MOVIPREP- polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid kit

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Prieinama:

Physicians Total Care, Inc.

INN (Tarptautinis Pavadinimas):

POLYETHYLENE GLYCOL 3350

Sudėtis:

POLYETHYLENE GLYCOL 3350 100 g in 1 L

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

MoviPrep® is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep is contraindicated in patients who have had a severe hypersensitivity reaction to any of its components. Pregnancy Category C. Animal reproduction studies have not been performed with MoviPrep.  It is also not known if MoviPrep can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. MoviPrep should be given to a pregnant woman only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when MoviPrep is administered to a nursing woman. The safety and effectiveness of MoviPrep in pediatric patients has not been established. Of the 413 patients in clinical studies receiving MoviPrep, 91 (22%) patients were aged 65 or older, while 25 (6%) patients were over 75 years of age.  No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other repo

Produkto santrauka:

MoviPrep® is supplied in powdered form.  MoviPrep is administered as an oral solution after reconstitution. NDC 54868-5890-0, MoviPrep, single use carton. Each carton contains a disposable container for reconstitution of MoviPrep® and an inner carton containing 4 pouches (2 of pouch A and 2 of pouch B). Rx only STORAGE Store carton/container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). When reconstituted, store upright and keep solution refrigerated. Use within 24 hours.

Autorizacija statusas:

New Drug Application

Prekės savybės

MOVIPREP - POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE,
POTASSIUM CHLORIDE,
SODIUM ASCORBATE AND ASCORBIC ACID
PHYSICIANS TOTAL CARE, INC.
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1 INDICATIONS AND USAGE
MoviPrep® is indicated for cleansing of the colon as a preparation
for colonoscopy in adults 18 years
of age or older.
2 DOSAGE AND ADMINISTRATION
The MoviPrep dose for colon cleansing for adult patients is 2 liters
(approximately 64 ounces) of
MoviPrep solution (with 1 additional liter of clear fluids) taken
orally prior to the colonoscopy in one
of the following ways:
1. SPLIT-DOSE MOVIPREP REGIMEN: The evening before the colonoscopy,
take the first liter of
MoviPrep solution over one hour (one 8 ounce glass every 15 minutes)
and then drink 0.5 liters
(approximately 16 ounces) of clear fluid. Then, on the morning of the
colonoscopy, take the second
liter of MoviPrep solution over one hour and then drink 0.5 liters of
clear liquid at least one hour
prior to the start of the colonoscopy; or
2. EVENING ONLY (FULL-DOSE) MOVIPREP REGIMEN: Around 6 PM in the
evening before the
colonoscopy, take the first liter of MoviPrep solution over one hour
(one 8 ounce glass every 15
minutes) and then about 1.5 hours later take the second liter of
MoviPrep solution over one hour. In
addition, take 1 liter (approximately 32 ounces) of additional clear
liquid during the evening before
the colonoscopy.
PREPARATION OF THE MOVIPREP SOLUTION:
MoviPrep solution is prepared by emptying the contents of 1 pouch A
and 1 pouch B into a suitable
glass container (or the container provided) and adding to the
container 1 liter of lukewarm water. Mix
the solution to ensure that the ingredients are completely dissolved.
If the patient prefers, the MoviPrep
solution can be refrigerated prior to drinking. The reconstituted
solution should be used within 24
hours.
After consumption of the first liter of MoviPrep solution, the above
mixing procedure should be
repeated with the second pouch A and pouch B to reconstitute the
second liter of the MoviPrep
solution.
3 D