STELARA ustekinumab 5.0 mg/1 mL solution for intravenous infusion injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Ustekinumab, Quantity: 135 mg

Tilgjengelig fra:

Janssen-Cilag Pty Ltd

INN (International Name):

Ustekinumab

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: histidine hydrochloride monohydrate; sucrose; polysorbate 80; methionine; disodium edetate; water for injections; histidine

Administreringsrute:

Intravenous Infusion

Enheter i pakken:

1 vial per carton

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Crohn?s Disease,STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a TNF alpha antagonist or have medical contraindications to such therapies.,Ulcerative Colitis,STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Produkt oppsummering:

Visual Identification: The solution is clear, colourless to light yellow with a pH of approximately 6.0; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2017-03-01

Informasjon til brukeren

STELARA (220610) ACMI
1

This medicine is subject to additional monitoring due to approval of
an extension of indications. This will allow quick
identification of new safety information. You can help by reporting
any side affects you may get. You can report side
effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
STELARA
® INJECTION
_Ustekinumab (rmc) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about STELARA
(pronounced stel-ahr-uh). It does not
contain all the available information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using STELARA
against the benefits this medicine is
expected to have for you.
If you have any concerns about using
STELARA, ask your doctor or
pharmacist.
IT IS IMPORTANT THAT YOU READ THIS
LEAFLET.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT STELARA IS
USED FOR
STELARA is a prescription medicine
that is used to treat:
•
adults and paediatric patients
(children and adolescents) 6 years
and older 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,
an inflammatory disease of the
bowel.
•
adults with moderate to severe
ulcerative colitis, an
inflammatory disease of the
bowel.
STELARA contains the active
ingredient ustekinumab, a
monoclonal antibody. Monoclonal
antibodies are proteins that recognise
and bind to other unique proteins.
Ustekinumab 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, Crohn's disease or ulcerative
colitis, IL-12 and IL-23 can cause
their immune system to attack
normal healthy parts of

Preparatomtale

46.200622
1
STELARA (220622) API
This medicinal product is subject to additional monitoring in
Australia due to approval of an
extension of indications. This will allow quick identification of new
safety information. Healthcare
professionals are asked to report any suspected adverse events at
www.tga.gov.au/reporting-
problems.
STELARA
®
USTEKINUMAB
A
USTRALIAN
P
RODUCT
I
NFORMATION
1.
NAME OF THE MEDICINE
Ustekinumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FOR SUBCUTANEOUS ADMINISTRATION
STELARA 45 mg solution for injection
Each vial contains 45 mg ustekinumab in 0.5 mL.
STELARA 45 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL.
STELARA 90 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 90 mg ustekinumab in 1 mL
FOR INTRAVENOUS INFUSION ONLY
STELARA 130 mg concentrate for solution for infusion
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
For a full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
FOR SUBCUTANEOUS ADMINISTRATION
Solution for subcutaneous injection.
The solution is clear to slightly opalescent, colourless to light
yellow.
FOR INTRAVENOUS INFUSION ONLY
Concentrate for solution for infusion.
The solution is clear, colourless to light yellow.
▼
Product Information - Australia
46.200622
2
STELARA (220602) API
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PLAQUE PSORIASIS
_ADULTS _
STELARA is indicated for the treatment of adult patients (18 years or
older) with moderate to severe
plaque psoriasis who are candidates for phototherapy or systemic
therapy.
_PAEDIATRIC POPULATION, 6 YEARS AND OLDER _
STELARA is indicated for the treatment of moderate to severe plaque
psoriasis in children and
adolescent patients from 6 years of age who are inadequately
controlled by, or are intolerant to,
other systemic therapies or phototherapies.
PSORIATIC ARTHRITIS (PSA)
STELARA, alone or in combination with methotrexate, is indicated for
the treatment of signs and
sympto