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Temobel capsules 20 mg, 100 mg, 250 mg

Trade name: Temobel. International nonproprietary name: . 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 , reticulosarcoma, osteogenous sarcoma, multiple myeloma, chronic lympholeukemia and powder for preparing solution for injection myeloleukemia and monoblastic , Wilms’ tumor, Ewing’s tumor, granulosarcoid, Trade name: Cyclophosphan. pulpy testis; autoimmune International nonproprietary name: disease: rheumatoid arthritis, . 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, , cancer of the neck and of the body of the uterus, urinary bladder cancer, prostate cancer, ,

Alkylating agents Indications for use ▶ Treatment of localised or metastatic bladder cancer in combination with . 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 (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 in combination with 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 of localised trihydrate). unresectable or metastatic breast cancer in relapse Dosage form: lyophilized patients aſt er adjuvant/non-adjuvant . powder for solution for infusion. The primary therapy shall include in ATC code: L01BC05. absence of contraindications. 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 .

Antimetabolites 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. 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 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 high-dose therapy is applied within the powder lyophilized fortablets preparing 2.5 mg solution and 5 mgfor induction and consolidation programs under primary injection / solution for injection 20 mg/ml acute lymphoblast and myeloblast leukemia; under secondary leukemia developed either aſt er the preceding Trade name: Cytarabine. cytostatic and/or beam International nonproprietary name: Cytarabine. therapy or as a result of Pharmaceutical form: the MDS transformation; Lyophilized powder injection, 100 mg, 1000 mg. Porous under primarily resistant white mass in form of tablet forms of acute leukemia; Solutions for injections 20 mg/ml. under resistant relapses Composition: each vial contains: of acute leukemia; under Active substance: cytarabine 1000 mg, 100 mg. a blast crisis of chronic Excipients: low-molecular polyvinyl pyrrolidone medical myeloleukemia; under grade Mr 12600 ± 2700 (povidone). resistant forms of highly ATC code: L01BC01. malignant Hodgkin’s Indications for use and non-Hodgkin’s lymphomas. ▶ Lymphoblast and myeloblast leukemia. ▶ Chronic myeloleukemia. ▶ Erythroleukemia, lymphogranulomatosis. Indications for use - B-cell chronic lymphocytic leukemia (CLL) in patients Belmed with suffi cient bone marrow reserve. The therapy with powder lyophilized for preparing solution the drug product as the for injection 50 mg essential one should be administered in patients Trade name: Fludarabine-Belmed. with progressing disease International nonproprietary name: Fludarabine. of Rai stage III/IV (Binet C) Description: white powder or porous mass compressed or Rai stage I/II (Binet A/B) as a tablet. when the patient has the Composition: each ampoule contains: symptoms connected with Active substance: fl udarabine phosphate – 50 mg. the disease or attribute of Excipients: mannitol, 1M sodium hydroxide solution. progressing disease. Pharmaceutical form: lyophilized powder for solution for injection 50 mg. ATC code: L01BB05.

Antimetabolites Indications for use ▶ Breast cancer (BC) concentrate for preparing solution Operable BC (adjuvant chemotherapy combined with for infusion 20 mg/ml and cyclophosphamide): – involving regional lymph glands; Trade name: Docetaxel. – without involving regional lymph glands in patients International nonproprietary name: Docetaxel. indicated for chemotherapy according to the established Description: clear light yellow solution. international selection criteria for initial chemotherapy Composition: each vial with a capacity of 1 ml, 2 ml, at early stages of BC (in case oа one or more factors 4 ml contains of high risk of recurrence: tumor size more than 2 cm, Active substance: docetaxel, mg 20, 40, 80. negative status of estrogen and progesterone receptors, Excipients: anhydrous citric acid, mg 4, 8, 16, anhydrous ethanol pharmacopoeial, ml 0.5, 1, 2, polysorbate 80, high histological level of tumor malignancy (level 2-3), ml to 1, to 2, to 4. age under 35 years old). Pharmaceutical form: concentrate for solution for Metastatic and/or locally advanced BC: infusion. – locally advanced or metastatic BC (fi rst line therapy ATC code: L01CD02. combined with doxorubicin); – metastatic BC with tumor hyperexpression HER2 (fi rst ▶ cancer metastatic stomach cancer line therapy combined with ); including cancer of esophagogastric transition – locally advanced or metastatic BC in non-eff ective zone (fi rst line therapy combined with cisplatin and previous chemotherapy including or 5-fl uorouracil). alkalising preparations (in monotherapy) or in non- eff ective previous chemotherapy including anthracyclines (combined with ). ▶ Non-small cell lung cancer non-operable, locally advanced or metastatic non-small cell lung cancer (combined with cisplatin or carboplatin) as fi rst line therapy or in monotherapy as second line therapy. ▶ Metastatic ovarian cancer second line therapy. ▶ Head and neck cancer. Locally advanced squamous cell carcinoma of head and neck (induction therapy combined with cisplatin and 5-fl uorouracil). ▶ Prostate cancer. metastatic prostate cancer, refractory to hormonal therapy (combined with or prednisone or prednisolone).

