Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Adalimumab 100 mg/mL; ; ;
AbbVie Limited
20 mg/0.2mL
Solution for injection
Active: Adalimumab 100 mg/mL Excipient: Mannitol Polysorbate 80 Water for injection
Prescription
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. Humira can be used alone or in combination with methotrexate.
Package - Contents - Shelf Life: Syringe, glass, (Type I), with a bromobutyl rubber stopper, plunger rod and needle, 0.2 mL fill - 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
2018-05-02
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. Прочитать полный документ