Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg
AbbVie Limited
15 mg
Modified release tablet
Active: Upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg Excipient: Colloidal silicon dioxide Hypromellose Magnesium stearate Mannitol Microcrystalline cellulose Opadry purple 85F100091 Tartaric acid
Prescription
Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis. Rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs).
Package - Contents - Shelf Life: Calendar pack, PVC/PE/PTFE Blister with push through Al foil, Starter Pack - 7 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture - Calendar pack, PVC/PE/PTFE Blister with push through Al foil - 28 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture
2019-01-30
Rinvoq ®_ 03 October 2023 Version_ _12 _ _ _ 1_ _ RINVOQ ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING RINVOQ? Rinvoq contains the active ingredient upadacitinib. Rinvoq is used to treat moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis, moderate to severe atopic dermatitis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. For more information, see Section 1. Why am I taking Rinvoq? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE RINVOQ? Check the list of ingredients at the end of the CMI. Do not take Rinvoq if you have ever had an allergic reaction to any of them. Talk to your doctor before you take this medicine if you have any other medical conditions, you are a current or past long-time smoker, take any other medicines or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take Rinvoq? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Rinvoq and affect how it works or Rinvoq may interfere with other medicines and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE RINVOQ? • The usual dose is one tablet once every day. • Do not split, crush, or chew the tablets. Swallow them whole with a full glass of water with or without food. More instructions can be found in Section 4. How do I take Rinvoq? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING RINVOQ? THINGS YOU SHOULD DO • Remind any doctor, pharmacist or dentist you visit that you are taking Rinvoq. • Keep all your appointments, including blood tests. • Tell your doctor if you develop an infection, or pain or swelling in the leg, or pain i Прочитайте повний документ
Rinvoq [upadacitinib] Data Sheet Version 16 CCDS v 16 0 7 September 2023 Page 1 of 86 NEW ZEALAND DATA SHEET 1 RINVOQ ® MODIFIED RELEASE TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rinvoq contains upadacitinib hemihydrate, equivalent to 15 mg, 30 mg or 45 mg of upadacitinib, a JAK inhibitor. The tablets do not contain gluten or lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Rinvoq 15 mg modified release tablets are purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a15’ on one side. Rinvoq 30 mg modified-release tablets are red, biconvex oblong, with dimensions of 14 x 8 mm and debossed with ‘a30’ on one side. Rinvoq 45 mg modified release tablets are yellow to mottled yellow, biconvex oblong, with dimensions of 14 x 8 mm and debossed with ‘a45’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid Arthritis Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis. Rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). Atopic Dermatitis Rinvoq is indicated for the treatment of adults and adolescents 12 years and older with moderate to severe atopic dermatitis who are candidates for systemic therapy. Rinvoq [upadacitinib] Data Sheet Version 16 CCDS v 16 0 7 September 2023 Page 2 of 86 Psoriatic arthritis Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with a non-biological DMARD. Ankylosing spondylitis Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Non-radiographic Axial Spondyloarthritis Rinvoq is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with Прочитайте повний документ