Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

akorn - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 0.75 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 injection 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 -

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

eugia us llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide 75 mg in 100 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 injection 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 or planned administration of another parenteral gp iib/iiia inhibitor - dependency on renal dialysis - hypersensitivity to eptifibatide injection or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations) . in animal reproduction studies, there was no evidence of adverse developmental effects when eptifibatide was administered intravenously to pregnant rats and rabbits at approximately 4 times the recommended maximum daily human dose. 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 miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of eptifibatide on the fetus data animal data embryo-fetal development studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats during the period of organogenesis at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits during the period of organogenesis at total daily doses of up to 36 mg/kg/day (also about 4 times the recommended maximum daily human dose on a body surface area basis). these studies revealed no evidence of harm to the fetus due to eptifibatide. risk summary there are no available data on the presence of eptifibatide in human milk, the effects on the breastfed infant, or the effects on milk production. as eptifibatide is a peptide, it is likely to be destroyed in the infant’s gastrointestinal tract and not absorbed orally by the breastfed infant. safety and effectiveness of eptifibatide in pediatric patients have not been studied. the pursuit and impact ii clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). there was no apparent difference in efficacy between older and younger patients treated with eptifibatide. the incidence of bleeding complications was higher in the elderly in both placebo and eptifibatide groups, and the incremental risk of eptifibatide-associated bleeding was greater in the older patients. no dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the pursuit study; no such limitation was stipulated in the esprit study [see adverse reactions (6.1)] . approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. total drug clearance is decreased by approximately 50% and steady-state plasma eptifibatide concentrations are doubled in patients with an estimated crcl <50 ml/min (using the cockcroft-gault equation). therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients [see dosage and administration (2)] . the safety and efficacy of eptifibatide in patients dependent on dialysis has not been established.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

aurobindo pharma limited - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) are indicated for the treatment of chronic hepatitis c (chc) in patients 3 years of age and older with compensated liver disease [see warnings and precautions (5.9, 5.10), and use in specific populations (8.4)]. the following points should be considered when initiating ribavirin capsules combination therapy with pegintron® or intron a® : - combination therapy with ribavirin capsules/pegintron is preferred over ribavirin capsules/intron a as this combination provides substantially better response rates [see clinical studies (14)]. - patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see clinical studies (14)]. - no safety and efficacy data are available for treatment duration lasting longer than one year.     ribavirin capsules combination therapy is contraindicated in: - pregnancy. ribavirin capsules may cause fetal harm when administered to a pregnant woman. ribavirin capsules are contraindicated in women who are pregnant or planning to become pregnant. if a patient becomes pregnant while taking ribavirin capsules, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.1) , and use in specific populations (8.1, 8.3)]. - men whose female partners are pregnant [see use in specific populations (8.3)] - patients with known hypersensitivity reactions such as stevens-johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin or any component of the product - patients with autoimmune hepatitis - patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia) - patients with creatinine clearance less than 50 ml/min [see clinical pharmacology (12.3)] - when coadministered with didanosine because exposure to the active metabolite of didanosine (dideoxyadenosine 5’-triphosphate) is increased. fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis, has been reported in patients receiving didanosine in combination with ribavirin [see drug interactions (7.1)].    risk summary ribavirin is contraindicated for use in pregnant women and in men whose female partners are pregnant [see contraindications (4)] . based on animal data, ribavirin use in pregnancy may be associated with birth defects. data from the ribavirin pregnancy registry are insufficient to identify a drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. in animal studies, ribavirin exposure was shown to have teratogenic and/or embryocidal effects (see data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2 to 4% and 15 to 20%, respectively. data human data available data from the ribavirin pregnancy registry on 88 live births from pregnancies in women directly exposed and 98 live births from pregnancies in women indirectly exposed (by a male partner) to ribavirin during pregnancy or during the 6 months prior to pregnancy show a higher rate of birth defects (9.09% and 6.12%, respectively) compared to a background birth defect rate of 2.72% in the metropolitan atlanta congenital defects program (macdp) birth defects surveillance system. no pattern of birth defects can be identified from these reports. the miscarriage rate was approximately 21%. the current sample size is insufficient for reaching definitive conclusions based on statistical analysis. trends suggesting a common etiology or relationship with ribavirin exposure were not observed. methodologic limitations of the ribavirin pregnancy registry include the use of macdp as the external comparator group. limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease and comorbidities. animal data embryotoxicity/teratogenicity studies with ribavirin were conducted in rats (oral doses of 0.3, 1 and 10 mg/kg on gestation days 6 to 15) and rabbits (oral dose of 0.1, 0.3 and 1 mg/kg on gestation days 6 to 18). ribavirin demonstrated significant embryocidal and teratogenic effects at doses well below the recommended human dose in all animal species in which adequate studies have been conducted. malformations of the skull, palate, eye, jaw, limbs, skeleton, and gastrointestinal tract were noted. the incidence and severity of teratogenic effects increased with escalation of the drug dose. survival of fetuses and offspring was reduced [see contraindications (4) and warnings and precautions (5.1)]. risk summary there are no data on the presence of ribavirin in human milk or the effects on the breastfed infant or milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ribavirin and any potential adverse effects on the breastfed infant from ribavirin or from the underlying maternal condition. ribavirin may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of treatment. patients should have periodic pregnancy tests during treatment and during the 9-month period after treatment has been stopped [see warnings and precautions (5.1)]. contraception female patients of reproductive potential should use effective contraception during treatment and for 9 months post-therapy. male patients and their female partners should use effective contraception during treatment with ribavirin and for the 6-month post-therapy period [see warnings and precautions (5.1)] . infertility based on animal data, ribavirin may impair male fertility. in animal studies, these effects were mostly reversible within a few months after drug cessation [see nonclinical toxicology (13.1)] .     safety and effectiveness of ribavirin in combination with pegintron has not been established in pediatric patients below the age of 3 years. for treatment with ribavirin/intron a, evidence of disease progression, such as hepatic inflammation and fibrosis, as well as prognostic factors for response, hcv genotype and viral load should be considered when deciding to treat a pediatric patient. the benefits of treatment should be weighed against the observed safety findings. long-term follow-up data in pediatric subjects indicates that ribavirin in combination with pegintron or with intron a may induce a growth inhibition that results in reduced height in some patients [see warnings and precautions (5.9) and adverse reactions (6.1)] . suicidal ideation or attempts occurred more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% vs. 1%) during treatment and off-therapy follow-up [see warnings and precautions (5.10)]. as in adult patients, pediatric patients experienced other psychiatric adverse reactions (e.g., depression, emotional lability, somnolence), anemia, and neutropenia [see warnings and precautions (5.2) ]. juvenile animal toxicity data in a study in which rat pups were dosed postnatally with ribavirin at doses of 10, 25, and 50 mg/kg/day, drug-related deaths occurred at 50 mg/kg (at rat pup plasma concentrations below human plasma concentrations at the human therapeutic dose) between study days 13 and 48. rat pups dosed from postnatal days 7 through 63 demonstrated a minor, dose-related decrease in overall growth at all doses, which was subsequently manifested as slight decreases in body weight, crown-rump length, and bone length. these effects showed evidence of reversibility, and no histopathological effects on bone were observed. no ribavirin effects were observed regarding neurobehavioral or reproductive development. clinical trials of ribavirin combination therapy did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently from younger subjects. ribavirin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients often have decreased renal function, care should be taken in dose selection. renal function should be monitored and dosage adjustments made accordingly. ribavirin should not be used in patients with creatinine clearance less than 50 ml/min [see contraindications (4)] . in general, ribavirin capsules should be administered to elderly patients cautiously, starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic and cardiac function, and of concomitant disease or other drug therapy. in clinical trials, elderly subjects had a higher frequency of anemia (67%) than younger patients (28%) [see warnings and precautions (5.2)].   the safety and efficacy of intron a and pegintron alone or in combination with ribavirin for the treatment of hepatitis c in liver or other organ transplant recipients have not been established. in a small (n=16) single-center, uncontrolled case experience, renal failure in renal allograft recipients receiving interferon alpha and ribavirin combination therapy was more frequent than expected from the center’s previous experience with renal allograft recipients not receiving combination therapy. the relationship of the renal failure to renal allograft rejection is not clear. the safety and efficacy of pegintron/ribavirin and intron a/ribavirin for the treatment of patients with hcv co-infected with hiv or hbv have not been established.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of patients 5 years of age and older with chronic hepatitis c (chc) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. the following points should be considered when initiating ribavirin tablets combination therapy with peginterferon alfa-2a: - this indication is based on clinical trials of combination therapy in patients with chc and compensated liver disease, some of whom had histological evidence of cirrhosis (child-pugh class a), and in adult patients with clinically stable hiv disease and cd4 count greater than 100 cells/mm3 . - this indication is based on achieving undetectable hcv rna after treatment for 24 or 48 weeks, based on hcv genotype, and maintaining a sustained virologic response (svr) 24 weeks after the last dose. - safety and efficacy data are not available for treatment longer than 48 weeks. - the safe

