Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

upl australia pty ltd - diuron - water dispersible granule - diuron urea-substituted active 900.0 g/kg - herbicide - asparagus | barley | bore drain weed control | cotton | drainage ditch | irrigation channel | lupin | oats | sugar cane | wheat - amaranth or amaranthus | amsinckia,yellow burrweed or burr grass | annual broadleaf weed | annual grass weed | annual or wimmera ryegrass | barley grass | barnyard grass or water grass | broadleaf weeds - see label | capeweed | charlock | clover | cobbler's pegs | common iceplant | corn gromwell, ironweed or sheepweed | crowsfoot grass | deadnettle | fat hen | guinea grass | hedge or wild mustard | london rocket | medic | melilotus or hexham scent | mimosa bush | mustard | perennial grass weed | perennial pigweed | poppy | prickly acacia | prince of wales feather | ryegrass | saffron thistle | soursob or oxalis | sow or milk thistle | spiny emex | summer or crab grass | three cornered jack or doublegee | turnip weed | volunteer turnip | wild or black oat | wild radish or radish weed | wild turnip | african wood sorrel | amaranthus cruentus | amaranthus powellii | amaranthus viridis | amsinckia angustifolia | amsinckia calycina | amsinckia hispida | amsinckia intermedia | amsinckia lycopsoides | annual grasses

Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

upl australia pty ltd - diuron - wettable powder - diuron urea-substituted active 800.0 g/kg - herbicide - asparagus | barley | bore drain weed control | cotton | lupin | oats | sugar cane | wheat | direct seeded | established in beds - amaranth or amaranthus | amsinckia,yellow burrweed or burr grass | annual broadleaf weed | annual grass weed | annual or wimmera ryegrass | barley grass | barnyard grass or water grass | capeweed | charlock | clover | cobbler's pegs | common iceplant | corn gromwell, ironweed or sheepweed | crowsfoot grass | deadnettle | fat hen | guinea grass | hedge or wild mustard | london rocket | medic | melilotus or hexham scent | mimosa bush | mustard | perennial pigweed | poppy | prickly acacia | prince of wales feather | ryegrass | saffron thistle | soursob or oxalis | sow or milk thistle | summer or crab grass | three cornered jack or doublegee | turnip weed | wild or black oat | wild radish or radish weed | wild turnip | african wood sorrel | amaranthus cruentus | amaranthus powellii | amaranthus viridis | amsinckia angustifolia | amsinckia calycina | amsinckia hispida | amsinckia intermedia | amsinckia lycopsoides | annual grasses | annual medic | annual summer grass | bermuda buttercup | brassica campestris | bra

Nemecko - nemčina - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

biologische heilmittel heel gmbh (3061574) - acidum thiocticum (pot.-angaben); arnica montana (pot.-angaben); cartilago articularis suis (pot.-angaben); coenzym a (pot.-angaben); embryo totalis suis (pot.-angaben); funiculus umbilicalis suis (pot.-angaben); nadidum (pot.-angaben); natrium diethyloxalaceticum (pot.-angaben); placenta suis (pot.-angaben); rhus toxicodendron (pot.-angaben); sanguinaria canadensis (pot.-angaben); solanum dulcamara (pot.-angaben); sulfur (pot.-angaben); symphytum officinale (pot.-angaben) - tablette - acidum thiocticum (pot.-angaben) (15080) 10 milligramm; arnica montana (pot.-angaben) (01798) 60 milligramm; cartilago articularis suis (pot.-angaben) (13587) 15 milligramm; coenzym a (pot.-angaben) (13802) 10 milligramm; embryo totalis suis (pot.-angaben) (13552) 15 milligramm; funiculus umbilicalis suis (pot.-angaben) (13559) 15 milligramm; nadidum (pot.-angaben) (15151) 10 milligramm; natrium diethyloxalaceticum (pot.-angaben) (13785) 10 milligramm; placenta suis (pot.-angaben) (13597) 15 milligramm; rhus toxicodendron (pot.-angaben) (01185) 30 milligramm; sanguinaria canadensis (pot.-angaben) (02137) 30 milligramm; solanum dulcamara (pot.-angaben) (02354) 20 milligramm; sulfur (pot.-angaben) (01215) 40 milligramm; symphytum officinale (pot.-angaben) (02487) 20 milligramm - rind; hund; pferd; schaf; katze; schwein; ziege