Plant alkaloids and other natural products concentrate for preparing solution for infusion 10 mg/ml

Trade name: Vinorelbine. International nonproprietary name: Vinorelbine. Description: clear colorless or pale-yellow solution. Composition: each vial contains: Active substance: vinorelbine (as vinorelbine tartrate) – 10 mg or 50 mg. Excipient: water for injections. Pharmaceutical form: concentrate for solution for infusion. ATC code: L01CA04. Indications for use ▶ Extensive inoperable non-small cell lung cancer of 3-4th grade. ▶ Disease breast cancer of 3-4th grade refractory or progressing aſt er chemotherapy including anthracyclines. ▶ Breast cancer (adjuvant therapy in patients with Paclitaxel lymph nodes metastasis aſt er standard combination concentrate for preparing solution therapy, the 1st line therapy in metastatic cancer and for infusion 100 mg/16,7 ml and 30 mg/5 ml the disease aggravation aſt er adjuvant therapy with anthracyclines, the 2nd line therapy with the disease aggravation aſt er combination chemotherapy with Trade Name: Paclitaxel. anthracycline antitumor antibiotics). International nonproprietary name: Paclitaxel. ▶ Non-small cell lung cancer (the 1st line therapy in Description: oily clear colorless or yellowish liquid. combination with cisplatin or monotherapy in patients Composition: 1 ml contains: who haven’t been planned for surgery and/or radiation Active ingredients: semisynthetic paclitaxel – 6 mg. therapy with the chance to be cured). Excipients: citric acid anhydrous, ethanol anhydrous, ▶ Kaposi’s sarcoma in AIDS patients: the 2nd line therapy. macrogolglycerol ricinoleate. ▶ Squamous cell carcinoma of head and neck. ATC code: L01CD01. Indications for use ▶ Transitional cell carcinoma of the bladder. ▶ Ovarian Cancer (the 1st line therapy (in combination with cisplatin) in patients with advanced metastatic or residual tumor (more than 1 cm) aſt er laparotomy and the 2nd line therapy in patients with advanced metastatic ovarian cancer aſt er unsuccessful standard therapy).

