ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see adverse reactions (6.2)]. risk summary there are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. there is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. in embryofetal development studies, administration of bimatoprost in pregnant mice and rats during organogenesis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [auc] levels). these adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended cl

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - bromfenac sodium (unii: 8ecv571y37) (bromfenac - unii:864p0921dw) - bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. none. teratogenic effects : pregnancy category c. reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [rhod]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times rhod) revealed no evidence of teratogenicity due to bromfenac. however, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss.  there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. nonteratogenic effects:

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - ziprasidone mesylate (unii: 3x6sax83jz) (ziprasidone - unii:6uka5vej6x) - ziprasidone mesylate for injection, intramuscular is indicated for acute agitation in schizophrenic patients. when deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the qt/qtc interval compared to several other antipsychotic drugs [see warnings and precautions (5.3)]. prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and  sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see warnings and precautions (5.3)] acute treatment of agitation in schizophrenia - ziprasidone mesylate for injection intramuscular is ind

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - ziprasidone mesylate (unii: 3x6sax83jz) (ziprasidone - unii:6uka5vej6x) - ziprasidone mesylate for injection, intramuscular is indicated for acute agitation in schizophrenic patients. when deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the qt/qtc interval compared to several other antipsychotic drugs [see warnings and precautions (5.3)]. prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and  sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see warnings and precautions (5.3)] acute treatment of agitation in schizophrenia - ziprasidone mesylate for injection intramuscular is ind

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. none pregnancy category d clofarabine injection may cause fetal harm when administered to a pregnant woman. clofarabine was teratogenic in rats and rabbits. developmental toxicity (reduced fetal body weight and increased post-implantation loss) and increased incidences of malformations and variations (gross external, soft tissue, skeletal and retarded ossification) were observed in rats receiving 54 mg/m 2 /day (approximately equivalent to the recommended clinical dose on a mg/m 2 basis), and in rabbits receiving 12 mg/m 2 /day (approximately 23% of the recommended clinical dose on a mg/m 2  basis). there are no adequate and well-controlled studies in pregnant women using clofarabine. if this drug is used during pregnancy, or if the patient becomes pregnant while taking t

