Singapore - englanti - HSA (Health Sciences Authority)

link healthcare singapore pte ltd - aprotinin - injection - 500000 kiu/50 ml - aprotinin 500000 kiu/50 ml

Singapore - englanti - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - rivaroxaban micronized - tablet, film coated - 2.5mg - rivaroxaban micronized 2.5mg

Singapore - englanti - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - rivaroxaban (micronized) - tablet, film coated - 15.00 mg - rivaroxaban (micronized) 15.00 mg

Singapore - englanti - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - rivaroxaban (micronized) - tablet, film coated - 20.00 mg - rivaroxaban (micronized) 20.00 mg

Singapore - englanti - HSA (Health Sciences Authority)

luye pharma (singapore) pte. ltd. - quetiapine fumarate 172.69mg eqv quetiapine - tablet, extended release - 150 mg - quetiapine fumarate 172.69mg eqv quetiapine 150 mg

Singapore - englanti - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - brinzolamide; timolol maleate 6.8mg/ml eqv timolol (as free base) - suspension, sterile - 10mg/ml - brinzolamide 10mg/ml; timolol maleate 6.8mg/ml eqv timolol (as free base) 5mg/ml

Uusi-Seelanti - englanti - Ministry for Primary Industries

elanco new zealand - doxapram hydrochloride - doxapram hydrochloride 20 g/litre - cns stimulant

Uusi-Seelanti - englanti - Ministry for Primary Industries

bayer new zealand limited - spiroxamine - emulsifiable concentrate - spiroxamine 500 g/litre - fungicide - fungicide

Yhdysvallat - englanti - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - methylphenidate hydrochloride extended-release capsules (cd) are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 15 years of age. methylphenidate hydrochloride extended-release capsules (cd) are contraindicated in patients with: - known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules (cd). angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules (cd). anaphylactic reactions have been reported in patients treated with other methylphenidate products [see adverse reactions (6)] . - concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crisis [see drug interactions (7)]. - methylphenidate hydrochloride extended-release capsules (cd) contain sucrose. therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride extended-release capsules (cd), during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388. risk summary published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations). no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adolescents on a mg/m2  basis. however, spina bifida was observed in rabbits at a dose 53 times the mrhd given to adolescents. a decrease in pup body weight was observed in a pre-and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the mrhd given to adolescents (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations fetal/neonatal adverse reactions cns stimulants, such as methylphenidate hydrochloride extended-release capsules (cd), can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. animal data in embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the mrhd of 60 mg/day given to adolescents on a mg/m2  basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the mrhd given to adolescents on a mg/m2  basis). there was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the mrhd of 60 mg/day given to adults on a mg/m2  basis), which was also maternally toxic. the no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the mrhd on a mg/m2  basis). when methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the mrhd of 60 mg/day given to adults on a mg/m2  basis), but no other effects on postnatal development were observed. the no effect level for pre-and postnatal development in rats was 15 mg/kg/day (~2 times the mrhd given to adolescents on a mg/m2  basis). risk summary limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride extended-release capsules (cd) and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release capsules (cd) or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of methylphenidate hydrochloride extended-release capsules (cd) for the treatment of adhd have been established in pediatric patients 6 to 15 years of age. the safety and effectiveness of methylphenidate hydrochloride extended-release capsules (cd) in pediatric patients younger than 6 years of age have not been established. long-term efficacy of methylphenidate hydrochloride extended-release capsules (cd) in pediatric patients have not been established. long-term suppression of growth growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended-release capsules (cd). pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.6)]. juvenile animal toxicity data . in a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the mrhd on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the mrhd on a mg/m2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the mrhd on a mg/m2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. methylphenidate hydrochloride extended-release capsules (cd) have not been studied in patients over the age of 65 years. methylphenidate hydrochloride extended-release capsules (cd) contain methylphenidate hydrochloride, a schedule ii controlled substance. cns stimulants, including methylphenidate hydrochloride extended-release capsules (cd), other methylphenidate-containing products, and amphetamines have a high potential for abuse. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physicological effect. drug addiction is a cluster of behavioral, cognitive, and psychological 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. both abuse and misuse may lead to addiction, and some individuals may develop addiction even when taking methylphenidate hydrochloride extended-release capsules (cd) as prescribed. signs and symptoms of cns stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or 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. individual who abuser cns stimulants may chew, snort, inject, or use other unapproved routes of administration which can result in overdose and death [see overdosage (10)].   to reduce the abuse of methylphenidate hydrochloride extended-release capsules (cd), assess the risk of abuse prior to prescribing. after prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of cns stimulants [see how supplied/storage and handling (16)] , monitor for signs of abuse while on therapy, and re-evaluate the need for methylphenidate hydrochloride extended-release capsule (cd) use. physical dependence methylphenidate hydrochloride extended-release capsules (cd) may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by a withdrawal signs and symptoms after abrupt discontinuation or significant dose reduction of a drug. withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of cns stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance methylphenidate hydrochloride extended-release capsules (cd) may produce tolerance from continued therapy. 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).

