Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
Adalimumab, Quantity: 50 mg/mL
Abbvie Pty Ltd
Adalimumab
Injection, solution
Excipient Ingredients: dibasic sodium phosphate dihydrate; polysorbate 80; monobasic sodium phosphate dihydrate; sodium chloride; citric acid monohydrate; water for injections; sodium citrate dihydrate; mannitol
Subcutaneous
2 prefilled syringes
(S4) Prescription Only Medicine
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.,Juvenile Idiopathic Arthritis: - Polyarticular Juvenile Idiopathic Arthritis: Humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - Enthesitis-Related Arthritis: Humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,Psoriatic Arthritis: Humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis: Humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn's Disease in adults and Children (6 years and older): Humira is indicated for the treatment of moderate to severe Crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,Ulcerative colitis: Humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see CLINICAL TRIALS).,Psoriasis in adults and children: Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,,Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age): Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,,Uveitis: Humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis 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.
Visual Identification: Aqueous solution practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-08-28
HUMIRA ® H U M I R A ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING HUMIRA? Humira contains the active ingredient adalimumab. Humira is used to treat various inflammatory conditions. For more information, see Section 1. Why am I using Humira? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE HUMIRA? Check the list of ingredients at the end of the CMI. Do not use Humira if you have ever had an allergic reaction to any of them. TALK TO YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE IF HE/SHE IS NOT AWARE THAT YOU HAVE ANY OTHER MEDICAL CONDITIONS, 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 use Humira? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Humira and affect how it works, or Humira 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 USE HUMIRA? Humira is injected under the skin (subcutaneous). More instructions can be found in Section 4. How do I use Humira? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING HUMIRA? THINGS YOU SHOULD DO • Remind any doctor or dentist or pharmacist you visit that you are using Humira. • Keep all your appointments, including for blood tests. • Tell your doctor if you develop an infection or you notice new or changed spots on your skin. • Tell your doctor if you are scheduled for any vaccines. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or change the dose unless your doctor tells you to. DRIVING OR USING MACHINES • Be careful before you drive or use any machines until you know how Humira affects you. The effects on your ability to drive or use machines whilst taking Humira are not known. DRINKING ALCOHOL • There is no information on the Citiți documentul complet
HUMIRA PI Version 49 10 February 2021 Page 1 of 84 AUSTRALIAN PI – HUMIRA ® (ADALIMUMAB) – SOLUTION FOR SUBCUTANEOUS INJECTION 1 NAME OF THE MEDICINE Adalimumab (rch) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Humira (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. Adult presentations contain 80 mg adalimumab per 0.8 mL (100 mg/mL), 40 mg adalimumab per 0.8 mL (50 mg/mL) or 40 mg adalimumab per 0.4 mL (100 mg/mL). Presentations for paediatric use only contain either 20 mg adalimumab per 0.4 mL (50 mg/mL) or 20 mg adalimumab per 0.2 mL (100 mg/mL). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Humira is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The solution of Humira is clear and colourless and isotonic with a pH of 5.2. The drug product is supplied as either a single-use pre-filled glass syringe or as a single use, pre-filled pen (Humira Pen). Enclosed within the pen is a single-use, pre-filled glass syringe. HUMIRA PI Version 49 10 February 2021 Page 2 of 84 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 Citiți documentul complet