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin injection, in combination with infusional fluorouracil and 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 is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary based on its direct interaction with dna, oxaliplatin 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 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 pregnant rats were administered oxaliplatin at less than one-tenth the recommended human dose based on body surface area during gestation days (gd) 1 to 5 (preimplantation), gd 6 to 10, or gd 11 to 16 (during organogenesis). oxaliplatin caused developmental mortality (increased early resorptions) when administered on days gd 6 to 10 and gd 11 to 16 and adversely affected fetal growth (decreased fetal weight, delayed ossification) when administered on days gd 6 to 10. risk summary there are no data on the presence of oxaliplatin or its metabolites in human or animal milk or its effects on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with oxaliplatin and for 3 months after the final dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating oxaliplatin [see use in specific populations (8.1)] . contraception oxaliplatin can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise female patients of reproductive potential to use effective contraception while receiving oxaliplatin and for 9 months after the final dose. males based on its mechanism action as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving oxaliplatin and for 6 months after the final dose [see nonclinical toxicology (13.1)] . infertility based on animal studies, oxaliplatin may impair fertility in males and females [see nonclinical toxicology (13.1)] . the safety and effectiveness of oxaliplatin in pediatrics have not been established. safety and effectiveness were assessed across 4 open-label studies in 235 patients aged 7 months to 22 years with solid tumors. in a multicenter, open-label, non-comparative, non-randomized study (ard5531), oxaliplatin was administered to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma. the dose limiting toxicity (dlt) was sensory neuropathy at a dose of 110 mg/m 2 . the main adverse reactions were: paresthesia (60%, grade 3 to 4: 7%), fever (40%, grade 3 to 4: 7%), and thrombocytopenia (40%, grade 3 to 4: 27%). no responses were observed. in an open-label non-randomized study (dfi7434), oxaliplatin was administered to 26 pediatric patients with metastatic or unresectable solid tumors, mainly neuroblastoma and ganglioneuroblastoma. the dlt was sensory neuropathy at a dose of 160 mg/m 2 . no responses were observed. in an open-label, single-agent study (ard5021), oxaliplatin was administered to 43 pediatric patients with recurrent or refractory embryonal cns tumors. the most common adverse reactions reported were: leukopenia (67%, grade 3 to 4: 12%), anemia (65%, grade 3 to 4: 5%), thrombocytopenia (65%, grade 3 to 4: 26%), vomiting (65%, grade 3 to 4: 7%), neutropenia (58%, grade 3 to 4: 16%), and sensory neuropathy (40%, grade 3 to 4: 5%). in an open-label single-agent study (ard5530), oxaliplatin was administered to 123 pediatric patients with recurrent solid tumors, including neuroblastoma, osteosarcoma, ewing sarcoma or peripheral pnet, ependymoma, rhabdomyosarcoma, hepatoblastoma, high grade astrocytoma, brain stem glioma, low grade astrocytoma, malignant germ cell tumor and other tumors. the most common adverse reactions reported were: sensory neuropathy (52%, grade 3 to 4: 12%), thrombocytopenia (37%, grade 3 to 4: 17%), anemia (37%, grade 3 to 4: 9%), vomiting (26%, grade 3 to 4: 4%), increased alt (24%, grade 3 to 4: 6%), increased ast (24%, grade 3 to 4: 2%), and nausea (23%, grade 3 to 4: 3%). the pharmacokinetic parameters of ultrafiltrable platinum were evaluated in 105 pediatric patients during the first cycle. the mean clearance in pediatric patients estimated by the population pharmacokinetic analysis was 4.7 l/h (%cv, 41%). mean platinum pharmacokinetic parameters in ultrafiltrate were c max of 0.75 ± 0.24 mcg/ml, auc 0-48h of 7.52 ± 5.07 mcg∙h/ml and auc inf of 8.83 ± 1.57 mcg.h/ml at 85 mg/m2 of oxaliplatin and c max of 1.10 ± 0.43 mcg/ml, auc 0-48h of 9.74 ± 2.52 mcg.h/ml and auc inf of 17.3 ± 5.34 mcg.h/ml at 130 mg/m2 of oxaliplatin. in the adjuvant treatment trial [see clinical studies (14.1)] , 400 patients who received oxaliplatin with fluorouracil/leucovorin were greater than or equal to 65 years. the effect of oxaliplatin in patients greater than or equal to 65 years was not conclusive. patients greater than or equal to 65 years receiving oxaliplatin experienced more diarrhea and grade 3 to 4 neutropenia (45% vs 39%) compared to patients less than 65 years. in the previously untreated advanced colorectal cancer trial [see clinical studies (14.2)] , 99 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. the same efficacy improvements in response rate, time to tumor progression, and overall survival were observed in the greater than or equal to 65 years patients as in the overall study population. adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, leukopenia, fatigue, and syncope. in the previously treated advanced colorectal cancer trial [see clinical studies (14.3)] , 55 patients who received oxaliplatin with fluorouracil and leucovorin were greater than or equal to 65 years. no overall differences in effectiveness were observed between these patients and younger adults. adverse reactions were similar in patients less than 65 and greater than or equal to 65 years, but older patients may have been more susceptible to diarrhea, dehydration, hypokalemia, and fatigue. no significant effect of age on the clearance of ultrafiltrable platinum has been observed [see clinical pharmacology (12.3)] . the auc of unbound platinum in plasma ultrafiltrate was increased in patients with renal impairment [see clinical pharmacology (12.3)] . no dose reduction is recommended for patients with mild (creatinine clearance 50 to 79 ml/min) or moderate (creatinine clearance 30 to 49 ml/min) renal impairment, calculated by cockcroft-gault equation. reduce the dose of oxaliplatin in patients with severe renal impairment (creatinine clearance less than 30 ml/min) [see dosage and administration (2.3)].

