Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - fluticasone furoate (unii: js86977wnv) (fluticasone - unii:cut2w21n7u) - fluticasone furoate 100 ug - arnuity ellipta is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. limitations of use arnuity ellipta is not indicated for the relief of acute bronchospasm. arnuity ellipta is contraindicated in the following conditions: risk summary there are insufficient data on the use of arnuity ellipta in pregnant women to inform a drug-associated risk (see clinical considerations) . in animal reproduction studies, fluticasone furoate administered by inhalation to rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest fluticasone furoate doses in the rat and rabbit studies were 4 times and 1 time, respectively, the maximum recommended human daily inhalation dose (mrhdid) (see data.) . the estimated risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk: in women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. data animal data: fluticasone furoate : in 2 separate embryofetal developmental studies, pregnant rats and rabbits received fluticasone furoate during the period of organogenesis at doses up to approximately 4 and 1 times, respectively, the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 91 and 8 mcg/kg/day, respectively). no evidence of structural abnormalities in fetuses was observed in either species. in a perinatal and postnatal developmental study in rats, dams received fluticasone furoate during late gestation and lactation periods at doses up to approximately 1 time the mrhdid (on a mcg/m2 basis at maternal inhalation doses up to 27 mcg/kg/day). no evidence of effects on offspring development was observed. risk summary there is no information available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production. low concentrations of other ics have been detected in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for arnuity ellipta and any potential adverse effects on the breastfed child from fluticasone furoate or from the underlying maternal condition. the safety and effectiveness of arnuity ellipta for maintenance treatment of asthma have been established in pediatric patients aged 5 years and older. use of arnuity ellipta for this indication in patients 12 years of age and older is supported by evidence from 4 adequate and well-controlled trials in adult and pediatric patients 12 years of age and older. use of arnuity ellipta for this indication in patients 5 to 11 years of age is supported by evidence from an adequate and well-controlled trial in patients 5 to 11 years of age [see dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.2)] . the safety and effectiveness of arnuity ellipta have not been established in pediatric patients less than 5 years of age. effects on growth orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. a reduction of growth velocity in these patients may occur as a result of poorly controlled asthma or from use of corticosteroids, including ics. the effects of long-term treatment of pediatric patients with ics, including fluticasone furoate, on final adult height are not known. controlled clinical trials have shown that ics may cause a reduction in growth in children. in these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appears to be related to dose and duration of exposure. this effect has been observed in the absence of laboratory evidence of hpa axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. the potential for “catch-up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied. the growth of pediatric patients receiving orally inhaled corticosteroids, including arnuity ellipta, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. to minimize the systemic effects of orally inhaled corticosteroids, including arnuity ellipta, each patient should be titrated to the lowest dose that effectively controls his/her symptoms. a randomized, double-blind, parallel-group, multicenter, 1-year, placebo-controlled trial evaluated the effect of once-daily treatment with arnuity ellipta 50 mcg on growth velocity assessed by stadiometry. the subjects were 457 prepubertal children (girls aged 5 to younger than 8 years and boys aged 5 to younger than 9 years). mean growth velocity over the 52-week treatment period was lower in the subjects receiving arnuity ellipta (5.90 cm/year) compared with placebo (6.06 cm/year). the mean difference in growth velocity was -0.16 cm/year (95% ci: -0.46, 0.14) [see warnings and precautions (5.10)] . for the 4 confirmatory trials, 71 subjects were aged 65 years and older (56 of which were treated with arnuity ellipta) and 5 were aged 75 years and older (1 of which was treated with arnuity ellipta) [see clinical studies (14.2)] . based on available data, no adjustment of the dosage of arnuity ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. clinical trials of arnuity ellipta did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and 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. fluticasone furoate systemic exposure increased by up to 3-fold in adult subjects with hepatic impairment compared with healthy subjects. use arnuity ellipta with caution in patients with moderate or severe hepatic impairment. monitor patients for corticosteroid-related side effects. the effect of hepatic impairment on fluticasone furoate systemic exposure in subjects aged younger than 18 years has not been evaluated [see clinical pharmacology (12.3)] . there were no significant increases in fluticasone furoate exposure in subjects with severe renal impairment (crcl <30 ml/min) compared with healthy subjects. no dosage adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] . instructions for use arnuity ellipta (ar-new-i-te e-lip-ta) (fluticasone furoate inhalation powder) for oral inhalation use read this before you start: your arnuity ellipta inhaler how to use your inhaler figure a figure b important notes: check the counter. see figure c. figure c prepare your dose: wait to open the cover until you are ready to take your dose. figure d figure e figure f figure g figure h figure i figure j figure k important note: when should you get a refill? figure l for more information about arnuity ellipta or how to use your inhaler, call 1-888-825-5249. trademarks are owned by or licensed to the gsk group of companies. glaxosmithkline, durham, nc 27701 ©2023 gsk group of companies or its licensor. arn:2ifu this instructions for use has been approved by the u.s. food and drug administration          revised: march 2023

