Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
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)
Novel Laboratories, Inc.
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350 420 g in 438.4 g
ORAL
PRESCRIPTION DRUG
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is contraindicated in patients known to be hypersensitive to any of the components. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.
PEG 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE with Flavor Pack is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has an attached lemon flavor pack, in powdered form, for the addition of the flavor pack by the pharmacist prior to dispensing. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND SODIUM BICARBONATE FOR ORAL SOLUTION with Flavor Pack : PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and lemon flavor pack 2 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. STORAGE : Store in sealed container at 25°C. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. NDC 40032-050-19 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873
Abbreviated New Drug Application
POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE - POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION NOVEL LABORATORIES, INC. ---------- PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE FOR ORAL SOLUTION WITH FLAVOR PACK RX ONLY DESCRIPTION PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is a white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride and one 2 g flavor pack (optional). When dissolved in water to a volume of 4 liters, PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. PEG- 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is administered orally or via nasogastric tube as a gastrointestinal lavage. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE Flavor Pack is available in lemon flavor. This preparation can be used without the addition of a PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE Flavor Pack. CLINICAL PHARMACOLOGY PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance. INDICATIONS AND USAGE PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy. CONTRAINDICATIONS PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is contraindicated in patients known to be hypersensitive to any of the components. Baca dokumen lengkapnya