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

lupin pharmaceuticals, inc. - lapatinib ditosylate (unii: g873gx646r) (lapatinib - unii:0vua21238f) - lapatinib is a kinase inhibitor indicated in combination with: (1) - capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (her2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab.        limitations of use: patients should have disease progression on trastuzumab prior to initiation of treatment with  lapatinib tablets  in combination with capecetabine. - letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the her2 receptor for whom hormonal therapy is indicated. lapatinib tablets in combination with an aromatase inhibitor have not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. lapatinib tablets are contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components. risk summary based on findings in animal studies and its mechanism of action, lapatinib tablets can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no available human data to inform of the drug-associated risks. in an animal reproduction study, administration of lapatinib to pregnant rats during organogenesis and through lactation led to death of offspring within the first 4 days after birth at maternal exposures that were ≥ 3.3 times the human clinical exposure based on auc following 1,250 mg dose of lapatinib plus capecitabine. when administered to pregnant animals during the period of organogenesis, lapatinib caused fetal anomalies (rats) or abortions (rabbits) at maternally toxic doses. (see data) advise pregnant women and females of reproductive potential of the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of lapatinib at 30, 60, and 120 mg/kg/day during the period of organogenesis. minor anomalies (left-sided umbilical artery, cervical rib, and precocious ossification) occurred in rats at the maternally toxic dose of 120 mg/kg/day (approximately 6.4 times the human clinical exposure based on auc following 1,250 mg dose of lapatinib plus capecitabine). in rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (approximately 0.07 and 0.2 times the human clinical exposure, respectively, based on auc following 1,250 mg dose of lapatinib plus capecitabine) and abortions at 120 mg/kg/day. maternal toxicity was associated with decreased fetal body weights and minor skeletal variations. in a pre- and post-natal development study, rats were given oral doses of 20, 60, and 120 mg/kg/day during gestation through lactation up to weaning. in rats, doses of 60 and 120 mg/kg/day (approximately 3.3 and 6.4 times the human clinical exposure, respectively, based on auc following 1,250 mg dose of lapatinib plus capecitabine) led to decrease in f1 postnatal survival (91% and 34% of the pups died by the fourth day after birth, at 60 and 120 mg/kg/day, respectively). risk summary there are no data on the presence of lapatinib in human milk, or its effects on the breastfed child, or milk production. because of the potential for serious adverse reactions in a breastfed child from lapatinib tablets, advise lactating women not to breastfeed during treatment with lapatinib tablets and for 1 week after the last dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of lapatinib tablets. contraception females based on findings in animal studies, lapatinib tablets can cause fetal harm when administered to a pregnant woman[see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with lapatinib tablets and for 1 week after the last dose. males based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with lapatinib tablets and for 1 week after the last dose[see use in specific populations (8.1)]. the safety and effectiveness of lapatinib tablets in pediatric patients have not been established of the total number of metastatic breast cancer patients in clinical studies of lapatinib tablets in combination with capecitabine (n = 198), 17% were 65 years of age and older, and 1% were 75 years of age and older. of the total number of hormone receptor-positive, her2-positive  metastatic breast cancer patients in clinical studies of lapatinib tablets in combination with letrozole  (n = 642), 44% were 65 years of age and older, and 12% were 75 years of age and older. no overall differences in safety or effectiveness were observed between elderly 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. lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing hemodialysis. there is no experience with lapatinib tablets in patients with severe renal impairment. however, renal impairment is unlikely to affect the pharmacokinetics of lapatinib given that less than 2% (lapatinib and metabolites) of an administered dose is eliminated by the kidneys. the pharmacokinetics of lapatinib were examined in subjects with pre-existing moderate (n = 8) or severe (n = 4) hepatic impairment (child-pugh class b/c, respectively) and in 8 healthy control subjects. systemic exposure (auc) to lapatinib after a single oral 100-mg dose increased approximately 14% and 63% in subjects with moderate and severe preexisting hepatic impairment, respectively. administration of lapatinib tablets in patients with severe hepatic impairment should be undertaken with caution due to increased exposure to the drug. a dose reduction should be considered for patients with severe preexisting hepatic impairment [see dosage and administration (2.2)] . in patients who develop severe hepatotoxicity while on therapy, lapatinib tablets should be discontinued and patients should not be retreated with lapatinib tablets [see warnings and precautions (5.2)] .