Yhdysvallat - englanti - NLM (National Library of Medicine)

kvk-tech, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 10 mg - methylphenidate hydrochloride extended-release tablets are indicated for the treatment of: • attention deficit hyperactivity disorders (adhd) in pediatric patients 6 years and older and adults • narcolepsy • hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release tablets. hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [see adverse reactions (6)] . • concomitant treatment with monoamine oxidase inhibitors (maois), or within 14 days following discontinuation of treatment with an maoi, because of the risk of hypertensive crises [see drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications, including methylphenidate hydrochloride extended-release tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for adhd medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/ risk summary published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there may be risks to the fetus associated with the use of cns stimulants use during pregnancy (see clinical considerations) . no effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adolescents on a mg/m2 basis. however, spina bifida was observed in rabbits at a dose 52 times the mrhd given to adolescents. a decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the mrhd given to adolescents (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations fetal/neonatal adverse reactions cns stimulants, such as methylphenidate hydrochloride extended-release tablets, can cause vasoconstriction and thereby decrease placental perfusion. no fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. data animal data in embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the mrhd of 60 mg/day given to adolescents on a mg/m 2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15times the mrhd given to adolescents on a mg/m 2 basis). there was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the mrhd of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic. the no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the mrhd on a mg/m 2 basis). when  methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the mrhd of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed. the no effect level for pre- and postnatal development in rats was 15 mg/kg/day (~2 times the mrhd given to adolescents on a mg/m 2 basis). risk summary limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7. there are no reports of adverse effects on the breastfed infant and no effects on milk production. long-term neurodevelopmental effects on infants from stimulant exposure are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride extended-release tablets and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride extended-release tablets or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. the safety and effectiveness of methylphenidate hydrochloride extended-release tablets for the treatment of adhd have been established in pediatric patients 6 to 17 years. the safety and effectiveness of methylphenidate hydrochloride extended-release tablets in pediatric patients less than 6 years have not been established. the long-term efficacy of methylphenidate hydrochloride extended-release tablets in pediatric patients has not been established. long-term suppression of growth growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride extended-release tablets. pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.7)] . juvenile animal toxicity data rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. a deficit in acquisition of a specific learning task was observed in females only. the doses at which these findings were observed are at least 4 times the mrhd of 60 mg/day given to children on a mg/m 2 basis. in a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal day 7) and continuing through sexual maturity (postnatal week 10). when these animals were tested as adults (postnatal weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 4 times the mrhd of 60 mg/day given to children on a mg/m 2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (8 times the mrhd given to children on a mg/m 2 basis). the no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the mrhd given to children on a mg/m 2 basis). the clinical significance of the long-term behavioral effects observed in rats is unknown. methylphenidate hydrochloride tablet has not been studied in the geriatric population. methylphenidate hydrochloride extended-release tablets contain methylphenidate hydrochloride, a schedule ii controlled substance. cns stimulants, including methylphenidate hydrochloride extended-release tablets, have a high potential for abuse. abuse is characterized by impaired control over drug use despite harm, and craving. signs and symptoms of cns stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or 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. abusers of cns stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see overdosage (10)] . to reduce the abuse of cns stimulants including methylphenidate hydrochloride extended-release tablets, assess the risk of abuse prior to prescribing. after prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of cns stimulants [see how supplied/storage and handling (16)] , monitor for signs of abuse while on therapy, and reevaluate the need for methylphenidate hydrochloride extended-release tablets use. tolerance tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug’s desired and/or undesired effects over time) can occur during chronic therapy with cns stimulants, including methylphenidate hydrochloride extended-release tablets. dependence physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with cns stimulants including methylphenidate hydrochloride extended-release tablets. withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of cns stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.