Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
Adalimumab, Quantity: 40 mg
Fresenius Kabi Australia Pty Ltd
Injection, solution
Excipient Ingredients: mannitol; citric acid monohydrate; sodium citrate dihydrate; sodium hydroxide; sodium chloride; water for injections; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate; polysorbate 80
Subcutaneous
3, 2, 6, 4, 1
(S4) Prescription Only Medicine
Rheumatoid Arthritis Idacio 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.,Idacio can be used alone or in combination with methotrexate.,Juvenile Idiopathic Arthritis Polyarticular Juvenile Idiopathic Arthritis Idacio 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). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,Enthesitis-Related Arthritis Idacio 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 Idacio 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 Idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,Crohn?s Disease in Adults and Children (? 6 years) Idacio 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 to infliximab,Ulcerative colitis Idacio 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 5.1 PHARMACODYNAMIC PROPERTIES-CLINICAL TRIALS).,Psoriasis in Adults and Children Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,Idacio 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) Idacio 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 Idacio 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: a clear solution for injection, practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-06-17
Page 1 of 12 IDACIO 40MG SOLUTION FOR INJECTION IN PREFILLED SYRINGE Adalimumab (rch) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Idacio. 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 IDACIO AND KEEP IT WITH THE MEDICINE. You may need to read it again. WHAT IDACIO IS USED FOR The active ingredient in this medicine is adalimumab, which is a fully human monoclonal antibody. Adalimumab recognises and binds to a specific protein (tumour necrosis factor or TNF- alpha), which is present at higher levels in some inflammatory diseases. Idacio is intended 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. Idacio 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 to help them move more freely. Your doctor will decide if Idacio should be used with another medicine called methotrexate, or on its own. Idacio can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. Polyarticular Juvenile Idiopathic Arthritis (pJIA) pJIA is an inflammatory disease of the joints. Idacio is used to reduce the signs and symptoms of moderate to severely active pJIA, in patients 2 years of age and older, when other medicines are not appropriate. Your doctor will decide whether Idacio should be used with another medicine called methotrexate or used alone. Enthesitis-related arthri read_full_document
Page 1 of 79 AUSTRALIAN PI – IDACIO ® (ADALIMUMAB) – SOLUTION FOR SUBCUTANEOUS INJECTION 1 NAME OF THE MEDICINE Adalimumab (rch) Idacio (adalimumab) is a biosimilar of Humira ® . 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Idacio 40 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL solution. Idacio 40 mg solution for injection in pre-filled pen Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL solution. Idacio 40 mg/0.8 mL solution for injection in a vial Each single dose vial contains 40 mg of adalimumab in 0.8 mL solution. Adalimumab is a recombinant human monoclonal antibody (mAb) which binds to Tumor Necrosis Factor-alpha (TNF) and blocks TNF interaction with the p55 and p75 cell surface receptors and inhibits the biological function of TNF. Adalimumab is an IgG1 antibody composed of two kappa light chains each with a molecular weight of approximately 24 kilo Daltons (kDa) and two IgG1 heavy chains each with a molecular weight of approximately 49 kDa based on the amino acid sequence. The total molecular weight of adalimumab with post-translational modifications is approximately 148 kDa. Each light chain consists of 214 amino acid residues and each heavy chain consists of 451 amino acid residues resulting in a total of 1330 amino acids for the entire IgG1 molecule. For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Idacio is a clear solution for injection for subcutaneous administration and is to be used on one patient on one occasion only. Idacio is practically free from visible particles with, pH 5.2 with an osmolality of approximately 325 mOsm/Kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rheumatoid Arthritis Idacio 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 read_full_document