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - lapatinib ditosilate monohydrate, quantity: 405 mg (equivalent: lapatinib, qty 250 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - human epidermal growth factor receptor 2 positive (her2+) over expressing advanced or metastatic breast cancer,tykerb is indicated in combination with:,? an aromatase inhibitor for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) (epidermal growth factor receptor 2) and for whom hormonal therapy is indicated.,? capecitabine for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting.,? paclitaxel for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate (see section 5.1 pharmacodynamic properties - clinical trials).

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

arysta lifescience australia pty ltd - abamectin; n-methylpyrrolidone; liquid hydrocarbon - emulsifiable concentrate - abamectin anthelmintic active 18.0 g/l; n-methylpyrrolidone solvent other 266.0 g/l; liquid hydrocarbon solvent other 60.0 g/l - insecticide - apple | carnation | chrysanthemum or tanacetum | citrus | cotton | hops | indoor foliage plant | ornamental | pear | rose | stra - broad mite | brown citrus rust mite | carmine mite | citrus rust mite or maori mite | european red mite | native budworm or bollworm | tobacco leafminer | tomato russet mite | brown citrus mite | carmine spider mite | citrus rust mites | heliothis | hemitarsonemus latus | native bollworm | potato moth | potato tuber moth | red spider mite | rust mite | spider mite | tetranychus australis | tetranychus crataegi | tetranychus marilandica | tetranychus viennensis | tomato mite (47236) | two-spotted mite | two-spotted spider mite

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

novartis pharmaceuticals corporation - lapatinib ditosylate (unii: g873gx646r) (lapatinib - unii:0vua21238f) - lapatinib 250 mg - tykerb® is indicated in combination with: - capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (her2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. limitations of use : patients should have disease progression on trastuzumab prior to initiation of treatment with tykerb in combination with capecitabine. - letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the her2 receptor for whom hormonal therapy is indicated. tykerb in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. tykerb is contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components. risk summary based on findings in animal studies and its mechanism of action, tykerb can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available human data to inform of the drug-associated risks. in an animal reproduction study, administration of lapatinib to pregnant rats during organogenesis and through lactation led to death of offspring within the first 4 days after birth at maternal exposures that were ≥ 3.3 times the human clinical exposure based on auc following 1,250 mg dose of lapatinib plus capecitabine. when administered to pregnant animals during the period of organogenesis, lapatinib caused fetal anomalies (rats) or abortions (rabbits) at maternally toxic doses (see data) . advise pregnant women and females of reproductive potential of the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of lapatinib at 30, 60, and 120 mg/kg/day during the period of organogenesis. minor anomalies (left-sided umbilical artery, cervical rib, and precocious ossification) occurred in rats at the maternally toxic dose of 120 mg/kg/day (approximately 6.4 times the human clinical exposure based on auc following 1,250 mg dose of lapatinib plus capecitabine). in rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (approximately 0.07 and 0.2 times the human clinical exposure, respectively, based on auc following 1,250 mg dose of lapatinib plus capecitabine) and abortions at 120 mg/kg/day. maternal toxicity was associated with decreased fetal body weights and minor skeletal variations. in a pre- and post-natal development study, rats were given oral doses of 20, 60, and 120 mg/kg/day during gestation through lactation up to weaning. in rats, doses of 60 and 120 mg/kg/day (approximately 3.3 and 6.4 times the human clinical exposure, respectively, based on auc following 1,250 mg dose of lapatinib plus capecitabine) led to decrease in f1 postnatal survival (91% and 34% of the pups died by the fourth day after birth, at 60 and 120 mg/kg/day, respectively). risk summary there are no data on the presence of lapatinib in human milk, or its effects on the breastfed child, or milk production. because of the potential for serious adverse reactions in a breastfed child from tykerb, advise lactating women not to breastfeed during treatment with tykerb and for 1 week after the last dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to the initiation of tykerb. contraception females based on findings in animal studies, tykerb can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with tykerb and for 1 week after the last dose. males based on findings in animal reproduction studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment with tykerb and for 1 week after the last dose [see use in specific populations (8.1)] . the safety and effectiveness of tykerb in pediatric patients have not been established. of the total number of metastatic breast cancer patients in clinical studies of tykerb in combination with capecitabine (n = 198), 17% were 65 years of age and older, and 1% were 75 years of age and older. of the total number of hormone receptor-positive, her2-positive metastatic breast cancer patients in clinical studies of tykerb in combination with letrozole (n = 642), 44% were 65 years of age and older, and 12% were 75 years of age and older. no overall differences in safety or effectiveness were observed between elderly 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. lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing hemodialysis. there is no experience with tykerb in patients with severe renal impairment. however, renal impairment is unlikely to affect the pharmacokinetics of lapatinib given that less than 2% (lapatinib and metabolites) of an administered dose is eliminated by the kidneys. the pharmacokinetics of lapatinib were examined in subjects with preexisting moderate (n = 8) or severe (n = 4) hepatic impairment (child-pugh class b/c, respectively) and in 8 healthy control subjects. systemic exposure (auc) to lapatinib after a single oral 100 mg dose increased approximately 14% and 63% in subjects with moderate and severe preexisting hepatic impairment, respectively. administration of tykerb in patients with severe hepatic impairment should be undertaken with caution due to increased exposure to the drug. a dose reduction should be considered for patients with severe preexisting hepatic impairment [see dosage and administration (2.2)] . in patients who develop severe hepatotoxicity while on therapy, tykerb should be discontinued and patients should not be retreated with tykerb [see warnings and precautions (5.2)] .