Plant alkaloids and other natural products leukemia and blast crisis of chronic myelogenous - leukemia. ▶ Malignant lymphomas, including Hodgkin’s disease Belmed and non-Hodgkin’s lymphoma. ▶ Multiple myeloma. solution for injection 1 mg/2 ml ▶ Solid tumors, including breast cancer, small cell lung cancer, head and neck tumors and soſt tissue Trade name: Vincristine-Belmed. sarcoma. International nonproprietary name: Vincristine. ▶ Solid tumors of children, including Ewing’s sarcoma, Description: clear, colorless or light yellow solution. embryonic rhabdomyosarcoma, neuroblastoma, Composition: each vial contains: Wilms tumor, retinoblastoma and medulloblastoma. Active substance: vincristine sulfate 0.5 mg (1 ml vial) or ▶ Idiopathic thrombocytopenic purpura (with 1 mg (2 ml vial); resistance to corticosteroids and ineff ectiveness Excipients: mannitol (E421), sulfuric acid (E513), sodium of splenectomy). It is not recommended to hydroxide (E524), water for injection. use vincristine as a fi rst-line preparation. The Pharmaceutical form: solution for intravenous recommended weekly doses of vincristine from 3 to administration. 4 weeks in some patients led to a stable remission. Pharmacotherapeutic group: Antineoplastic drugs. If the patient does not respond to vincristine aſt er Vinca alkaloids and their analogues. 3 to 6 doses, then the probability of positive dynamics ATC code: L01CA02. for additional doses is small. Indications for use ▶ Leukemia, including acute lymphocytic leukemia, chronic lymphocytic leukemia, acute myeloblastic Doxorubicin hydrochloride prophylaxis aſt er surgical procedures), thyroid gland, ovaries. powder lyophilized for preparing solution ▶ Osteogenic sarcomata for injection 10 mg and soſt tissue sarcomata; Ewing’s sarcoma; neuro- Trade name: Doxorubicin hydrochloride. blastoma; Wilms’ tumor, International nonproprietary name: Doxorubicin. cancer of endometrium, Composition: one vial contains: Kaposi’s sarcoma in case of Active ingredients: doxorubicin hydrochloride – 10 mg. AIDS, retinoblastoma. Excipients: mannitol. ▶ Malignant thymoma, Pharmaceutical form: lyophilized powder for injection, hepatoblastoma, primary 10 mg. hepatocellular carcinoma. ATC code: L01DB01. ▶ Other solid tumors: Indications for use cancer of endometrium, neck ▶ Acute lymphoblastic and myeloblastic leukemia, of uterus, malignant ovary chronic lymphatic leukemia, myelomatosis, tumors, cancer of prostate lymphogranulomatosis, non-Hodgkin’s lymphoma. gland, cancer of esophagus, ▶ Breast cancer. cancer of stomach, cancer ▶ Carcinoma of lung (especially small cell carcinoma), of adrenal glands, cancer of urinary bladder (treatment and secondary liver and cancer of pancreas.

Cytotoxic antibiotics and related substances Photolon® powder lyophilized for preparing solution for injection 100 mg

Trade name: Photolon®. (squamous cell cearcinoma, basal International nonproprietary cell carcinoma), melanoma and name (INN): none. intracutaneous metastases of Description: Greenish black breast cancer, superfi cial mucosal porous mass. Violet tint is allowed. tumors (vulva, esophagus, rectum); Composition: each bottle/vial intraoperative photodynamic contains: therapy of malignant tumors of the Active ingredient: chlorin E6 brain (in the combination therapy); (trisodium salt of chlorin E6) – diagnostics of malignant tumors 100 mg. by spektrofl uorescent method. Excipients: low-molecular polyvinyl Ophthalmology: photodynamic pyrrolidone medical grade Mr therapy of ophthalmologic 12600±2700 (povidone). diseases, diseases of organ Pharmaceutical form: lyophilized of vision accompanied by powder for injection, 100 mg. the development of vascular ATC code: L01XD. neoplasms in its structure: Indications for use subretinal neovascular membranes Oncology: in under central involutional of pre-cancerous lesions and chorioretinal dystrophy and myopic malignant tumors: skin cancers maculopathy. powder lyophilized for preparing solution for infusion 50 mg and 100 mg

Trade name: Oxaliplatin. ATC code: L01XA03. International nonproprietary name: Oxaliplatin. Indications for use Description: white or almost white powder or porous ▶ III stage colorectal cancer (Dukes’ stage C) adjuvant mass. therapy aſt er the primary tumor radical resection in Composition: one bottle/vial contains: Active substance: oxaliplatin – 50 mg and 100 mg. combination with 5-fl uorouracil and folic acid; Excipients: lactose monohydrate. ▶ disseminated colorectal cancer (monotherapy or Pharmaceutical form: lyophilized powder for infusion. combined therapy with 5-fl uorouracil and folic acid).

Cytotoxic antibiotics and related substances capsules 250 mg

Trade name: Hydroxycarbamide. International nonproprietary name: Hydroxycarbamide. Description: White hard gelatin capsules No. 0. Capsule content – white or white with yellowish tint powder. Allowed presence seals the capsule mass in form of a column or tablets which, when pressing a glass rod disintegrate. Composition: each capsule contains: Active ingredients: hydroxycarbamide – 250 mg. Excipients: citric acid monohydrate, disodium phosphate anhydrous, calcium stearate, sodium laurilsulfate, sodium citrate 5.5-hydrate. Indications for use Hard gelatin capsule composition: gelatin, glycerin, Melanoma, resistant chronic myeloid leukosis, recurrent purifi ed water, titanium dioxide, sodium laurilsulfate. metastatic or unresectable ovarian cancer, cervical Pharmaceutical form: capsules 250 mg. cancer, head and neck cancer with exception of lips ATC code: L01XX05. (simultaneously with radiation therapy). Anastrozole tablets 1 mg

