País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Adalimumab, Quantity: 40 mg
Amgen Australia Pty Ltd
Injection, solution
Excipient Ingredients: polysorbate 80; acetate; sucrose; water for injections; sodium hydroxide
Subcutaneous
6, 1, 2, 4
(S4) Prescription Only Medicine
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.,Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis AMGEVITA 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). AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-Related Arthritis AMGEVITA 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 AMGEVITA is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderately to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.,Ankylosing Spondylitis AMGEVITA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn?s Disease in Adults and Children (6 years and old) AMGEVITA 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 AMGEVITA 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.,Psoriasis in Adults and Children AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,AMGEVITA 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 AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,Uveitis AMGEVITA 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: Liquid, practically free from particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2017-11-09
AMGEVITA ® A M G E V I T 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 AMGEVITA? AMGEVITA pre-filled syringes and pre-filled SureClick ® pens contain the active ingredient adalimumab. AMGEVITA is used to treat various inflammatory conditions. For more information, see Section 1. Why am I using AMGEVITA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE AMGEVITA? Read this leaflet carefully before you use AMGEVITA and keep it with the medicine. Check the list of ingredients at the end of the CMI. Do not use AMGEVITA if you have ever had an allergic reaction to any of the ingredients. TALK TO YOUR DOCTOR IF 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 AMGEVITA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with AMGEVITA and affect how it works. AMGEVITA may interfere with other medicines and 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 AMGEVITA? AMGEVITA is injected under the skin (subcutaneous). More instructions can be found in Section 4. How do I use AMGEVITA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING AMGEVITA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using AMGEVITA. • Keep all your appointments, including those for blood tests. • Tell your doctor if you develop an infection or you notice new or changed spots on your skin. • Talk to your doctor if you are scheduled for any vaccines. THINGS YOU SHOULD NOT DO • Do not stop using AMGEVITA suddenly 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 AMGEVITA affects you. • The effe Leer el documento completo
PRODUCT INFORMATION – AMGEVITA ® PAGE 1 OF 71 AUSTRALIAN PRODUCT INFORMATION – AMGEVITA ® (ADALIMUMAB) SOLUTION FOR SUBCUTANEOUS INJECTION 1. NAME OF THE MEDICINE Adalimumab. AMGEVITA is a biosimilar medicine to the reference product Humira ® (adalimumab). The evidence for comparability supports the use of AMGEVITA for the listed indications. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AMGEVITA 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Each pre-filled syringe contains adalimumab 20 mg in 0.4 mL solution (50 mg/mL). AMGEVITA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Each pre-filled syringe contains adalimumab 40 mg in 0.8 mL solution (50 mg/mL). AMGEVITA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Each pre-filled pen contains adalimumab 40 mg in 0.8 mL solution (50 mg/mL). EXCIPIENTS AMGEVITA contains no antimicrobial agent. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM AMGEVITA is a sterile, preservative free solution of adalimumab for subcutaneous administration. The solution of AMGEVITA is a clear liquid with a pH of 5.2. AMGEVITA is supplied as either a single use pre-filled glass syringe or as a single use pre-filled SureClick ® pen. Enclosed within the pre-filled pen is a single use, pre-filled glass syringe. The presentation for paediatric use contains 20 mg adalimumab per 0.4 mL (50 mg/mL). The adult presentations contain 40 mg adalimumab per 0.8 mL (50 mg/mL). 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 moderate to severely active RA. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate (MTX). AMGEVITA can be used alone or in combination with MTX. PRODUCT INFORMATION – AMGEVITA ® PAGE 2 OF 71 JUVENILE IDIOPATHIC ARTHRITIS (JIA) _POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA) _ Leer el documento completo