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

nucare pharmaceuticals,inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. - pantoprazole sodium delayed-release tablets are contraindic

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

preferred pharmaceuticals, inc. - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets are indicated for the treatment of: prophylaxis: fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. there is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. coadministration of terfenadine is contraindicated in

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

preferred pharmaceuticals, inc. - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets are indicated for the treatment of: prophylaxis: fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. there is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. coadministration of terfenadine is contraindicated in

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

preferred pharmaceuticals inc. - fluconazole (unii: 8vzv102jfy) (fluconazole - unii:8vzv102jfy) - fluconazole tablets, usp are indicated for the treatment of: prophylaxis. fluconazole tablets, usp are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. there is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. coadministration of terfenadine is contraind

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

nucare pharmaceuticals,inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium delayed-release tablets, usp are indicated for: pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole is indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome. - pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. hypersensitivity reactions may include ana

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

preferred pharmaceuticals, inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets  are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. teratogenic effects pregnancy category c repro

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

preferred pharmaceuticals, inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium delayed-release tablets, usp are indicated for: pantoprazole sodium delayed-release tablets, usp are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets, usp may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets, usp are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets, usp are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. teratogenic effects pregnancy catego

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

preferred pharmaceuticals, inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. reproduction studies have been performed in rats at oral pant

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

regeneron pharmaceuticals, inc. - cemiplimab (unii: 6qvl057int) (cemiplimab - unii:6qvl057int) - libtayo is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mcscc) or locally advanced cscc (lacscc) who are not candidates for curative surgery or curative radiation. libtayo is indicated for the treatment of patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. libtayo in combination with platinum‐based chemotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) with no egfr, alk or ros1 aberrations and is: - locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or - metastatic. libtayo as a single agent is indicated for the first-line treatment of adult patients with nsclc whose tumors have high pd-l1 expression [tumor proportion score (tps) ≥ 50%] as determined by an fda-approved test [see dosage and administration (2.1)] , with no egfr, alk or ros1 aberrations, and is: - locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or - metastatic. none. risk summary based on its mechanism of action, libtayo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of libtayo in pregnant women. animal studies have demonstrated that inhibition of the pd-1/pd-l1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see data) . human igg4 immunoglobulins (igg4) are known to cross the placenta; therefore, libtayo has the potential to be transmitted from the mother to the developing fetus. advise women of the potential risk to a fetus. 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. data animal data animal reproduction studies have not been conducted with libtayo to evaluate its effect on reproduction and fetal development. a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. in murine models of pregnancy, blockade of pd-l1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering libtayo during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1/pd-l1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 and pd-l1 knockout mice. based on its mechanism of action, fetal exposure to cemiplimab-rwlc may increase the risk of developing immune-mediated disorders or altering the normal immune response. risk summary there is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of libtayo. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating libtayo [see use in specific populations (8.1)] . contraception libtayo can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise females of reproductive potential to use effective contraception during treatment with libtayo and for at least 4 months after the last dose. the safety and effectiveness of libtayo have not been established in pediatric patients. libtayo as a single agent of the 1281 patients who received libtayo as a single agent in clinical studies, 26% were 65 years up to 75 years and 22% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. of the 358 patients with mcscc or lacscc who received libtayo as a single agent in study 1540, 30% were 65 years up to 75 years and 48% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. of the 138 patients with bcc who received libtayo as a single agent in study 1620, 27% were 65 years up to 75 years, and 31% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients. libtayo in combination with platinum-based chemotherapy of the 312 patients with nsclc who received libtayo in combination with platinum-based chemotherapy in study 16113, 35% were 65 years up to 75 years and 6% were 75 years or older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

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

lupin pharmaceuticals, inc. - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)] , heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)], in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary use of mycophenolate mofetil (mmf) during pregnancy is associated with