Австралія - англійська - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amlodipine besilate,atorvastatin calcium propylene glycol solvate -

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amlodipine besilate,atorvastatin calcium propylene glycol solvate -

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amlodipine besilate,atorvastatin calcium propylene glycol solvate -

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amlodipine besilate,atorvastatin calcium propylene glycol solvate -

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amlodipine besilate,atorvastatin calcium propylene glycol solvate -

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - amlodipine besilate,atorvastatin calcium propylene glycol solvate -

США - англійська - NLM (National Library of Medicine)

salix pharmaceuticals, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 100 g in 1 l - moviprep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. moviprep is contraindicated in the following conditions: risk summary there are no available data on moviprep in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with moviprep. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. risk summary there are no data available on the presence of moviprep in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk o

США - англійська - NLM (National Library of Medicine)

affordable pharmaceuticals, llc - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - polyethylene glycol 3350 420 g in 4 l - peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is contraindicated in the following conditions: - gastrointestinal (gi) obstruction, ileus, or gastric retention - bowel perforation - toxic colitis or toxic megacolon - known allergy or hypersensitivity to any component of peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [see how supplied/storage and handling ( 16)] animal reproduction studies have not been conducted with peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. it is also not known whether peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive

США - англійська - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 420 g in 438.4 g - gavilyte-n is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. gavilyte-n is contraindicated in the following conditions: - gastrointestinal (gi) obstruction, ileus, or gastric retention - bowel perforation - toxic colitis or toxic megacolon - known allergy or hypersensitivity to any component of gavilyte-n for oral solution [see how supplied/storage and handling (16)] animal reproduction studies have not been conducted with gavilyte-n. it is also not known whether gavilyte-n can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. gavilyte-n should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when gavilyte-n is administered to a nursing woman. safety and effectiveness of gavilyte-n in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of gavilyte-n in adults with additional safety and efficacy data from published studies of similar formulations. use of gavilyte-n in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. dehydration has been reported in one child and hypokalemia has been reported in 3 children. clinical studies of gavilyte-n did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

США - англійська - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium cation - unii:lyr4m0nh37), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 236 g in 274.31 g - gavilyte-g is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults. gavilyte-g is contraindicated in the following conditions: - gastrointestinal (gi) obstruction [see warnings and precautions (5.6)] - bowel perforation [see warnings and precautions (5.6)] - toxic colitis or toxic megacolon - gastric retention - ileus - hypersensitivity to any component of gavilyte-g [see warnings and precautions (5.8)] animal reproduction studies have not been conducted with gavilyte-g. it is also not known whether gavilyte-g can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. gavilyte-g should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when gavilyte-g is administered to a nursing woman. safety and effectiveness of gavilyte-g in pediatric patients have not been established. clinical studies of