Singapur - angličtina - HSA (Health Sciences Authority)

biomed diagnostics pte ltd - hematology - the hemosil acustar adamts13 activity is a quantitative, fully automated, chemiluminescent immunoassay (cia) for the measurement of adamts13 activity. the assay is for use in human 3.2% or 3.8% citrated plasma on the acl acustar® in a laboratory setting by healthcare professionals. the assay results aid in the diagnosis and monitoring of thrombotic thrombocytopenic purpura (ttp). the results should be used in conjunction with other clinical and laboratory findings. for use in adult population. for prescription use only

Filipíny - angličtina - FDA (Food And Drug Administration)

oboi laboratories; importer: phil pharmawealth, inc.; distributor: phil pharmawealth, inc. - phytomenadione - solution for injection (i.m./i.v.) - 10 mg/ml

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

ascend laboratories, llc - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg - linezolid is indicated for the treatment of nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14) ]. linezolid is indicated for the treatment of community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14) ]. linezolid is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus pyogenes , or streptococcus agalactiae . linezolid has not been studied in the treatment of decubitus ulcers [see clinical studies (14) ]. linezolid is indicated for the treatment of uncomplicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes [see clinical studies (14) ]. linezolid is indicated for the treatment of vancomycin-resistant enterococcus faecium infections, including cases with concurrent bacteremia [see clinical studies (14) ]. - linezolid is not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [see warnings and precautions (5.4) ]. - the safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see clinical studies (14) ]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. linezolid formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components. linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases a or b (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. risk summary available data from published and postmarketing case reports with linezolid use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. when administered during organogenesis, linezolid did not cause malformations in mice, rats, or rabbits at maternal exposure levels approximately 6.5 times (mice), equivalent to (rats), or 0.06 times (rabbits) the clinical therapeutic exposure, based on aucs. however, embryo-fetal lethality was observed in mice at 6.5 times the estimated human exposure. when female rats were dosed during organogenesis through lactation, postnatal survival of pups was decreased at doses approximately equivalent to the estimated human exposure based on aucs (see data ). the background risk of major birth defects and miscarriage for the indicated populations 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 to 4% and 15 to 20%, respectively. data animal data in mice, embryo-fetal toxicities were observed only at doses that caused maternal toxicity (clinical signs and reduced body weight gain). an oral dose of 450 mg/kg/day given from gestation day (gd) 6 to 16 (6.5 times the estimated human exposure based on aucs) correlated with increased postimplantational embryo death, including total litter loss, decreased fetal body weights, and an increased incidence of costal cartilage fusion. neither maternal nor embryo-fetal toxicities were observed at doses up to 150 mg/kg/day. fetal malformations were not observed. in rats, fetal toxicity was observed at 15 and 50 mg/kg/day administered orally from gd 6 to 17 (exposures 0.22 times to approximately equivalent to the estimated human exposure, respectively, based on aucs). the effects consisted of decreased fetal body weights and reduced ossification of sternebrae, a finding often seen in association with decreased fetal body weights. fetal malformations were not observed. maternal toxicity, in the form of reduced body weight gain, was seen at 50 mg/kg/day. in rabbits, reduced fetal body weight occurred only in the presence of maternal toxicity (clinical signs, reduced body weight gain and food consumption) when administered at an oral dose of 15 mg/kg/day given from gd 6 to 20 (0.06 times the estimated human exposure based on aucs). fetal malformations were not observed. when female rats were treated with 50 mg/kg/day (approximately equivalent to the estimated human exposure based on aucs) of linezolid during pregnancy and lactation (gd 6 through lactation day 20), survival of pups was decreased on postnatal days 1 to 4. male and female pups permitted to mature to reproductive age, when mated, showed an increase in preimplantation loss. risk summary linezolid is present in breast milk. based on data from available published case reports, the daily dose of linezolid that the infant would receive from breastmilk would be approximately 6% to 9% of the recommended therapeutic infant dose (10 mg/kg every 8 hours). there is no information on the effects of linezolid on the breastfed infant; however, diarrhea and vomiting were the most common adverse reactions reported in clinical trials in infants receiving linezolid therapeutically [see adverse reactions (6.1) ] and (see clinical considerations). there is no information on the effects of linezolid on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for linezolid and any potential adverse effects on the breastfed child from linezolid or from the underlying maternal condition. clinical considerations advise lactating women to monitor a breastfed infant for diarrhea and vomiting. infertility males based on findings from studies in rats, linezolid may reversibly impair fertility in male patients [see nonclinical toxicology (13.1) ]. the safety and effectiveness of linezolid for the treatment of pediatric patients with the following infections are supported by evidence from adequate and well-controlled studies in adults, pharmacokinetic data in pediatric patients, and additional data from a comparator-controlled study of gram-positive infections in pediatric patients ranging in age from birth through 11 years [see indications and usage (1), clinical pharmacology (12.3) and clinical studies (14)]: - nosocomial pneumonia - complicated skin and skin structure infections - community-acquired pneumonia (also supported by evidence from an uncontrolled study in patients ranging in age from 8 months through 12 years) - vancomycin-resistant enterococcus faecium infections the safety and effectiveness of linezolid for the treatment of pediatric patients with the following infection have been established in a comparator-controlled study in pediatric patients ranging in age from 5 through 17 years [see clinical studies (14)]: - uncomplicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible strains only) or streptococcus pyogenes pharmacokinetic information generated in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (csf) linezolid concentrations following single and multiple dosing of linezolid; therapeutic concentrations were not consistently achieved or maintained in the csf. therefore, the use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended. the pharmacokinetics of linezolid have been evaluated in pediatric patients from birth to 17 years of age. in general, weight-based clearance of linezolid gradually decreases with increasing age of pediatric patients. however, in preterm (gestational age <34 weeks) neonates <7 days of age, linezolid clearance is often lower than in full-term neonates <7 days of age. consequently, preterm neonates <7 days of age may need an alternative linezolid dosing regimen of 10 mg/kg every 12 hours [see dosage and administration (2.1) and clinical pharmacology (12.3)]. in limited clinical experience, 5 out of 6 (83%) pediatric patients with infections due to gram-positive pathogens with minimum inhibitory concentrations (mics) of 4 mcg/ml treated with linezolid had clinical cures. however, pediatric patients exhibit wider variability in linezolid clearance and systemic exposure (auc) compared with adults. in pediatric patients with a sub-optimal clinical response, particularly those with pathogens with mic of 4 mcg/ml, lower systemic exposure, site and severity of infection, and the underlying medical condition should be considered when assessing clinical response [see clinical pharmacology (12.3) and dosage and administration (2)]. of the 2,046 patients treated with linezolid in phase 3 comparator-controlled clinical trials, 589 (29%) were 65 years or older and 253 (12%) were 75 years or older. 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - terbinafine hydrochloride, quantity: 281.25 mg (equivalent: terbinafine, qty 250 mg) - tablet - excipient ingredients: hypromellose; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate - treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as trichophyton (e.g. t. rubrum, t. mentagrophytes, t. verrucosum, t. violaceum), microsporum canis and epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy. onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

