Amerika Serikat - Inggris - NLM (National Library of Medicine)

slate run pharmaceuticals, llc - mycophenolate sodium (unii: wx877sqi1g) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids. mycophenolic acid delayed-release tablets and mycophenolate mofetil (mmf) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (mpa), mycophenolate mofetil, or to any of its excipients. reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing reports [see adverse reactions ( 6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolic acid delayed-release tablets treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-617-8191. risk summary following oral or intravenous (iv) administration, mmf is metabolized to mycophenolic acid (mpa), the active ingredient in mycophenolic acid delayed-release tablets and the active form of the drug. use of mmf during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems (see human data) . oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.05 and 1.1 times exposure at the recommended clinical doses in kidney transplant patients for rats and rabbits, respectively) (see animal data) . risks and benefits of mycophenolic acid delayed-release tablets should be discussed with the patient. when appropriate, consider alternative immunosuppressants with less potential for embryo-fetal toxicity. the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. 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 human data a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23% to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities, including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45% to 49% following mmf exposure. animal data in animal reproductive toxicology studies, congenital malformations and pregnancy loss occurred when pregnant rats and rabbits received mycophenolate at dose multiples equivalent to and less than the recommended human dose. oral administration of mycophenolate sodium to pregnant rats from gestational day 7 to day 16 at a dose as low as 1 mg per kg resulted in malformations including anophthalmia, exencephaly, and umbilical hernia. the systemic exposure at this dose represents 0.05 times the clinical exposure at the human dose of 1,440 mg per day of mycophenolic acid delayed-release tablets. oral administration of mycophenolate to pregnant rabbits from gestational day 7 to day 19 resulted in embryofetal lethality and malformations, including ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at doses equal to or greater than 80 mg per kg per day, in the absence of maternal toxicity. this corresponds to about 1.1 times the recommended clinical dose based on bsa. risk summary there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child (see data) . studies in rats treated with mmf have shown mycophenolic acid to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mycophenolic acid delayed-release tablets and any potential adverse effects on the breastfed infant from mycophenolic acid delayed-release tablets or from the underlying maternal condition. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. data limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34 to 40 weeks gestation and breastfed for up to 14 months. no adverse events were reported. females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning. pregnancy planning for female patients taking mycophenolic acid delayed-release tablets who are considering pregnancy, consider alternative immunosuppressants with less potential for embryo-fetal toxicity. risks and benefits of mycophenolic acid delayed-release tablets should be discussed with the patient. pregnancy testing to prevent unplanned exposure during pregnancy, females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolic acid delayed-release tablets. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryo-fetal toxicity whenever possible. contraception female patients females of reproductive potential taking mycophenolic acid delayed-release tablets must receive contraceptive counseling and use acceptable contraception (see table 5 for acceptable contraception methods). patients must use acceptable birth control during entire mycophenolic acid delayed-release tablets therapy, and for 6 weeks after stopping mycophenolic acid delayed-release tablets, unless the patient chooses abstinence (she chooses to avoid heterosexual intercourse completely). patients should be aware that mycophenolic acid delayed-release tablets reduce blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness [see patient counseling information ( 17), drug interactions ( 7.8)] . or or   choose one barrier method   from each column (must   choose two methods) male patients genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 2.5 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolic acid delayed-release tablets and for at least 90 days after cessation of treatment [see use in specific populations ( 8.1), nonclinical toxicology ( 13.1), patient counseling information ( 17)] . the safety and effectiveness of mycophenolic acid delayed-release tablets have been established in pediatric kidney transplant patients 5 to 16 years of age who were initiated on mycophenolic acid delayed-release tablets at least 6 months post-transplant. use of mycophenolic acid delayed-release tablets in this age group is supported by evidence from adequate and well-controlled studies of mycophenolic acid delayed-release tablets in a similar population of adult kidney transplant patients with additional pharmacokinetic data in pediatric kidney transplant patients [see dosage and administration ( 2.2, 2.3), clinical pharmacology ( 12.3)] . pediatric doses for patients with bsa<1.19 m 2 cannot be accurately administered using currently available formulations of mycophenolic acid delayed-release tablets. the safety and effectiveness of mycophenolic acid delayed-release tablets in de novo pediatric kidney transplant patients and in pediatric kidney transplant patients below the age of 5 years have not been established. clinical studies of mycophenolic acid delayed-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. of the 372 patients treated with mycophenolic acid delayed-release tablets in the clinical trials, 6% (n=21) were 65 years of age and older and 0.3% (n=1) were 75 years of age and older. 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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

