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

oz crop pty ltd - imazapyr - water soluble granules - imazapyr imidazolinone active 750.0 g/kg - herbicide

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

oz crop pty ltd - picloram present as the hexyloxypropylamine salt; triclopyr present as the butoxyethyl ester - emulsifiable concentrate - picloram present as the hexyloxypropylamine salt anilide/aniline-pyrimidine active 100.0 g/l; triclopyr present as the butoxyethyl ester pyridine-pyridinoxy active 300.0 g/l - herbicide

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

waverley pharma inc - pemetrexed disodium heptahydrate (unii: 9t47e4om16) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous nsclc, with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (nsclc). - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use: pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies 14.1]. pemetrexed for injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. pemetrexed for injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see adverse reactions (6.1)]. risk summary based on findings from animal studies and its mechanism of action, pemetrexed for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on pemetrexed for injection use in pregnant women. in animal reproduction studies, intravenous administration of pemetrexed to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and malformations at doses lower than the recommended human dose of 500 mg/m2 [see data] . advise pregnant women of the potential risk to a fetus [see use in special populations (8.3)] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data pemetrexed was teratogenic in mice. daily dosing of pemetrexed by intravenous injection to pregnant mice during the period of organogenesis increased the incidence of fetal malformations (cleft palate; protruding tongue; enlarged or misshaped kidney; and fused lumbar vertebra) at doses (based on bsa) 0.03 times the human dose of 500 mg/m2 . at doses, based on bsa, greater than or equal to 0.0012 times the 500 mg/m2 human dose, pemetrexed administration resulted in dose-dependent increases in developmental delays (incomplete ossification of talus and skull bone; and decreased fetal weight). risk summary there is no information regarding the presence of pemetrexed or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in breastfed infants from pemetrexed for injection, advise women not to breastfeed during treatment with pemetrexed for injection and for one week after last dose. contraception females pemetrexed for injection can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with pemetrexed for injection for at least 6 months after the final dose of pemetrexed for injection. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with pemetrexed for injection and for 3 months after the final dose [see nonclinical toxicology (13.1)] . infertility males pemetrexed for injection may impair fertility in males of reproductive potential. it is not known whether these effects on fertility are reversible [see nonclinical toxicology (13.1)] . the safety and effectiveness of pemetrexed for injection in pediatric patients have not been established. the safety and pharmacokinetics of pemetrexed for injection were evaluated in two clinical studies conducted in pediatric patients with recurrent solid tumors. pemetrexed for injection was administered at doses ranging from 400 to 2480 mg/m2 intravenously over 10 minutes on day 1 of a 21-day cycle to 32 pediatric patients with recurrent solid tumors in a dose-finding study. the maximum tolerated dose (mtd) was determined to be 1910 mg/m2 (60 mg/kg for patients <12 months old). pemetrexed for injection was administered at the mtd every 21 days in an activity-estimating study enrolling 72 patients with relapsed or refractory osteosarcoma, ewing sarcoma/peripheral primitive neural ectodermal tumor (pnet), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial pnet, or non-brainstem high grade glioma. patients in both studies received concomitant vitamin b12 and folic acid supplementation and dexamethasone. no tumor responses were observed. adverse reactions observed in pediatric patients were similar to those observed in adults. single-dose pharmacokinetics of pemetrexed for injection administered at doses ranging from 400 to 2480 mg/m2 were evaluated in 22 patients (13 males and 9 females) age 4 to 18 years (average age 12 years). pemetrexed exposure (auc and cmax ) appeared to increase proportionally with dose. average clearance (2.30 l/h/m2 ) and half-life (2.3 hours) were similar in pediatric patients compared to adults. of the 3,946 patients enrolled in clinical studies of pemetrexed for injection, 34% were 65 and over and 4% were 75 and over. no overall differences in effectiveness were observed between these patients and younger patients. the incidences of grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials. [see adverse reactions (6.1) and clinical studies (14.1, 14.2)]. pemetrexed for injection is primarily excreted by the kidneys. decreased renal function results in reduced clearance and greater exposure (auc) to pemetrexed for injection compared with patients with normal renal function [warnings and precautions (5.2, 5.6) and clinical pharmacology (12.3)] . no dose is recommended for patients with creatinine clearance less than 45 ml/min [see dosage and administration (2.3)].

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

shiseido (australia) pty ltd - octyl methoxycinnamate,titanium dioxide -

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

shiseido (australia) pty ltd - octyl methoxycinnamate,titanium dioxide -

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

oz crop pty ltd - epoxiconazole - suspension concentrate - epoxiconazole ungrouped active 125.0 g/l - fungicide - barley | wheat - leaf rust | leaf rust - puccinia hordei | septoria nodorum blotch on wheat | stripe rust | puccinia recondita f.sp. triti | puccinia triticina | wheat leaf rust | yellow rust

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

oz crop pty ltd - imidacloprid - suspension concentrate - imidacloprid guanidine active 350.0 g/l - insecticide - capsicum or pepper | cucurbit | eggplant | sugar cane - ratoon crop | sweet potato | tomato | cantaloupe | choko | cucumber | gh - childers canegrub | greyback canegrub | silverleaf whitefly | bemisia tabaci (biotype b) | cotton whitefly | poinsettia whitefly

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

oz crop pty ltd - cloquintocet-mexyl; clodinafop; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - cloquintocet-mexyl acetate active 60.0 g/l; clodinafop acid active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 100.0 g/l; liquid hydrocarbon solvent other 575.0 g/l - herbicide - wheat - see label for exceptions - annual ryegrass | canary grass | paradoxa grass | wild oat | annual phalaris | canary grass

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

oz crop pty ltd - soyal phospholipids; propionic acid - dispersible concentrate - soyal phospholipids ungrouped active 350.0 g/l; propionic acid acid-general active 350.0 g/l - surfactant - agricultural chemical additive | herbicide additive | wetting agent | activator | penetrant | post emergent herbicide | spray ac - reduce alkaline hydrolysis | tank mixing | wetting agent (use as directed) | additive | agricultural chemical | herbicide | improve penetrating properties | minimise antagonism | spray tank

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

oz crop pty ltd - alpha-cypermethrin; liquid hydrocarbon - emulsifiable concentrate - alpha-cypermethrin pyrethroid active 100.0 g/l; liquid hydrocarbon solvent other 741.9 g/l - insecticide - apple | apricot | asparagus - except white asparagus | banksia | broccoli | brussels sprouts | cabbage | canola | cauliflower | - aphid control-prevent virus transmission | apple dimpling bug - c. liebknechti | apple weevil | autumn gum moth | banksia moth - danima banksiae | blackheaded pasture cockchafer | blue oat or pea mite | bronzed field beetle | brown pasture looper | cabbage moth | cabbage white butterfly | cadmus spp. | cluster caterpillar | common armyworm - mythimna convecta | corn earworm | cotton budworm or bollworm | cutworm - agrotis spp. | eucalyptus leaf beetle | eucalyptus weevil | garden or south african vine weevil | green mirid bug | grey cluster bug | helicoverpa spp. | liparetrus spp. - adults | native budworm or bollworm | pasture webworm - hednota spp. | pea weevil | pink or brown cutworm | plague thrips | redlegged earth mite | rice bloodworm | rough bollworm | rutherglen bug | sorghum midge | southern or barley armyworm | staphylinid beetle | tobacco budworm | tobacco looper or looper caterpillar | tomato grub | vegetable weevil | wingless grasshopper | acrossidius tasmaniae | barley armyworm | barley grub |