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

agprotect australasia pty ltd - glyphosate present as the isopropylamine salt - soluble concentrate - glyphosate present as the isopropylamine salt glycine active 450.0 g/l - herbicide

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

agprotect australasia pty ltd - alpha-cypermethrin; liquid hydrocarbon - emulsifiable concentrate - alpha-cypermethrin pyrethroid active 100.0 g/l; liquid hydrocarbon solvent other 735.0 g/l - herbicide

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

medi-physics, inc. dba ge healthcare - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - ceretec, when reconstituted with technetium tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ceretec, when reconstituted with technetium tc 99m exametazime (with or without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for cerebral scintigraphy as an adjunct in the detection of altered regional cerebral perfusion in stroke. none risk summary limited available data with technetium tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks for major birth defects and miscarriage. technetium tc 99m exametazime is transferred across the placenta [see data]. animal reproduction studies with technetium tc 99m exametazime have not been conducted. however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering technetium tc 99m exametazime administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium tc 99m exametazime and the gestational timing of exposure. 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 2-4% and 15-20%, respectively. data human data limited published literature describes tc 99m exametazime crossing the placental barrier and visualization of radioactivity in the fetal liver. no adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mgy, which represents less than 10 mgy fetal doses. risk summary there are limited data available in the scientific literature on the presence of technetium tc 99m exametazime in human milk. there are no data available regarding the effects of technetium tc 99m exametazime on the breastfed infant or on milk production. exposure of technetium tc 99m exametazime to a breast fed infant can be minimized by temporary discontinuation of breastfeeding [see clinical considerations ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ceretec and any potential adverse effects on the breastfed child from ceretec or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration of technetium tc 99m exametazime injection or technetium tc 99m exametazime-labeled leukocytes for 12 to 24 hours, where the duration corresponds to the typical range of administered activity, 259 mbq to 925 mbq (7 mci to 25 mci). ceretec is indicated for use in pediatric patients from 2 to 17 years of age for leukocyte labelled scintigraphy and brain scintigraphy. the use of ceretec for leukocyte labelled scintigraphy and brain scintigraphy is supported by extrapolation from clinical effectiveness in adults. the safety and dosing recommendations are based on clinical experience. safety and effectiveness in pediatric patients less than 2 years of age have not been established. clinical studies of ceretec did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and radiation exposure may be greater in patients with impaired renal function. a reduction in administered tc 99m can be considered provided an adequate number of leukocytes are administered.

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

bryant ranch prepack - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies  (14)]. sprintec is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.4)] have diabetes mellitus with vascular disease [see warnings and precautions (5.6)] have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] - have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] - have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] - have cerebrovascular disease [see warnings and precautions (5.1)] - have coronary artery disease [see warnings and precautions (5.1)] - have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] - have uncontrolled hypertension [see warnings and precautions (5.4)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.6)] - have headaches with focal neurological symptoms or migraine headaches with aura [see warnings and precautions (5.7)] women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - women over age 35 with any migraine headaches [see warnings and precautions (5.7)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.2)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.8)] - pregnancy, because there is no reason to use cocs during pregnancy [see warnings and precautions (5.9) and use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.11)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.3)] there is little or no increased risk of birth defects in women who inadvertently use cocs during early pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose cocs prior to conception or during early pregnancy. do not administer cocs to induce withdrawal bleeding as a test for pregnancy. do not use cocs during pregnancy to treat threatened or habitual abortion. advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. cocs can reduce milk production in breastfeeding mothers. this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of sprintec tablets have been established in women of reproductive age. efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. sprintec has not been studied in postmenopausal women and are not indicated in this population. the pharmacokinetics of sprintec have not been studied in subjects with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with hepatic impairment. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal and coc causation has been excluded. [see contraindications (4) and warnings and precautions (5.2).] the pharmacokinetics of sprintec have not been studied in women with renal impairment.

Israel - English - Ministry of Health

gilead sciences israel ltd - anti-cd19 car t cells - dispersion for infusion - anti-cd19 car t cells - acute lymphoblastic leukaemia tecartus is indicated for the treatment of adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).mantle cell lymphoma tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton's tyrosine kinase (btk) inhibitor unless ineligible to btk inhibitor •limitation of use : tecartus is not indicated for the treatment of patients with active central nervous system lymphoma

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

oztec rural pty limited - permethrin (25:75::cis:trans); liquid hydrocarbon - emulsifiable concentrate - permethrin (25:75::cis:trans) pyrethroid active 100.0 g/l; liquid hydrocarbon solvent other 750.0 g/l - household insecticide - amenity area | fabric (cotton) - repellant treatment | home garden use - general | lawn | mosquito nets - repellant treatment | - ant | auger beetle | bed bug | biting fly | carpet pest | cockroach | flea | flying insect | furniture beetle | lawn armyworm | mosquito | pinhole borer | powderpost beetle | silverfish | spider | subterranean termite - coptotermes spp. | adult mosquitoes | argentine ant | bedbug | ctenocephalides spp. | flies | grass grub | ground fleas | large cockroach | lawn caterpillar | mosquitoes | moths | pharaoh ant | platypodiae | small cockroach

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

oztec rural pty limited - permethrin (25:75::cis:trans) - dust - permethrin (25:75::cis:trans) pyrethroid active 10.0 g/kg - insecticide - commercial/industrial premises | domestic and/or public area | hide and skin preparation pest control | mushroom bed | pest c. i - ant | bed bug | cockroach | european wasp | flea | hide or skin beetle | mushroom or sciarid fly | potato moth | silverfish | 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)

oztec rural pty limited - brodifacoum - bait - brodifacoum coumarin active 0.05 g/kg - vertebrate poison - agricultural/farm buildings | commercial/industrial premises | domestic and/or public area | industrial and/or domestic premises - mouse - mus spp. | rat

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

oztec rural pty ltd - chlorpyrifos; liquid hydrocarbon - emulsifiable concentrate - chlorpyrifos organophosphorus active 500.0 g/l; liquid hydrocarbon solvent other 480.0 g/l - insecticide

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

oztec rural pty limited - metaldehyde - bait - metaldehyde aldehyde active 15.0 g/kg - molluscicide - around plants and/or border areas - common slug | snail | bradybaena similaris | deroceras caruanae | helix aspersa | sigmurethra | theba pisana