Israel - English - Ministry of Health

lapidot medical import and marketing ltd - lidocaine hydrochloride monohydrate - solution for injection - lidocaine hydrochloride monohydrate 20 mg/ml - lidocaine - local and regional anaesthesia.severe symptomatic ventricular tachycardia or tachy-arrhythmia, if assessed to be life-threatening.

Israel - English - Ministry of Health

abic marketing ltd, israel - lorcaserin hydrochloride hemihydrate - film coated tablets - lorcaserin hydrochloride hemihydrate 10.4 mg - lorcaserin - belviq is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (bmi) of:• 30 kg/m2 or greater (obese), or • 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

fmc australasia pty ltd - permethrin (40:60::cis:trans) - dust - permethrin (40:60::cis:trans) pyrethroid active 20.0 g/kg - insecticide - crawl spaces | floor void | food preparation and/or storage area | hide and skin preparation pest control | industrial and/or do - ant | bed bug | bird mite | cockroach | european wasp | flea | hide or skin beetle | mushroom or sciarid fly | potato moth | silverfish | spider | subterranean termite - coptotermes spp. | argentine ant | bedbug | ctenocephalides spp. | dermestes ater | dermestes maculatus | ground fleas | large cockroach | pharaoh ant | potato tuber moth | small cockroach | tobacco leafminer

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ensystex australasia pty ltd - permethrin - dust - permethrin pyrethroid active 10.0 g/kg - insecticide - domestic premises | european wasp - nest | food preparation area | food storage area | indoor domestic area | living area | outd - ant | bed bug | carpet beetle | cockroach | european wasp | flea | silverfish | argentine ant | bedbug | ctenocephalides spp. | ground fleas | large cockroach | pharaoh ant | small cockroach

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

edw pharma, inc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - tiglutik is indicated for the treatment of amyotrophic lateral sclerosis (als). tiglutik is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)]. risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated with use of tiglutik during pregnancy. data animal data oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose. the mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (rhdd, 100 mg) on a mg/m2 basis. when riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. the no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the rhdd on a mg/m2 basis. maternal toxicity was observed at the highest dose tested in rat and rabbit. when riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. the mid dose, a no-effect dose for pre- and postnatal developmental toxicity, is approximately equal to the rhdd on a mg/m2 basis. risk summary there are no data on the presence of riluzole in human milk, the effects on the breastfed infant, or the effects on milk production. riluzole or its metabolites have been detected in milk of lactating rat. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tiglutik and any potential adverse effects on the breastfed infant from tiglutik or from the underlying maternal condition. in rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see nonclinical toxicology (13.1)]. safety and effectiveness in pediatric patients have not been established. in clinical studies of riluzole, 30% of patients were 65 years and over. no overall differences in safety or effectiveness were observed between these patients and younger patients, and 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. patients with mild [child-pugh's (cp) score a] or moderate (cp score b) hepatic impairment had increases in auc, compared to patients with normal hepatic function. thus, patients with mild or moderate hepatic impairment may be at increased risk of adverse reactions. the impact of severe hepatic impairment on riluzole exposure is unknown. use of tiglutik is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [see clinical pharmacology (12.3)]. japanese patients are more likely to have higher riluzole concentrations. consequently, the risk of adverse reactions may be greater in japanese patients [see clinical pharmacology (12.3)].

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

avkare - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions ( 6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated with use of riluzole during pregnancy. data animal data oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose. the mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (rhdd, 100 mg) on a mg/m 2 basis. when riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. the no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the rhdd on a mg/m 2 basis. maternal toxicity was observed at the highest dose tested in rat and rabbit. when riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. the mid dose, a no-effect dose for pre-and postnatal developmental toxicity, is approximately equal to the rhdd on a mg/m 2 basis. risk summary it is not known if riluzole is excreted in human milk. riluzole or its metabolites have been detected in milk of lactating rat. women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown. in rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see nonclinical toxicology ( 13.1)] . safety and effectiveness of riluzole tablets in pediatric patients have not been established. in clinical studies of riluzole tablets, 30% of patients were 65 years and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and 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. patients with mild [child-pugh's (cp) score a] or moderate (cp score b) hepatic impairment had increases in auc compared to patients with normal hepatic function. thus, patients with mild or moderate hepatic impairment may be at increased of adverse reactions. the impact of severe hepatic impairment on riluzole exposure is unknown. use of riluzole tablets is not recommended in patients with baseline elevation of elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [clinical pharmacology ( 12.3)] . japanese patients are more likely to have higher riluzole concentrations. consequently, the risk of adverse reactions may be greater in japanese patients [see clinical pharmacology ( 12.3)] .

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

ascend laboratories, llc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole is indicated for the treatment of amyotrophic lateral sclerosis (als).  riluzole is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated wi

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

rising pharmaceuticals, inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole is indicated for the treatment of amyotrophic lateral sclerosis (als) riluzole is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)]. risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated wit

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

american health packaging - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions ( 6.1)]. risk summary there are no studies of riluzole tablets in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a pos

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

glenmark pharmaceuticals inc., usa - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)]. risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data]. based on these results, women should be advised of a possible risk to the fetus associated with use of riluzole during pregnancy. data risk summary it is not known if riluzole is excreted in human milk. riluzole or its metabolites have been detected in milk of lactating rats. women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown. in rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see nonclinical toxicology (13.1)]. safety and effectiveness of riluzole in pediatric patients have not been established. in clinical studies of riluzole, 30% of patients were 65 years and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and 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. patients with mild [child-pugh’s (cp) score a] or moderate (cp score b) hepatic impairment had increases in auc compared to patients with normal hepatic function. thus, patients with mild or moderate hepatic impairment may be at increased risk of adverse reactions. the impact of severe hepatic impairment on riluzole exposure is unknown. use of riluzole is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [clinical pharmacology (12.3)]. japanese patients are more likely to have higher riluzole concentrations. consequently, the risk of adverse reactions may be greater in japanese patients [see clinical pharmacology (12.3)].