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chiesi usa, inc. - reteplase (unii: dqa630rie9) (reteplase - unii:dqa630rie9) - retavase is indicated for use in acute st-elevation myocardial infarction (stemi) to reduce the risk of death and heart failure. limitation of use: the risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose stemi puts them at low risk for death or heart failure. because thrombolytic therapy increases the risk of bleeding, retavase is contraindicated in the following situations: - active internal bleeding - recent stroke - intracranial or intraspinal surgery or serious head trauma within 3 months - intracranial conditions that increase the risk of bleeding (e.g. neoplasms, arteriovenous malformation, or aneurysms) - bleeding diathesis - current severe uncontrolled hypertension risk summary limited published data with retavase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.  in animal reproduction studies, reteplase administered to pregnant rabbits resulted in hemorrhaging in the genital tract, leading to abortions i

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

chiesi usa, inc. - poractant alfa (unii: ke3u2023np) (poractant alfa - unii:ke3u2023np) - poractant alfa 80 mg in 1 ml - curosurf® (poractant alfa) intratracheal suspension is indicated for the rescue treatment of respiratory distress syndrome (rds) in premature infants.  curosurf reduces mortality and pneumothoraces associated with rds.  none. the safety and effectiveness of curosurf for the rescue treatment, including the reduction of mortality and pneumothoraces, of respiratory distress syndrome (rds) have been established in premature infants and the information on this use is discussed throughout the labeling. the safety and effectiveness of curosurf in the treatment of full term infants or older pediatric patients with respiratory failure has not been established.

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chiesi usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - ferriprox oral solution is indicated for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)]. risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortalit

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

chiesi usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - ferriprox tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes. ferriprox tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with sickle cell disease or other anemias. - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)]. risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%,

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

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see data ). the limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. based on evidence and developmental toxicity in animal studies, deferiprone tablets can cause fetal harm when administered to a pregnant woman. advise pregnant women and females of reproductive potential of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage is 2-4% and 15-20%, respectively. data: human data: post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. animal data: during organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. the daily dose was administered as two equal divided doses approximately 7 hours apart. doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the mrhd, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). the 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations, such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia, and fused bones. the dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. in rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the mhrd, respectively. risk summary: there is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone tablets, and for at least 2 weeks after the last dose. pregnancy testing: pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone tablets. contraception: females: deferiprone tablets can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 6 months after the last dose. males: based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information . clinical studies of deferiprone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mor

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

chiesi usa, inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - ferriprox tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias.       limitation s of use • safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [ see adverse reactions ( 6.2 )] . risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal

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

chiesi usa, inc. - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 0.1 mg in 1 ml - cardene® i.v. (nicardipine hydrochloride) premixed injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.  for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.1)] . cardene i.v. premixed injection is contraindicated in patients with advanced aortic stenosis because part of the effect of cardene i.v. premixed injection is secondary to reduced afterload.  reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. pregnancy category c there are no adequate and well-controlled studies of nicardipine use in pregnant women.  however,  limited human data in pregnant women with preeclampsia or pre-term labor are available.  in animal studies, no embryotoxicity occurred in rats with oral doses 8 times the maximum recommended human dose (mrhd) based on body surface area (mg/m2 ), but did occur in rabbits

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chiesi usa, inc. - zileuton (unii: v1l22wve2s) (zileuton - unii:v1l22wve2s) - zileuton 600 mg - zyflo is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. zyflo tablets are contraindicated in patients with: - active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal (≥3xuln) (see precautions, hepatic ). - hypersensitivity to zileuton or any of its inactive ingredients.

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chiesi usa, inc. - cangrelor (unii: 6aq1y404u7) (cangrelor - unii:6aq1y404u7) - cangrelor 50 mg - kengreal is indicated as an adjunct to percutaneous coronary intervention (pci) to reduce the risk of periprocedural myocardial infarction (mi), repeat coronary revascularization, and stent thrombosis (st) in patients who have not been treated with a p2y12 platelet inhibitor and are not being given a glycoprotein iib/iiia inhibitor [see clinical studies ( 14.1 )]. kengreal is contraindicated in patients with significant active bleeding [see warnings and precautions ( 5.1 ) and adverse reactions ( 6.1 )] . kengreal is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to kengreal or any component of the product [see adverse reactions ( 6.1 )] . risk summary there are no available data on cangrelor use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant women and fetus (see clinical considerations ). in animal reproduction studies, continuous inf