Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Adalimumab 50 mg/mL;
Amgen New Zealand Limited
40 mg/0.8mL
Solution for injection
Active: Adalimumab 50 mg/mL Excipient: Glacial acetic acid Polysorbate 80 Sodium hydroxide Sucrose Water for injection
Prescription
Rheumatoid Arthritis AMGEVITA 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. AMGEVITA can be used alone or in combination with methotrexate.
Package - Contents - Shelf Life: Syringe, glass, (Type I), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 1 dose units - 36 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), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 2 dose units - 36 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), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 4 dose units - 36 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), pre-filled (0.8 mL deliverable volume), with stainless steel needle & bromobutyl plunger - 6 dose units - 36 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
2018-05-17
AMGEVITA® CMI AMGEVITA® PRE-FILLED SYRINGE PRE-FILLED PEN _ _ _Adalimumab (ada-lim-u-mab) _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS CMI This leaflet answers some common questions about AMGEVITA. 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. SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING AMGEVITA. READ THIS LEAFLET CAREFULLY BEFORE YOU USE AMGEVITA AND KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT AMGEVITA IS USED FOR AMGEVITA is a medicine used to treat the following inflammatory conditions: • Rheumatoid arthritis (RA) • Polyarticular juvenile idiopathic arthritis ( polyarticular JIA) • Enthesitis-related arthritis (ERA) • Psoriasis (Ps) • Psoriatic arthritis (PsA) • Ankylosing spondylitis (AS) • Non-radiographic axial spondyloarthritis (nr-axSpA) • Crohn's disease • Ulcerative colitis • Hidradenitis suppurativa (HS) and • Uveitis. AMGEVITA contains the active substance adalimumab. Adalimumab is a fully human monoclonal antibody; a protein made by a type of blood cell to fight a foreign protein in the body. Adalimumab recognises and binds to a specific protein (tumour necrosis factor or TNF-alpha), which is present at higher levels in some inflammatory diseases. By attaching to the target protein, the active substance in AMGEVITA decreases inflammation. More information about these conditions is provided below and on the page 2. 1. RHEUMATOID ARTHRITIS (RA) is an inflammatory disease of the joints. Signs and symptoms of RA include: • joint pain • tenderness • swelling and • stiffness. AMGEVITA is used to reduce the signs and symptoms of moderate to severely active RA, as well as slow down and protect the joints from further damage. AMGEVITA can be used alone or in combination with another medi Izlasiet visu dokumentu
NEW ZEALAND DATA SHEET AMGEVITA NZ DATA SHEET PAGE 1 OF 93 AMGEVITA ® SOLUTION FOR INJECTION 1. PRODUCT NAME AMGEVITA ® adalimumab (rch) solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE AMGEVITA 20 mg Each 0.4 mL single-use pre-filled syringe contains 20 mg of adalimumab. AMGEVITA 40 mg Each 0.8 mL single-use pre-filled syringe or pre-filled pen contains 40 mg 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. AMGEVITA 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. AMGEVITA 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 1,330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMGEVITA is a biosimilar medicine. The prescribing clinician should be involved in any decision regarding interchangeability (see https://medsafe.govt.nz/profs/riss/ Biosimilars. asp). Data comparing AMGEVITA with the reference product Humira ® can be found in sections 4.8 and 5.1 of this data sheet. EXCIPIENTS For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM SOLUTION FOR INJECTION AMGEVITA is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The solution of AMGEVITA is clear and colourless with a pH of 5.2. NEW ZEALAND DATA SHEET AMGEVITA NZ DATA SHEET PAGE 2 OF 93 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RHEUMATOID ARTHRITIS (RA) AMGEVITA is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with mode Izlasiet visu dokumentu