pharmacor pty ltd - metoprolol succinate, quantity: 23.75 mg - tablet, modified release - excipient ingredients: microcrystalline cellulose; ethylcellulose; triethyl citrate; silicified microcrystalline cellulose; methacrylic acid copolymer; sodium stearylfumarate; macrogol 6000; povidone; purified talc; croscarmellose sodium; silicon dioxide; titanium dioxide; hypromellose; peg-150 distearate; lauromacrogol 400 - stable, chronic heart failure as an adjunct to other heart failure therapy.

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

pharmacor pty ltd - metoprolol succinate, quantity: 23.75 mg - tablet, modified release - excipient ingredients: macrogol 6000; ethylcellulose; sodium stearylfumarate; silicon dioxide; triethyl citrate; microcrystalline cellulose; purified talc; methacrylic acid copolymer; croscarmellose sodium; povidone; silicified microcrystalline cellulose; titanium dioxide; hypromellose; peg-150 distearate; lauromacrogol 400 - stable, chronic heart failure as an adjunct to other heart failure therapy.

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

pharmacor pty ltd - metoprolol succinate, quantity: 23.75 mg - tablet, modified release - excipient ingredients: triethyl citrate; macrogol 6000; croscarmellose sodium; povidone; sodium stearylfumarate; purified talc; silicon dioxide; silicified microcrystalline cellulose; methacrylic acid copolymer; ethylcellulose; microcrystalline cellulose; titanium dioxide; hypromellose; peg-150 distearate; lauromacrogol 400 - stable, chronic heart failure as an adjunct to other heart failure therapy.

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

arrotex pharmaceuticals pty ltd - metoprolol succinate, quantity: 23.75 mg - tablet, modified release - excipient ingredients: purified talc; macrogol 6000; microcrystalline cellulose; povidone; silicon dioxide; triethyl citrate; sodium stearylfumarate; croscarmellose sodium; silicified microcrystalline cellulose; methacrylic acid copolymer; ethylcellulose; titanium dioxide; hypromellose; peg-150 distearate; lauromacrogol 400 - stable, chronic heart failure as an adjunct to other heart failure therapy.

Irlandia - Inggris - HPRA (Health Products Regulatory Authority)

ipsen pharmaceuticals limited - triptorelin pamoate - powder and solvent for prolonged-release suspension for injection - 22.5 milligram(s) - gonadotropin releasing hormone analogues; triptorelin

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

merck sharp & dohme (australia) pty ltd - pneumococcal purified capsular polysaccharides, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; phenol; sodium chloride - pneumovax 23 is indicated for immunisation of individuals in the following situations: all individuals over the age of 65 years; individuals with asplenia, either functional or anatomical, including sickle cell disease, in persons more than 2 years of age; where possible the vaccine should be given at least 14 days before splenectomy; immunocompromised patients at increased risk of pneumococcal disease (eg patients with hiv infection before the development of aids, nephrotic syndrome, multiple myeloma, lymphoma, hodgkin's disease and organ transplantation); aboriginal and torres strait islander people over 50 years of age; immunocompetent persons at increased risk of complications from pneumococcal disease because of chronic illness (eg chronic cardiac, renal or pulmonary disease, diabetes mellitus, alcoholism and cirrhosis); patients with cerebrospinal fluid leaks. in australia, the national health and medical research council (nhmrc) currently recommends the vaccination of tobacco smokers with the 23-valent

