However, lower starting doses should be considered in patients with severe renal impairment (serum creatinine 5 mg/dl). Paediatric population The safety and efficacy of this medicinal product in children has not been established. Intravesical administration This medicinal product can be given by intravesical administration for the treatment of superficial bladder cancer and carcinoma-in-situ. It should not be given intravesically for the treatment of invasive tumours that have penetrated the bladder wall, systemic therapy or surgery is more appropriate in these situations (see section.3). This medicinal product has also been successfully used intravesically as a prophylactic agent after transurethral resection of superficial tumours to prevent recurrence. For the treatment of superficial bladder cancer the following regimen is recommended, using the dilution table below: 8 weekly instillations of 50 mg/50 ml (diluted with saline or distilled sterile water). If local toxicity (chemical cystitis) is observed: a dose reduction to 30 mg/50 ml is advised. Carcinoma-in-situ: up to 80 mg/50 ml (depending on individual tolerability of the patient) For prophylaxis: 4 weekly administrations of 50 mg/50 ml followed by 11 monthly instillations at the same dose.
Breast Cancer, in the adjuvant treatment of early breast cancer patients with positive lymph nodes, intravenous doses of epirubicin hydrochloride ranging from 100 mg/m2 (as a single dose on day 1) to 120 mg/m2 (in two divided doses on days 1 and 8) every 3-4. For high dose treatment, epirubicin may be gratis given as an intravenous bolus over 3-5 minutes or as an infusion of up to 30 minutes duration. Lower doses (60-75 mg/m2 for conventional treatment and 105-120 mg/m2 for high dose treatment) are recommended for patients whose bone marrow function has been impaired by previous chemotherapy or radiotherapy, by age, or neoplastic bone marrow infiltration. The total dose per cycle may be divided over 2-3 successive days. The following doses of this medicinal product are commonly used in monotherapy and combination chemotherapy for various tumours, as shown: Epirubicin HCl Dose (mg/m2)a. Cancer Indication, monotherapy, combination Therapy, gastric cancer 6090 50 Bladder cancer 50 mg/50 ml or 80 mg/50 ml (carcinoma in situ) Prophylaxis: 50 mg/50 ml weekly for 4 weeks then monthly for 11 months a doses generally given day 1 or day 1, 2 and. Combination therapy If epirubicin hydrochloride is used in combination with other cytotoxic products, the dose should be reduced accordingly. Commonly used doses are shown in the table above. Liver impairment The major route of elimination of epirubicin hydrochloride is the hepatobiliary system. In patients with impaired liver function the dose should be reduced based on serum bilirubin levels as follows: Serum Bilirubin ast* Dose reduction.4 3 mg/100 ml (24 51 µmol/l) 50 3 mg/100 ml ( 51 µmol/l) 4 times upper normal limit 75 * ast.
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This medicinal product is for intravenous or intravesical use only. Intravenous administration, it is advisable to administer epirubicin hydrochloride via the tubing of a free-running intravenous saline or glucose infusion after checking that the needle is properly placed in the vein. Care should be taken to avoid extravasation (see section.4). In case of extravasation, administration should be stopped immediately. Conventional dose, when epirubicin hydrochloride is used as a single agent, the recommended dosage in adults is 60-90 mg/m2 body area. Epirubicin hydrochloride should be injected intravenously over 3-5 minutes. The dose should be repeated at 21-day intervals, depending upon the patient's haematomedullar status. If signs smaakpapillen of toxicity, including severe neutropenia/neutropenic fever and thrombocytopenia occur (which could persist at day 21 dose modification or postponement of the subsequent dose may be required.
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Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period. Beyond 16 weeks, patients with inadequate response to humira 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other e benefits and risks of continued 40 mg weekly or 80 mg every other. If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week. Hidradenitis suppurativa the recommended Humira dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days followed. Two weeks later (day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day). Antibiotics may be continued during treatment with Humira if necessary. It is recommended that the patient should use a topical antiseptic wash on their hs lesions on a daily basis during treatment with Humira. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. Should treatment be interrupted, humira 40 mg every week or 80 mg every other week may be re-introduced (see section.1).
Posology Rheumatoid arthritis The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Humira. Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections.4 and.1. In monotherapy, some patients who experience a decrease in their response to humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period. Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Dose interruption There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. Available data suggest that re-introduction of Humira after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption. Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of as and psoriatic arthritis The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of as and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week. Psoriasis The recommended dose of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
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Paediatric plaque psoriasis, humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections.1 and.2). Crohn's disease, humira is indicated for treatment of moderately to severely active crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for. Paediatric Crohn's disease, humira is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who. Ulcerative colitis, humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (aza or who are intolerant to or have medical contraindications for such.
Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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. Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section.4). Patients treated with Humira should be given the special alert card. After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary. During treatment with Humira, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
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Humira has not been studied in patients aged less than 2 years. Humira is ontstoken indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, sekwester who have had an inadequate response to, or who are intolerant of, conventional therapy (see section.1). Axial spondyloarthritis, ankylosing spondylitis (as humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence. Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis, humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section.1) and to improve physical function. Psoriasis, humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
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Pharmaceutical form, solution for aneurisma injection. (injection clear, colourless solution. Rheumatoid arthritis, humira in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years 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 (for the efficacy in monotherapy see section.1).
Name of the medicinal product. Humira 40 mg solution for injection in pre-filled syringe. Humira 40 mg solution for injection in pre-filled pen. Qualitative and quantitative hond composition, humira 40 mg solution for injection in pre-filled syringe. Each.4 ml single dose pre-filled syringe contains 40 mg of adalimumab. Each.4 ml single dose pre-filled pen contains 40 mg of adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese hamster ovary cells. For the full list of excipients, see section.1.
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Each vial of 25 ml of solution contains 50 mg of epirubicin hydrochloride. Each vial of 50 ml of solution contains 100 mg of epirubicin hydrochloride. Each vial of 100 ml of solution contains 200 mg of epirubicin hydrochloride. Excipient(s) with known effect, epirubicin 2 mg/ml, solution for injection contains sodium (3.6 mg/ml.16 mmol/ml). For the zelf full list of excipients, see section.1. Solution for injection, a clear red solution. Clinical particulars.1 Therapeutic indications, epirubicin Hydrochloride 2 mg/ml, solution for injection is used in the treatment of a range of neoplastic conditions including: Breast and gastric carcinomas, When administered intravesically, this medicinal product has been shown to be beneficial in the treatment of: papillary. 4.2 Posology and method of administration.
typing to refine. Advanced search back to top, active ingredient epirubicin hydrochloride. Legal Category, pOM: Prescription only medicine. Name of the medicinal product. Epirubicin 2 mg/ml, solution for injection. Qualitative and quantitative composition, epirubicin Hydrochloride 2 mg/ml 1 ml of solution for injection contains 2 mg of epirubicin hydrochloride. Each vial of 5 ml of solution contains 10 mg of epirubicin hydrochloride. Each vial of 10 ml of solution contains 20 mg of epirubicin hydrochloride.