Canada - English - Health Canada

mega-lab manufacturing co ltd - calcium hypochlorite - tablet - 54.4% - calcium hypochlorite 54.4% - disinfectants (for agents used on object)

Canada - English - Health Canada

mega-lab manufacturing co ltd - triethylene glycol; alcohol anhydrous; o-phenylphenol; p-tert-pentylphenol - aerosol - 4.66%; 50.16%; 0.10%; 0.03% - triethylene glycol 4.66%; alcohol anhydrous 50.16%; o-phenylphenol 0.10%; p-tert-pentylphenol 0.03% - disinfectants (for agents used on object)

Israel - English - Ministry of Health

bayer israel ltd - moxifloxacin as hydrochloride - film coated tablets - moxifloxacin as hydrochloride 0.4 g - moxifloxacin - moxifloxacin - for the treatment of the following bacterial infections in patients of 18 years and older• respiratory infections : - uncomplicated acute bacterial sinusitis (abs) - acute exacerbations of chronic bronchitis (aecb) megaxin tablets should be used to treat adequately diagnosed abs and aecb only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection. - community acquired pneumonia, except severe cases. megaxin tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection. • community-acquired spontaneous and wound infections of the skin and skin structure.appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with megaxin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.consideration should be given to official guidance on the appropriate use of antibacterial agents.

Israel - English - Ministry of Health

bayer israel ltd - moxifloxacin as hydrochloride - film coated tablets - moxifloxacin as hydrochloride 0.4 g - moxifloxacin - moxifloxacin - for the treatment of the following bacterial infections in patients of 18 years and older• respiratory infections : - uncomplicated acute bacterial sinusitis (abs) - acute exacerbations of chronic bronchitis (aecb) megaxin tablets should be used to treat adequately diagnosed abs and aecb only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection. - community acquired pneumonia, except severe cases. megaxin tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection. • community-acquired spontaneous and wound infections of the skin and skin structure.appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with megaxin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.consideration should be given to official guidance on the appropriate use of antibacterial agents.

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

omegapharm - acetylcysteine, quantity: 800 mg - solution - excipient ingredients: hydrochloric acid; water for injections; disodium edetate; sodium hydroxide - adjuvant therapy for patients with abnormal, viscid or inspissated mucous secretions in such conditions as: - chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung); - acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis); - pulmonary complications of cystic fibrosis; - pulmonary complications associated with surgery; - post-traumatic chest conditions; - atelectasis due to mucus obstruction; - tracheostomy care; - anaesthesia. acetylcysteine may also be used as an adjunct to diagnostic bronchial studies (bronchograms, bronchospirometry and bronchial wedge catheterisation).

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

omegapharm - acetylcysteine, quantity: 2000 mg - solution - excipient ingredients: disodium edetate; sodium hydroxide; water for injections; hydrochloric acid - adjuvant therapy for patients with abnormal, viscid or inspissated mucous secretions in such conditions as: - chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung); - acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis); - pulmonary complications of cystic fibrosis; - pulmonary complications associated with surgery; - post-traumatic chest conditions; - atelectasis due to mucus obstruction; - tracheostomy care; - anaesthesia. acetylcysteine may also be used as an adjunct to diagnostic bronchial studies (bronchograms, bronchospirometry and bronchial wedge catheterisation).

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

par pharmaceutical inc. - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 900 mg - omega-3-acid ethyl esters capsules, usp are indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (≥500 mg/dl) hypertriglyceridemia (htg). usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, usp and should continue this diet during treatment with omega-3-acid ethyl esters capsules, usp. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting  therapy with omega-3-acid ethyl esters. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug ther

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

golden state medical supply, inc. - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 900 mg - -  omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (≥500 mg/dl) hypertriglyceridemia (htg). -   usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters. -  laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. -  

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

northstar rx llc - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 1 g - omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg per dl) hypertriglyceridemia (htg). usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceri

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

amneal pharmaceuticals llc - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 1 g - omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg/dl) hypertriglyceridemia. usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of tg-lowering drug therapy. limitations of use: the effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. the effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. risk summary the available data from published case reports and the pharmacovigilance database on the use of omega-3-acid ethyl esters in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, omega-3-acid ethyl esters given orally to female rats prior to mating through lactation did not have adverse effects on reproduction or development when given at doses 5 times the maximum recommended human dose (mrhd) of 4 grams/day, based on a body surface area comparison. omega-3-acid ethyl esters given orally to rats and rabbits during organogenesis was not teratogenic at clinically relevant exposures, based on body surface area comparison (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. data animal data: in female rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) beginning 2 weeks prior to mating through lactation, no adverse effects were observed at 2,000 mg/kg/day (5 times the mrhd based on body surface area [mg/m2 ]). in a dose-ranging study, female rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) beginning 2 weeks prior to mating through postpartum day 7 had decreased live births (20% reduction) and pup survival to postnatal day 4 (40% reduction) at or greater than 3,000 mg/kg/day in the absence of maternal toxicity at 3,000 mg/kg/day (7 times the mrhd based on body surface area [mg/m2 ]). in pregnant rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses at a maternally toxic dose (increased food consumption) of 6,000 mg/kg/day (14 times the mrhd based on body surface area [mg/m2 ]). in pregnant rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) from gestation day 14 through lactation day 21, no adverse effects were observed at 2,000 mg/kg/day (5 times the mrhd based on body surface area [mg/m2 ]). in pregnant rabbits given oral doses of omega-3-acid ethyl esters (375, 750, or 1,500 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses given 375 mg/kg/day (2 times the mrhd based on body surface area [mg/m2 ]). however, at higher doses, increases in fetal skeletal variations and reduced fetal growth were evident at maternally toxic doses (reduced food consumption and body weight gain) greater than or equal to 750 mg/kg/day (4 times the mrhd), and embryolethality was evident at 1,500 mg/kg/day (7 times the mrhd). risk summary published studies have detected omega-3 fatty acids, including epa and dha, in human milk. lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. there are no data available on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for omega-3-acid ethyl esters and any potential adverse effects on the breastfed child from omega-3-acid ethyl esters or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. a limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters. safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.