Malta - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - film-coated tablet - lapatinib 250 mg - antineoplastic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - lapatinib ditosilate monohydrate, quantity: 405 mg (equivalent: lapatinib, qty 250 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - human epidermal growth factor receptor 2 positive (her2+) over expressing advanced or metastatic breast cancer,tykerb is indicated in combination with:,? an aromatase inhibitor for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) (epidermal growth factor receptor 2) and for whom hormonal therapy is indicated.,? capecitabine for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting.,? paclitaxel for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate (see section 5.1 pharmacodynamic properties - clinical trials). tykerb, in combination with capecitabine, is indicated for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline, a taxane and trastuzumab.

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

arysta lifescience australia pty ltd - simazine - water dispersible granule - simazine triazine active 900.0 g/kg - herbicide - almond | apple | asparagus | berry fruit | canola - tt only - post sowing, pre emer | chickpea | citrus | corymbia spp. | dam | - amaranth or amaranthus | amaranthus - pre emergence | annual ryegrass | annual ryegrass - suppression | annual thistle | annual weeds - see label | barley grass | barley grass - suppression | barnyard or water grass | bindy-eye | black bindweed - suppression | blue-green algae - phormidium spp. | broadleaf weeds - pre emergence | brome grass | brome grass - suppression | capeweed | cereal - self-sown | charlock | chickweed | clover | corn gromwell, ironweed or sheepweed | creeping oxalis | deadnettle | dock | dock - suppression | doublegee - suppression | fat hen | fumitory | geranium | indian hedge mustard | ivy leaf speedwell | lesser swinecress or bittercress | london rocket | medic | mustard | native geranium | nettle | paradoxa grass | paradoxa grass - suppression | paterson's curse | potato or yellow weed | prickly lettuce | purple goosefoot | radish | redshank | ryegrass - suppression | saffron thistle | sand fescue | shepherd's purse | silver grass or rat's-tail fescue | silvergrass - vulpia spp. | so

