Malta - English - Medicines Authority

elc group s.r.o. pobrezni 394/12, karlin 186 00 prague 8, czech republic - levodropropizine - syrup - levodropropizine 30 ml/5ml - cough and cold preparations

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

j c & a t searle pty ltd - tau-fluvalinate; myclobutanil - other liquids to be applied undiluted - tau-fluvalinate pyrethroid active 0.1 g/l; myclobutanil triazole active 0.05 g/l - mixed function pesticide - ornamental | ornamental flowering annual | ornamental flowering perenials | rose | shrub | carnation | chrysanthemum | indoor fo - aphid | black spot | budworms | powdery mildew | rust | thrip | two spotted mite | whitefly | red spider mite | scab | spider mite | thrips spp. | two-spotted mite | two-spotted spider mite

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

takeda pharmaceuticals australia pty ltd - protein c, quantity: 1000 iu - injection, intravenous infusion - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

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

takeda pharmaceuticals australia pty ltd - protein c, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

New Zealand - English - Ministry for Primary Industries

bayer new zealand limited - tebuconazole; prothioconazole - emulsifiable concentrate - tebuconazole 125 g/litre; prothioconazole 125 g/litre - fungicide - fungicide

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

brunnings garden products pty ltd - tau-fluvalinate; myclobutanil - suspoemulsion - tau-fluvalinate pyrethroid active 4.8 g/l; myclobutanil triazole active 2.2 g/l - mixed function pesticide - ornamental | ornamental flowering annual | ornamental flowering perenials | rose | shrub | carnation | chrysanthemum | indoor fo - aphid | black spot | helicoverpa spp. | powdery mildew | rust | thrip | two spotted mite | whitefly | corn earworm | cotton bollworm | heliothis | native budworm | red spider mite | scab | spider mite | thrips spp. | tobacco budworm | tomato grub | two-spotted mite | two-spotted spider mite

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

baxter healthcare corporation - valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), alanine (unii: of5p57n2zx) (alanine - unii:of5p57n2zx), glycine (unii: te7660xo1c) (glycine - unii:te7660xo1c), arginine (unii: 94zla3w45f) (arginine - unii:94zla3w45f), proline (unii: 9dlq4ciu6v) (proline - unii:9dlq4ciu6v), glutamic acid (unii: 3kx376gy7l) (glutamic acid - unii:3kx376gy7l), serine (unii: 452vly9402) (serine - unii:452vly9402), aspartic acid (unii: 30kyc7miai) (aspartic acid - unii:30kyc7miai), tyrosine (unii: 42hk56048u) (tyrosine - unii:42hk56048u) - valine 1.44 g in 100 ml - prosol is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. prosol may be used to treat negative nitrogen balance in patients. the use of prosol is contraindicated in: risk summary limited published data with injectable amino acids solutions, including prosol in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. however, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see clinical considerations]. animal reproduction studies have not been conducted with injectable amino acids solutions, including prosol. the 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. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. clinical considerations disease-associated maternal and/or embryo-fetal risk severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary there are no data available to assess the presence of injectable amino acids, including prosol in human milk, the effects of prosol on the breastfed infant or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of prosol to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prosol and any potential adverse effects on the breastfed child from prosol or from the underlying maternal condition. neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects [see dosage and administration (2.7)]. plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. hyperammonemia is of special significance in infants (birth to two years). this reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. it is essential that blood ammonia be measured frequently in infants [see warnings and precautions (5.7)]. because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with prosol may be at risk of aluminum toxicity [see warnings and precautions (5.8)]. patients, including pediatric patients, may be at risk for pnald [see warnings and precautions (5.9)]. clinical studies with prosol have not been performed to determine whether subjects aged 65 and over respond differently from other 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 drug therapy. in patients with impaired renal function, parenteral nutrition solutions containing prosol should be administered with caution. frequent clinical evaluation and laboratory tests to monitor renal function such as serum electrolytes (especially phosphate and potassium) and fluid balance should be conducted [see dosage and administration (2.6) , and warnings and precautions (5.10)]. in patients with impaired liver function, parenteral nutrition solutions containing prosol should be administered starting at the low end of the dosing range [see dosage and administration (2.5)]. frequent clinical evaluation and laboratory tests to monitor liver function such as bilirubin and liver function parameters should be conducted [see warnings and precautions (5.7) ].

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

takeda pharmaceuticals america, inc. - protein c (unii: 3z6s89txpw) (protein c - unii:3z6s89txpw) - protein c 500 [iu] in 5 ml - ceprotin, protein c concentrate (human), is an anticoagulant indicated for neonates, pediatric and adult patients with severe congenital protein c deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. none. risk summary there are no data with ceprotin use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ceprotin. it is also not known whether ceprotin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ceprotin has not been studied for use during labor and delivery. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively, regardless of drug exposure. risk summary there is no information regarding the presence of ceprotin in human milk, the effect on the breastfed infant, or the effects on milk production. ceprotin has not been studied for use in nursing mothers

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

proterra pty ltd - paraquat present as paraquat dichloride - suspension 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

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

j c & a t searle pty ltd - tau-fluvalinate; myclobutanil - suspension concentrate - tau-fluvalinate pyrethroid active 9.6 g/l; myclobutanil triazole active 4.4 g/l - mixed function pesticide - ornamental | rose | carnation | chrysanthemum | indoor foliage plant | rose | sturt's desert rose - aphid | black spot | helicoverpa spp. | native budworm or bollworm | powdery mildew | rust | thrip | two spotted mite | whitefly | corn earworm | cotton bollworm | heliothis | native bollworm | native budworm | red spider mite | scab | spider mite | thrips spp. | tobacco budworm | tomato grub | two-spotted mite | two-spotted spider mite