Plenvu

PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.

Dosage Forms And Strengths

PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution.

First dose: one pouch labeled Dose 1; Second dose: two pouches labeled Dose 2 Pouch A and Dose 2 Pouch B.

• Dose 1 contains 100 grams of polyethylene glycol (PEG) 3350, NF; 9 grams of sodium sulfate, NF; 2 grams of sodium chloride, USP/NF; and 1 gram of potassium chloride, USP/NF.
• Dose 2 Pouch A contains 40 grams of PEG 3350, NF; 3.2 grams of sodium chloride, USP/NF; and 1.2 grams of potassium chloride, USP/NF.
• Dose 2 Pouch B contains 48.11 grams of sodium ascorbate, USP/NF; and 7.54 grams of ascorbic acid, USP/NF.

Storage And Handling

PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is supplied as a white to yellow powder for reconstitution.

Dose 1 contains 100 grams of PEG 3350, NF; 9 grams of sodium sulfate, NF; 2 grams of sodium chloride, USP/NF; and 1 gram of potassium chloride, USP/NF: NDC 70628-400-32.

Dose 2 Pouch A contains 40 grams of PEG 3350, NF; 3.2 grams of sodium chloride, USP/NF; and 1.2 grams of potassium chloride, USP/NF: NDC 70628-400-31.

Dose 2 Pouch B contains 48.11 grams of sodium ascorbate, USP/NF; and 7.54 grams of ascorbic acid, USP/NF: NDC 70628-400-30.

PLENVU, single-use inner carton: The inner carton contains three pouches labeled Dose 1, Dose 2 Pouch A and Dose 2 Pouch B: NDC 70628-400-00.

PLENVU, single-use outer carton: Each outer carton contains the inner carton, prescribing information and patient information and a disposable mixing container with lid for reconstitution of PLENVU: NDC 70628-337-00.

Store pack at room temperature, between 68°F to 77°F (20°C to 25°C) with excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature]. The pack may be stored in a refrigerator.

Manufactured by: Norgine Limited 7 Tir-y-berth Industrial Estate New Road, Tir-y-berth Hengoed, CF82 8SJ United Kingdom (GBR). Revised: May 2018.

Included as part of the "PRECAUTIONS" Section