Nemecko - nemčina - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

biologische heilmittel heel gmbh (3061574) - acidum thiocticum (pot.-angaben); arnica montana (pot.-angaben); cartilago articularis suis (pot.-angaben); coenzym a (pot.-angaben); embryo totalis suis (pot.-angaben); funiculus umbilicalis suis (pot.-angaben); nadidum (pot.-angaben); natrium diethyloxalaceticum (pot.-angaben); placenta suis (pot.-angaben); rhus toxicodendron (pot.-angaben); sanguinaria canadensis (pot.-angaben); solanum dulcamara (pot.-angaben); sulfur (pot.-angaben); symphytum officinale (pot.-angaben) - tablette - acidum thiocticum (pot.-angaben) (15080) 10 milligramm; arnica montana (pot.-angaben) (1798) 60 milligramm; cartilago articularis suis (pot.-angaben) (13587) 15 milligramm; coenzym a (pot.-angaben) (13802) 10 milligramm; embryo totalis suis (pot.-angaben) (13552) 15 milligramm; funiculus umbilicalis suis (pot.-angaben) (13559) 15 milligramm; nadidum (pot.-angaben) (15151) 10 milligramm; natrium diethyloxalaceticum (pot.-angaben) (13785) 10 milligramm; placenta suis (pot.-angaben) (13597) 15 milligramm; rhus toxicodendron (pot.-angaben) (1185) 30 milligramm; sanguinaria canadensis (pot.-angaben) (2137) 30 milligramm; solanum dulcamara (pot.-angaben) (2354) 20 milligramm; sulfur (pot.-angaben) (1215) 40 milligramm; symphytum officinale (pot.-angaben) (2487) 20 milligramm

Filipíny - angličtina - FDA (Food And Drug Administration)

eon pharmatek inc.; distributor: eon pharmatek inc. - piperacillin (as sodium) , tazobactam (as sodium) - powder for iv injection - 4 g/500 mg

Bulharsko - bulharčina - Изпълнителна агенция по лекарствата

biologische heilmittel heel gmbh - oral solution

Bulharsko - bulharčina - Изпълнителна агенция по лекарствата

biologische heilmittel heel gmbh - ointment

Bulharsko - bulharčina - Изпълнителна агенция по лекарствата

biologische heilmittel heel gmbh - tablets

Spojené štáty - angličtina - NLM (National Library of Medicine)

bionpharma inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine 12.5 mg - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine is contraindicated in patients: - who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings  and precautions ( 5.1) ] . - with hepatic impairment [see use in specific populations ( 8.6),  clinical pharmacology ( 12.3) ] . - taking monoamine oxidase inhibitors (maois). tetrabenazine should not be used in combination with an maoi, or within a minimum of 14 days of discontinuing therapy with an maoi [see drug interactions ( 7.3) ] . - taking reserpine. at least 20 days should elapse after stopping reserpine before starting tetrabenazine [see drug interactions ( 7.2) ] . - taking deutetrabenazine or valbenazine [see drug interactions ( 7.7)]. risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality. administration of a major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on the developing fetus and offspring (increased mortality, decreased growth, and neurobehavioral and reproductive impairment). the adverse developmental effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data tetrabenazine had no clear effects on embryofetal development when administered to pregnant rats throughout the period of organogenesis at oral doses up to 30 mg/kg/day (or 3 times the maximum recommended human dose [mrhd] of 100 mg/day on a mg/m 2 basis). tetrabenazine had no effects on embryofetal development when administered to pregnant rabbits during the period of organogenesis at oral doses up to 60 mg/kg/day (or 12 times the mrhd on a mg/m 2 basis). when tetrabenazine (5, 15, and 30 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, an increase in stillbirths and offspring postnatal mortality was observed at 15 and 30 mg/kg/day and delayed pup maturation was observed at all doses. a no-effect dose for pre- and postnatal developmental toxicity in rats was not identified. the lowest dose tested (5 mg/kg/day) was less than the mrhd on a mg/m 2 basis. because rats dosed orally with tetrabenazine do not produce 9-desmethyl-β-dhtbz, a major human metabolite of tetrabenazine, the metabolite was directly administered to pregnant and lactating rats. oral administration of 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) throughout the period of organogenesis produced increases in embryofetal mortality at 15 and 40 mg/kg/day and reductions in fetal body weights at 40 mg/kg/day, which was also maternally toxic. when 9-desmethyl-β-dhtbz (8, 15, and 40 mg/kg/day) was orally administered to pregnant rats from the beginning of organogenesis through the lactation period, increases in gestation duration, stillbirths, and offspring postnatal mortality (40 mg/kg/day); decreases in pup weights (40 mg/kg/day); and neurobehavioral (increased activity, learning and memory deficits) and reproductive (decreased litter size) impairment (15 and 40 mg/kg/day) were observed. maternal toxicity was seen at the highest dose. the no-effect dose for developmental toxicity in rats (8 mg/kg/day) was associated with plasma exposures (auc) of 9-desmethyl-β-dhtbz in pregnant rats lower than that in humans at the mrhd. risk summary there are no data on the presence of tetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetrabenazine and any potential adverse effects on the breastfed infant from tetrabenazine or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. the pharmacokinetics of tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects. because the safety and efficacy of the increased exposure to tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of tetrabenazine in hepatic impairment to ensure safe use. the use of tetrabenazine in patients with hepatic impairment is contraindicated [see contraindications ( 4),  clinical  pharmacology ( 12.3) ] . patients who require doses of tetrabenazine greater than 50 mg per day, should be first tested and genotyped to determine if they are poor (pms) or extensive metabolizers (ems) by their ability to express the drug metabolizing enzyme, cyp2d6. the dose of tetrabenazine should then be individualized accordingly to their status as either poor (pms) or extensive metabolizers (ems)  [see dosage and administration ( 2.2), warnings and precautions ( 5. 3),  clinical pharmacology ( 12.3) ] . poor metabolizers poor cyp2d6 metabolizers (pms) will have substantially higher levels of exposure to the primary metabolites (about 3-fold for α-htbz and 9-fold for β-htbz) compared to ems. the dosage should, therefore, be adjusted according to a patient’s cyp2d6 metabolizer status by limiting a single dose to a maximum of 25 mg and the recommended daily dose to not exceed a maximum of 50 mg/day in patients who are cyp2d6 pms [see dosage and administration ( 2.2), warnings and precautions ( 5.3),  clinical pharmacology ( 12.3) ] . extensive / intermediate metabolizers in extensive (ems) or intermediate metabolizers (ims), the dosage of tetrabenazine can be titrated to a maximum single dose of 37.5 mg and a recommended maximum daily dose of 100 mg [see dosage and administration  ( 2.2 ), drug interactions ( 7.1),  clinical pharmacology ( 12.3) ] . tetrabenazine is not a controlled substance. clinical trials did not reveal patients developed drug seeking behaviors, though these observations were not systematic. abuse has not been reported from the postmarketing experience in countries where tetrabenazine has been marketed. as with any cns-active drug, prescribers should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of tetrabenazine misuse or abuse (such as development of tolerance, increasing dose requirements, drug-seeking behavior). abrupt discontinuation of tetrabenazine from patients did not produce symptoms of withdrawal or a discontinuation syndrome; only symptoms of the original disease were observed to re‑emerge  [see dosage and  administration ( 2.4) ] .

