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Summary of Product Characteristics Sandoz Business use only Page 1 of 16 1.3.1 spc-label-pl - common-spc-005 - 11 20150902 (DK/H/0797/005/R/001 Response on updated FRAR - correction) METHOTREXATE DISODIUM 10 MG / 1 ML SOLUTION FOR 722-0357.00 INJECTION Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT [nationally completed name], 10 mg/ml, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 10 mg methotrexate Each vial with 5 ml of concentrate contains 50 mg methotrexate Each vial with 50 ml of concentrate contains 500 mg methotrexate Excipients with known effect: Each ml contains 0.043mmol (or 0.97mg) sodium For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear, yellow solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Methotrexate is indicated in the treatment of different malignant diseases such as acute lymphatic leukaemia (ALL) and breast cancer. 4.2 Posology and method of administration Treatment with methotrexate should be initiated by or in consultation with a doctor with considerable experience of cytostatic treatment. Methotrexate can be given intramuscularly, intravenously, intraarterially or intrathecally. The dose is usually calculated per m2 body surface. Calcium folinate rescue is necessary when methotrexate is given at doses exceeding 500 mg/m2 body surface and has to be considered with doses of 100 mg – 500 mg/m2 body surface. As a rule, the first dose of Calcium folinate is 15 mg (6-12 mg/m²) to be given 12-24 hours (24 hours at the latest) after the beginning of methotrexate infusion. The same dose is given every 6 hours throughout a period of 72 hours. After several parenteral doses treatment can be switched to the oral form. Forty-eight hours after the start of the methotrexate-infusion, the residual methotrexate-level should be measured. If the residual methotrexate-level is < 0.5 µmol/l, an intensification of the rescue regime might be necessary. In addition to calcium folinate administration, the prompt excretion of methotrexate has to be assured by maintenance of high urine output (adequate hydration) alkalinisation of urine (e.g. with sodium bicarbonate 8.4%) Renal function should be monitored through daily measurements of serum creatinine. For more detailed information, please refer to the Summary of Product Characteristics of Calcium Folinate. If signs of leukopenia appear, temporary interruption of methotrexate is advisable. The following regimens are only examples. Acute lymphatic leukaemia: 3.3 mg/m2 in combination with other cytostatic agents once daily for 4-6 weeks. Sandoz Business use only Page 2 of 16 1.3.1 spc-label-pl - common-spc-005 - 11 20150902 (DK/H/0797/005/R/001 Response on updated FRAR - correction) METHOTREXATE DISODIUM 10 MG / 1 ML SOLUTION FOR 722-0357.00 INJECTION 2.5 mg/kg every two weeks. 30 mg/m2/week maintenance therapy. 20 mg/m2 in combination with other cytostatic agents once weekly. In children: Doses of up to 8000 mg/m2 i.v. have been used sequentially (with subsequent folinic acid administration) for consolidation of remission and maintenance treatment. Oral treatment with doses up to 20 mg/m2/week is used together with intravenous administration and intrathecal CNS prophylaxis (see below) as maintenance treatment. In adults: Maintenance treatment with the sequential POMP combination and intrathecal CNS prophylaxis (see below) with methotrexate is customary. On relapse, high-dose methotrexate can be tried. Breast cancer: 40 mg/m2 i.v. in combination with other cytostatic agents on day 1, or 1 and 3, or 1 and 8, or 3 x per year. Methotrexate forms part of CMF regimen, in which the methotrexate dose is usually 40 mg i.v. on days 1 and 8. The treatment is repeated at 3-week intervals. Patients with impaired renal function: Methotrexate should be used with caution in patients with impaired renal function. The dose should be adjusted as follows: % of dose that should be administered Creatinine clearance (ml/min) >50 100% 20 – 50 50% <20 methotrexate must not be used. Patients with impaired hepatic function: Methotrexate should be administered with great caution, if at all, to patients with significant current or previous liver disease, especially when caused by alcohol. Methotrexate is contraindicated if bilirubin values are >5 mg/dl (85.5 µmol/L). Elderly Dose reduction should be considered in elderly patients due to reduced liver and kidney function as well as lower folate reserves which occur with increased age. 4.3 Contraindications Hypersensitivity to methotrexate or to any of the excipients listed in section 6.1. severe hepatic impairment [bilirubin > 5 mg/dl (85.5 µmol/l)] Alcohol abuse. severe renal impairment (creatinine clearance < 20 ml/min or serum creatinine values above 2mg/dl, (see also section 4.2 and 4.4) Pre-existing blood dycrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anaemia. Serious, acute or chronic infections such as tuberculosis and HIV. Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease. Pregnancy, breast-feeding (see section 4.6). Concurrent vaccination with live vaccines. 4.4 Special warnings and precautions for use Patients receiving therapy should be appropriately monitored, so that signs of possible toxic effects or adverse reactions can be recognised and assessed without delay. Hence, methotrexate should be only administered by - or under the supervision of - doctors whose knowledge and experience include the use of antimetabolite therapy. Sandoz Business use only Page 3 of 16 1.3.1 spc-label-pl - common-spc-005 - 11 20150902 (DK/H/0797/005/R/001 Response on updated FRAR - correction) METHOTREXATE DISODIUM 10 MG / 1 ML SOLUTION FOR 722-0357.00 INJECTION Due to the risk of severe or even fatal toxic reactions, the patients should be thoroughly informed by the doctor about the risks (including early signs and symptoms of toxicity) and recommended safety measures. They are to be informed about the necessity to immediately consult the physician if symptoms of intoxication occur as well as about the subsequent necessary monitoring of symptoms of intoxication (including regular laboratory tests). Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy. In addition, methotrexate causes embryotoxicity, abortion and foetal defects in humans. Therefore the possible risks of effects on reproduction should be discussed with male and female patients of childbearing potential (see section 4.6). Men treated with methotrexate are recommended not to father a child during treatment and at least 6 months thereafter. Since treatment with methotrexate can lead to severe and possibly irreversible disorders in spermatogenesis, men should seek advice about the possibility of sperm preservation before starting therapy. Skin and mucosal contacts with methotrexate are to be avoided. In the case of contamination, the parts concerned should be rinsed with plenty of water. Recommended examinations and safety measures: Before initiating therapy or upon resuming therapy after a rest period: Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest X-ray and renal function tests. If clinically indicated, exclude tuberculosis and hepatitis. During therapy (in the first two weeks weekly, then every two weeks for the next month; afterwards, depending on leukocyte count and stability of the patient at least once monthly during the next six months and at least every three months thereafter) Increased monitoring frequency should also be considered when increasing the dose. Particularly elderly patients should be examined for early signs of toxicity in short intervals. Examination of the oral cavity and throat for mucosal changes. Complete blood count with differential blood count and platelets. Haematopoietic suppression induced by methotrexate may occur abruptly and at apparently safe doses. In the event of any significant drop in leukocytes or platelets, treatment must be discontinued immediately and appropriate supportive therapy instituted. Patients must be instructed to report all signs and symptoms suggestive of infection. In patients concomitantly taking haematotoxic medications (e.g. leflunomide), the blood count and platelets should be closely monitored. During longer-term therapy with methotrexate bone marrow biopsies are to be performed. Liver function tests: Particular attention should be paid to the onset of liver toxicity. Treatment should not be initiated or should be discontinued if there are any abnormalities in liver function tests or liver biopsies, or if these develop during therapy. Such abnormalities should return to normal within two weeks; after which, treatment may be resumed at the discretion of the doctor. Temporary increases in transaminases to twice or three times of the upper limit of normal have been reported by patients at a frequency of 13 – 20 %. Persistent anomalies of liver-related enzymes and/or decrease in serum albumin may be indicative for severe hepatotoxicity. Enzyme diagnostics does not allow any reliable prediction of the development of a morphologically detectable hepatotoxicity, i.e. even in case of normal transaminases, hepatic fibrosis only histologically
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