GAVILYTE - C TM- polyethylene glycol-3350 and electrolytes with flavor pack powder, for solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)

Verfügbar ab:

Lupin Pharmaceuticals,Inc.

INN (Internationale Bezeichnung):

POLYETHYLENE GLYCOL 3350

Zusammensetzung:

POLYETHYLENE GLYCOL 3350 240 g in 278.26 g

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

GaviLyte- C with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. GaviLyte- C with flavor pack is contraindicated in patients known to be hypersensitive to any of the components. GaviLyte- C with flavor pack is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

Produktbesonderheiten:

GaviLyte- C with flavor pack is supplied in 4 liter bottles with an attached lemon flavor pack. Each 4 liter bottle contains polyethylene glycol-3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution. GaviLyte- C with flavor pack 4liter: NDC 43386-060-19 Store at 20° to 25°C (68° to 77°F): excursions permitted between 15° to 30°C (59° to 86°F). KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 LA0601900203 Rev. 09/2017

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

GAVILYTE - C TM- POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR
PACK POWDER, FOR
SOLUTION
LUPIN PHARMACEUTICALS,INC.
----------
GAVILYTE™-C WITH FLAVOR PACK
(PEG-3350 (240 G) AND ELECTROLYTES FOR ORAL SOLUTION, USP) WITH FLAVOR
PACK
DESCRIPTION
GaviLyte- C with flavor pack is a white, colon lavage preparation
provided as water-soluble
components for solution. In solution this preparation with lemon
flavor pack added delivers the
following, in grams per liter.
Polyethylene glycol 3350 240.00
Sodium chloride 5.84
Potassium chloride 6.72
Sodium bicarbonate 2.98
Sodium sulfate 22.72
Flavor ingredients 0.500
When dissolved in sufficient water to make 4 liters, the final
solution contains 125 mEq/L sodium, 10
mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L
chloride and 18 mEq/L
polyethylene glycol 3350. The reconstituted solution is an isosmotic
solution, for oral administration,
having mild salty taste. This preparation can be used without the
lemon flavor pack and is administered
orally or via nasogastric tube.
Each lemon flavor pack (2 g) contains natural lemon flavor powder,
saccharin sodium, maltodextrin.
CLINICAL PHARMACOLOGY
GaviLyte- C with flavor pack cleanses the bowel by induction of
diarrhea. The osmotic activity of
polyethylene glycol 3350, in combination with the electrolyte
concentration, results in virtually no net
absorption or excretion of ions or water. Accordingly, large volumes
may be administered without
significant changes in fluid and electrolyte balance.
INDICATIONS AND USAGE
GaviLyte- C with flavor pack is indicated for bowel cleansing prior to
colonoscopy or barium enema
X-ray examination.
CONTRAINDICATIONS
GaviLyte- C with flavor pack is contraindicated in patients known to
be hypersensitive to any of the
components. GaviLyte- C with flavor pack is contraindicated in
patients with ileus, gastrointestinal
obstruction, gastric retention, bowel perforation, toxic colitis or
toxic megacolon.
WARNINGS
Flavor pack is for use only in combination with the contents of the
a