Dianeal Low Calcium With Dextrose Injection, Solution
Product Images NDC 0941-0735

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Dianeal Low Calcium With Dextrose (NDC 0941-0735). 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 document dated November 4, 2024, regarding the temporary importation of DIANEAL PD4 Glucose Solutions for peritoneal dialysis from Ireland due to drug shortages. It includes details on Baxter's manufacturing and FDA status, a table listing product names, container volumes, product codes, bag quantities per carton, and NDC codes for DIANEAL PD4 solutions (1.36% and 2.27% glucose).*

FDA Label Image

Dianeal Dhcp Letter 2 (Image 02)

Text panel providing important notes about DIANEAL PD4 Glucose Solution for Peritoneal Dialysis, including calcium content, labeling differences between Ireland-manufactured and U.S.-manufactured products, product compatibility with peritoneal dialysis sets, barcode scanning issues, and prescribing information for the U.S. market. It highlights clinical relevance and instructions for healthcare providers about product differences.*

FDA Label Image

Dianeal Dhcp Letter 3 (Image 03)

This text panel provides contact information and instructions for reporting adverse events and product quality issues related to DIANEAL Peritoneal Dialysis Solution. It includes phone numbers, online reporting links, and references to the FDA-approved full prescribing information and Medical Information Service contact details from Baxter Healthcare Corporation.*

FDA Label Image

Dianeal Dhcp Letter 4 (Image 04)

A table comparing key differences among DIANEAL Peritoneal Dialysis Solutions for APD therapy, including DIANEAL PD4 from Ireland and two US FDA approved products, DIANEAL Low Calcium and DIANEAL PD2. The table details product names, labeled fill volumes, container types, bags per carton, indications, and active ingredient dextrose concentrations with equivalent glucose levels for clarity.*

FDA Label Image

Dianeal Dhcp Letter 5 (Image 05)

A detailed comparison table showing active ingredients, electrolyte content, pH, additional information, storage conditions, and expiration dating for three formulations: Imported Product from Ireland (DIANEAL PD4), US FDA Approved Product DIANEAL Low Calcium, and DIANEAL PD2. The table includes concentrations of sodium chloride, calcium chloride, magnesium chloride, chloride, lactate, glucose/dextrose, and osmolarity values, along with storage recommendations and a 24-month expiration period for all products.*

FDA Label Image

Dianeal Dhcp Letter 6 (Image 06)

Comparison chart showing container closure systems and closures for DIANEAL PD4 imported from Ireland, and US FDA approved DIANEAL Low Calcium and DIANEAL PD2. The image includes photographs of solution bags and closure components, highlighting color-coded luer connectors (green, blue) and pull ring caps indicating dextrose concentrations (yellow for 1.5%, green for 2.5%). Differences in closure features are noted below each column.*

FDA Label Image

Dianeal Dhcp Letter 7 (Image 07)

Table comparing labels of 2500 mL DIANEAL PD solution containers, featuring imported 2500 mL DIANEAL PD4 (Ireland) and US FDA approved 3000 mL DIANEAL Low Calcium PD and DIANEAL PD-2 solutions. The table displays label layout, concentration details, and instructions for Baxter's peritoneal dialysis solutions with 1.5% dextrose content.*

FDA Label Image

Dianeal Dhcp Letter 8 (Image 08)

Label for DIANEAL LOW CALCIUM PD SOLUTION, 2500 mL, for peritoneal dialysis. The label shows concentrations of glucose (1.36% w/v), sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. The label includes storage instructions and usage notes. The product is labeled by Vantive US Healthcare LLC, with branding from Baxter.*

FDA Label Image

Dianeal Dhcp Letter 9 (Image 09)

Label panel displaying three products: Imported DIANEAL PD4 (2.27% w/v, 22.7 mg/mL) in a 2500 mL volume from Ireland, and two US FDA approved peritoneal dialysis solutions by Baxter—DIANEAL Low Calcium PD Solution (2.5 mEq/L) and Dianeal PD-2 Solution with 2.5% Dextrose, each approximately 3000 mL. The labels include detailed formulation and usage instructions, warnings, and storage information for intraperitoneal administration.*