Spojené štáty - angličtina - NLM (National Library of Medicine)

provention bio, inc. - teplizumab (unii: s4m959u2ij) (teplizumab - unii:s4m959u2ij) - tzield is indicated to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with stage 2 type 1 diabetes [see dosage and administration (2.1)] . none. risk summary available case reports from clinical trials with tzield are insufficient to identify a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. although there are no data on teplizumab-mzwv, monoclonal antibodies can be actively transported across the placenta, and tzield may cause immunosuppression in the utero- exposed infant (see clinical considerations). to minimize exposure to a fetus, avoid use of tzield during pregnancy and at least 30 days (6 half-lives) prior to planned pregnancy. tzield is not active in rodents. in animal reproduction studies, mice were given a surrogate anti-mouse cd3 antibody subcutaneously during organogenesis through lactation. pups born to dams administered the murine surrogate antibody during pregnancy showed a reduction in the adaptive immune response consistent with the expected pharmacology (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population 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. report pregnancies to provention bio, inc.'s adverse event reporting line at 1-800-633-1610. clinical considerations fetal/neonatal adverse reactions transport of endogenous igg antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. because teplizumab-mzwv may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to teplizumab-mzwv in utero. there are insufficient data regarding infant serum levels of teplizumab-mzwv at birth and the duration of persistence of teplizumab- mzwv in infant serum after birth to identify a specific timeframe to delay live virus immunizations in infants exposed in utero. data animal data in an embryo-fetal developmental toxicity study, pregnant mice were administered a murine surrogate anti-mouse cd3 antibody by subcutaneous injection at dose levels of 0, 0.03, 0.3, or 20 mg/kg on gestation days 6, 10, and 14. increase in post-implantation loss occurred in the 20 mg/kg group, in the presence of maternal toxicity. in a pre- and postnatal development toxicity study in pregnant mice, in which the murine surrogate antibody was administered every 3 days from gestation day 6 through lactation day 19 at doses of 0, 0.3, 3, or 20 mg/kg, no maternal toxicity or increased incidence of post- implantation loss was observed. reductions in t cell populations and increases in b cells, and a reduction in the adaptive immune response to keyhole limpet hemocyanin (klh) were observed in the offspring on postnatal days 35 and 84 at 20 mg/kg. the surrogate antibody was present in the offspring serum at level less than 1.5% that of maternal serum at the high dose. a trend towards reduction in fertility was observed in the offspring of dams administered the murine surrogate antibody at 20 mg/kg. the human relevance of this finding is unknown. risk summary there are no data on the presence of teplizumab-mzwv in either human or animal milk, the effects on the breastfed child, or the effects on milk production. endogenous maternal igg and monoclonal antibodies are transferred into human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to teplizumab-mzwv are unknown. although the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tzield and any potential adverse effects on the breastfed child from tzield or from the underlying maternal condition, a lactating woman may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after tzield administration to minimize drug exposure to a breastfed child. the safety and effectiveness of tzield to delay the onset of stage 3 type 1 diabetes have been established in pediatric patients 8 years of age and older with stage 2 type 1 diabetes. use of tzield for this indication is supported by evidence from an adequate and well-controlled study (study tn-10) in adults and pediatric patients 8 years of age and older (including 29 pediatric patients). adverse reactions observed in pediatric patients 8 years of age and older who received tzield were consistent with those reported in adult patients [see adverse reactions (6.1)] . the safety and effectiveness of tzield have not been established in pediatric patients younger than 8 years of age. stage 2 type 1 diabetes is largely a condition that occurs in pediatric and younger adult patients. clinical studies of tzield to delay the onset of stage 3 t1d did not include patients 65 years of age and older.