Temobel capsules 20 mg, 100 mg, 250 mg Trade name: Temobel. International nonproprietary name: Temozolomide. Pharmaceutical form: capsules 20 mg, 100 mg and 250 mg. Composition: each capsule contains: Active ingredients: temozolomide. Excipients: stearic acid, tartaric acid, colloidal anhydrous silica, sodium starch glycolate type A, anhydrous lactose. ATC code: L01AX03. Indications for use ▶ Children over the age of 3 years and adult patients ▶ Adult patients with newly-diagnosed glioblastoma with malignant glioma, such as glioblastoma multiforme concomitantly with radiotherapy and multiforme or anaplastic astrocytoma, showing subsequently as monotherapy. recurrence or progression aſt er standard therapy. Alkylating agents AmoxicillinTemodex powder for preparing capsules gel for local 250 usemg 100 mg Trade name: Temodex. Pharmacotherapeutic group: Antitumor agent of International non-proprietary name: Temozolomide. alkylating action. Description: powder from white to greenish-gray or ATC code: L01AX03. brown. Indications for use Composition: each package contains: temozolomide The newly discovered multiform glioblastoma (as part of (in the form of temodex (mixture of temozolomide and sodium dextran phosphate)) – 100 mg. combined treatment in combination with radiotherapy); Dosage form: powder for gel preparation for topical Malignant glioma (glioblastoma multiforme or anaplastic use. astrocytoma). retinoblastoma, lymphogranulomatosis, lymphosarcoma, Cyclophosphan non-Hodgkin lymphoma, reticulosarcoma, osteogenous sarcoma, multiple myeloma, chronic lympholeukemia and powder for preparing solution for injection myeloleukemia and monoblastic leukemia, Wilms’ tumor, Ewing’s tumor, granulosarcoid, Trade name: Cyclophosphan. pulpy testis; autoimmune International nonproprietary name: disease: rheumatoid arthritis, Cyclophosphamide. psoriatic arthritis, systemic Pharmaceutical form: powder for preparing solution disorders of the connective for injections. tissue, autoimmune hemolytic Composition: each vial contains: anemia, nephritic syndrome, Active substance: cyclophosphamide – 200 mg. suppression of the host- ATC code: L01AA01. against-transplant reaction. Indications for use Small cell carcinoma of the lung, ovarian carcinoma, breast cancer, cancer of the neck and of the body of the uterus, urinary bladder cancer, prostate cancer, neuroblastoma, Alkylating agents Indications for use Gemcitabine ▶ Treatment of localised or metastatic bladder cancer in combination with cisplatin. powder lyophilized for preparing solution for injection 200 mg, 1000 mg ▶ Treatment of localised or metastatic pancreatic adenocarcinoma. ▶ First-line therapy of localised or metastatic non- Trade name: Gemcitabine. small cell lung cancer (NSCLC) in combination with International nonproprietary cisplatin. Gemcitabine monotherapy is possible in name: Gemcitabine. elderly patients or patients with physical function 2. Composition: each 10 ml vial contains: ▶ Treatment of localised or metastatic epithelial Active substance: gemcitabine ovarian cancer in combination with carboplatin in (as gemcitabine hydrochloride) – relapse patients aſt er at least 6 months of delaying 200 mg and 1000 mg. time to relapse aſt er the end of the fi rst line of Excipients: mannitol, sodium platinum-based therapy. acetate (as sodium acetate ▶ Complex treatment with paclitaxel of localised trihydrate). unresectable or metastatic breast cancer in relapse Dosage form: lyophilized patients aſt er adjuvant/non-adjuvant chemotherapy. powder for solution for infusion. The primary therapy shall include anthracycline in ATC code: L01BC05. absence of contraindications. Cladribine solution for injection 1 mg/ml Trade name: Cladribine. ATC Code: L01BB04. International nonproprietary name: Cladribine. Indications for use Dosage form: solution for injection 1 mg/ml. ▶ Hairy Cell Leukemia. Description: a clear colorless solution. ▶ Chronic lymphatic leukemia (progressing forms and Composition: each vial contains: the ones resistant to fi rst line polychemotherapy Active ingredient: cladribine – 10 mg. drugs). Excipients: potassium dihydrogen phosphate, sodium chloride, 1 M solution of sodium hydroxide, water for ▶ Low-grade and intermediate magliant non- injection. Hodgkin’s lymphomas. Antimetabolites Mercaptopurine tablets 50 mg Trade name: Mercaptopurine. International nonproprietary name: Mercaptopurine. Description: light yellow fl at round beveled tablets. Composition: each tablet contains: Active ingredient: mercaptopurine – 50 mg. Excipients: lactose monohydrate, sodium starch glycolate type A, calcium stearate, potato starch. Pharmaceutical form: tablets. ATC code: L01BB02. Indications for use Acute lymphatic leukemia, acute myeloleukemia (remission induction