Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

pharmacosmos uk ltd - ferric derisomaltose - solution for injection - 100mg/1ml

États-Unis - anglais - NLM (National Library of Medicine)

bora pharmaceutical laboratories inc. - 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.comor 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 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 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.

Australie - anglais - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bec feed solutions pty ltd - ferric oxide colloidal; vitamin b12 = cyanocobalamin - parenteral liquid/solution/suspension - ferric oxide colloidal mineral-iron active 100.0 mg/ml; vitamin b12 = cyanocobalamin vitamin-b12 active 75.0 ug/ml - nutrition & metabolism - pig - piglet | neonatal piglet | new born pig | sucker pig - iron & haemopoietic agent | anaemia | haemopoietic agents | hematinic | iron deficiency

Union européenne - anglais - EMA (European Medicines Agency)

shield tx (uk) limited - ferric maltol - anemia, iron-deficiency - antianemic preparations - feraccru is indicated in adults for the treatment of iron deficiency anaemia (ida) in patients with inflammatory bowel disease (ibd).

Canada - anglais - Health Canada

nutrition zone products inc. - vitamin e (d-alpha tocopheryl acid succinate, d-alpha tocopherol); calcium (calcium citrate, calcium carbonate); magnesium (magnesium citrate); potassium (potassium citrate); manganese (manganese citrate, manganese gluconate); iron (ferric citrate); zinc (zinc citrate); copper (copper citrate, copper gluconate); iodine (kelp); chromium (chromium hvp chelate); selenium (selenium hvp chelate); vanadium (vanadium citrate) - tablet - 300unit; 500mg; 250mg; 125mg; 10mg; 5mg; 10mg; 1mg; 0.5mg; 100mcg; 100mcg; 75mcg - vitamin e (d-alpha tocopheryl acid succinate, d-alpha tocopherol) 300unit; calcium (calcium citrate, calcium carbonate) 500mg; magnesium (magnesium citrate) 250mg; potassium (potassium citrate) 125mg; manganese (manganese citrate, manganese gluconate) 10mg; iron (ferric citrate) 5mg; zinc (zinc citrate) 10mg; copper (copper citrate, copper gluconate) 1mg; iodine (kelp) 0.5mg; chromium (chromium hvp chelate) 100mcg; selenium (selenium hvp chelate) 100mcg; vanadium (vanadium citrate) 75mcg

États-Unis - anglais - NLM (National Library of Medicine)

akebia therapeutics, inc. - tetraferric tricitrate decahydrate (unii: q91187k011) (ferric cation - unii:91o4lml611) - ferric cation 210 mg - auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see warnings and precautions (5.1)] . risk summary there are no available data on auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted using auryxia. skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. however, oral administration of other ferric or ferrous compounds to gravid cd1-mice and wistar-rats caused no fetal malformation. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. clinical considerations the effect of auryxia on the absorption of vitamins and other nutrients has not been studied in pregnant women. requirements for vitamins and other nutrients are increased in pregnancy. risk summary there are no human data regarding the effect of auryxia in human milk, the effects on the breastfed child, or the effects on milk production. data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (dmt-1) and ferroportin-1 (fpn-1). hence, there is a possibility of infant exposure when auryxia is administered to a nursing woman. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for auryxia and any potential adverse effects on the breastfed child from auryxia or from the underlying maternal condition. the safety and efficacy of auryxia have not been established in pediatric patients. juvenile animal toxicity data in animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. because auryxia is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity. clinical studies of auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of auryxia.

États-Unis - anglais - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1)] , which may have serious consequences, such as fetal bradycardia (see clinical considerations) . advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. ferrlecit contains benzyl alcohol as a preservative. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is

Arménie - anglais - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

hankook korus pharm co. - ascorbic acid - tablets - 500mg

Philippines - anglais - FDA (Food And Drug Administration)

vet specialists, inc.; distributor: vet specialists, inc. - vitamins , minerals (vet.) - oral solution - formulation: each ml contains: potassium citrate............24.1 mg ferric ammonium citrate...23 mg sodium glycerophosphate... 16.3 mg manganese sulphate............2.2 mg

Kenya - anglais - Pharmacy and Poisons Board

asence pharma private limited sarabhai campus dr. vikram sarabhai marg wadi - ferric ammonium citrate 200mgmg + vit b12 50mcg +… - syrup - ferric ammonium citrate 200mgmg + vit b12 50mcg +… - other combinations of vitamin b-complex