Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0729

Product Visual Gallery

This gallery contains 24 technical images submitted to the FDA as part of the official labeling for Dianeal Low Calcium With Dextrose (NDC 0941-0729). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vantive Us Healthcare Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Dianeal Dhcp Letter 1 (Image 01)

Prescribing information dated November 4, 2024, about temporary importation of DIANEAL PD4 Solution for Peritoneal Dialysis from Ireland to address U.S. drug shortages. It includes details on product coordination, distribution restrictions, and a table listing DIANEAL PD4 products by description, container volume, product code, bags per carton, and NDC codes.*

FDA Label Image

Dianeal Dhcp Letter 2 (Image 02 01)

This text panel details product differences and clinical considerations for DIANEAL PD4 Dextrose Solution and other DIANEAL Low Calcium with Dextrose formulations for peritoneal dialysis. It addresses differences in calcium concentrations, container labeling, barcode accuracy, import status, connector compatibility, and provides instructions for healthcare providers on product use, reporting adverse events, and where to find key product comparison tables.*

FDA Label Image

Dianeal Dhcp Letter 3 (Image 03)

Text document providing contact information for reporting product quality issues related to DIANEAL Peritoneal Dialysis Solution, references to FDA-approved prescribing information, and Baxter Healthcare Corporation's medical affairs contact details. It includes a signature from Geovana Basso, M.D., and mentions product comparison table attachments.*

FDA Label Image

Dianeal Dhcp Letter 4 (Image 04)

A comparative table detailing key differences among DIANEAL peritoneal dialysis solutions for APD therapy, including imported DIANEAL PD4 from Ireland and U.S. FDA-approved DIANEAL Low Calcium and DIANEAL PD2 products. The table covers product names, labeled fill volume, container types, bags per carton, indications, and active ingredient concentrations of dextrose.*

FDA Label Image

Dianeal Dhcp Letter 5 (Image 05)

A table comparing three DIANEAL product formulations: Imported Product from Ireland DIANEAL PD4, U.S. FDA Approved DIANEAL Low Calcium, and U.S. FDA Approved DIANEAL PD2. It details active ingredient concentrations, electrolyte content per liter, pH ranges, additional information about glucose/dextrose content and osmolarity, storage conditions, and expiration dating, highlighting formulation differences.*

FDA Label Image

Dianeal Dhcp Letter 6 (Image 06)

Comparison chart showing container closure systems and closures for DIANEAL PD4 imported from Ireland versus U.S. FDA approved DIANEAL Low Calcium and DIANEAL PD2 by Baxter. The image illustrates differences in luer connectors and color-coded pull ring caps indicating dextrose concentration levels (yellow for 1.5%, green for 2.5%, red for 4.25%).*

FDA Label Image

Dianeal Dhcp Letter 7 (Image 07)

A comparison table of 5000 mL DIANEAL peritoneal dialysis (PD) solution container labels from Baxter. It includes three label versions: an imported product from Ireland, the US FDA-approved DIANEAL Low Calcium PD Solution, and the US FDA-approved DIANEAL PD-2 Solution. The table highlights product names, concentrations, package volume, barcodes, and safety/usage information for each label.*

FDA Label Image

Dianeal Dhcp Letter 8 (Image 08)

Label for Vantive DIANEAL PD4 Glucose 1.36% w/v / 13.6 mg/ml solution for peritoneal dialysis in a 5000 mL container. The label lists active ingredients including glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride with their respective concentrations. It includes usage instructions, storage, and safety warnings. The label is identified as an imported product from Ireland by Vantive US Healthcare LLC.*

FDA Label Image

Dianeal Dhcp Letter 9 (Image 09)

Packaging label for DIANEAL LOW CALCIUM WITH DEXTROSE peritoneal dialysis injection solution by Baxter. The label shows 5000 mL bags with strengths including 2.5 mEq/L calcium and 2.5% dextrose. It includes detailed composition, usage instructions, cautions, and manufacturing information for intraperitoneal use.*

FDA Label Image

Dianeal Dhcp Letter 10 (Image 10)

Label of DIANEAL LOW CALCIUM WITH DEXTROSE, an intraperitoneal injection solution for peritoneal dialysis with active ingredients including dextrose 2.27% w/v (22.7 g/L), sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. This Vantive US Healthcare LLC product is presented in a 5000 mL container. The label includes ingredient concentrations and storage instructions.*

FDA Label Image

Dianeal Dhcp Letter 11 (Image 11)

Packaging label image showing multiple versions of DIANEAL Low Calcium Peritoneal Dialysis Solution with Dextrose, including an imported product from Ireland (5000 mL) and US FDA approved products (DIANEAL Low Calcium PD Solution with 4.25% Dextrose and DIANEAL PD-2 PD Solution with 4.25% Dextrose). The labels include strengths, directions for use, warnings, and manufacturer information for Baxter and Baxter Healthcare Corporation.*

FDA Label Image

Dianeal Dhcp Letter 12 (Image 12)

Packaging label for Vantive Version of DIANEAL Glucose 3.86% solution, 5000 mL bag. The label includes ingredient concentrations and storage instructions. The label is branded with Baxter at the top right and is specified as a solution for peritoneal dialysis imported from Ireland.*

