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

nutrien ag solutions limited - glufosinate-ammonium - soluble concentrate - glufosinate-ammonium organophosphorus-phosphinic ac active 200.0 g/l - herbicide - avocado plantation | banana plantation | blackberry | boysenberry | cane berry fruit - inter row | commercial area - general | f - amaranth or amaranthus | annual ryegrass | apple-of-peru | argentine peppercress | awnless barnyard grass | barley grass | barnyard grass or water grass | billygoat weed or blue top | bindweed | black bindweed | bladder ketmia | blady grass | bordered panic | brome grass | calopo | caltrop or yellow vine | cape tulip | capeweed | centro | clammy goosefoot | clover glycine | cobbler's pegs | common bittercress or flickweed | common fumitory | common pigweed | common sida | common storksbill | couch grass | cowpea | crowsfoot grass | deadnettle | fat hen | foxtail millet | giant sensitive plant | green crumbweed | greenleaf desmodium | hedge or wild mustard | johnson grass | lesser canary grass | liverseed or urochloa grass | medic | mintweed | new zealand spinach | paspalum spp. | paterson's curse | pinkburr | potato or yellow weed | prairie grass | prickly lettuce | primocane control | red natal grass | saffron thistle | sago weed | scarlet or red pimpernel | shamrock | sheep, shore or winged slender thistle

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

alphapharm pty ltd - glibenclamide; metformin hydrochloride -

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

c. rudduck proprietary limited - piperonyl butoxide; pyrethrins - emulsifiable concentrate - piperonyl butoxide benzodioxole active 160.0 g/l; pyrethrins pyrethroid-pyrethrin active 40.0 g/l - insecticide - areas external to house & shed | barn | barracks | commercial premises - general | container | domestic premises | factory | fer - ant | aphid | beetle | caterpillar | cockroach | earwig | fly | flying insect | grain weevil | leafhopper | midge | mosquito | moth | silverfish | spider | thrip | whitefly | adult | adult mosquitoes | argentine ant | budworm | flies | large cockroach | looper | mosquitoes | moths | pharaoh ant | sitophilus granarius | sitophilus oryzae | sitophilus zeamais | small cockroach | thrips spp.

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

sun pharmaceutical industries, inc. - gemcitabine hydrochloride (unii: u347pv74il) (gemcitabine - unii:b76n6sbz8r) - infugem in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. infugem in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. infugem in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (stage iiia or iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc). infugem is indicated as first-line treatment for patients with locally advanced (nonresectable stage ii or stage iii) or metastatic (stage iv) adenocarcinoma of the pancreas. infugem is indicated for patients previously treated with fluorouracil. infugem is contraindicated in patients with a known hypersensitivity to gemcitabine. reactions include anaphylaxis [see adverse

Singapore - English - HSA (Health Sciences Authority)

b. braun singapore pte ltd - orthopaedics - intended for fixation in proximal tibial repositioning osteotomy

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - orthopaedics - it is for fixation of complex proximal and distal tibial fractures, particularly those involving the joint, when: - soft tissue injuries preclude open reduction and internal fixation, or the fracture pattern does not allow placement of schanz screws for construction of a standard external fixator frame.

Singapore - English - HSA (Health Sciences Authority)

arqon pte. ltd. - orthopaedics - the b-one® total hip system is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions: osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (nidjd), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or girdlestone resection; and fracture-dislocation of the hip. the b-one® total hip system is intended for cementless use only. b-one® total hip system components are not intended for use with other total hip systems.

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

chemocentryx, inc. - avacopan (unii: o880nm097t) (avacopan - unii:o880nm097t) - tavneos is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (anca)-associated vasculitis (granulomatosis with polyangiitis [gpa] and microscopic polyangiitis [mpa]) in combination with standard therapy including glucocorticoids. tavneos does not eliminate glucocorticoid use. tavneos is contraindicated in patients with serious hypersensitivity reaction to avacopan or to any of the excipients [see warnings and precautions (5.2)]. risk summary there are no adequate and well-controlled studies with tavneos in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of avacopan to pregnant hamsters and rabbits during the period of organogenesis produced no evidence of fetal harm with exposures up to approximately 5 and 0.6 times, respectively, the exposure at the maximum recommended human dose (mrhd) of 30 mg twice daily (on an area under the curve [auc] basis). avacopan caused an increase in the number of abortions in rabbits at an exposure 0.6 times the mrhd (see animal data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. 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 in an embryo-fetal development study with pregnant hamsters dosed by the oral route during the period of organogenesis from gestation days 6 to 12, avacopan produced an increase in the incidence of a skeletal variation, described as supernumerary ribs, at an exposure that was 5 times the mrhd (on an auc basis with a maternal oral dose of 1000 mg/kg/day). no structural abnormalities were noted with exposures up to 5 times the mrhd (on an auc basis with maternal oral doses up to 1000 mg/kg/day). in an embryo-fetal development study with pregnant rabbits dosed by the oral route during the period of organogenesis from gestation days 6 to 18, avacopan caused an increase in the number of abortions at an exposure 0.6 times the mrhd (on an auc basis with a maternal oral dose of 200 mg/kg/day), however, no evidence of fetal harm was observed with such exposures. maternal toxicity, as evidenced by decreased body weight gains, was observed at exposures 0.6 times and higher than the mrhd (on an auc basis with maternal oral doses of 30 mg/kg/day and higher). in a prenatal and postnatal development study with pregnant hamsters dosed by the oral route during the periods of gestation and lactation from gestation day 6 to lactation day 20, avacopan had no effects on the growth and development of offspring with exposures up to approximately 5 times the mrhd (on an auc basis with maternal oral doses up to 1000 mg/kg/day). risk summary there are no available data on the effects of avacopan on the breastfed child or on milk production. it is unknown whether avacopan is secreted in human milk. avacopan was detected in the plasma of undosed hamster pups nursing from drug-treated dams (see animal data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tavneos and any potential adverse effects on the breast-fed infant from tavneos or from the underlying maternal condition. animal data avacopan has not been measured in the milk of lactating animals; however, it was detected in the plasma of nursing offspring in a pre- and post-natal development study with hamsters at a pup to maternal plasma ratio of 0.37. this finding suggests that avacopan is secreted into the milk of lactating hamsters. [see nonclinical toxicology (13.1)]. the safety and effectiveness of tavneos in pediatric patients have not been established. of the 86 geriatric patients who received tavneos in the phase 3 randomized clinical trial for anca-associated vasculitis [see clinical studies (14)] , 62 patients were between 65-74 years and 24 were 75 years or older. no overall differences in safety or effectiveness were observed between geriatric patients and younger patients. no dose adjustment is required for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . tavneos has not been studied in patients with anca-associated vasculitis who are on dialysis. no dosage adjustment is recommended for patients with mild or moderate (as indicated by the child-pugh method) hepatic impairment [clinical pharmacology (12.3)] . tavneos has not been studied in patients with severe hepatic impairment (child-pugh class c).