and supporting therapy). Offi cial instructions on proper treatment of the above diseases should be taken into account. ATC code: L01BA01. Methotrexate Indications for use Lympho- and myeloblastic leukosis, neuroleukemia, tablets 2.5 mg and 5 mg myelomatosis, trophoblastomas (uterine chorioepithelioma, cystic mole, incl. invasive mole), Trade name: Methotrexate. esophageal cancer, epidermoid cancer of head and neck, International nonproprietary name: Methotrexate. cancer of urinary bladder, cancer of lung, liver cancer, Description: biconvex, yellow fi lm–coated tablets. breast cancer, renal carcinoma, cancer of ureters, Composition: each tablet contains: prostate cancer, cervical cancer, cancer of vulva, ovarian Active substance: methotrexate – 2.5 mg or 5 mg. cancer, testicular cancer, Hodgkin’s and non-Hodgkin’s Excipients: lactose monohydrate, povidone, calcium lymphoma (incl. Burkitt’s lymphoma), mycosis fungoides stearate, potato starch, coating: opadry II color; (local treatment), non-metastatic osteogenic sarcoma. composition: opadry II yellow: polyvinyl alcohol-part. Rheumatoid arthritis (incl. Felty’s syndrome), steroid- hydrolyzed, macrogol / polyethylene glycol, quinoline dependent bronchial asthma (if glucocorticoids are yellow aluminum lake (E-104), sunny sunset yellow FCF contraindicated), Crohn’s disease, chronic nonspecifi c aluminum lake (E-110), talc, titanium dioxide, iron oxide ulcerative colitis, lichen ruber planus, psoriasis, yellow (E-172). psoriatic arthritis, Reiter’s syndrome, Sezary syndrome, Pharmaceutical form: fi lm-coated tablet. disseminatedeminated scsclerosis.lerosis. Pharmaceutical group: Anticancer drugs. Antimetabolites. Antimetabolites Methotrexate is indicated for treatment of gestational Methotrexate choriocarcinoma, chorioadenoma destruens and hydatidiform mole. powder lyophilized for preparing solution In case of acute lymphoblastic leukemia, methotrexate for injection 10 mg, 50 mg, 1000 mg is indicated for the prophylactics of meningeal leukemia and is used in maintenance therapy in Trade name: Methotrexate. combination with other chemotherapeutic agents. International non-proprietary name: Methotrexate. Methotrexate is also indicated for the treatment of Description: porous mass or powder of from meningeal leukemia. yellow, orange to yellow-brown Methotrexate is used alone or in combination with other nonhomogenous color, hygroscopic. anticancer agents in the treatment of breast cancer, Composition: each ampoule/vial epidermoid cancers of the head and neck, advanced contains: mycosis fungoides (cutaneous T-cell lymphoma), and lung Active substance: methotrexate (in cancer, particularly squamous cell and small cell types. the form of methotrexate sodium) – Methotrexate is also used in combination with other 10 mg, 50 mg, 1000 mg. chemotherapeutic agents for treatment of advanced Pharmaceutical form: lyophilized stage non-Hodgkin’s lymphoma. powder for solution for injection. Methotrexate in high doses followed by calcium folinate ATC code: L01BA01. rescue in combination with other chemotherapeutic Indications for use agents is eff ective in prolonging relapse-free survival Oncologic diseases. in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation of the rheumatoid arthritis, who have had an insuffi cient primary tumor. therapeutic response to, or are intolerant of, an adequate Psoriasis fi rst-line therapy including a full dose Methotrexate is indicated for the of non-steroidal anti-infl ammatory symptomatic control of severe, recalcitrant, agents (NSAIDs). disabling psoriasis in patients who do not Aspirin, (NSAIDs), and/or low dose have adequate response to other forms of steroids may be continued, although therapy, but only when the diagnosis has the possibility of increased toxicity with been established, by biopsy and/or aſt er concomitant use of NSAIDs including dermatologic consultations. It is important salicylates has not been fully explored. to ensure that a psoriasis fl are is not due to Steroids may be reduced gradually in an undiagnosed disease aff ecting immune patients who respond to methotrexate. responses. Combined use of methotrexate with Rheumatoid arthritis including polyarticular- gold, penicillamine, hydroxychloroquine, course juvenile rheumatoid arthritis sulfasalazine, or cytotoxic agents, has Methotrexate is indicated in the management of selected category of adult not been studied and may increase the patients with severe, active rheumatoid incidence of adverse eff ects. Rest and arthritis (ACR criteria), or children with physiotherapy as indicated should be active polyarticular-course juvenile continued. Antimetabolites ▶ Non-Hodgkin’s lymphoma. MethotrexateCytarabine ▶ Syndrome of bone marrow dysplasia. The Cytarabine high-dose