الولايات المتحدة - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - 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.

الولايات المتحدة - الإنجليزية - 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

الاتحاد الأوروبي - الإنجليزية - 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).

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

kadmon pharmaceuticals, llc - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribasphere® (ribavirin capsules usp) 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 ribasphere combination therapy with peginterferon alfa-2b or interferon alfa-2b: ribasphere combination therapy is contraindicated in: teratogenic effects pregnancy category x [see contraindications (4), warnings and precautions (5.1), and nonclinical toxicology (13.1) ]. 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 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

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

clinect nz pty limited - ribavirin 200mg;  ;   - film coated tablet - 200 mg - active: ribavirin 200mg     excipient: colloidal silicon dioxide croscarmellose sodium crospovidone magnesium stearate microcrystalline cellulose opadry white 03f180000 povidone - ibavyr is indicated in combination with other oral agents for the treatment of chronic hepatitis c (chc) in adults.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

clinect nz pty limited - ribavirin 400mg;  ;   - film coated tablet - 400 mg - active: ribavirin 400mg     excipient: colloidal silicon dioxide croscarmellose sodium crospovidone magnesium stearate microcrystalline cellulose opadry orange 04f93451 povidone - ibavyr is indicated in combination with other oral agents for the treatment of chronic hepatitis c (chc) in adults.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

clinect nz pty limited - ribavirin 600mg;  ;   - film coated tablet - 600 mg - active: ribavirin 600mg     excipient: colloidal silicon dioxide croscarmellose sodium crospovidone magnesium stearate microcrystalline cellulose opadry white 03f180000 povidone - ibavyr is indicated in combination with other oral agents for the treatment of chronic hepatitis c (chc) in adults.

الولايات المتحدة - الإنجليزية - 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