Malta - engleski - Medicines Authority

alliance pharmaceuticals limited avonbridge house, bath road, chippenham, wiltshire sn15 2bb, united kingdom - betacarotene, chromium, folic acid, phytomenadione, ascorbic acid, copper, cyanocobalamin, biotin, ergocalciferol, dl, alfa, tocopheryl acetate, pantothenic acid, molybdenum, nicotinamide, zinc, iodine, iron, magnesium, manganese, selenium, pyridoxine, thiamine, riboflavin - soft capsule - betacarotene 1250 iu chromium 50 µg folic acid 100 µg phytomenadione 25 µg ascorbic acid 25 mg copper 1 mg cyanocobalamin 2 µg d-biotin 50 µg ergocalciferol 200 iu dl-alfa-tocopheryl acetate 5 mg pantothenic acid 2 mg molybdenum 50 µg nicotinamide 7.5 mg zinc 5 mg iodine 75 µg iron 5 mg magnesium 1 mg manganese 1.25 mg selenium 25 µg pyridoxine 1 mg thiamine 1.5 mg riboflavin 1 mg - vitamins

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

ncs healthcare of ky, llc dba vangard labs - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 25 mg - sertraline hydrochloride tablets usp are indicated for the treatment of major depressive disorder in adults. the efficacy of sertraline hydrochloride tablets usp in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical trials under clinical pharmacology). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the antidepressant action of sertraline hydrochloride tablets u

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

united airlines - sodium monofluorophosphate (unii: c810jcz56q) (fluoride ion - unii:q80vpu408o) - fluoride ion 7.6 mg in 1 g - anticavity helps protect against cavities

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

united laboratories inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - anti-microbial hand sanitizer - helps reduce bacteria that potentially can cause disease - helps prevent cross contamination by hand contact - recommended for repeated use

Australija - engleski - APVMA (Australian Pesticides and Veterinary Medicines Authority)

united phosphorus ltd. - mcpa present as the 2-ethyl hexyl ester - herbicide - barley | cereal rye | oats | pasture | triticale | wheat | high intensity usage - bathurst burr | capeweed | charlock | dandelion - taraxacum officinale | fat hen | fumitory | hedge or wild mustard | london rocket | noogoora burr | saffron thistle | scotch thistle | skeleton weed | slender, shore or sheep thistle | spear or black thistle | stinkwort | variegated thistle | wild radish or radish weed | wild sage | wild turnip | blessed thistle | brassica campestris | brassica kaber | brassica rapa ssp. sylvestris | brassica rapa var. sylvestris | brassica sinapistrum | bull thistle | cabbage thistle | carduus marianus | cockleburr | common dandelion | cotton thistle | crambling mustard | english dandelion | european dandelion | false star thistle | hedge mustard | heraldic thistle | holy thistle | jointed charlock | lady's thistle | milk thistle | pink weed | radish (wild) | sage (wild) | shore thistle | sisymbrium orientale | slender thistle | spear thistle | spotted thistle | st mary's thistle | taraxacum spp. | true dandelion | true scotch thistle | tumbling mustard | white charlock | whi

Filipini - engleski - FDA (Food And Drug Administration)

united labs inc - hydroxyzine (as hydrochloride) - tablet - 10 mg

Filipini - engleski - FDA (Food And Drug Administration)