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

axichem pty ltd - oxyfluorfen; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - oxyfluorfen diphenyl ether active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 108.0 g/l; liquid hydrocarbon solvent other 606.0 g/l - herbicide - apple - dormant treatment | brassica vegetables | broccoli | cabbage | cauliflower | cotton (prior to sowing) | custard apple | - amsinckia | amsinckia, yellow burrweed - seedling | barley grass | barnyard or water grass | bellvine - seedling (ipomoea spp.) | blackberry nightshade | bladder ketmia | caltrop - tribulis terrestis | capeweed | capeweed - seedling | chickweed | cleavers | common cotula or carrot weed | cotula or carrot weed - seedling | crowsfoot grass | crowsfoot grass - seedling | deadnettle | deadnettle - seedling | dock | erodium, crowfoot or storksbill | fat hen | field bindweed | fumitory | fumitory - pink & white | giant or black pigweed | groundsel | groundsel (s. vulgaris) - seedling | hillside burrgrass | liverseed grass - seedling | liverseed or urochloa grass | lovegrass | marshmallow - seedling | perennial pigweed | pigeon grass | plantain | potato or yellow weed | potato weed - seedling | prickly lettuce | red natal grass | red pigweed (p. oleracea) - seedling | redshank - prince of wales feather | redshank (a. cruentus) - seedling | refer to glyphosate 360 g/l label | refer to glyphosate 450 g/l label | refer

