contraindication to, or are
intolerant to other systemic therapies including cyclosporin,
methotrexate or PUVA.
PEDIATRIC PLAQUE PSORIASIS:
STELARA
®
is indicated for the treatment of pediatric patients (children and
adolescents) (6
years and older) with moderate to severe plaque psoriasis who are
inadequately controlled by, or
are intolerant to, other systemic therapies or phototherapies.
PSORIATIC ARTHRITIS (PSA):
STELARA
®
, alone or in combination with methotrexate (MTX), is indicated for:

the treatment of adult patients (18 years or older) with active
psoriatic arthritis when the
response to previous non-biological disease-modifying anti-rheumatic
drug (DMARD)
therapy has been inadequate

inhibiting the progression of structural damage
2
CROHN’S DISEASE:
STELARA
®
is indicated for the treatment of adults with moderately to severe
active Crohn’s
disease who have:

failed or were intolerant to treatment with immunomodulators or
corticosteroids, but
never failed treatment with a tumor necrosis factor (TNF) blocker or

failed or were intolerant to treatment w