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide tablets usp are indicated for the treatment of adults with active rheumatoid arthritis (ra).  leflunomide is contraindicated in: -  pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)]. - patients with severe hepatic impairment [see warnings and precautions (5.2)]. - patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. - patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972 or visit http://www.pregnancystudies.org/participate-ina-study/. risk summary leflunomide is contraindicated for use in pregnant women because of the potential for fetal harm. in animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of and equivalent to the maximum recommended human dose (mrhd) based on auc, respectively in rats and rabbits, caused teratogenicity (rats and rabbits) and embryo-lethality (rats) [see data] . pregnancy exposure registry data are not available at this time to inform the presence or absence of drug-associated risk with the use of leflunomide during pregnancy. the background risk of major birth defects and miscarriage for the indicated populations is unknown. the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, stop treatment with leflunomide, apprise the patient of the potential hazard to a fetus, and perform the accelerated drug elimination procedure to achieve teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)] .  clinical considerations fetal/neonatal adverse reactions lowering the plasma concentration of the active metabolite, teriflunomide, by instituting an accelerated drug elimination procedure as soon as pregnancy is detected may decrease the risk to the fetus from leflunomide. the accelerated drug elimination procedure includes verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3) and clinical pharmacology (12.3)] . data animal data in an embryofetal development study, pregnant rats administered leflunomide during organogenesis from gestation days 7 to 19 at a dose approximately 1/10 of the mrhd (on an auc basis at a maternal oral dose of 15 mg/kg), teratogenic effects, most notably anophthalmia or microophthalmia and internal hydrocephalus, were observed. under these exposure conditions, leflunomide also caused a decrease in the maternal body weight and an increase in embryolethality with a decrease in fetal body weight for surviving fetuses. in an embryofetal development study, pregnant rabbits administered leflunomide during organogenesis from gestation days 6 to 18 at a dose approximately equivalent to the mrhd (on an auc basis at a maternal oral dose of 10 mg/kg), a teratogenic finding of fused, dysplastic sternebrae was observed. leflunomide was not teratogenic in rats and rabbits at doses approximately 1/150 and 1/10 of the mrhd, respectively (on an auc basis at maternal oral dose of 1 mg/kg in both rats and rabbits). in a pre- and post-natal development study, when female rats were treated leflunomide at a dose that was approximately 1/100 of the mrhd (on an auc basis at a maternal dose of 1.25 mg/kg) beginning 14 days before mating and continuing until the end of lactation, the offspring exhibited marked (greater than 90%) decreases in postnatal survival. risk summary clinical lactation studies have not been conducted to assess the presence of leflunomide in human milk, the effects of leflunomide on the breastfed child, or the effects of leflunomide on milk production. because of the potential for serious adverse reactions in a breastfed infant from leflunomide, advise a nursing woman to discontinue breastfeeding during treatment with leflunomide. leflunomide may cause fetal harm when administered during pregnancy. advise females of the potential risk to the fetus. advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see use in specific populations (8.1)] . women receiving leflunomide treatment who wish to become pregnant should discontinue leflunomide and undergo an accelerated drug elimination procedure to achieve plasma teriflunomide concentrations of less than 0.02 mg/l (0.02 mcg/ml) [see warnings and precautions (5.3)] . pregnancy testing exclude pregnancy in females of reproductive potential before starting treatment with leflunomide. contraception females advise females of reproductive potential to use effective contraception during treatment with leflunomide and while undergoing a drug elimination procedure until verification that the plasma teriflunomide concentration is less than 0.02 mg/l [see warnings and precautions (5.3)] . the safety and effectiveness of leflunomide in pediatric patients have not been established. the safety and effectiveness of leflunomide in the treatment of polyarticular course juvenile idiopathic arthritis (jia) was evaluated in a single multicenter, double-blind, active-controlled trial in 94 pediatric patients (1:1 randomization) with polyarticular course juvenile idiopathic arthritis (jia) as defined by the american college of rheumatology (acr). in this population, leflunomide treatment was found not to be effective. the safety of leflunomide was studied in 74 patients with polyarticular course jia ranging in age from 3 to 17 years (47 patients from the active-controlled study and 27 from an open-label safety and pharmacokinetic study). the most common adverse events included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness. less common adverse events included anemia, hypertension, and weight loss. fourteen pediatric patients experienced alt and/or ast elevations, nine between 1.2 and 3-fold the upper limit of normal, five between 3 and 8-fold the upper limit of normal.  of the total number of subjects in controlled clinical trials (trials 1, 2, and 3) of leflunomide, 234 subjects were 65 years and over [see clinical studies (14)] . 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. no dosage adjustment is needed in patients over 65. dedicated studies of the effect of hepatic impairment on leflunomide pharmacokinetics have not been conducted. given the need to metabolize leflunomide into the active species, the role of the liver in drug elimination/recycling, and the possible risk of increased hepatic toxicity, the use of leflunomide in patients with hepatic impairment is not recommended. dedicated studies of the effect of renal impairment on leflunomide pharmacokinetics have not been conducted. given that the kidney plays an important role in drug elimination, caution should be used when leflunomide is administered to these patients.

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients know

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc - etomidate (unii: z22628b598) (etomidate - unii:z22628b598) - etomidate injection, usp is indicated by intravenous injection for the induction of general anesthesia. when considering use of etomidate, the usefulness of its hemodynamic properties (see clinical pharmacology ) should be weighed against the high frequency of transient skeletal muscle movements (see adverse reactions ). intravenous etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization. etomidate is contraindicated in patients who have shown hypersensitivity to it.

ABD - İngilizce - NLM (National Library of Medicine)

fosun pharma usa inc. - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg /m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2 ) ] . do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens. pregnancy category d risk summary dexrazoxane for injection can cause fetal harm when administered to pregnant women. dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precaut