New Zealand - English - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - granisetron hydrochloride 1.12 mg/ml equivalent to granisetron 1 mg/ml - concentrate for injection - 1 mg/ml - active: granisetron hydrochloride 1.12 mg/ml equivalent to granisetron 1 mg/ml excipient: citric acid monohydrate hydrochloric acid sodium chloride sodium hydroxide water for injection - adults: granisetron is indicated for the prevention of nausea and vomiting induced by cytotoxic chemotherapy. the prevention of nausea and vomiting induced by radiotherapy. the prevention and treatment of postoperative nausea and vomiting. children: granisetron is indicated for the prevention of nausea and vomiting induced by cytotoxic chemotherapy.

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

hikma pharmaceuticals usa inc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron [see adverse reactions (6.2)]. the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy [see data] . available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (bsa), respectively [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age.   two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however this association was not confirmed in other studies.  several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the us medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy).  animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis.  with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring.  at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on bsa. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21.  with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. r isk summary it is not known whether ondansetron is present in human milk.  there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production.  however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breast-fed infant from ondansetron or from the underlying maternal condition. little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see clinical studies (14.2)].  little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see clinical studies (14.1), dosage and administration (2)]. the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged >4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see clinical pharmacology (12.3)]. of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting us- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology (12.3)] . in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration (2.3)] . although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min), no dosage adjustment is recommended [see clinical pharmacology (12.3)] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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

hikma pharmaceuticals usa inc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron [see adverse reactions (6.2)]. the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy [see data] . available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (bsa), respectively [see data].   the background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the us medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis.  with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring.  at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on bsa. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21.  with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. r isk summary it is not known whether ondansetron is present in human milk.  there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production.  however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breast-fed infant from ondansetron or from the underlying maternal condition. little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see clinical studies (14.2)].  little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see clinical studies (14.1), dosage and administration (2)]. the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged >4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see clinical pharmacology (12.3)]. of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting us- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology (12.3)] . in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration (2.3)] . although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min), no dosage adjustment is recommended [see clinical pharmacology (12.3)] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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

cardinal health 107, llc - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron [see adverse reactions (6.2)]. the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy [see data] . available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (bsa), respectively [see data].   the background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the us medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis.  with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring.  at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on bsa. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21.  with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. risk summary it is not known whether ondansetron is present in human milk.  there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production.  however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breast-fed infant from ondansetron or from the underlying maternal condition. little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see clinical studies (14.2)].  little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see clinical studies (14.1), dosage and administration (2)]. the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged >4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see clinical pharmacology (12.3)]. of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting us- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology (12.3)] . in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration (2.3)] . although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min), no dosage adjustment is recommended [see clinical pharmacology (12.3)] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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

baxter healthcare corporation - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron [see adverse reactions (6.2)]. the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. risk summary published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see data) . available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (bsa), respectively (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the us medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis. with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on bsa. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron injection on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron injection and any potential adverse effects on the breast-fed infant from ondansetron injection or from the underlying maternal condition. little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see clinical studies (14.2)].  little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see clinical studies (14.1), dosage and administration (2)]. the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged > 4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see clinical pharmacology (12.3)]. of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting us- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology (12.3)] . in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration (2.3)] . although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/min), no dosage adjustment is recommended [see clinical pharmacology (12.3)] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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

hospira, inc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron [see adverse reactions (6.2)] . the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. risk summary published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see data) . available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (bsa), respectively (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the us medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis. with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on bsa. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ondansetron and any potential adverse effects on the breast-fed infant from ondansetron or from the underlying maternal condition. little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see clinical studies (14.2)] . little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see clinical studies (14.1), dosage and administration (2)] . the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged > 4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see clinical pharmacology (12.3)] . of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting us- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology (12.3)] . in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration (2.3)] . although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/min), no dosage adjustment is recommended [see clinical pharmacology (12.3)] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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

athenex pharmaceutical division, llc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron [see adverse reactions ( 6.2)] . the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. risk summary published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see data) . available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (bsa), respectively (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the us medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis. with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on bsa. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ondansetron and any potential adverse effects on the breast-fed infant from ondansetron or from the underlying maternal condition. little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see clinical studies ( 14.2)] . little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see clinical studies ( 14.1), dosage and administration ( 2)] . the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged > 4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see clinical pharmacology ( 12.3)] . of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting us- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology ( 12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology ( 12.3)] . in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration ( 2.3)] . although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/min), no dosage adjustment is recommended [see clinical pharmacology ( 12.3)] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - ondansetron as hydrochloride dihydrate - solution for injection - ondansetron as hydrochloride dihydrate 2 mg/ml - ondansetron - ondansetron - adults:for the mangement of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.for the prevention and treatment of post-operative nausea and vomiting (ponv).paediatric population:for the mangement of chemotherapy-induced nausea and vomiting (cinv) in children aged ≥ 6 months, and for the prevention and treatment of ponv in children aged ≥ 1 month.

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

sandoz inc - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate 1.25 mg - dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (mixed salts of a single entity amphetamine product) is indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. in patients known to be hypersensitive to amphetamine, or other components of mixed salts of a single entity amphetamine product. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products (see adverse reactions). patients taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis (see warnings and drug interactions). mixed salts of a single entity amphetamine product contains amphetamine, a schedule ii controlled substance. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings and precautions). dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate can be diverted for non‑medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate may produce physical dependence. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate may produce tolerance. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Malta - English - Medicines Authority

accord healthcare limited - ondansetron - solution for infusion or injection - ondansetron 2 mg/ml - antiemetics and antinauseants