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

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)

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.

United States - English - 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

United States - English - 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