Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - lantus is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis. lantus is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to insulin glargine or any of the excipients in lantus [see warnings and precautions (5.5)] risk summary published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular huma

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

epic pharma, llc - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr) - in the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. if test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. rifampin is indicated in the treatment of all forms of tuberculosis. a three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., rifater® (sanofi-aventis u.s. llc)) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. the advisory council for the elimination of tuberculosis, the american thoracic society, and centers for disease control and prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (inh), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of inh resistance is very low. the need for a fourth drug should be reassessed when the results of susceptibility testing are known. if community rates of inh resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is hiv positive. rifampin iv is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth. rifampin is indicated for the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx. rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (see warnings.) rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. so that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. to reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. rifampin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (see warnings.) rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity. (see precautions, drug interactions.) rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance. rifampin is contraindicated in patients receiving praziquantel since therapeutically effective blood levels of praziquantel may not be achieved. in patients receiving rifampin who need immediate treatment with praziquantel alternative agents should be considered. however, if treatment with praziquantel is necessary, rifampin should be discontinued 4 weeks before administration of praziquantel. treatment with rifampin can then be restarted one day after completion of praziquantel treatment. rifampin is contraindicated in patients receiving lurasidone. concomitant use of lurasidone with strong cyp3a4 inducers (e.g., rifampin) decreased the exposure of lurasidone compared to the use of lurasidone alone. (see precautions, drug interactions).

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

puracap laboratories llc dba blu pharmaceuticals - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr) - in the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. if test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. rifampin is indicated in the treatment of all forms of tuberculosis. a three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., rifater® (sanofi-aventis u.s. llc)) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. the advisory council for the elimina

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - sargramostim (unii: 5taa004e22) (sargramostim - unii:5taa004e22) - sargramostim 500 ug in 1 ml - leukine is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (aml). leukine is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. leukine is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (pbpc) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-hodgkin's lymphoma (nhl), acute lymphoblastic leukemia (all) and hodgkin's lymphoma (hl). leukine is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from hla-matched related donors. leukine is indicated for the treatm

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - plerixafor (unii: s915p5499n) (plerixafor - unii:s915p5499n) - plerixafor 24 mg in 1.2 ml - mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (hscs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-hodgkin's lymphoma (nhl) or multiple myeloma (mm). mozobil is contraindicated in patients with a history of hypersensitivity to plerixafor [see warnings and precautions (5.1)] . anaphylactic shock has occurred with use of mozobil. risk summary limited available data with mozobil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, subcutaneous administration of plerixafor to pregnant rats during organogenesis at doses 10-times the maximum recommended human doses resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth [see data] . advise pregnant women of the potential risk to the fetus. advise women of reproductive potential to avoid becoming pregnant while receiving treatment with mozobil [see warn

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr) - rifampin 600 mg in 10 ml - in the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. if test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. rifampin is indicated in the treatment of all forms of tuberculosis. a three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. the advisory council for the elimination of tuberculosis, the american thoracic society, and centers for disease control and prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (inh), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of inh resistance is very low. the need for a fourth drug should be reassessed when the results of susceptibility testing are known. if community rates of inh resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is hiv positive. rifadin iv is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth. rifampin is indicated for the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx. rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (see warnings.) rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. so that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. to reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. rifadin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (see warnings.) rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity. (see precautions, drug interactions.) rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance. rifampin is contraindicated in patients receiving praziquantel since therapeutically effective blood levels of praziquantel may not be achieved. in patients receiving rifampin who need immediate treatment with praziquantel alternative agents should be considered. however, if treatment with praziquantel is necessary, rifampin should be discontinued 4 weeks before administration of praziquantel. treatment with rifampin can then be restarted one day after completion of praziquantel treatment. rifampin is contraindicated in patients receiving lurasidone. concomitant use of lurasidone with strong cyp3a4 inducers (e.g., rifampin) decreased the exposure of lurasidone compared to the use of lurasidone alone. (see precautions, drug interactions).

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr) - rifampin 150 mg - in the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. if test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. rifampin is indicated in the treatment of all forms of tuberculosis. a three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. the advisory council for the elimination of tuberculosis, the american thoracic society, and centers for disease control and prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (inh), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of inh resistance is very low. the need for a fourth drug should be reassessed when the results of susceptibility testing are known. if community rates of inh resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is hiv positive. rifadin iv is indicated for the initial treatment and retreatment of tuberculosis when the drug cannot be taken by mouth. rifampin is indicated for the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx. rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (see warnings.) rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. so that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. to reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. rifadin is contraindicated in patients with a history of hypersensitivity to rifampin or any of the components, or to any of the rifamycins. (see warnings.) rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity. (see precautions, drug interactions.) rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance. rifampin is contraindicated in patients receiving praziquantel since therapeutically effective blood levels of praziquantel may not be achieved. in patients receiving rifampin who need immediate treatment with praziquantel alternative agents should be considered. however, if treatment with praziquantel is necessary, rifampin should be discontinued 4 weeks before administration of praziquantel. treatment with rifampin can then be restarted one day after completion of praziquantel treatment. rifampin is contraindicated in patients receiving lurasidone. concomitant use of lurasidone with strong cyp3a4 inducers (e.g., rifampin) decreased the exposure of lurasidone compared to the use of lurasidone alone. (see precautions, drug interactions).

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - rifampin (unii: vjt6j7r4tr) (rifampin - unii:vjt6j7r4tr), isoniazid (unii: v83o1voz8l) (isoniazid - unii:v83o1voz8l), pyrazinamide (unii: 2kni5n06ti) (pyrazinamide - unii:2kni5n06ti) - rifampin 120 mg - rifater is indicated in the initial phase of the short-course treatment of pulmonary tuberculosis. during this phase, which should last 2 months, rifater should be administered on a daily, continuous basis (see dosage and administration). following the initial phase and treatment with rifater, treatment should be continued with rifampin and isoniazid (e.g., rifamate) for at least 4 months. treatment should be continued for a longer period of time if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is hiv positive. in the treatment of tuberculosis, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. bacteriologic smears or cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to r

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - clofarabine (unii: 762rdy0y2h) (clofarabine - unii:762rdy0y2h) - clolar® is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. none. risk summary in animal reproduction studies, intravenous administration of clofarabine to pregnant rats and rabbits during organogenesis at doses approximately 0.2 to 1-times the maximum recommended human dose of 52 mg/m2 based on body surface area (bsa) resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities (see data) . advise pregnant women of the potential risk to a fetus. there are no available data on clolar use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. clofarabine should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Kanada - Inggeris - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - laronidase - solution - 0.58mg - laronidase 0.58mg - enzymes