Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - paclitaxel (unii: p88xt4is4d) (paclitaxel - unii:p88xt4is4d) - paclitaxel 6 mg in 1 ml - paclitaxel injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. as first-line therapy, paclitaxel injection is indicated in combination with cisplatin. paclitaxel injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. in the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors (see clinical studies, breast carcinoma ). paclitaxel injection is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. prior therapy should have included an anthracycline unl

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 40 mg in 2 ml - - irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. - irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients. pregnancy category d [see warnings and precautions (5.9)] irinotecan hydrochloride injection can cause fetal harm when administered to a pregnant woman. radioactivity related to 14 c-irinotecan crosses the placenta of rats following intravenous administration of 10 mg/kg (which in separate studies produced an irinotecan cmax and auc about 3 and 0.5 times, respectively, the corresponding values in patients administered 125 mg/m2 ). intravenous administration of irinotecan 6 mg/kg/day to rats and rabbits during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses. in separate studies in rats, this dose produced an irinotecan cmax

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - - irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. - irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients. pregnancy category d [see warnings and precautions (5.9)] irinotecan hydrochloride injection can cause fetal harm when administered to a pregnant woman. radioactivity related to 14 c-irinotecan crosses the placenta of rats following intravenous administration of 10 mg/kg (which in separate studies produced an irinotecan cmax and auc about 3 and 0.5 times, respectively, the corresponding values in patients administered 125 mg/m2 ). intravenous administration of irinotecan 6 mg/kg/day to rats and rabbits during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses. in separate studies in rats, this dose produced an irinotecan cmax

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 2 mg in 1 ml - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current o

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - pamidronate disodium (unii: 8742t8zqza) (pamidronic acid - unii:oyy3447omc) - pamidronate disodium 3 mg in 1 ml - pamidronate disodium injection is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. pamidronate disodium injection is indicated for the treatment of patients with moderate to severe paget’s disease of bone. pamidronate disodium injection is indicated in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma [see clinical studies (14.3)] . the safety and efficacy of pamidronate disodium injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established. pamidronate disodium is contraindicated in patients with hypersensitivity to pamidronate disodium, other bisphosphonates, or mannitol. reactions to pamidronate disodium injection and to mannitol have included anaphylaxis. pregnancy category d [see warnings and precautions (5.2)] risk summary there are no ad

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 6 mg in 0.5 ml - sumatriptan succinate injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. limitations of use: - use only if a clear diagnosis of migraine or cluster headache has been established. if a patient has no response to the first migraine or cluster headache attack treated with sumatriptan succinate injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. - sumatriptan succinate injection is not indicated for the prevention of migraine or cluster headache attacks. sumatriptan succinate injection is contraindicated in patients with: - ischemic coronary artery disease (cad) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including prinzmetal’s angina [see warnings and precautions (5.1)] . - wolff-parkinson-white syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to diminish symptoms associated with exercise. studies establishing effectiveness included patients with nyha functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (58%), pah associated with congenital systemic-to-pulmonary shunts (23%), or pah associated with connective tissue diseases (19%) [see clinical studies (14.1)] . in patients with pah requiring transition from epoprostenol, treprostinil injection is indicated to diminish the rate of clinical deterioration. consider the risks and benefits of each drug prior to transition. none risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal studies, no adverse reproductive and developmental

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - adrucil (fluorouracil injection) is indicated for the treatment of patients with: none. teratogenic effects pregnancy category d risk summary there are no adequate and well-controlled studies with fluorouracil in pregnant women. based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. malformations included cleft palate and skeletal defects. in monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see clinical pharmacology (12.1)]. animal data malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouracil wa

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine 1 mg in 1 ml - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated (see clinical considerations ). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data ). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxima

Estados Unidos - inglês - NLM (National Library of Medicine)

teva parenteral medicines, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - adrucil (fluorouracil injection) is indicated for the treatment of patients with: none. teratogenic effects pregnancy category d risk summary there are no adequate and well-controlled studies with fluorouracil in pregnant women. based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. malformations included cleft palate and skeletal defects. in monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see clinical pharmacology (12.1)]. animal data malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouracil wa