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

upl australia pty ltd - bifenthrin; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - bifenthrin pyrethroid active 100.0 g/l; n-methyl-2-pyrrolidone solvent other 50.0 g/l; liquid hydrocarbon solvent other 567.5 g/l - insecticide - apricot | banana | barley | canola | citrus | clover | commercial building/structure - external | cotton | domestic building/str - african black beetle | ant | apple dimpling bug - c. liebknechti | argentine stem weevil | banana rust thrip | banana weevil borer | bill bug | black or black house ant | blue oat or pea mite | brown pasture looper | bryobia mite - bryobia spp. | carmine mite | carpophilus beetle | citrus leaf-eating weevil | coastal brown ant | cockroach | corn earworm | cotton budworm or bollworm | false wireworm | fig longicorn | flea | fly | funnel ant | green mirid bug | lawn armyworm | longtailed mealy bug | meat ant | mosquito | native budworm or bollworm | paper nest wasp | pasture webworm | redlegged earth mite | sod webworm | spider | stinging ant | strawberry spider mite | subterranean termite - coptotermes spp. | sugar ant | sugarcane wireworm - agrypnus variabilis | tick | tick - except paralysis tick | tomato russet mite | two spotted mite | vegetable weevil | whitefly | adult mosquitoes | argentine ant | banana spider mite | banded sugar ant | billbug | campylomma livida | coptotermes acinaciformis | coptoterme

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

amgrow pty ltd - bifenthrin; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - bifenthrin pyrethroid active 100.0 g/l; n-methyl-2-pyrrolidone solvent other 50.0 g/l; liquid hydrocarbon solvent other 567.5 g/l - insecticide - apricot | banana | barley | canola | citrus | clover | commercial building/structure - external | cotton | domestic building/str - african black beetle | ant | apple dimpling bug - c. liebknechti | argentine stem weevil | banana rust thrip | banana weevil borer | bill bug | black or black house ant | blue oat or pea mite | brown pasture looper | bryobia mite - bryobia spp. | carmine mite | carpophilus beetle | citrus leaf-eating weevil | coastal brown ant | cockroach | corn earworm | cotton budworm or bollworm | false wireworm | fig longicorn | flea | fly | funnel ant | green mirid bug | lawn armyworm | longtailed mealy bug | meat ant | mosquito | native budworm or bollworm | paper nest wasp | pasture webworm | redlegged earth mite | sod webworm | spider | stinging ant | strawberry spider mite | subterranean termite - coptotermes spp. | sugar ant | sugarcane wireworm - agrypnus variabilis | tick | tick - except paralysis tick | tomato russet mite | two spotted mite | vegetable weevil | whitefly | adult mosquitoes | argentine ant | banana spider mite | banded sugar ant | billbug | campylomma livida | coptotermes acinaciformis | coptoterme

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

4 farmers australia pty ltd - diflufenican; mcpa present as the ethyl hexyl ester; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - diflufenican anilide/aniline-nicotinanilide active 25.0 g/l; mcpa present as the ethyl hexyl ester phenoxy acids-mcpa-ester active 250.0 g/l; n-methyl-2-pyrrolidone solvent other 150.0 g/l; liquid hydrocarbon solvent other 330.0 g/l - herbicide - barley | cereal rye | cereal undersown with clover | clover - seed production | clover for hay production | established clover b - canola - brassica napus | capeweed | charlock | chickweed - suppression | common sowthistle - suppression | corn gromwell, ironweed or sheepweed | cowvine - suppression | crassula | deadnettle | denseflower fumitory | dock - suppression | doublegee - suppression | fat hen - suppression | fireweed - suppression | fumitory | hedge or wild mustard | hexham scent - suppression | horehound - suppression | hyssop loosestrife - suppression | iceplant - suppression | indian hedge mustard | london rocket | long storksbill - suppression | marshmallow - suppression | mouse-ear chickweed - suppression | night-scented stock - suppression | paterson's curse - suppression | peppercress - suppression | prickly lettuce | purple goosefoot | rough poppy - suppression | saffron thistle | saffron thistle - suppression | scarlet pimpernel - suppression | shepherd's purse | skeleton weed - suppression | sorrel | stemless thistle - suppression | toad rush | tree hogweed - suppression | turnip weed | variegated thistle - suppression