Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Ustekinumab 90mg;
Janssen-Cilag (New Zealand) Ltd
Ustekinumab 90 mg
90 mg
Solution for injection
Active: Ustekinumab 90mg Excipient: Histidine as histidine hydrochloride Polysorbate 80 Sucrose Water for injection
Syringe, glass, Prefilled, 1 mL
Prescription
Prescription
Janssen Biologics BV
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.
Package - Contents - Shelf Life: Syringe, glass, Prefilled - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days not refrigerated stored at or below 30°C protect from light. no return to refrigeration
2009-09-01
STELARA (231016) ACMI 1 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 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 their body like the skin and nails. Ustekinumab can block IL-12 and IL-23 from causing the immune system to attack the skin, nails, joints or the digestive tract. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR’S PRESCRIPTION. BE Lees het volledige document
51.230601 1 STELARA (231016) ADS STELARA USTEKINUMAB NEW ZEALAND DATA SHEET 1. PRODUCT NAME STELARA 45 mg solution for injection in vial. STELARA 45 mg solution for injection in pre-filled syringe. STELARA 90 mg solution for injection in pre-filled syringe. STELARA 130 mg concentrate for solution for infusion. 2. QUALITATIVE AND QUANTIITATIVE COMPOSITION SOLUTION FOR INJECTION VIAL AND PRE-FILLED SYRINGE _(FOR SUBCUTANEOUS ADMINISTRATION)_ Each vial contains 45 mg ustekinumab in 0.5 mL. Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL or 90 mg ustekinumab in 1 mL. CONCENTRATE FOR SOLUTION FOR INFUSION _(FOR INTRAVENOUS INFUSION AS THE INDUCTION DOSE FOR USE _ _IN CROHN’S DISEASE AND ULCERATIVE COLITIS ONLY)_ Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL). STELARA (ustekinumab) is a human IgG1kappa monoclonal antibody with an approximate molecular weight of 148,600 daltons. STELARA 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. For the full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM SOLUTION FOR INJECTION VIAL AND PRE-FILLED SYRINGE _(FOR SUBCUTANEOUS ADMINISTRATION)_ The solution is clear to slightly opalescent, colourless to light yellow with a pH of approximately 6.0. CONCENTRATE FOR SOLUTION FOR INFUSION _(FOR INTRAVENOUS INFUSION)_ The solution is clear, colourless to light yellow with a pH of approximately 6.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PLAQUE PSORIASIS 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. 51.230601 2 STELARA (231016) ADS PSORIATIC ARTHRITIS (PSA) STELARA, alone or in combination with methotrexate, is indicated for the treatment signs and symptoms, including reduction of the rate of progression of peripheral joint damage as measured by X-ray, of active psoriatic arthritis in adult patie Lees het volledige document