Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Adalimumab 100 mg/mL; ; ;
AbbVie Limited
Adalimumab 100 mg/mL
40 mg/0.4mL
Solution for injection
Active: Adalimumab 100 mg/mL Excipient: Mannitol Polysorbate 80 Water for injection
Prescription
AbbVie Bioresearch Centre
Uveitis Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Package - Contents - Shelf Life: Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 2 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 4 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light - Syringe, glass, Type I, with bromobutyl rubber stopper and needle. 0.4mL - 6 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light
2016-04-04
_ _ _ _ _Humira Pre-filled Syringe _ _Version 03 _ _28 March 2019 _ _ _ _Page 1 of 8 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ HUMIRA PRE-FILLED SYRINGE _ _ _ADALIMUMAB (RCH) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Humira. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU USE HUMIRA AND KEEP IT WITH THE MEDICINE. You may need to read it again. WHAT HUMIRA IS USED FOR Humira is intended for the treatment of: • Rheumatoid arthritis Humira is used to reduce the signs and symptoms of moderately to severely active rheumatoid arthritis, a painful disease of the joints, as well as slow down and protect against damage to joints. Signs and symptoms of rheumatoid arthritis include joint pain, tenderness, swelling and stiffness. • Polyarticular juvenile idiopathic Arthritis Humira is used for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis, which is an inflammatory disease, involving multiple joints, with diagnosis typically occurring in children 2 years of age and older. • Enthesitis-related arthritis Humira is used to treat enthesitis-related arthritis, an inflammatory disease of the joints that begins before the 16 th birthday, in patients from 6 years of age. • Psoriatic arthritis Humira is used to reduce the signs and symptoms, as well as inhibit the progression of joint damage of moderately to severely active psoriatic arthritis, a disease of the joints and skin, with some similarities to rheumatoid arthritis, as well as psoriasis and other factors. • Ankylosing spondylitis Humira is used to reduce the signs and symptoms in patients with active anky Perskaitykite visą dokumentą
Humira Data Sheet 21 February 2022 Page 1 of 84 Version 53 NEW ZEALAND DATA SHEET 1. HUMIRA ® ADALIMUMAB (RCH) SOLUTION FOR INJECTION. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION HUMIRA 20 mg: each 0.4 mL single-use pre-filled syringe contains 20 mg of adalimumab. HUMIRA 20 mg: each 0.2 mL single-use pre-filled syringe contains 20 mg of adalimumab. HUMIRA 40 mg: each 0.8 mL single-use pre-filled syringe or pen contains 40 mg of adalimumab. HUMIRA 40mg: each 0.4mL single-use pre-filled syringe or pen contains 40mg of adalimumab. HUMIRA 80 mg: each 0.8 mL single use pre-filled syringe or pen contains 80mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells. Adalimumab is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. Humira was created using phage display technology resulting in fully human heavy and light chain variable regions, which confer specificity to human tumour necrosis factor (TNF), and human IgG1 heavy chain and kappa light chain sequences. Humira binds with high affinity and specificity to soluble tumour necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Humira is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The solution of Humira is clear and colourless with a pH of 5.2. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid Arthritis Humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. Perskaitykite visą dokumentą