FDA Label Image

Dianeal Dhcp Letter 10 (Image 10)

The image shows a drug facts panel for DIANEAL PD4, a peritoneal dialysis solution imported from Ireland. It details the composition per liter including glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride concentrations. Additional handling and safety instructions are included. The layout compares this imported product with two US FDA-approved formulations.*

FDA Label Image

Dianeal Representative Container Label (Image 11)

Drug facts panel for DIANEAL PD4 Glucose 1.36% solution for peritoneal dialysis by Baxter. It lists the formula with concentrations of anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and water for injections per liter. Osmolarity and ion concentrations are provided. Usage instructions emphasize intraperitoneal infusion only, single use, storage conditions, and safety notes.*

FDA Label Image

Dianeal Representative Carton Label (Image 12)

DIANEAL LOW CALCIUM WITH DEXTROSE 1.36% w/v glucose injection solution for peritoneal dialysis. The label lists ingredients per 1000 ml: anhydrous glucose 13.6 g, sodium chloride 5.38 g, sodium lactate 4.48 g, calcium chloride 0.184 g, magnesium chloride 0.051 g, with water for injections. Pack contains four 2500 ml bags, each with a Luer connector. Manufactured by Baxter Healthcare Ltd.*

FDA Label Image

Dianeal Representative Container Label (Image 13)

DIANEAL PD4 Glucose 1.36% w/v (13.6 mg/ml) solution for peritoneal dialysis. The label details the chemical formula ratios per liter, including anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and water for injection. It also displays osmolarity values and handling instructions. The product is manufactured by Vantive Limited, UK, and the container volume is 2500 ml.*

FDA Label Image

Dianeal Representative Carton Label (Image 14)

Label for Dianeal PD4 Glucose 1.36% w/v (13.6 mg/ml) solution for peritoneal dialysis packaged in 2500 ml bags, 4 bags per unit. The formula table lists amounts of anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride per liter. It includes usage instructions for intraperitoneal infusion only, storage guidelines, and manufacturer information, Vantive Limited, United Kingdom.*

FDA Label Image

Dianeal Representative Container Label (Image 15)

Drug facts panel for DIANEAL PD4 Glucose Solution for Peritoneal Dialysis by Baxter, 2500 mL. Lists formula concentrations per liter for anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and water for injections. Provides osmolarity and ion concentrations (Na+, Ca++, Mg++, Cl-, C3H5O3-). Includes usage instructions emphasizing intraperitoneal infusion, storage conditions, and warnings.*

FDA Label Image

Dianeal Representative Carton Label (Image 16)

Label of Dianeal PD4 Glucose 2.27% w/v (22.7 mg/ml) solution for peritoneal dialysis in four 2500 ml bags. The label lists the formula with anhydrous glucose 22.7 g, sodium chloride 5.38 g, sodium lactate 4.48 g, calcium chloride 0.184 g, and magnesium chloride 0.051 g per 1000 ml. It includes usage instructions, storage conditions, and manufacturer details: Baxter Healthcare Limited, UK and Baxter Holding B.V., Netherlands.*

FDA Label Image

Dianeal Representative Container Label (Image 17)

DIANEAL PD4 Glucose 2.27% w/v (22.7 mg/ml) solution for peritoneal dialysis in a 2500 ml container by Vantive. The label details the formula including anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride, and water for injections. It specifies osmolarity and ion concentrations and includes usage instructions and storage conditions.*

FDA Label Image

Dianeal Representative Carton Label (Image 18)

Label for Dianeal PD4 Glucose 2.27% w/v (22.7 mg/ml) solution for peritoneal dialysis. The label lists the formula contents by gram per liter, including anhydrous glucose, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride. It indicates a single bag with a Luer connector, storage instructions, and manufacturer details (Vantive Limited, UK). Package size is 2500 ml x 4.*

* 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.