STELARA ustekinumab 45 mg/0.5 mL solution for injection pre-filled syringe

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Ustekinumab, Quantity: 45 mg

Tilgjengelig fra:

Janssen-Cilag Pty Ltd

INN (International Name):

Ustekinumab

Legemiddelform:

Injection, solution

Sammensetning:

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

Administreringsrute:

Subcutaneous

Enheter i pakken:

1

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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 symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological DMARD therapy has been inadequate.,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: Pre-filled syringe with a rubber plunger stopper. The solution is clear to slightly opalescent, colourless to light yellow; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2010-08-19

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