Verenigde Staten - Engels - NLM (National Library of Medicine)

american regent, inc. - estradiol valerate (unii: okg364o896) (estradiol - unii:4ti98z838e) - estradiol valerate injection is indicated in the: 1.    treatment of moderate to severe vasomotor symptoms associated with the menopause. 2.    treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.  when prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3.    treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4.    treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). estradiol valerate injection should not be used in women with any of the following conditions: 1.    undiagnosed abnormal genital bleeding. 2.    known, suspected, or history of cancer of the breast. 3.    known or suspected estrogen-dependent neoplasia. 4.    active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5.    active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial i

Verenigde Staten - Engels - NLM (National Library of Medicine)

bryant ranch prepack - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - fluocinonide cream usp, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see use in specific populations (8.4) ]. treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. therapy should be discontinued when control of the disease is achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. do not use more than half of the 120 g tube per week. fluocinonide cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. none. teratogenic effects pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluocinonide

Verenigde Staten - Engels - NLM (National Library of Medicine)

bryant ranch prepack - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - fluocinonide cream usp, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see use in specific populations (8.4) ]. treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. therapy should be discontinued when control of the disease is achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. do not use more than half of the 120 g tube per week. fluocinonide cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. none. teratogenic effects pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluocinonide

Verenigde Staten - Engels - NLM (National Library of Medicine)

bryant ranch prepack - fluocinonide (unii: 2w4a77ypan) (fluocinonide - unii:2w4a77ypan) - fluocinonide cream usp, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see use in specific populations (8.4) ]. treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. therapy should be discontinued when control of the disease is achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. do not use more than half of the 120 g tube per week. fluocinonide cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. none. teratogenic effects pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluocinonide

Verenigde Staten - Engels - NLM (National Library of Medicine)

northwind pharmaceuticals, llc - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram tablet is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see clinical studies ( 14.1) ]. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. escitalopram tablet, is indicated for the acute treatment of generalized anxiety disorder (gad) in adults [ see clinical studies ( 14.2) ]. generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectati

Verenigde Staten - Engels - NLM (National Library of Medicine)

slate run pharmaceuticals, llc - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride extended-release capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation . risk  summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules in pregnant women.  adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride extended-release capsules  [see  data]. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal  data oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats during the period of organogenesis resulted in decreased skeletal ossificationin fetuses at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg) is 2 times the maximum recommended human daily dose (mrhd) of memantine hydrochloride extended-release capsules (28 mg) on a body surface area (mg/m 2 ) basis.  oral administration of memantine to rabbits (0, 3, 10, or 30 mg/kg/day) during the period of organogenesis resulted in no adverse developmental effects. the highest dose tested is approximately 20 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m 2  basis. in rats, memantine (0, 2, 6, or 18 mg/kg/day) was administered orally prior to and throughout mating and, in females, through the period of organogenesis or continuing throughout lactation to weaning. decreased skeletal ossification in fetuses and decreased body weight in pups were observed at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg/day) is 2 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m 2  basis. oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats from late gestation throughout lactation to weaning, resulted in decreased pup weights at the highest dose tested. the higher no-effect dose (6 mg/kg/day) is approximately 2 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m 2  basis. risk  summary there are no data on the presence of memantine in human milk, the effects on the breastfed infant, or the effects of memantine hydrochloride extended-release capsules on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for memantine hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from memantine hydrochloride extended-release capsules or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6 to 12 years with autism spectrum disorders (asd), including autism, asperger’s disorder and pervasive development disorder-not otherwise specified (pdd-nos).memantine has not been studied in pediatric patients under 6 years of age or over 12 years of age. memantine treatment was initiated at 3 mg/day and the dose was escalated to the target dose (weight-based) by week 6. oral doses of memantine 3, 6, 9, or 15 mg extended-release capsules were administered once daily to patients with weights <20 kg, 20 to 39 kg, 40 to 59 kg and ≥60 kg, respectively. in a randomized, 12-week double-blind, placebo-controlled parallel study (study a) in patients with autism, there was no statistically significant difference in the social responsiveness scale (srs) total raw score between patients randomized to memantine (n=54) and those randomized to placebo (n=53). in a 12-week responder-enriched randomized withdrawal study (study b) in 471 patients with asd, there was no statistically significant difference in the loss of therapeutic response rates between patients randomized to remain on full-dose memantine (n=153) and those randomized to switch to placebo (n=158). the overall safety profile of memantine in pediatric patients was generally consistent with the known safety profile in adults [see adverse reactions ( 6.1 )] . in study a, the adverse reactions in the memantine group (n=56) that were reported in at least 5% of patients and at least twice the frequency of the placebo group (n=58) are listed in table 2. the adverse reactions that were reported in at least 5% of patients in the 12 to 48 week open-label study to identify responders to enroll in study b are listed in table 3. in the randomized withdrawal study (study b), the adverse reaction in patients randomized to placebo (n=160) and reported in at least 5% of patients and twice that of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a juvenile animal study, male and female juvenile rats were administered memantine (15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 14 through pnd 70. body weights were reduced at 45 mg/kg/day. delays in sexual maturation were noted in male and female rats at doses ≥30 mg/kg/day. memantine induced neuronal lesions in several areas of the brain on pnd 15 and 17 at doses ≥30 mg/kg/day. behavioral toxicity (decrease percent of auditory startle habituation) was noted for animals in the 45 mg/kg/day dose group. the 15 mg/kg/day dose was considered the no-observed-adverse-effect-level (noael) for this study. in a second juvenile rat toxicity study, male and female juvenile rats were administered memantine (1, 3, 8, 15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 7 through pnd 70.  due to early memantine-related mortality, the 30 and 45 mg/kg/day dose groups were terminated without further evaluation. memantine induced apoptosis or neuronal degeneration in several areas of the brain on pnd 8, 10, and 17 at a dose of 15 mg/kg/day. the noael for apoptosis and neuronal degeneration was 8 mg/kg/day. behavioral toxicity (effects on motor activity, auditory startle habituation, and learning and memory) was noted at doses ≥3 mg/kg/day during treatment, but was not seen after drug discontinuation. therefore, the 1 mg/kg/day dose was considered the noael for the neurobehavioral effect in this study. the majority of people with alzheimer’s disease are 65 years of age and older. in the clinical study of memantine hydrochloride extended-release, the mean age of patients was approximately 77 years; over 91% of patients were 65 years and older, 67% were 75 years and older, and 14% were at or above 85 years of age. the efficacy and safety data presented in the clinical trial sections were obtained from these patients. there were no clinically meaningful differences in most adverse reactions reported by patient groups ≥65 years old and <65 years old. no dosage adjustment is needed in patients with mild or moderate renal impairment. a dosage reduction is recommended in patients with severe renal impairment [see dosage and administration ( 2.3 ) and clinical pharmacology ( 12.3 )] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride extended-release capsules were not studied in patients with severe hepatic impairment  [see clinical pharmacology ( 12.3 )] .

Zuid-Afrika - Engels - South African Health Products Regulatory Authority (SAHPRA)

macleods pharmaceuticals sa (pty) ltd - film-coated tablets - not indicated - each tablet contains tadalafil 5,0 mg

Zuid-Afrika - Engels - South African Health Products Regulatory Authority (SAHPRA)

macleods pharmaceuticals sa (pty) ltd - film-coated tablets - not indicated - each tablet contains tadalafil 20,0 mg

Armenië - Engels - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

zambon switzerland ltd. - acetylcysteine - granules for oral solution - 200mg