Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

genentech, inc. - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck) - trastuzumab 440 mg in 20 ml - herceptin is indicated for adjuvant treatment of her2 overexpressing node positive or node negative (er/pr negative or with one high risk feature [see clinical studies (14.1)] ) breast cancer - as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel - as part of a treatment regimen with docetaxel and carboplatin - as a single agent following multi-modality anthracycline based therapy. select patients for therapy based on an fda-approved companion diagnostic for herceptin [see dosage and administration (2.1)] . herceptin is indicated: - in combination with paclitaxel for first-line treatment of her2-overexpressing metastatic breast cancer - as a single agent for treatment of her2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for herceptin [see dosage and administration (2.1)] . herceptin is indicated, in combinat

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - idarucizumab (unii: 97rwb5s1u6) (idarucizumab - unii:97rwb5s1u6) - idarucizumab 50 mg in 1 ml - praxbind is indicated in patients treated with pradaxa when reversal of the anticoagulant effects of dabigatran is needed: - for emergency surgery/urgent procedures - in life-threatening or uncontrolled bleeding none. risk summary there are no available data on praxbind use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproductive and development studies have not been conducted with idarucizumab. it is also not known whether praxbind can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. praxbind should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there are no data on the effects of praxbind on the breastfed child or on milk production. it is not known whether idarucizumab is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when praxbind is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for praxbind and any potential adverse effects on the breastfed child from praxbind or from the underlying maternal condition. safety and effectiveness have not been established in pediatric patients. a total of 454 (90%) patients treated with idarucizumab in the case series trial were 65 years of age and older, and 318 (63%) were 75 years of age and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

genentech, inc. - pertuzumab (unii: k16aiq8ctm) (pertuzumab - unii:k16aiq8ctm) - pertuzumab 30 mg in 1 ml - perjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with her2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for metastatic disease [see dosage and administration (2.2) and clinical studies (14.1)] . perjeta is indicated for use in combination with trastuzumab and chemotherapy for - the neoadjuvant treatment of patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer [see dosage and administration (2.2) and clinical studies (14.2)] . - the adjuvant treatment of patients with her2-positive early breast cancer at high risk of recurrence [see dosage and administration (2.2) and clinical studies (14.3)] . perjeta is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients. pregnancy pharmacovigilance program there is a pre

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

genentech, inc. - trastuzumab emtansine (unii: se2kh7t06f) (ado-trastuzumab emtansine - unii:se2kh7t06f) - ado-trastuzumab emtansine 20 mg in 1 ml - kadcyla® , as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either: - received prior therapy for metastatic disease, or - developed disease recurrence during or within six months of completing adjuvant therapy. select patients for therapy based on an fda-approved companion diagnostic for kadcyla [see dosage and administration (2.1) ]. kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab -based treatment. select patients for therapy based on an fda-approved companion diagnostic for kadcyla [see dosage and administration (2.1) ]. none. pregnancy pharmacovigilance program there is a pregnancy pharmacovigilance program for kadcyla. if kadcyla is administered during pregnancy, or if a patient becomes pregnant while r

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

genentech, inc. - obinutuzumab (unii: o43472u9x8) (obinutuzumab - unii:o43472u9x8) - obinutuzumab 1000 mg in 40 ml - gazyva, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. gazyva, in combination with bendamustine followed by gazyva monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen. gazyva, in combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage ii bulky, iii or iv follicular lymphoma. gazyva is contraindicated in patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use [see warnings and precautions (5.4)]. risk summary based on findings from animal studies and its mechanism of action, gazyva can cause fetal b-cell depletion [see clinical pharmacology (12.1)] . there are no data with gazyva use in pre

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

genentech, inc. - ranibizumab (unii: zl1r02vt79) (ranibizumab - unii:zl1r02vt79) - ranibizumab 10 mg in 1 ml - lucentis is indicated for the treatment of patients with:           lucentis is contraindicated in patients with ocular or periocular infections. lucentis is contraindicated in patients with known hypersensitivity to ranibizumab or any of the excipients in lucentis. hypersensitivity reactions may manifest as severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of lucentis administration in pregnant women. administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [cmax ]) after a single eye treatment at the recommended clinical dose. no skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see animal data] . animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. based on the anti-vegf mechanism of action for ranibizumab [see clinical pharmacology (12.1)] , treatment with lucentis may pose a risk to human embryofetal development. lucentis should be given to a pregnant woman only if clearly needed. data animal data an embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. pregnant animals received intravitreal injections of ranibizumab every 14 days starting on day 20 of gestation, until day 62 at doses of 0, 0.125, and 1 mg/eye. skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab. the 1 mg/eye dose resulted in trough serum ranibizumab levels up to 13 times higher than predicted cmax levels with single eye treatment in humans. no skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures equivalent to single eye treatment in humans. no effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed. risk summary there are no data available on the presence of ranibizumab in human milk, the effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production/excretion. because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when lucentis is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lucentis and any potential adverse effects on the breastfed child from ranibizumab. infertility no studies on the effects of ranibizumab on fertility have been conducted and it is not known whether ranibizumab can affect reproduction capacity. based on the anti-vegf mechanism of action for ranibizumab, treatment with lucentis may pose a risk to reproductive capacity. the safety and effectiveness of lucentis in pediatric patients have not been established. in the clinical studies, approximately 76% (2449 of 3227) of patients randomized to treatment with lucentis were ≥ 65 years of age and approximately 51% (1644 of 3227) were ≥ 75 years of age [see clinical studies (14)]. no notable differences in efficacy or safety were seen with increasing age in these studies. age did not have a significant effect on systemic exposure.

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - crohn disease - immunostimulants, - treatment of moderately to severely active crohn's disease for the reduction of signs and symptoms, and the induction and maintenance of sustained response and remission, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or are intolerant to or have medical contraindications to such therapies.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - bevacizumab, quantity: 400 mg - injection, concentrated - excipient ingredients: water for injections; monobasic sodium phosphate monohydrate; trehalose dihydrate; polysorbate 20; dibasic sodium phosphate heptahydrate - ? metastatic colorectai cancer avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. ? locally recurrent or metastatic breast cancer avastin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated.(see clinical trials). ? advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) avastin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous non-small cell lung cancer. ? advanced and/or metastatic renai cell cancer avastin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer ? grade iv glioma avastin (bevacizumab) as a single agent, is indicated for t

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - bevacizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; polysorbate 20; trehalose dihydrate; dibasic sodium phosphate heptahydrate - ? metastatic colorectai cancer avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. ? locally recurrent or metastatic breast cancer avastin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated.(see clinical trials). ? advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) avastin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous non-small cell lung cancer. ? advanced and/or metastatic renai cell cancer avastin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer ? grade iv glioma avastin (bevacizumab) as a single agent, is indicated for t

Իսրայել - անգլերեն - Ministry of Health

roche pharmaceuticals (israel) ltd - tocilizumab - solution for injection - tocilizumab 162 mg / 0.9 ml - tocilizumab - - actemra in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti rheumatic drugs (dmards) or tumor necrosis factor (tnf) antagonists. in these patients, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. - actemra 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. - actemra in combination with methotrexate (mtx) in indicated for the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx - actemra (tocilizumab) is indicated for the treatment of giant cell arteritis (gca) in adult patients. - actemra in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. - actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. actemra can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx.