Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - tirofiban hydrochloride, quantity: 14.05 mg (equivalent: tirofiban, qty 12.5 mg) - injection, concentrated - excipient ingredients: mannitol; sodium hydroxide; hydrochloric acid; dibasic sodium phosphate dihydrate; water for injections - tirofiban juno, in combination with heparin, is indicated for patients with unstable angina or non-q-wave myocardial infarction to prevent cardiac ischaemic events. (see pharmacology and dosage and administration.)

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

american health packaging - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules, usp in combination with interferon alfa-2b (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, usp combination therapy with intron a ® : - these indications are based on achieving undetectable hcv-rna after treatment for 24 or 48 weeks and maintaining a sustained virologic response (svr) 24 weeks after the last dose. - 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 of longer than one year. ribavirin capsules combination therapy is contraindicated i

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

sandoz inc - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules usp in combination with interferon alfa-2b (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 combination therapy with intron a: ribavirin combination therapy is contraindicated in: [see contraindications (4), warnings and precautions (5.1), and nonclinical toxicology (13.1)] . ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. it is not known whether ribavirin contained in sperm will exert a potential teratogenic effect upon fertilization of the ova. in a study in rats, it was concluded that dominant lethality was not induced by ribavirin at doses up to 200 mg/kg for 5 days (estimated human equivalent doses of 7.14 to 28.6 mg/kg, based on body surface area adjustment for a 60 kg adult; up to 1.7 times

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

state of florida doh central pharmacy - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin capsules are indicated in combination with intron a (interferon alfa-2b, recombinant) injection for the treatment of chronic hepatitis c in patients 18 years of age and older with compensated liver disease previously untreated with alpha interferon or in patients 18 years of age and older who have relapsed following alpha interferon therapy. the safety and efficacy of ribavirin capsules with non-pegylated interferons other than the intron a product have not been established. adults with compensated chronic hepatitis c and detectable hcv rna (assessed by a central laboratory using a research-based rt-pcr assay) who were previously untreated with alpha interferon therapy were enrolled into two multi-center, double-blind trials (us and international) and randomized to receive ribavirin capsules 1200 mg/day (1000 mg/day for patients weighing ≤75 kg) plus intron a injection 3 miu tiw or intron a injection plus placebo for 24 or 48 weeks followed by 24 weeks of off-therapy follow-up. the international stu

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

richmond pharmaceuticals, 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 combination therapy with peginterferon alfa-2b or interferon alfa-2b: ribavirin combination therapy is contraindicated in: pregnancy category x [see contraindications (4), warnings and precautions (5.1), and nonclinical toxicology (13.1) ]. treatment and posttreatment potential risk to the fetus ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. it is not known whether ribavirin contained in sperm will exert a potential teratogenic effect upon fertilization of the ova. in a study in rats, it was concluded that dominant lethality was not induced by ribavirin at doses up to 200 mg/kg for 5 days (estimat

European Union - English - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin mylan is indicated for the treatment of chronic hepatitis c and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). 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).please refer also to the interferon alfa-2b summary of product characteristics (smpc) for prescribing information particular to that product.naïve patientsadult patientsribavirin mylan 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 serum hepatitis-c-virus (hcv) rna.children and adolescentsribavirin mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for serum 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).previously treatment-failure patientsadult patientsribavirin mylan 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 alpha monotherapy but who have subsequently relapsed.

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

aurobindo pharma limited - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin tablets in combination with pegasys® (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 pegasys® :  - 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 safety and efficacy of ribavirin tablets and pegasys® therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy. - the safety and efficacy of ribavirin tablets therapy for the treatment of adenovirus, rsv, parainfluenza or influenza infections have not been established. ribavirin tablets should not be used for these indications. ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered. ribavirin tablets are contraindicated in: - women who are pregnant. ribavirin tablets may cause fetal harm when administered to a pregnant woman. ribavirin tablets are contraindicated in women who are or may become pregnant. 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 the fetus [see warnings and precautions (5.1), use in specific populations (8.1), and patient counseling information (17)] . - men whose female partners are pregnant. - patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). - in combination with didanosine. reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials [see drug interactions (7.1)] . ribavirin tablets and pegasys® combination therapy are contraindicated in patients with: - autoimmune hepatitis. - hepatic decompensation (child-pugh score greater than 6; class b and c) in cirrhotic chc monoinfected patients before treatment [see warnings and precautions (5.3)] . - hepatic decompensation (child-pugh score greater than or equal to 6) in cirrhotic chc patients coinfected with hiv before treatment [see warnings and precautions (5.3)] . pregnancy: category x [see contraindications (4)] .  ribavirin produced significant embryocidal and/or teratogenic effects 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)] .  in conventional embryotoxicity/teratogenicity studies in rats and rabbits, observed no-effect dose levels were well below those for proposed clinical use (0.3 mg/kg/day for both the rat and rabbit; approximately 0.06 times the recommended daily human dose of ribavirin). no maternal toxicity or effects on offspring were observed in a peri/postnatal toxicity study in rats dosed orally at up to 1 mg/kg/day (approximately 0.01 times the maximum recommended daily human dose of ribavirin). treatment and post-treatment: potential risk to the fetus ribavirin is known to accumulate in intracellular components from where it is cleared very slowly. it is not known whether ribavirin is contained in sperm, and if so, will exert a potential teratogenic effect upon fertilization of the ova. however, because of the potential human teratogenic effects of ribavirin, male patients should be advised to take every precaution to avoid risk of pregnancy for their female partners. ribavirin should not be used by pregnant women or by men whose female partners are pregnant. female patients of childbearing potential and male patients with female partners of childbearing potential should not receive ribavirin unless the patient and his/her partner are using effective contraception (two reliable forms) during therapy and for 6 months post therapy [see contraindications (4)] . it is not known whether ribavirin is excreted in human milk. because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with ribavirin, based on the importance of the therapy to the mother. pharmacokinetic evaluations in pediatric patients have not been performed. safety and effectiveness of ribavirin have not been established in patients below the age of 5 years. clinical studies of ribavirin and pegasys® did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. specific pharmacokinetic evaluations for ribavirin in the elderly have not been performed. the risk of toxic reactions to this drug may be greater in patients with impaired renal function. the dose of ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 ml/min; and the dose of pegasys® should be reduced in patients with creatinine clearance less than 30 ml/min [see dosage and administration (2.4); use in specific populations (8.7)] . a pharmacokinetic study in 42 subjects demonstrated there is no clinically significant difference in ribavirin pharmacokinetics among black (n=14), hispanic (n=13) and caucasian (n=15) subjects. renal function should be evaluated in all patients prior to initiation of ribavirin by estimating the patient’s creatinine clearance. a clinical trial evaluated treatment with ribavirin and pegasys® in 50 chc subjects with moderate (creatinine clearance 30 to 50 ml/min) or severe (creatinine clearance less than 30 ml/min) renal impairment or end stage renal disease (esrd) requiring chronic hemodialysis (hd). in 18 subjects with esrd receiving chronic hd, ribavirin was administered at a dose of 200 mg daily with no apparent difference in the adverse event profile in comparison to subjects with normal renal function. dose reductions and temporary interruptions of ribavirin (due to ribavirin-related adverse reactions, mainly anemia) were observed in up to one-third esrd/hd subjects during treatment; and only one-third of these subjects received ribavirin for 48 weeks. ribavirin plasma exposures were approximately 20% lower in subjects with esrd on hd compared to subjects with normal renal function receiving the standard 1000/1200 mg ribavirin daily dose. subjects with moderate (n=17) or severe (n=14) renal impairment did not tolerate 600 mg or    400 mg daily doses of ribavirin, respectively, due to ribavirin-related adverse reactions, mainly anemia, and exhibited 20% to 30% higher ribavirin plasma exposures (despite frequent dose modifications) compared to subjects with normal renal function (creatinine clearance greater than 80 ml/min) receiving the standard dose of ribavirin. discontinuation rates were higher in subjects with severe renal impairment compared to that observed in subjects with moderate renal impairment or normal renal function. pharmacokinetic modeling and simulation indicate that a dose of 200 mg daily in patients with severe renal impairment and a dose of 200 mg daily alternating with 400 mg the following day in patients with moderate renal impairment will provide plasma ribavirin exposure similar to patients with normal renal function receiving the approved regimen of ribavirin. these doses have not been studied in patients [see dosage and administration (2.4),  and clinical pharmacology (12.3)] . based on the pharmacokinetic and safety results from this trial, patients with creatinine clearance less than or equal to 50 ml/min should receive a reduced dose of ribavirin; and patients with creatinine clearance less than 30 ml/min should receive a reduced dose of pegasys® . the clinical and hematologic status of patients with creatinine clearance less than or equal to 50 ml/min receiving ribavirin should be carefully monitored. patients with clinically significant laboratory abnormalities or adverse reactions which are persistently severe or worsening should have therapy withdrawn [see dosage and administration (2.4), clinical pharmacology (12.3), and pegasys® package insert] . the effect of hepatic impairment on the pharmacokinetics of ribavirin following administration of ribavirin has not been evaluated. the clinical trials of ribavirin were restricted to patients with child-pugh class a disease. no clinically significant differences in the pharmacokinetics of ribavirin were observed between male and female subjects. ribavirin pharmacokinetics, when corrected for weight, are similar in male and female patients. the safety and efficacy of pegasys® and ribavirin treatment have not been established in patients with liver and other transplantations. as with other alpha interferons, liver and renal graft rejections have been reported on pegasys® , alone or in combination with ribavirin [see adverse reactions (6.2)] .

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

richmond pharmaceuticals, inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin in combination with peginterferon alfa-2a is 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 combination therapy with peginterferon alfa-2a: ribavirin is contraindicated in: ribavirin and peginterferon alfa-2a combination therapy is contraindicated in patients with: teratogenic effects pregnancy: category x [see contraindications (4)] . ribavirin produced significant embryocidal and/or teratogenic effects 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)] . in

United States - English - 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

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

amneal pharmaceuticals llc - 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 or planned administration of another parenteral gp iib/iiia inhibitor - dependency on renal dialysis - hypersensitivity to eptifibatide 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.