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - umeclidinium bromide (unii: 7an603v4jv) (umeclidinium - unii:ge2t1418sv) - umeclidinium 62.5 ug - incruse ellipta is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). incruse ellipta is contraindicated in the following conditions: risk summary there are insufficient data on the use of umeclidinium in pregnant women to inform a drug‑associated risk. umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (mrhdid). (see data.) the estimated risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data: in separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the mrhdid, respectively (on an auc basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits). no evidence of teratogenic effects was observed in either species. in a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods with no evidence of effects on offspring development at doses up to approximately 26 times the mrhdid (on an auc basis at maternal subcutaneous doses up to 60 mcg/kg/day). risk summary there is no information available on the presence of umeclidinium in human milk, the effects on the breastfed child, or the effects on milk production. umeclidinium was detected in the plasma of offspring of lactating rats treated with umeclidinium suggesting its presence in maternal milk. (see data.) the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for incruse ellipta and any potential adverse effects on the breastfed child from umeclidinium or from the underlying maternal condition. data subcutaneous administration of umeclidinium to lactating rats at greater than or equal to 60 mcg/kg/day resulted in a quantifiable level of umeclidinium in 2 of 54 pups, which may indicate transfer of umeclidinium in milk. the safety and effectiveness of incruse ellipta have not been established in pediatric patients. incruse ellipta is not indicated for use in pediatric patients. based on available data, no adjustment of the dosage of incruse ellipta in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. clinical trials of incruse ellipta included 810 subjects aged 65 years and older, and, of those, 183 subjects were aged 75 years and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects. patients with moderate hepatic impairment (child-pugh score of 7-9) showed no relevant increases in cmax or auc, nor did protein binding differ between subjects with moderate hepatic impairment and their healthy controls. studies in subjects with severe hepatic impairment have not been performed [see clinical pharmacology (12.3)] . patients with severe renal impairment (crcl <30 ml/min) showed no relevant increases in cmax or auc, nor did protein binding differ between subjects with severe renal impairment and their healthy controls. no dosage adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] . instructions for use incruse ellipta (in-cruise e-lip-ta) (umeclidinium inhalation powder) for oral inhalation use read this before you start: your incruse ellipta inhaler how to use your inhaler figure a figure b important notes: check the counter. see figure c. figure c prepare your dose: wait to open the cover until you are ready to take your dose. figure d step 1. open the cover of the inhaler. see figure d. figure e step 2. breathe out. see figure e. figure f step 3. inhale your medicine. see figure f. figure g figure h figure i step 4. breathe out slowly and gently. see figure i. figure j step 5. close the inhaler. see figure j. important note: when should you get a refill? figure k for more information about incruse ellipta or how to use your inhaler, call 1-888-825-5249. trademarks are owned by or licensed to the gsk group of companies. glaxosmithkline, durham, nc 27701 ©2023 gsk group of companies or its licensor. inc:3ifu this instructions for use has been approved by the u.s. food and drug administration               revised: december 2023

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline llc - hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th), triamterene (unii: ws821z52lq) (triamterene - unii:ws821z52lq) - hydrochlorothiazide 25 mg - this fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. dyazide is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. dyazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. dyazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. since dyazide may enhance the action of these agents, dosage adjustments may be necessary. the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathological causes or from the physiologic and mechanical conseque

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - salbutamol sulphate eqv salbutamol - solution - 0.5% w/v - salbutamol sulphate eqv salbutamol 0.5% w/v

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - major depressive disorder: bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical trials). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure 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,

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human, immunization, disease outbreaks - vaccines, - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.,

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - retigabine - tablet, film coated - 100.0 mg

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - retigabine - tablet, film coated - 200.0 mg

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - retigabine - tablet, film coated - 300.0 mg