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teva parenteral medicines, inc. - mesna (unii: nr7o1405q9) (2-mercaptoethanesulfonic acid - unii:vhd28s0h7f) - mesna 100 mg in 1 ml - mesna injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. limitation of use: mesna injection is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. mesna is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see warnings and precautions (5.1)]. risk summary mesna is used in combination with ifosfamide or other cytotoxic agents. ifosfamide can cause fetal harm when administered to a pregnant woman. refer to the ifosfamide prescribing information for more information on use during pregnancy. mesna injection contains the preservative benzyl alcohol. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see warnings and precautions (5.3) and use in specific populations (8.4)]. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all

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teva parenteral medicines, inc. - epoprostenol sodium (unii: 4k04iq1of4) (epoprostenol - unii:dcr9z582x0) - epoprostenol 0.5 mg - epoprostenol sodium for injection is indicated for the treatment of pulmonary arterial hypertension (pah) (who group i) to improve exercise capacity. trials establishing effectiveness included predominantly (97%) patients with new york heart association (nyha) functional class iii-iv symptoms and etiologies of idiopathic or heritable pah (49%) or pah associated with connective tissue diseases (51%). epoprostenol is contraindicated in patients with heart failure caused by reduced left ventricular ejection fraction [see clinical studies ( 14.3)] . epoprostenol is contraindicated in patients with a hypersensitivity to the drug or any of its ingredients. risk summary limited published data from case series and case reports have not established an association with epoprostenol and major birth defects, miscarriage or adverse maternal or fetal outcomes when epoprostenol is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations) . in

United States - English - NLM (National Library of Medicine)

teva parenteral medicines, inc. - ifosfamide (unii: um20qqm95y) (ifosfamide - unii:um20qqm95y) - ifosfamide 1 g in 20 ml - ifosfamide injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. it should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. ifosfamide is contraindicated in patients with: - known hypersensitivity to administration of ifosfamide. - urinary outflow obstruction. ifosfamide can cause fetal harm when administered to a pregnant woman. fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide-containing chemotherapy regimens during pregnancy. animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in vivo . in pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m2 dose of ifosfamide was administered on day 11 of gestation. embryo-lethal effects were observed in rats following the administration of 54 mg/m2 doses of ifosfamide from the 6th through the 15th day of gestatio

United States - English - NLM (National Library of Medicine)

teva parenteral medicines, inc. - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration ). in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested.  improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials

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teva parenteral medicines, inc. - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (sclc) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan injection, in combination with cisplatin, is indicated for the treatment of patients with stage iv-b, recurrent, or persistent cervical cancer not amenable to curative treatment. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions (6.2)]. risk summary based on animal data and its mechanism of action, topotecan injection can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of topotecan in pregnancy. to

United States - English - NLM (National Library of Medicine)

teva parenteral medicines, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - 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

United States - English - NLM (National Library of Medicine)

teva parenteral medicines, inc. - bleomycin sulfate (unii: 7dp3ntv15t) (bleomycin - unii:40s1vhn69b) - bleomycin 15 [usp'u] - bleomycin for injection should be considered a palliative treatment. it has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. the response to bleomycin is poorer in patients with previously irradiated head and neck cancer. hodgkin's disease, non-hodgkin's lymphoma. embryonal cell, choriocarcinoma, and teratocarcinoma. bleomycin for injection has also been shown to be useful in the management of: bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.

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teva parenteral medicines, inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial

United States - English - NLM (National Library of Medicine)

teva parenteral medicines, inc. - romidepsin (unii: cx3t89xqbk) (romidepsin - unii:cx3t89xqbk) - romidepsin injection is indicated for the treatment of cutaneous t-cell lymphoma (ctcl) in adult patients who have received at least one prior systemic therapy. none. risk summary based on its mechanism of action and findings from animal studies, romidepsin injection can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. in an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see data) . advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving romidepsin and for at least 1 month after the last dose. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a backgrou

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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