Singapore - English - HSA (Health Sciences Authority)

demant singapore pte ltd - ear, nose & throat - the hearing aid is intended to amplify and transmit sound to the ear, and thereby compensate for impaired hearing within mild to severe-to-profound hearing loss. this hearing aid is intended for use by adults and children older than 36 months.

Singapore - English - HSA (Health Sciences Authority)

demant singapore pte ltd - ear, nose & throat - the hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing within mild to severe to profound hearing loss. the hearing aid is intended for use by adults and children older than 36 months.

Singapore - English - HSA (Health Sciences Authority)

demant singapore pte ltd - ear, nose & throat - the hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing. this hearing aid is intended for use by adults and children older than 36 months.

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

ge healthcare inc. - human albumin microspheres (unii: t8c6w1n6nw) (human albumin microspheres - unii:t8c6w1n6nw), perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - human albumin microspheres 10 mg in 1 ml - optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. do not administer optison to patients with known or suspected hypersensitivity to perflutren or albumin [see warnings and precautions (5.5)] . risk summary there are no data with optison use in pregnant women to inform any drug-associated risks. no adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of optison to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see data ). 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 animal data optison was administered intravenously to rats at doses of 0.25, 5 and 10 ml/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 ml, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 ml/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. no significant findings attributable solely to a direct effect on the fetus were detected in the studies. there are no data on the presence of perflutren protein-type a microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for optison and any potential adverse effects on the breastfed infant from optison or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in a clinical study of optison, 35% were 65 and over, while 14% were 75 and over. no overall differences in safety or effectiveness were observed between these 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.

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

biotis life science pty ltd - glyphosate present as the mono-ammonium salt - water dispersible granule - glyphosate present as the mono-ammonium salt glycine active 680.0 g/kg - herbicide - agricultural area - general | calomba daisy seed set control | cotton | cotton - pre harvest | crop - weed control prior to sowi - african lovegrass | african turnip weed | amaranth or amaranthus | amsinckia | annual phalaris | annual ryegrass | annual weeds | artichoke thistle | australian bluebell - w. gracilis | bamboo | barley grass | barnyard grass or water grass | bathurst burr | bent grass - agrostis spp. | bitou bush or boneseed | blackberry | bladder ketmia | blady grass | boggabri weed | boxthorn | bracken | brome grass | burr medic | button grass | calomba daisy | caltrop or yellow vine | camel or afghan melon | canary grass | capeweed | carpet grass | cat's ear or flatweed | chickweed | chinese scrub | cobbler's pegs | cocksfoot | columbus grass - seedling | common pigweed | common sowthistle - suppression | common thornapple | couch | cudweed | cumbungi | deadnettle | dock | dock - seedling | english couch or rope twitch | erodium spp. | eucalyptus - seedling | fumitory | furze or gorse | giant or black pigweed | glyceria or reed sweet grass | gooseberry | ground cherry - physalis angulata | groundsel bush | guinea grass | h

Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - miconazole nitrate ; prednisolone acetate; polymyxin b sulfate - ear drops, suspension - prednisolone and antiinfectives

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v; hydrocortisone 10mg equivalent to 1% w/v hydrocortisone;  ;  ; ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v; hydrocortisone 10mg equivalent to 1% w/v hydrocortisone - ear drops - active: ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v hydrocortisone 10mg equivalent to 1% w/v hydrocortisone     excipient: benzyl alcohol glacial acetic acid lecithin polysorbate 20 polyvinyl alcohol purified water sodium acetate trihydrate sodium chloride active: ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v hydrocortisone 10mg equivalent to 1% w/v hydrocortisone excipient: benzyl alcohol glacial acetic acid lecithin polysorbate 20 polyvinyl alcohol purified water sodium acetate trihydrate sodium chloride - the treatment of acute bacterial external otitis caused by organisms susceptible to the action of ciprofloxacin, including pseudomonas aeruginosa, staphylococcus aureus, acinetobacter anitratus (baumannii), stenotrophomonas maltophilia, enterobacteriaceae, enterococcus faecalis and proteus mirabilis.

Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - miconazole nitrate ; prednisolone acetate; polymyxin b sulfate - ear drops, suspension - miconazole, combinations

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

troy laboratories pty ltd - piperonyl butoxide; dichlorophen; pyrethrins - misc. aural, ophthalmic, oro/naso pharyngeal - piperonyl butoxide benzodioxole active 5.0 mg/ml; dichlorophen phenol active 5.0 mg/ml; pyrethrins pyrethroid-pyrethrin active 500.0 ug/ml - ear,nose,throat preps. - cat | dog | bitch | castrate | cat - queen | cat - tom | kitten | puppy - ear mange mite | ear mites

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

dechra veterinary products (australia) pty. ltd. - polymyxin b sulfate; prednisolone acetate; miconazole nitrate - misc. aural, ophthalmic, oro/naso pharyngeal - polymyxin b sulfate antibiotic active 0.696 mg/ml; prednisolone acetate steroid-glucocorticoid active 5.0 mg/ml; miconazole nitrate triazole active 23.0 mg/ml - ear,nose,throat preps. - cat | dog | bitch | castrate | cat - queen | cat - tom | kitten | puppy - ear mange mite | infections of the skin | otitis externa | abscesses | acute canine otitis | anal sacculitis | associated with yeast &/or bac | chronic canine otitis | ear mites | fungal | gingivitis | gram negative bacteria | gram positive bacteria | malassezia pachydermatis | otitis (canine) | post-parturient infections | pyoderma | septicaemia | yeast