united labs inc - hydroxyzine hydrochloride - film-coated tablet - 25 mg

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

remedyrepack inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 70 mg - alendronate sodium tablets, usp are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets, usp increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies ( 14.1).] alendronate sodium tablets, usp are indicated for the prevention of postmenopausal osteoporosis [see clinical studies ( 14.2)]. alendronate sodium tablets, usp are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies ( 14.3)]. alendronate sodium tablets, usp are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies ( 14.4)]. alendronate sodium tablets, usp are indicated for the treatment of paget's disease of bone in men and women. treatment is indicated in patients with paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease. [see clinical studies ( 14.5).] the optimal duration of use has not been determined. the safety and effectiveness of alendronate sodium for the treatment of osteoporosis are based on clinical data of four years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. alendronate sodium tablets are contraindicated in patients with the following conditions: - inability to stand or sit upright for at least 30 minutes [see dosage and administration ( 2.6); warnings and precautions ( 5.1)] - hypocalcemia [see warnings and precautions ( 5.2)] - hypersensitivity to any component of this product. hypersensitivity reactions including urticaria and angioedema have been reported [see adverse reactions ( 6.2)] . risk summary available data on the use of alendronate sodium in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. discontinue alendronate sodium when pregnancy is recognized. in animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of the highest recommended 40 mg clinical daily dose (based on body surface area, mg/m 2 ). oral administration of alendronate to rats during organogenesis resulted in reduced fetal ossification starting at doses 3 times the 40 mg clinical daily dose. no similar fetal effects were observed in pregnant rabbits dosed orally during organogenesis at doses equivalent to approximately 10 times the 40 mg clinical daily dose. delayed or failed delivery of offspring, protracted parturition, and late pregnancy maternal and fetal deaths due to maternal hypocalcemia occurred in rats at oral doses as low as one tenth the 40 mg clinical daily dose ( see data) . bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. the amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. the impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data reproduction studies in rats dosed orally from before mating to the end of gestation or lactation showed decreased postimplantation survival starting at 2 mg/kg/day and decreased body weight gain starting at 1 mg/kg/day, doses equivalent to less than half the 40 mg clinical daily dose based on body surface area, mg/m 2 . incidence of incomplete fetal ossification in vertebral, skull, and sternebral bones were increased in rats dosed orally during organogenesis starting at 10 mg/kg/day (approximately 3 times the 40 mg clinical daily dose). no similar fetal effects were observed in pregnant rabbits dosed orally during organogenesis at up to 35 mg/kg/day (equivalent to approximately 10 times the 40 mg clinical daily dose). both total and ionized calcium decreased in pregnant rats dosed orally with 15 mg/kg/day alendronate (approximately 4 times the 40 mg clinical daily dose) resulting in delays and failures of delivery. protracted parturition due to maternal hypocalcemia was observed when rats were treated from before mating through gestation starting at 0.5 mg/kg/day (approximately one tenth the 40 mg clinical daily dose). maternotoxicity (late pregnancy deaths) also occurred in the female rats treated orally with 15 mg/kg/day (approximately 4 times the 40 mg clinical daily dose) for varying gestational time periods. these maternal deaths were lessened but not eliminated by cessation of treatment. calcium supplementation in the drinking water or by subcutaneous minipump to rats dosed orally with 15 mg/kg/day alendronate could not ameliorate the hypocalcemia or prevent the dystocia-related maternal and neonatal deaths. however, intravenous calcium supplementation prevented maternal, but not neonatal deaths. risk summary it is not known whether alendronate is present in human breast milk, affects human milk production, or has effects on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for alendronate sodium and any potential adverse effects on the breastfed child from alendronate sodium or from the underlying maternal condition. alendronate sodium is not indicated for use in pediatric patients. the safety and efficacy of alendronate sodium were examined in a randomized, double-blind, placebo-controlled two-year study of 139 pediatric patients, aged 4-18 years, with severe osteogenesis imperfecta (oi). one-hundred-and-nine patients were randomized to 5 mg alendronate sodium daily (weight less than 40 kg) or 10 mg alendronate sodium daily (weight greater than or equal to 40 kg) and 30 patients to placebo. the mean baseline lumbar spine bmd z-score of the patients was -4.5. the mean change in lumbar spine bmd z-score from baseline to month 24 was 1.3 in the alendronate sodium-treated patients and 0.1 in the placebo-treated patients. treatment with alendronate sodium did not reduce the risk of fracture. sixteen percent of the alendronate sodium patients who sustained a radiologically-confirmed fracture by month 12 of the study had delayed fracture healing (callus remodeling) or fracture non-union when assessed radiographically at month 24 compared with 9% of the placebo-treated patients. in alendronate sodium-treated patients, bone histomorphometry data obtained at month 24 demonstrated decreased bone turnover and delayed mineralization time; however, there were no mineralization defects. there were no statistically significant differences between the alendronate sodium and placebo groups in reduction of bone pain. the oral bioavailability in children was similar to that observed in adults. the overall safety profile of alendronate sodium in osteogenesis imperfecta patients treated for up to 24 months was generally similar to that of adults with osteoporosis treated with alendronate sodium. however, there was an increased occurrence of vomiting in osteogenesis imperfecta patients treated with alendronate sodium compared to placebo. during the 24-month treatment period, vomiting was observed in 32 of 109 (29.4%) patients treated with alendronate sodium and 3 of 30 (10%) patients treated with placebo. in a pharmacokinetic study, 6 of 24 pediatric osteogenesis imperfecta patients who received a single oral dose of alendronate sodium 35 or 70 mg developed fever, flu-like symptoms, and/or mild lymphocytopenia within 24 to 48 hours after administration. these events, lasting no more than 2 to 3 days and responding to acetaminophen, are consistent with an acute-phase response that has been reported in patients receiving bisphosphonates, including alendronate sodium. [see adverse reactions ( 6.2).] of the patients receiving alendronate sodium in the fracture intervention trial (fit), 71% (n=2302) were greater than or equal to 65 years of age and 17% (n=550) were greater than or equal to 75 years of age. of the patients receiving alendronate sodium in the united states and multinational osteoporosis treatment studies in women, osteoporosis studies in men, glucocorticoid-induced osteoporosis studies, and paget's disease studies [see clinical studies ( 14.1), ( 14.3), ( 14.4), ( 14.5)], 45%, 54%, 37%, and 70%, respectively, were 65 years of age or over. no overall differences in efficacy or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. alendronate sodium is not recommended for patients with creatinine clearance less than 35 ml/min . no dosage adjustment is necessary in patients with creatinine clearance values between 35-60 ml/min [see clinical pharmacology ( 12.3)] . as there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. no dosage adjustment is necessary [see clinical pharmacology ( 12.3)] .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

eon labs, inc. - nizatidine (unii: p41pml4ghr) (nizatidine - unii:p41pml4ghr) - nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. in most patients, the ulcer will heal within 4 weeks. nizatidine capsules are indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. the consequences of continuous therapy with nizatidine capsules for longer than 1 year are not known. nizatidine capsules are indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to gerd. nizatidine capsules are indicated for up to 8 weeks for the treatment of active benign gastric ulcer. before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration. nizatidine is contraindicated in patients with known hypersensitivity to the drug. because cross- sensitivity in this class of compounds has been observed, h2 -receptor antagonists, including nizatidin

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

eon labs, inc. - labetalol hydrochloride (unii: 1gev3baw9j) (labetalol - unii:r5h8897n95) - labetalol hydrochloride tablets, usp are indicated in the management of hypertension. labetalol hydrochloride tablets, usp may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. labetalol hydrochloride is contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product [see warnings] . beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.