Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
Ustekinumab, Quantity: 45 mg
Janssen-Cilag Pty Ltd
Ustekinumab
Injection, solution
Excipient Ingredients: water for injections; sucrose; polysorbate 80; histidine; histidine hydrochloride monohydrate
Subcutaneous
1
(S4) Prescription Only Medicine
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.
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
Registered
2010-08-19
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 Đọc toàn bộ tài liệu