Panama - angleščina - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

genentech, inc - trastuzumab - trastuzumab....440 mg / agua bacteriostÁtica para inyectable (alcohol bencÍlico)....20 ml

Združene države Amerike - angleščina - NLM (National Library of Medicine)

genentech, inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg

Združene države Amerike - angleščina - NLM (National Library of Medicine)

genentech, inc. - alteplase (unii: 1rxs4ue564) (alteplase - unii:1rxs4ue564) - alteplase 2.2 mg in 2 ml - cathflo® activase® (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. cathflo activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation (see description).

Združene države Amerike - angleščina - NLM (National Library of Medicine)

genentech, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 10 mg in 2 ml - growth hormone deficiency (ghd) - nutropin aq® is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (gh). growth failure secondary to chronic kidney disease (ckd) - nutropin aq is indicated for the treatment of growth failure associated with ckd up to the time of renal transplantation. nutropin aq therapy should be used in conjunction with optimal management of ckd. idiopathic short stature (iss) - nutropin aq is indicated for the treatment of iss, also called non-ghd short stature, defined by height sds ≤ –2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. short stature associated with turner syndrome (ts) - nutropin aq is indicated for the treatment of short stature associated wit

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

genentech, inc. - erlotinib hydrochloride (unii: da87705x9k) (erlotinib - unii:j4t82ndh7e) - erlotinib 25 mg - tarceva® is indicated for:     •    the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see clinical studies (14.1, 14.3)]. limitations of use:     •    safety and efficacy of tarceva have not been established in patients with nsclc whose tumors have other egfr mutations [see clinical studies (14.1, 14.2)].     •    tarceva is not recommended for use in combination with platinum-based chemotherapy [see clinical studies (14.4)] . tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see clinical studies (14.5)] . none. risk summary based on animal data and its mechanism of action, tarc

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

genentech, inc. - alectinib hydrochloride (unii: p9yy73lo6j) (alectinib - unii:lij4ct1z3y) - alectinib 150 mg - alecensa is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc) as detected by an fda-approved test. none. risk summary based on animal studies and its mechanism of action, alecensa can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on alecensa use in pregnant women. administration of alectinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7 times those observed in humans treated with alectinib at 600 mg twice daily (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in a preliminary rabbit embryo-fetal study, adm

Združene države Amerike - angleščina - NLM (National Library of Medicine)

genentech, inc. - water (unii: 059qf0ko0r) (water - unii:059qf0ko0r) -

Združene države Amerike - angleščina - NLM (National Library of Medicine)

genentech, inc. - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - herceptin hylecta is indicated for adjuvant treatment of adults with 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 trastuzumab [see dosage and administration (2.1)] . herceptin hylecta is indicated in adults: - 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 trastuzumab [see dosage and administration (2