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

zydus lifesciences limited - 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 one year. ribavirin capsules combination

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)

oceanside pharmaceuticals - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 6 g - ribavirin for inhalation solution, usp is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to rsv. treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. only severe rsv lower respiratory tract infection should be treated with ribavirin for inhalation solution, usp. the vast majority of infants and children with rsv infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of ribavirin for inhalation solution, usp aerosol (3 to 7 days) and should not be treated with the drug. thus the decision to treat with ribavirin for inhalation solution, usp should be based on the severity of the rsv infection. the presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonar

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

zydus pharmaceuticals usa inc. - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 6 g - ribavirin for inhalation solution, usp is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. only severe rsv lower respiratory tract infection should be treated with ribavirin for inhalation solution, usp. the vast majority of infants and children with rsv infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of ribavirin for inhalation solution, usp aerosol (3 to 7 days) and should not be treated with the drug. thus the decision to treat with ribavirin for inhalation solution, usp should be based on the severity of the rsv infection. the presence of an underlying condition such as prematurity, immunosuppr

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

zydus lifesciences limited - 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

European Union - English - 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).

European Union - English - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin teva pharma b.v. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) in adults (see sections 4.2, 4.4, and 5.1).ribavirin teva pharma b.v. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).

European Union - English - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin teva is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults, children 3 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 patients adult patients ribavirin teva 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.paediatric patients (children 3 years of age and older and adolescents) ribavirin teva is indicated, in a combination regimen with interferon alfa­2b, for the treatment of children and adolescents 3 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 hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis.previous treatment failure patientsadult patients ribavirin teva 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)

kadmon pharmaceuticals, llc - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribasphere (ribavirin, usp) 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 ribasphere combination therapy with peginterferon alfa-2a: ribasphere (ribavirin, usp) is contraindicated in: ribasphere 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) an

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

bryant ranch prepack - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin for inhalation solution, usp is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to rsv. treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. only severe rsv lower respiratory tract infection should be treated with ribavirin for inhalation solution, usp. the vast majority of infants and children with rsv infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of ribavirin for inhalation solution, usp aerosol (3 to 7 days) and should not be treated with the drug. thus the decision to treat with ribavirin for inhalation solution, usp should be based on the severity of the rsv infection. the presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of rsv infection. use of aerosolized ribavirin for inhalation solution, usp in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used (see warnings and dosage and administration). rsv infection should be documented by a rapid diagnostic method such as demonstration of viral antigen in respiratory tract secretions by immunofluorescence3,4 or elisa5 before or during the first 24 hours of treatment. treatment may be initiated while awaiting rapid diagnostic test results. however, treatment should not be continued without documentation of rsv infection. non-culture antigen detection techniques may have false positive or false negative results. assessment of the clinical situation, the time of year and other parameters may warrant reevaluation of the laboratory diagnosis. in two placebo-controlled trials in infants hospitalized with rsv lower respiratory tract infection, aerosolized ribavirin for inhalation solution, usp treatment had a therapeutic effect, as judged by the reduction in severity of clinical manifestations of disease by treatment day 3.3,4 treatment was most effective when instituted within the first 3 days of clinical illness. virus titers in respiratory secretions were also significantly reduced with ribavirin for inhalation solution, usp in one of these original studies.4 additional controlled studies conducted since these initial trials of aerosolized ribavirin for inhalation solution, usp in the treatment of rsv infection have supported these data. a randomized, double-blind, placebo-controlled evaluation of aerosolized ribavirin for inhalation solution, usp at the recommended dose was conducted in 28 infants requiring mechanical ventilation for respiratory failure caused by documented rsv infection.6 mean age was 1.4 months (sd, 1.7 months). seven patients had underlying diseases predisposing them to severe infection and 21 were previously normal. aerosolized ribavirin for inhalation solution, usp treatment significantly decreased the duration of mechanical ventilation required (4.9 vs. 9.9 days, p=0.01) and duration of required supplemental oxygen (8.7 vs. 13.5 days, p=0.01). intensive patient management and monitoring techniques were employed in this study. these included endotracheal tube suctioning every 1 to 2 hours; recording of proximal airway pressure, ventilatory rate, and fl o2 every hour; and arterial blood gas monitoring every 2 to 6 hours. to reduce the risk of ribavirin for inhalation solution, usp precipitation and ventilator malfunction, heated wire tubing, two bacterial filters connected in series in the expiratory limb of the ventilator (with filter changes every 4 hours), and water column pressure release valves to monitor internal ventilator pressures were used in connecting ventilator circuits to the spag® -2. employing these techniques, no technical difficulties with ribavirin for inhalation solution, usp administration were encountered during the study. adverse events consisted of bacterial pneumonia in one case, staphylococcus bacteremia in one case and two cases of post-extubation stridor. none were felt to be related to ribavirin for inhalation solution, usp administration. ribavirin for inhalation solution, usp is contraindicated in individuals who have shown hypersensitivity to the drug or its components, and in women who are or may become pregnant during exposure to the drug. ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted (rodents and rabbits). therefore, although clinical studies have not been performed, it should be assumed that ribavirin for inhalation solution, usp may cause fetal harm in humans. studies in which the drug has been administered systemically demonstrate that ribavirin is concentrated in the red blood cells and persists for the life of the erythrocyte.