Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Adalimumab 50 mg/mL; ;
AbbVie Limited
Adalimumab 50 mg/mL
40 mg/0.8mL
Solution for injection
Active: Adalimumab 50 mg/mL Excipient: Citric acid monohydrate Dibasic sodium phosphate dihydrate Dimeticone Mannitol Monobasic sodium phosphate dihydrate Polysorbate 80 Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection
Syringe, glass, prefilled 40mg/0.8mL Hospital, 1 dose unit
Prescription
Prescription
Lonza Biologics Tuas Pte Ltd
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, prefilled 40mg/0.8mL Hospital - 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, prefilled 40mg/0.8mL - 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, prefilled 40mg/0.8mL x 2 - 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, prefilled 40mg/0.8mL - 3 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, prefilled 40mg/0.8mL x 6 induction pack - 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
2002-05-28
Humira Version 02 25 February 2022 Page 1 of 7 HUMIRA ® 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 The active ingredient in this medicine is adalimumab, which is a fully human monoclonal antibody. Monoclonal antibodies are proteins 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. Humira is used for the treatment of a number of inflammatory diseases: Rheumatoid arthritis Rheumatoid arthritis is an inflammatory disease of the joints. Signs and symptoms of rheumatoid arthritis include joint pain, tenderness, swelling and stiffness. Humira is used to reduce the signs and symptoms of moderate to severely active rheumatoid arthritis as well as to slow down and protect the joints from further damage. Polyarticular juvenile idiopathic arthritis (pJIA) pJIA is an inflammatory disease of the joints. Humira is used to reduce the signs and symptoms of moderately to severely active pJIA in patients 2 years of age and older. Enthesitis-related arthritis (ERA) ERA is an inflammatory disease of the joints and the places where tendons join the bone. Humira is used to treat ERA in patients 6 years of age and older. Psoriatic arthritis (PsA) PsA is an inflammatory disease of the joints and skin that is usually associated with psoriasis. Signs and symptoms include joint pain Lue koko asiakirja
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. Lue koko asiakirja