Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - flunisolide - spray - 25microgram/1dose

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - flunisolide - spray - 25microgram/1dose

Izrael - angielski - Ministry of Health

megapharm ltd - macimorelin as acetate - granules for suspension - macimorelin as acetate 60 mg - macimorelin - this medicinal product is for diagnostic use only.macimorelin aeterna zentaris is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

santarus, inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - glumetza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glumetza is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/minute/1.73 m2) [see warnings and precautions ( 5.1)] . - known hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with glumetza in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were observed when metformin was administered to pregnant sprague dawley rats and rabbits during the period of organogenesis at doses up to 3 and 1 times, respectively, a 2,000 mg clinical dose, based on body surface area [see data]. the estimated background risk of major birth defects is 6–10% in women with pregestational diabetes mellitus with an hba1c >7 and has been reported to be as high as 20–25% in women with an hba1c >10. the estimated background risk of miscarriage for the indicated population is 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. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data human data published data from postmarketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. however, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. animal data metformin hcl was not teratogenic or embyrolethal when administered to rats prior to pregnancy through the period of organogenesis at doses up to 900 mg/kg, or when administered to rabbits during the period of organogenesis at doses up to 90 mg/kg. risk summary limited published studies report that metformin is present in human milk [see data]. however, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glumetza and any potential adverse effects on the breastfed child from glumetza or from the underlying maternal condition. data published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. however, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. discuss the potential for unintended pregnancy with premenopausal women as therapy with glumetza may result in ovulation in some anovulatory women. safety and effectiveness of glumetza in pediatric patients have not been established. clinical studies of glumetza did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 other drug therapy and the higher risk of lactic acidosis. assess renal function more frequently in elderly patients [see dosage and administration ( 2.2) and warnings and precautions ( 5.1)]. metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. glumetza is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (egfr) below 30 ml/minute/1.73 m2 [see dosage and administration ( 2.2), contraindications ( 4), warnings and precautions ( 5.1), and clinical pharmacology ( 12.3)]. use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. glumetza is not recommended in patients with hepatic impairment [see warnings and precautions ( 5.1)].

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

santarus, inc. - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate 40 mg - fenoglide® is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides (tg), and apolipoprotein b (apo b), and to increase high-density lipoprotein (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. fenoglide is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g., >2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenoglide therapy on reducing this risk has not been adequately studied. fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see warnings and precautions (5.1)

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

santarus, inc. - conestat alfa (unii: 5qs67n4551) (conestat alfa - unii:5qs67n4551) - conestat alfa 2100 u - ruconest is a c1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (hae). limitation of use:  effectiveness was not established in hae patients with laryngeal attacks. pregnancy category b. studies performed in rats and rabbits at doses up to 12.5 times the human dose of 50 u/kg could not exclude an effect on embryofetal development. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, ruconest should only be used during pregnancy if clearly needed. the safety and efficacy of ruconest administration prior to or during labor and delivery have not been established. use only if clearly needed. it is not known if ruconest is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ruconest is administered to a nursing woman. the safety and efficacy of ruconest were evaluated

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

santarus, inc. - bromocriptine mesylate (unii: ffp983j3od) (bromocriptine - unii:3a64e3g5zo) - bromocriptine 0.8 mg - cycloset is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use - cycloset should not be used to treat type 1 diabetes or diabetic ketoacidosis. - limited efficacy data in combination with thiazolidinediones. - efficacy has not been confirmed in combination with insulin. cycloset is contraindicated in: - patients with known hypersensitivity to bromocriptine, ergot-related drugs, or any of the excipients in cycloset. - patients with syncopal migraine. bromocriptine increases the likelihood of a hypotensive episode among patients with syncopal migraine. loss of consciousness during a migraine may reflect dopamine receptor hypersensitivity. cycloset is a dopamine receptor agonist and may, therefore, potentiate the risk for syncope in these patients. - postpartum patients. serious and life-threatening adverse reactions have been reported with bromocriptine use in this population [see warnings and precautions (5.7), adverse reactions

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

santarus inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 9 mg - uceris® extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. uceris is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of uceris. anaphylactic reactions have occurred with other budesonide formulations [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations (see clinical considerations). in animal reproduction studies with pregnant rats and rabbits, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats and rabbits at these dose levels (see data ). based on animal da

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

syntara limited - mannitol, quantity: 40 mg - inhalation, powder for - excipient ingredients: - to assist in the treatment of bronchiectasis to assist in the treatment of cystic fibrosis identification of bronchial hyperresponsiveness to inhaled mannitol

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

syntara limited - mannitol, quantity: 40 mg - inhalation, powder for - excipient ingredients: gelatin - identifying bronchial hyper-responsiveness in subjects with a baseline fev1 of 70% or more of the predicted value for adults. the osmohale test should not be used in patients below 6 years of age due to their inability to provide reproducible spirometric measurements. there is limited information on the use of osmohale in patients 6-18 years of age therefore osmohale is not recommended in this population.