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

e.r. squibb & sons, l.l.c. - nivolumab (unii: 31yo63lbsn) (nivolumab - unii:31yo63lbsn), relatlimab (unii: af75xof6w3) (relatlimab - unii:af75xof6w3) - opdualag™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. none.       risk summary based on findings in animals and mechanism of action, opdualag can cause fetal harm when administered to a pregnant woman. administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see data ). human igg4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. the effects of opdualag are likely to be greater during the second and third trimesters of pregnancy. there are no available data on opdualag in pregnant women to evaluate a drug-associated risk. advise the patient of the potential risk to a fetus. 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 opdualag injection for intravenous use contains nivolumab and relatlimab [see description (11)] . nivolumab: one function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining immune tolerance to the fetus. the effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on auc). nivolumab administration resulted in a non-dose-related increase in spontaneous abortion and increased neonatal death. in surviving infants (18 of 32 compared to 11 of 16 vehicle-exposed infants) of cynomolgus monkeys treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period. relatlimab: there are no available animal data on relatlimab. the effects of a murine surrogate anti-lag-3 antibody was evaluated in mice using syngeneic and allogeneic breeding models. when anti-lag-3 antibodies were administered beginning on gestation day 6, there were no maternal or developmental effects in either syngeneic or allogeneic breedings. risk summary there are no data on the presence of nivolumab and relatlimab in human milk, the effects on the breastfed child, or the effects on milk production. because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with opdualag and for at least 5 months after the last dose [see pharmacokinetics (12.3)] . opdualag can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating opdualag [see use in specific populations (8.1)] . contraception advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose of opdualag [see clinical pharmacology (12.3)] . the safety and effectiveness of opdualag for the treatment of unresectable or metastatic melanoma have been established in pediatric patients 12 years of age or older who weigh at least 40 kg. use of opdualag for this indication is supported by evidence from an adequate and well-controlled study in adults and additional data analyses that suggest that nivolumab and relatlimab exposures in pediatric patients 12 years of age who weigh at least 40 kg are expected to result in similar safety and efficacy to that of adults. the pharmacokinetics of monoclonal antibodies and the course of unresectable or metastatic melanoma are sufficiently similar in adults and pediatric patients 12 years of age or older to allow extrapolation of data from adult patients to pediatric patients 12 years of age or older (who weigh at least 40 kg). a recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of opdualag have not been established in pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age. of the 355 patients treated with opdualag in relativity-047, 47% of patients were 65 years or older, 29% were 65 to 74 years, 17% were 75 to 84 years, and 1.7% were 85 years and older. no overall differences in safety or effectiveness were observed between elderly patients and younger patients.

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

bristol-myers squibb australia pty ltd - nivolumab, quantity: 255.6 mg; relatlimab, quantity: 85.2 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; water for injections; pentetic acid; sucrose; polysorbate 80; histidine - opdualag is indicated for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab; relatlimab - concentrate for solution for infusion - relatlimab 4 mg/ml; nivolumab 12 mg/ml - nivolumab - opdualag is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

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

dual-shave llc - benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - benzoyl peroxide 5 g in 100 g - acne treatment for the treatment of acne and to prevent skin blemishes when shaving. when not to use this product: if you have extremely sensitive skin or are highly sensitive to benzoyl peroxide. stop use and ask a doctor if: irritation becomes acute.

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

syngenta australia pty ltd - s-metolachlor - emulsifiable concentrate - s-metolachlor anilide/aniline-acetanilides active 960.0 g/l - herbicide - barley | broccoli | brussels sprouts | cabbage | canola | cauliflower | cocksfoot | cotton | green bean | haifa white clover | m - annual or wimmera ryegrass | annual ryegrass - suppression | apple-of-peru | awnless barnyard grass | barnyard grass or water grass | barnyard or water grass | bellvine | billygoat weed or blue top | blackberry nightshade | caltrop or yellow vine | chickweed | common cotula or carrot weed | common thornapple | crowsfoot grass | deadnettle | evening primrose | fat hen | fiddle dock | fierce thornapple | giant or black pigweed | green summer grass | guinea grass | italian ryegrass | liverseed or urochloa grass | lovegrass | mintweed | needle burr | nettle leaf goosefoot | nightshade - solanum gigrum | nightshade - solanum sarrachoides | noogoora burr | passionfruit vine | pigeon grass | pigweed spp. | potato or yellow weed | powell's amaranth or powell's slim | redroot or redroot amaranth | redshank or slim amaranth - seedling | redshank,slim or spleen amaranth | shepherd's purse | sow or milk thistle | square weed or borreria | star of bethlehem or cupid's flower | stinging or dwarf nettle | summer grass | sum

Singapore - English - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - fenoterol hbr; ipratropium bromide 21 mcg/dose eqv ipratropium bromide anhydrous - aerosol, spray - 50 mcg/dose - fenoterol hbr 50 mcg/dose; ipratropium bromide 21 mcg/dose eqv ipratropium bromide anhydrous 20 mcg/dose

Singapore - English - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - fenoterol hydrobromide; ipratropium bromide 0.261 mg/ml eqv ipratropium bromide anhydrous - solution - 0.5 mg/ml - fenoterol hydrobromide 0.5 mg/ml; ipratropium bromide 0.261 mg/ml eqv ipratropium bromide anhydrous 0.25 mg/ml

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

sumitomo chemical australia pty. limited - prallethrin; cyphenothrin - aerosol - prallethrin ungrouped active 0.5 g/kg; cyphenothrin pyrethroid active 1.0 g/kg - household insecticide - domestic pest control | garden shed | homestead | houses | outbuildings - cockroach infestation - heavy/residual | crawling insect | fly | flying insect | mosquito | adult mosquitoes | ants | cockroach - residual control | cockroachs | fleas | flies | mosquitoes | moths | silverfish

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

2022 environmental science au pty ltd - permethrin 25:75 - wettable powder - permethrin 25:75 pyrethroid active 250.0 g/kg - insecticide - agricultural/farm buildings | animal housing | barracks | canteen and/or bakery and/or restaurant | commercial premises - genera - ant | bed bug | biting fly | carpet beetle | clothes moth | cockroach | common housefly | flea | hide or skin beetle | horse fly | mosquito | paralysis tick | seed-harvesting ant | shellfish | silverfish | spider | adult mosquitoes | argentine ant | australian paralysis tick | bedbug | ctenocephalides spp. | dermestes ater | dermestes maculatus | ground fleas | house fly | large cockroach | niditinea spp. | pharaoh ant | pheidole anthracina | scrub tick | seedharvesting ant | small cockroach | tinea spp. | tineola spp.