United States - English - 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.

United States - English - 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

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

affordable pharmaceuticals, llc - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium cation - unii:lyr4m0nh37, sulfate ion - unii:7is9n8kpmg), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q3 - polyethylene glycol 3350 236 g in 4 l - peg-3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults. peg-3350 and electrolytes for oral solution 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 peg-3350 and electrolytes for oral solution [see warnings and precautions ( 5.8)] animal reproduction studies have not been conducted with peg-3350 and electrolytes for oral solution. it is also not known whether peg-3350 and electrolytes for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. peg-3350 and electrolytes for oral solution should be given to a pregnant woman only if clearly nee

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

braintree laboratories, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium cation - unii:lyr4m0nh37, sulfate ion - unii:7is9n8kpmg), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q3 - polyethylene glycol 3350 236 g in 4 l - golytely is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults. golytely 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 golytely [see warnings and precautions ( 5.8)] animal reproduction studies have not been conducted with golytely. it is also not known whether golytely can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. golytely 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 golytely is administered to a nursing woman. safety and effectiv

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

braintree laboratories, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - polyethylene glycol 3350 420 g in 4 l - nulytely is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. nulytely 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 nulytely [ see how supplied/storage and handling ( 16) ] pregnancy category c. animal reproduction studies have not been conducted with nulytely. it is also not known whether nulytely can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. nulytely 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 nulytely is administered to a nursing woman. safety and effectiveness of nulyte

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

lupin pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium sulfate anhydrous - unii:36kcs0r750), 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, ileus, or gastric retention - bowel perforation - toxic colitis or toxic megacolon - known allergy or hypersensitivity to any component of gavilyte-g [see how supplied/storage and handling (16) ] pregnancy category c. 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 gavilyte-g did n

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

wallace pharmaceuticals inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 420 g in 4 l - trilyte is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. trilyte is contraindicated in the following conditions: animal reproduction studies have not been conducted with trilyte. it is also not known whether trilyte can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. trilyte 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 trilyte is administered to a nursing woman. safety and effectiveness of trilyte in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of trilyte in adults with additional safety and efficacy data from published studies of similar formulations. use of trilyte in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as

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

nexgen pharma, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - for the treatment of occasional constipation. this product should be used for 2 weeks or less or as directed by a physician. polyethylene glycol 3350 nf is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol. there have been no reports of accidental overdosage. in the event of overdosage, diarrhea would be the expected major event. if an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. medication should be terminated and free water administered. the oral ld50 is > 50 gm/kg in mice, rats and rabbits.

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

nucare pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - for the treatment of occasional constipation. this product should be used for 2 weeks or less or as directed by a physician. polyethylene glycol 3350 nf is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

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

synedgen, inc. - poly(n-acetyl, n-arginyl)glucosamine (50000-80000 mw) (unii: ua7my2jy0e) (poly(n-acetyl, n-arginyl)glucosamine (50000-80000 mw) - unii:ua7my2jy0e) - poly(n-acetyl, n-arginyl)glucosamine (50000-80000 mw) 1 g in 1 g - derived from chitin obtained from arctic shrimp shells, synoplex® has an approximate molecular weight of 20 to 100 kda. each gram of synoplex® contains 1 gram of poly (acetyl, arginyl) glucosamine. synoplex® is supplied as a dry soluble powder, that is rehydrated with sterile water prior to use. synoplex® acts on the bacterial membrane causing aggregation of bacteria and pore formation leading to reduction of viable bacteria and prevention of biofilm formation.