FDA Label Image

Representative Dianeal Container Label.jpg (Image 13)

Label for DIANEAL PD4 Glucose 1.36% w/v (13.6 mg/ml) solution for peritoneal dialysis. The label details the formula with concentrations of anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride per liter, along with osmolarity and electrolyte values. The 5000 ml solution is for intraperitoneal use only, manufactured by Baxter Healthcare Ltd, UK.*

FDA Label Image

Representative Dianeal Carton Label (Image 14)

Label for Dianeal PD4 Glucose 1.36% w/v (13.6 mg/ml) solution for peritoneal dialysis in a 5000 ml x 2 package. The label lists the formula per liter, including anhydrous glucose (13.6 g), sodium chloride (5.38 g), sodium lactate (4.48 g), calcium chloride (0.184 g), and magnesium chloride (0.051 g). It includes handling instructions, storage conditions, and manufacturer information for Baxter Healthcare Limited and Baxter Holding B.V.*

FDA Label Image

Representative Dianeal Container Label (Image 15)

Label for DIANEAL PD4 Glucose 2.27% w/v (22.7 mg/ml) injection solution for peritoneal dialysis by Baxter. The label lists the formula with components anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride with respective concentrations in g/l. It includes osmolarity data and storage/use instructions for intraperitoneal infusion. The container volume is 5000 ml.*

FDA Label Image

Representative Dianeal Carton Label (Image 16)

Label for Dianeal PD4 Glucose 2.27% w/v (22.7 mg/ml) solution for peritoneal dialysis. The package contains 2 bags of 5000 ml each. Lists ingredients including glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride with their amounts in grams per liter. Includes usage instructions, storage guidelines, and manufacturer information for Baxter Healthcare Ltd, UK and Baxter Holding B.V., Netherlands.*

FDA Label Image

Representative Dianeal Container Label (Image 17)

Drug facts text panel for DIANEAL PD4 Glucose 3.86% w/v solution for peritoneal dialysis by Baxter. It lists formula components including anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride with their quantities, osmolarity, and electrolyte concentrations. Instructions highlight its intraperitoneal use only, storage conditions, and single-use status.*

FDA Label Image

Representative Dianeal Carton Label (Image 18)

Label for Dianeal PD4 Glucose 3.86% w/v (38.6 mg/ml) solution for peritoneal dialysis. The label lists the formula per liter including anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. It indicates a 5000 ml x 2 single bag package with Luer connector. Manufacturer details include Baxter Healthcare Limited, UK, and Baxter Holding B.V., Netherlands. Storage instructions note not to store above 25°C or freeze.*

FDA Label Image

Representative Dianeal Container Label (Image 19)

Label for DIANEAL PD4 Glucose 1.36% w/v (13.6 mg/ml) solution for peritoneal dialysis, 5000 ml volume. The formulation lists amounts of anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride with their chemical formulas and concentrations. It includes instructions emphasizing use for intraperitoneal infusion only, single use, and storage conditions. Manufactured by Vantive Limited.*

FDA Label Image

Representative Dianeal Carton Label (Image 20)

Packaging label of Dianeal PD4 Glucose 1.36% w/v (13.6 mg/ml) solution for peritoneal dialysis by Vantive US Healthcare LLC. The label lists the formula with anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride quantities per 1000 ml. It indicates a 5000 ml x 2 bag volume with a Luer connector and usage instructions specifying intraperitoneal infusion only, storage conditions, and manufacturer address in Liverpool, UK.*

FDA Label Image

Representative Dianeal Container Label (Image 21)

Label for DIANEAL PD4, an intraperitoneal injection solution for peritoneal dialysis containing 2.27% w/v glucose (22.7 mg/ml) in a 5000 ml container. The label lists the formula with specific amounts of anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and water for injections. It includes osmolarity and electrolyte concentrations, handling instructions, and manufacturer details for Vantive Limited, UK.*

FDA Label Image

Representative Dianeal Carton Label (Image 22)

Label for Dianeal PD4 Glucose 2.27% Injection Solution for Peritoneal Dialysis containing sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and anhydrous glucose. The label lists ingredient amounts per liter and indicates a 5000 ml x 2 packaging. It includes storage instructions and manufacturer information from Vantive US Healthcare LLC, UK.*

FDA Label Image

Representative Dianeal Container Label (Image 23)

Label for DIANEAL PD4 Glucose Injection 3.86% w/v (38.6 mg/ml), a solution for peritoneal dialysis by Vantive. The 5000 ml container lists ingredients including anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride with detailed concentrations and osmolarity values. It includes instructions for intraperitoneal use and storage precautions.*

FDA Label Image

Representative Dianeal Carton Label (Image 24)

DIANEAL PD4 Glucose 3.86% w/v (38.6 mg/ml) solution for peritoneal dialysis in a 5000 ml x 2 bag. The label lists the formula with anhydrous glucose 38.6 g/l, sodium chloride 5.38 g/l, sodium lactate 4.48 g/l, calcium chloride 0.184 g/l, and magnesium chloride 0.051 g/l. It is marked for UK use, includes a barcode, and advises storage below 25°C without refrigeration. Manufactured by Vantive Limited in Liverpool, UK.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.