United States - English - 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

Philippines - English - FDA (Food And Drug Administration)

glaxosmithkline consumer healthcare philippines, inc. - multivitamins , zinc , copper - film-coated tablet - formulation: each film-coated tablet contains: ascorbic acid (vitamin c)-500 mg niacinamide (vitamin b3)-100 mg pantothenic acid (as calcium pantothenate) (vitamin b5)-20 mg thiamine hydrochloride (vitamin b1)-15 mg zinc (as zinc oxide)-15 mg riboflavin (vitamin b2)-10 mg pyridoxine (as hydrochloride) (vitamin b6)-5 mg copper ( as cupric sulphate anhydrous)-500 mcg folic acid (vitamin b9)-400 mcg biotin (vitamin b7)-45 mcg cyanocobalamin (vitamin b12)-12 mcg al-alpha tocopheryl acetate (vitamin e) -30 iu

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg;   - powder for inhalation - 62.5 mcg - active: umeclidinium bromide 74.2ug equivalent to umeclidinium 62.5 mcg   excipient: lactose monohydrate magnesium stearate - incruse ellipta is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).,

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

glaxosmithkline australia pty ltd - umeclidinium bromide, quantity: 74.2 microgram (equivalent: umeclidinium, qty 62.5 microgram) - inhalation, powder for - excipient ingredients: magnesium stearate; lactose monohydrate - incruse ellipta is indicated as a long term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd)

Canada - English - Health Canada

glaxosmithkline inc - umeclidinium (umeclidinium bromide) - powder - 62.5mcg - umeclidinium (umeclidinium bromide) 62.5mcg - antimuscarinics antispasmodics

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - umeclidinium bromide - inhalation powder - 65microgram/1dose

Philippines - English - FDA (Food And Drug Administration)

glaxosmithkline consumer healthcare philippines, inc. - multivitamins , zinc , copper - film-coated tablet - formulation: ascorbic acid (vitamin c)-300mg niacinamide (vitamin b3)-66mg thiamine mononitrate (vitamin b1)-33mg dl-alpha tocopheryl acetate (vitamin e)-30mg riboflavin (vitamin b2)-30mg pantothenic acid (as calcium pantothenate) (vitamin b5)-20mg pyridoxine hcl (vitamin b6)-13.3mg folic acid (vitamin b9)-300mcg cyanocobalamin (vitamin b12)-140mcg biotin (vitamin b7)-40mcg lutein-600mcg zinc (as oxide)-15mg copper (as cupric sulfate anhydrous)-500mcg

Canada - English - Health Canada

glaxosmithkline inc - polymyxin b (polymyxin b sulfate); bacitracin (bacitracin zinc); neomycin (neomycin sulfate); hydrocortisone - ointment - 5000unit; 400unit; 5mg; 10mg - polymyxin b (polymyxin b sulfate) 5000unit; bacitracin (bacitracin zinc) 400unit; neomycin (neomycin sulfate) 5mg; hydrocortisone 10mg - antibiotics

Canada - English - Health Canada

glaxosmithkline inc - polymyxin b (polymyxin b sulfate); bacitracin (bacitracin zinc); neomycin (neomycin sulfate) - ointment - 5000unit; 400unit; 3.5mg - polymyxin b (polymyxin b sulfate) 5000unit; bacitracin (bacitracin zinc) 400unit; neomycin (neomycin sulfate) 3.5mg - antibiotics