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of chronic hepatitis c (chc) in patients 3 years of age and older with compensated liver disease [see warnings and precautions (5.9, 5.10), and use in specific populations (8.4)]. the following points should be considered when initiating ribavirin capsules combination therapy with pegintron® or intron a® : - combination therapy with ribavirin /pegintron is preferred over ribavirin /intron a as this combination provides substantially better response rates [see clinical studies (14) ]. - patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see clinical studies (14) ]. - no safety and efficacy data are available for treatment duration lasting longer than

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

state of florida doh central pharmacy - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of adults with chronic hepatitis c virus infection who have compensated liver disease and have not been previously treated with interferon alpha. patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (child-pugh class a) and patients with hiv disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy). ribavirin tablet is contraindicated in: - patients with known hypersensitivity to ribavirin tablets or to any component of the tablet. - women who are pregnant. - men whose female partners are pregnant. - patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). ribavirin tablets and peginterferon alfa-2a combination therapy is contraindicated in patients with: - autoimmune hepatitis. - hepatic decompensation (child-pugh score greater than 6; class b and c) in c

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

accord healthcare 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 injection 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 - histo

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

human genome sciences, inc. - raxibacumab (unii: 794pgl549s) (raxibacumab - unii:794pgl549s) - raxibacumab 50 mg in 1 ml - raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to bacillus anthracis in combination with appropriate antibacterial drugs. raxibacumab is also indicated for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. the effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. it is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax. [see clinical studies (14.1).] safety and pharmacokinetics (pk) of raxibacumab have been studied in adult healthy volunteers. there have been no trials of safety or pk of raxibacumab in the pediatric population. an extrapolation approach was used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults. [see use in specific populations (8.4).] raxibacumab binds to the protective antigen (pa) of b

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

emergent manufacturing operations baltimore llc - raxibacumab (unii: 794pgl549s) (raxibacumab - unii:794pgl549s) - raxibacumab 50 mg in 1 ml - raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to bacillus anthracis in combination with appropriate antibacterial drugs. raxibacumab is also indicated for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. the effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. it is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax [see clinical studies (14.1)]. safety and pharmacokinetics (pk) of raxibacumab have been studied in adult healthy volunteers. there have been no trials of safety or pk of raxibacumab in the pediatric population. an extrapolation approach was used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults [see use in specific populations (8.4)]. raxibacumab binds to the protective antigen (pa) of b.

Европска Унија - Енглески - EMA (European Medicines Agency)

biopartners gmbh - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin biopartners is indicated for the treatment of chronic hepatitis-c-virus (hcv) infection in adults, children three years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. ribavirin monotherapy must not be used. there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).naïve patientsadult patientsribavirin biopartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for hepatitis c viral ribonucleic acid (hcv-rna) (see section 4.4)children three years of age and older and adolescentsribavirin biopartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children three years of age and older and adolescents, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for hcv-rna.when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis (see section 4.4).previous-treatment-failure patientsadult patientsribavirin biopartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alfa monotherapy but who have subsequently relapsed (see section 5.1).