Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
Ustekinumab, Quantity: 90 mg
Janssen-Cilag Pty Ltd
Ustekinumab
Injection, solution
Excipient Ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine
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
Licence status A
2010-08-19
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 Прочитать полный документ
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 Прочитать полный документ