Trade name: Anastrozole. International nonproprietary name: Anastrozole. Description: White or off -white round, biconvex fi lm- coated tablets. Coating roughness on tablets surface is permissible. Composition: each tablet contains: Active substance – anastrozole – 1 mg. Excipients – sodium starch glycolate (A type), povidone K-25, calcium stearate, sodium lauryl sulfate, lactose monohydrate, opadry II white (85 F). Composition of coating substance (opadry II white (85 F)): partially hydrolyzed polyvinyl alcohol, macrogol/ polyethyleneglycol, talc (E553b); titanium dioxide (E171). Pharmaceutical form: fi lm-coated tablets. Pharmacotherapeutic group: antineoplastic agent, estrogen synthesis inhibitor. ATC code: L02BG03. Advanced breast cancer in postmenopausal women. Indications for use Adjuvant therapy of early hormone-positive breast Adjuvant therapy of early hormone-positive breast cancer in postmenopausal period aſt er taking tamoxifen cancer in postmenopausal period. during 2-3 years.

Other medicines for oncological diseases therapy Calcium folinate powder lyophilized for preparing solution for injection 50 mg and 100 mg

Trade name: Calcium folinate. International nonproprietary name: Calcium folinate. Pharmaceutical form: lyophilized powder for solution for intravenous and intramuscular injection. Description: light yellow to yellow porous mass, non- uniform color. Hygroscopic. Composition: each vial contains: Active ingredient: calcium folinate (calculated as folinic ▶ Colorectal cancer (as a part of the combined therapy acid) – 50 mg or 100 mg. with fl uorouracil). Excipient: methylparahydroxybenzoate. ▶ Megaloblastic anemia on the background of folic Pharmaceutical group: Folic acid antagonist antidote, acid defi cit (including one on the background of 5-fl uorouracil biological action modifi er, vitamin. malabsorption syndrome, undernutrition, pregnancy, ATC code: V03AF03. sprue, in infancy in case of hereditary dihydrofolate Indications for use reductase defi ciency). ▶ Intoxications caused by folic acid antagonists (methotrexate, trimethoprim, and pyrimetamine). ▶ Prevention of the methotrexate toxic eff ect when it is administered in elevated and high doses. Zoledronic acid powder lyophilized for solution for infusion 4 mg

Trade name: Zoledronic acid. International nonproprietary name: Zoledronic acid. Description: white powder or porous mass. Hygroscopic. Contents: 1 vial contains: Active substance: zoledronic acid (as zoledronic acid monohydrate) – 4 mg. Excipients: mannitol, sodium citrate 5, 5-hydrate. Pharmaceutical form: lyophilized powder for solution for infusion. Pharmacotherapeutic group: drug products for bone treatment. Bisphosphonates. ATC code: М05ВА08. Indications for use Treatment of hypercalcemia caused by malignant tumor (at blood serum concentration of calcium adjusted by the albumin level >12 mg/ml or 3 mmole/l). Treatment of patients with metastases in bones with malignant solid tumors and multiple myeloma in combination with standard antineoplastic therapy.

Other medicines for oncological diseases therapy Tropisetron solution for injection 1 mg/ml

Indications for use Preventing nausea and vomiting developing because of Trade name: Tropisetron. anti-tumor chemotherapy. International not patented name: Tropisetron. Stopping nausea and vomiting developing in the Pharmacotherapeutic group: serotoninergic postoperative period. preparations, anti-vomiting preparations. Preventing nausea and vomiting developing aſt er Composition: each ampoule of 5 ml contents: gynecologic intra-abdominal surgeries. When the Active ingredient: tropisetron hydrochloride – 5 mg. preparation is prescribed for optimizing the ratio “eff ect/ Excipient: sodium citrate, citric acid monohydrate, water risk” it should be applied exclusively by the females for injection. having data about postoperative nausea and vomiting in ATC code: A04AA03. the anamnesis.

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