HIGHLIGHTS OF PRESCRIBING INFORMATION Stany Zjednoczone - angielski - NLM (National Library of Medicine)

highlights of prescribing information

teva parenteral medicines, inc. - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone acetate 150 mg in 1 ml - medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. limitations of use : the use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see dosage and administration (2.1) and warnings and precautions (5.1)] . the use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)] . - known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients [see warnings and precautions (5.5)] . - significant liver disease [see warnings and p

VINCASAR PFS- vincristine sulfate injection, solution Stany Zjednoczone - angielski - NLM (National Library of Medicine)

vincasar pfs- vincristine sulfate injection, solution

teva parenteral medicines, inc. - vincristine sulfate (unii: t5iro3534a) (vincristine - unii:5j49q6b70f) - vincristine sulfate 1 mg in 1 ml - vincasar pfs is indicated in acute leukemia. vincasar pfs has also been shown to be useful in combination with other oncolytic agents in hodgkin’s disease, non-hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and wilms’ tumor. patients with the demyelinating form of charcot-marie-tooth syndrome should not be given vincasar pfs. careful attention should be given to those conditions listed under warnings  and precautions .

TOPOSAR- etoposide injection, solution, concentrate Stany Zjednoczone - angielski - NLM (National Library of Medicine)

toposar- etoposide injection, solution, concentrate

teva parenteral medicines, inc. - etoposide (unii: 6plq3cp4p3) (etoposide - unii:6plq3cp4p3) - etoposide 20 mg in 1 ml - toposar (etoposide injection) is indicated in the management of the following neoplasms: toposar (etoposide injection) in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy. etoposide injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

OXALIPLATIN injection, solution, concentrate Stany Zjednoczone - angielski - NLM (National Library of Medicine)

oxaliplatin injection, solution, concentrate

teva parenteral medicines, inc. - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 50 mg in 10 ml - oxaliplatin injection, used in combination with infusional fluorouracil/leucovorin, is indicated for: - adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. - treatment of advanced colorectal cancer. oxaliplatin injection should not be administered to patients with a history of known allergy to oxaliplatin or other platinum compounds [see warnings and precautions ( 5.1 )]. risk summary based on direct interaction with dna, oxaliplatin injection can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman of the potential hazard to a fetus. in the u.s. general population, the estimated background

HIGHLIGHTS OF PRESCRIBING INFORMATION Stany Zjednoczone - angielski - NLM (National Library of Medicine)

highlights of prescribing information

teva parenteral medicines, inc. - adenosine (unii: k72t3fs567) (adenosine - unii:k72t3fs567) - adenosine 3 mg in 1 ml - adenosine injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. adenosine is contraindicated in patients with: - second- or third-degree av block (except in patients with a functioning artificial pacemaker) [see warnings and precautions (5.2)] - sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see warnings and precautions (5.2)] - known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see warnings and precautions (5.3)] - known hypersensitivity to adenosine [see warnings and precautions (5.7)] animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. because it is not known whether adenosine can cause fetal harm when administered to pregnant women, adenosine should be used during pregnancy only if clearly needed. it is not known whether adenosine is excreted

SULFAMETHOXAZOLE AND TRIMETHOPRIM injection, solution, concentrate Stany Zjednoczone - angielski - NLM (National Library of Medicine)

sulfamethoxazole and trimethoprim injection, solution, concentrate

teva parenteral medicines, inc. - sulfamethoxazole (unii: je42381tnv) (sulfamethoxazole - unii:je42381tnv), trimethoprim (unii: an164j8y0x) (trimethoprim - unii:an164j8y0x) - sulfamethoxazole and trimethoprim injection is indicated in the treatment of pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age and older. sulfamethoxazole and trimethoprim injection is indicated in the treatment of enteritis caused by susceptible strains of shigella flexneri and shigella sonnei in adults and pediatric patients two months of age and older. sulfamethoxazole and trimethoprim injection is indicated in the treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of escherichia coli, klebsiella species, enterobacter species, morganella morganii, proteus mirabilis and proteus vulgaris when oral administration of sulfamethoxazole and trimethoprim injection is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract. to reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxa

DACARBAZINE injection, powder, for solution Stany Zjednoczone - angielski - NLM (National Library of Medicine)

dacarbazine injection, powder, for solution

teva parenteral medicines, inc. - dacarbazine (unii: 7gr28w0fji) (dacarbazine - unii:7gr28w0fji) - dacarbazine 200 mg in 20 ml - dacarbazine for injection is indicated in the treatment of metastatic malignant melanoma. in addition, dacarbazine for injection is also indicated for hodgkin's disease as a secondary-line therapy when used in combination with other effective agents. dacarbazine for injection is contraindicated in patients who have demonstrated a hypersensitivity to it in the past.

SULFAMETHOXAZOLE AND TRIMETHOPRIM injection, solution, concentrate Stany Zjednoczone - angielski - NLM (National Library of Medicine)

sulfamethoxazole and trimethoprim injection, solution, concentrate

teva parenteral medicines, inc. - sulfamethoxazole (unii: je42381tnv) (sulfamethoxazole - unii:je42381tnv), trimethoprim (unii: an164j8y0x) (trimethoprim - unii:an164j8y0x) - sulfamethoxazole 80 mg in 1 ml - sulfamethoxazole and trimethoprim injection is indicated in the treatment of pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age and older. sulfamethoxazole and trimethoprim injection is indicated in the treatment of enteritis caused by susceptible strains of shigella flexneri and shigella sonnei in adults and pediatric patients two months of age and older. sulfamethoxazole and trimethoprim injection is indicated in the treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of escherichia coli, klebsiella species, enterobacter species, morganella morganii, proteus mirabilis and proteus vulgaris when oral administration of sulfamethoxazole and trimethoprim injection is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract. to reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxa

ENOXAPARIN SODIUM injection, solution Stany Zjednoczone - angielski - NLM (National Library of Medicine)

enoxaparin sodium injection, solution

teva parenteral medicines, inc. - enoxaparin sodium (unii: 8nz41mik1o) (enoxaparin - unii:e47c0nf7lv) - enoxaparin sodium 30 mg in 0.3 ml - enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (dvt), which may lead to pulmonary embolism (pe): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see clinical studies (14.1) ] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness enoxaparin sodium injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction, when concurrently admin

CISPLATIN injection, solution Stany Zjednoczone - angielski - NLM (National Library of Medicine)

cisplatin injection, solution

teva parenteral medicines, inc. - cisplatin (unii: q20q21q62j) (cisplatin - unii:q20q21q62j) - cisplatin 50 mg in 50 ml - cisplatin injection is indicated for the treatment of advanced testicular cancer. cisplatin injection is indicated for the treatment of advanced ovarian cancer. cisplatin injection is indicated for the treatment of advanced bladder cancer. cisplatin injection is contraindicated in patients with severe hypersensitivity to cisplatin [see warnings and precautions (5.4)] . risk summary based on human data from published literature, cisplatin injection can cause fetal harm when administered to pregnant women. advise pregnant women and females of reproductive potential of the potential risk to a fetus. data demonstrates transplacental transfer of cisplatin. exposure of pregnant women to cisplatin-containing chemotherapy has been associated with oligohydramnios, intrauterine growth restriction, and preterm birth. cases of neonatal acute respiratory distress syndrome, cytopenias, and hearing loss have been reported. cisplatin injection administration to animals during and after organogenesis resulted in teratogenicit