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

axichem pty ltd - paraquat present as paraquat dichloride - soluble concentrate - paraquat present as paraquat dichloride pyridine-bipyridyl active 250.0 g/l - herbicide - aid to cultivation - weed control | annual clover - selective weed control | annual ryegrass - toxin minimization | banana | chi - annual grass weed | annual or wimmera ryegrass | annual ryegrass | annual weeds | anoda weed | apple-of-peru | barley grass | bellvine | blue heliotrope or blue top | broadleaf weeds | columbus grass | common morning glory | crop management | general weed - older | general weed - post-crop emergence | general weed - pre-crop emergence | general weed - pre-planting | grass weed | ground or annual ground cherry | milkweed | pre-harvest weed control | retain protein in pasture | saffron thistle | stagger weed | thornapple | total weed control | wandering jew | weed control - refer to additive label | weed seedling | wild oat | annual gooseberry | annual grasses | broadleaf grass | castor oil (false) | commelina spp. | datura ferox | datura meteloides | datura stramonium | datura tatula | false castor oil | false star thistle | field stachys | gooseberry | hedge-nettle | inter-row weed control | max. retention of protein | mexican fire plant | mint weed | physalis angulata | purple flowered thornapple | rigid rye

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

axichem pty ltd - abamectin; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - abamectin anthelmintic active 18.0 g/l; n-methyl-2-pyrrolidone solvent other 265.0 g/l; liquid hydrocarbon solvent other 58.0 g/l - insecticide - apple | capsicum or pepper | citrus | cotton | hops | ornamental (see label) | pear | strawberry | tomato - field grown | trelli - 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 | two spotted 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

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

axichem pty ltd - mcpa present as the potassium salt; terbutryn - suspension concentrate - mcpa present as the potassium salt phenoxy acids-mcpa active 160.0 g/l; terbutryn triazine active 275.0 g/l - herbicide - barley | oats - see label for varieties | subclover pasture - see lbl 4 varieties | sugar cane | wheat | bacchus marsh | clare | - australian crassula | ball mustard - suppression | barnyard or water grass | bellvine | blackberry nightshade | blue billygoat weed | blue billygoat weed - suppression | calopo | capeweed | capeweed - seedling | centro | charlock | cinderella weed | common morning glory | common sensitive plant | corn gromwell, ironweed or sheepweed | crassula | crowsfoot grass | deadnettle | fat hen | fumitory - red | fumitory - white | giant or black pigweed | giant sensitive plant | green summer grass | ground or annual ground cherry | guinea grass | indian hedge mustard | ivy leaf speedwell | long storksbill - seedling | mallee catchfly | melilotus or hexham scent | native jute | paterson's curse | paterson's curse - seedling | perennial pigweed | pimpernels | pink convolvulus | pinkburr | rattlepod | red convolvulus | rough poppy | rounded chamomile | saffron thistle | scented woolly sage | sow or milk thistle | square weed or borreria | star of bethlehem or cupid's flower | stemless thistle | stinking passion flower or

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

axichem pty ltd - cloquintocet-mexyl; clodinafop-propargyl; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - cloquintocet-mexyl acetate active 60.0 g/l; clodinafop-propargyl pyridine 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 - annual ryegrass | canary grass - phalaris minor | paradoxa grass | wild oat | annual phalaris | canary grass | dwarf canary grass | lesser canary grass

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

axichem pty ltd - atrazine - water dispersible granule - atrazine triazine active 900.0 g/kg - herbicide - broom millet - dryland | broom millet - irrigated | canola - post emergence | canola - post sowing/pre-emergence | dryland forag - amaranth or amaranthus | annual broadleaf weeds - see label | annual broadleaf weeds & grasses-see lab | annual clovers | annual ground cherry | annual ryegrass | barley grass | barnyard or water grass | bellvine | billygoat weed or blue top | black bindweed | blackberry nightshade | bladder ketmia | blue billygoat weed | borreria | broadleaf weeds | broadleaf weeds and grasses | brome grass | burr | caltrop or yellow vine | capeweed | charlock | clover | cobbler's pegs | common sida | common thornapple | corn gromwell - pre emergence | crowsfoot grass | dock | dwarf marigold | fat hen | flannel weed | fleabane | fumitory | geranium | giant or black pigweed | giant sensitive plant | giant sensitive plant - with other weeds | ivy leaf speedwell | london rocket | loosestrife | lovegrass | mexican poppy | mintweed | mouse-ear chickweed | mustard | noogoora burr | paddy melon | parthenium weed | paterson's curse | perennial pigweed | pigeon grass | plains grass | rhodes grass | ryegrass | ryegrass - suppression |