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

arysta lifescience australia pty ltd - mcpa present as the 2-ethyl hexyl ester - emulsifiable concentrate - mcpa present as the 2-ethyl hexyl ester phenoxy acids-mcpa-ester active 570.0 g/l - herbicide - barley | cereal rye | cereal rye - up to early flag leaf only | grass pasture | grass seed crop | oats | triticale | wheat | whe - bathurst burr | capeweed | charlock | dandelion - taraxacum officinale | fat hen | fumitory | hedge or wild mustard | lincoln weed, sand rocket or mustard | london rocket | noogoora burr | paterson's curse | saffron thistle | scotch thistle | skeleton weed | slender or shore thistle - suppression | spear or black thistle | stinkwort | turnip weed | variegated thistle | volunteer canola | volunteer safflower | volunteer sunflower | wild radish or radish weed | wild sage | wild turnip | blessed thistle | brassica campestris | brassica kaber | brassica rapa ssp. sylvestris | brassica rapa var. sylvestris | brassica sinapistrum | bull thistle | cabbage thistle | carduus marianus | cockleburr | common dandelion | cotton thistle | crambling mustard | echium lycopsis | echium spp. | english dandelion | european dandelion | false star thistle | giant mustard | hedge mustard | heraldic thistle | holy thistle | jointed charlock | lady's thistle | milk thistle | pink weed | purple bugloss | purple viper's bugloss | radi

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

arysta lifescience australia pty ltd - fluroxypyr as the methyl heptyl ester; liquid hydrocarbon - emulsifiable concentrate - fluroxypyr as the methyl heptyl ester pyridine-pyridinoxy active 200.0 g/l; liquid hydrocarbon solvent other 586.0 g/l - herbicide - aerial spraying | agricultural non-crop areas | basal bark | broadcast application | commercial/industrial land | forest | grass - amaranth or amaranthus | annual ground cherry | anoda weed | apple-of-peru | balsam pear | bathurst burr | bedstraw | bellvine | bellyache bush | bittercress or swinecress | black bindweed | black nightshade | blackberry nightshade | bladder ketmia | blue billygoat weed | blue heliotrope or blue top | boggabri weed | bokhara clover | broadleaf pepper tree | caltrop or yellow vine | centro | chinee apple | chinese celtis | cleavers | cobbler's pegs | cockspur thorn | common sensitive plant | cowpea | cowvine | deadnettle | dock | dwarf amaranth or boggabri weed | flannel weed | fumitory | giant or black pigweed | giant sensitive plant | green amaranth | hairy wandering jew | honey locust | lablab bean | lantana spp. | limebush | madeira vine | marsh or smallflower mallow | melilotus or hexham scent | milkweed | mimosa bush | mimosa pigra | mintweed | mistflower or creeping crofton weed | morning glory - ipomoea spp. | mother-of-millions | mustard | noogoora burr | perennial ground cherry | perennial pigweed |

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

arysta lifescience australia pty ltd - atrazine - water dispersible granule - atrazine triazine active 900.0 g/kg - herbicide - broom millet - dryland | broom millet - irrigated | canola - tt only - post sowing, pre emer | canola-triazine tolerant only-pos - amaranth or amaranthus | annual grass weed - suppression | annual ground cherry | annual or wimmera ryegrass - seedling | annual ryegrass - suppression | barley grass | barley grass - suppression | barnyard or water grass | bellvine | billygoat weed or blue top | black bindweed | blackberry nightshade | bladder ketmia | borreria | broadleaf weeds | broadleaf weeds - see label | broadleaf weeds and grasses | brome grass - bromus unioloides | brome grass - suppression | budda or butter pea | burr | caltrop or yellow vine | capeweed | charlock | clover | cobbler's pegs | common sida | common thornapple | corn gromwell, ironweed or sheepweed | crowsfoot grass | dock | dwarf marigold | fat hen | flannel weed - sida cordifolia | fleabane | fumitory | geranium | giant or black pigweed | giant sensitive plant | ivy leaf speedwell | london rocket | loosestrife | lovegrass | medic | mexican or prickly poppy | mintweed | mouse-ear chickweed | mustard | noogoora burr | paddy melon | parthenium weed | paterson's curse | p