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

astellas pharma australia pty ltd - tacrolimus, quantity: 5 mg - capsule, modified release - excipient ingredients: lactose monohydrate; titanium dioxide; hypromellose; sodium lauryl sulfate; iron oxide red; magnesium stearate; iron oxide yellow; ethylcellulose; gelatin; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; shellac; strong ammonia solution; sulfuric acid - prograf-xl is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

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

astellas pharma australia pty ltd - tacrolimus, quantity: 1 mg - capsule, modified release - excipient ingredients: hypromellose; iron oxide yellow; gelatin; sodium lauryl sulfate; titanium dioxide; ethylcellulose; iron oxide red; magnesium stearate; lactose monohydrate; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; shellac; strong ammonia solution; sulfuric acid - prograf-xl is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

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

astellas pharma australia pty ltd - tacrolimus, quantity: 0.5 mg - capsule, modified release - excipient ingredients: iron oxide yellow; hypromellose; iron oxide red; titanium dioxide; lactose monohydrate; ethylcellulose; magnesium stearate; sodium lauryl sulfate; gelatin; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; shellac; strong ammonia solution; sulfuric acid - prograf-xl is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.

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

astellas pharma australia pty ltd - tacrolimus, quantity: 0.5 mg - capsule, hard - excipient ingredients: lactose monohydrate; croscarmellose sodium; purified water; iron oxide yellow; magnesium stearate; hypromellose; titanium dioxide; gelatin; hyprolose; butan-1-ol; iron oxide red; industrial methylated spirit; simethicone; lecithin; ethanol; shellac; strong ammonia solution; sulfuric acid - prograf is indicated for use as an adjunct to liver, kidney, heart or lung allograft transplantation in adults and children.

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

astellas pharma australia pty ltd - tacrolimus, quantity: 5 mg/ml - injection, concentrated - excipient ingredients: peg-60 hydrogenated castor oil; ethanol - prograf is indicated for use as an adjunct to liver, kidney, heart or lung allograft transplantation in adults and children.

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

astellas pharma australia pty ltd - tacrolimus, quantity: 5 mg - capsule, hard - excipient ingredients: lactose monohydrate; hypromellose; iron oxide red; gelatin; magnesium stearate; titanium dioxide; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; strong ammonia solution; sulfuric acid - prograf is indicated for use as an adjunct to liver, kidney, heart or lung allograft transplantation in adults and children.

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

astellas pharma australia pty ltd - tacrolimus, quantity: 1 mg - capsule, hard - excipient ingredients: titanium dioxide; croscarmellose sodium; hypromellose; magnesium stearate; lactose monohydrate; gelatin; purified water; hyprolose; butan-1-ol; iron oxide red; industrial methylated spirit; simethicone; lecithin; ethanol; shellac; strong ammonia solution; sulfuric acid - prograf is indicated for use as an adjunct to liver, kidney, heart or lung allograft transplantation in adults and children.

United States - English - NLM (National Library of Medicine)

lake erie medical & surgical supply dba quality care products llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - proair hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other proair hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6 )] . teratogenic effects: pregnancy category c: there are no adequate and well-controlled studies of proair hfa inhalation aerosol or albuterol sulfate in pregnant women. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients treated with albuterol. some of the mothers were tak

United States - English - NLM (National Library of Medicine)

teva respiratory, llc - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - proair hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other proair hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. for more information, contact the mothers to baby pregnancy studies conducted by the organization of teratology information specialists at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. risk summary there are no randomized clinical studies of use of albuterol during pregnancy. available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. there are clinical considerations with use of albuterol in pregnant women [see clinical considerations] . in animal reproduction studies, when albuterol sulfate was administered subcutaneously to pregnant mice there was evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (mrhdid) [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) are 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 embryo/fetal risk in women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia 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. labor or delivery because of the potential for beta-agonist interference with uterine contractility, use of proair hfa inhalation aerosol for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. proair hfa inhalation aerosol has not been approved for the management of pre-term labor. serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2 -agonists, including albuterol. data animal data in a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure nine-tenths of the mrhdid for adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the mrhdid (on a mg/m2 basis at a maternal dose of 2.5 mg/kg). similar effects were not observed at approximately one-eleventh the mrhdid for adults (on a mg/m2 basis at a maternal dose of 0.025 mg/kg).  cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). in a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the mrhdid (on a mg/m2 basis at a maternal dose of 50 mg/kg).  in a rat reproduction study, an albuterol sulfate/hfa-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 80 times the mrhdid (on a mg/m2 basis at a maternal dose of 10.5 mg/kg). a study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. risk summary there are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production. however, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability [see clinical pharmacology (12.2)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albuterol and any potential adverse effects on the breastfed child from albuterol or from the underlying maternal condition. the safety and effectiveness of proair hfa inhalation aerosol for the treatment or prevention of bronchospasm in children 12 years of age and older with reversible obstructive airway disease is based on one 6-week clinical trial in 116 patients 12 years of age and older with asthma comparing doses of 180 mcg four times daily with placebo, and one single-dose crossover study comparing doses of 90, 180, and 270 mcg with placebo in 58 patients [see clinical studies (14.1) ] . the safety and effectiveness of proair hfa inhalation aerosol for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single-dose crossover study in 24 adults and adolescents with exercise-induced bronchospasm comparing doses of 180 mcg with placebo [see clinical studies (14.2) ]. the safety of proair hfa inhalation aerosol in children 4 to 11 years of age is based on one 3-week clinical trial in 50 patients 4 to 11 years of age with asthma using the same formulation of albuterol as in proair hfa inhalation aerosol comparing doses of 180 mcg four times daily with placebo. the effectiveness of proair hfa inhalation aerosol in children 4 to 11 years of age is extrapolated from clinical trials in patients 12 years of age and older with asthma and exercise-induced bronchospasm, based on data from a single-dose study comparing the bronchodilatory effect of proair hfa 90 mcg and 180 mcg with placebo in 55 patients with asthma and a 3-week clinical trial using the same formulation of albuterol as in proair hfa inhalation aerosol in 95 asthmatic children 4 to 11 years of age comparing a dose of 180 mcg albuterol four times daily with placebo [see clinical studies (14.1) ]. the safety and effectiveness of proair hfa inhalation aerosol in pediatric patients below the age of 4 years have not been established. clinical studies of proair hfa inhalation aerosol did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between elderly and younger patients. 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 [see warnings and precautions (5.4, 5.7) ] . all beta2 -adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

United States - English - NLM (National Library of Medicine)

proficient rx lp - albuterol sulfate (unii: 021sef3731) (albuterol - unii:qf8svz843e) - albuterol 90 ug - proair hfa inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. proair hfa inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. proair hfa inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other proair hfa inhalation aerosol components. rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see warnings and precautions (5.6) ] . teratogenic effects: pregnancy category c: there are no adequate and well-controlled studies of proair hfa inhalation aerosol or albuterol sulfate in pregnant women. during worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients treated with albuterol. some of the mothers were tak