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.

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Dianeal Dhcp Letter 1 (Image 01)

This document provides important prescribing information regarding the temporary importation of DIANEAL P4 Solution for Peritoneal Dialysis from Ireland to address shortages in the United States market. Baxter Healthcare Corporation is coordinating with the FDA for this temporary importation. Health care professionals are advised about the availability of DIANEAL products and additional details on the imported products for use in Automated Peritoneal Dialysis therapy. The text also mentions the composition and glucose concentrations of the DIANEAL PD4, PD-2, and Low Calcium solutions manufactured in Ireland.*

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Dianeal Dhcp Letter 2 (Image 02 01)

This is a detailed text comparing various Dianeal solutions for peritoneal dialysis, specifically focusing on differences in calcium concentrations, country of manufacture, labeling, product packaging, and administration protocols. The text highlights the importance of monitoring serum calcium levels and ensuring correct dextrose concentrations. It also mentions the compatibility of Luerock connectors and the need for healthcare providers to be aware of specific differences between EU-manufactured and U.S.-manufactured products. The text emphasizes the importance of accurately scanning barcodes and following proper procedures to avoid errors in drug administration for patient safety. The provided tables offer further details on product disparities for reference.*

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Dianeal Dhcp Letter 3 (Image 03)

Not available.*

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Dianeal Dhcp Letter 4 (Image 04)

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Dianeal Dhcp Letter 5 (Image 05)

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Dianeal Dhcp Letter 6 (Image 06)

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Dianeal Dhcp Letter 7 (Image 07)

This is a comparison table showing different labels for 5000 mL DIANEAL PD Solution Containers. The labels for US-approved 6000 mL solution are also mentioned. There are no differences in composition or safety-related information between the labels. The table includes labels from both Baxter and another brand, representing all potential labeling scenarios during a transition.*

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Dianeal Dhcp Letter 8 (Image 08)

This is a list of approved Baxter medical products, including DIANEAL PD4 and DIANEAL 0.2 PD Solutions. It appears to be a reference for healthcare professionals to identify and order the products. *

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Dianeal Dhcp Letter 9 (Image 09)

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Dianeal Dhcp Letter 10 (Image 10)

This text appears to be a list of Baxter medical products, including DIANEAL PD solutions. These specific products mentioned are DIANEAL PDs, DIANEAL Low Calcium PD Solution, and DIANEAL PD-2 PD Solution. This information can be used by medical professionals or individuals seeking specific Baxter products.*

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Dianeal Dhcp Letter 11 (Image 11)

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Dianeal Dhcp Letter 12 (Image 12)

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Representative Dianeal Container Label.jpg (Image 13)

This text appears to be a label or description of a Baxter solution for Peritoneal Dialysis. The solution contains glucose and other components for intraperitoneal infusion. It provides instructions for use, storage, and precautions, such as ensuring the solution is clear before use and discarding unused solution. It also warns against intravenous infusion and highlights that the solution is for single use only. Additional details include manufacturer information and batch numbers.*

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Representative Dianeal Carton Label (Image 14)

This text is a detailed description of a solution for peritoneal dialysis called Dianeal B Glucose. It includes information on the formula, direction for use (intraperitoneal infusion only), storage instructions, manufacturer details, and precautions. The solution comes in a single bag with a Luer connector and each pack contains 5000 ml x 2.*

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Representative Dianeal Container Label (Image 15)

This is a description for a peritoneal dialysis solution called "DIANEAL T Glucose 2,27%". The solution is free from bacterial endotoxins and is intended for intraperitoneal infusion, not for intravenous infusion. It is for single use only and should be discarded if unused. It should be used immediately once removed from the packaging, and should not be stored above 25°C or refrigerated. The solution comes from Baxter Healthcare Ltd and the packaging contains important safety instructions and contact information.*

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Representative Dianeal Carton Label (Image 16)

This is a description of Dianeal solution, which is used for Peritoneal Dialysis. It contains ingredients such as Glucose, Sodium Chloride, Sodium Lactate, Calcium Chloride, and Magnesium Chloride, among others. The solution comes in single bags and should not be stored above 25°C. It is not for intravenous use and should only be used intraperitoneally. The package should be discarded if the solution is not clear or the container is damaged. The solution is free from bacterial endotoxins and is for single use only. The text also includes contact information for Baxter Healthcare Limited in the UK, as well as regulatory information such as lot number and expiration date.*

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Representative Dianeal Container Label (Image 17)

This is a description for Baxter FPB5235R 5000 DIANEAL 0 Glucose 3.86% solution for Peritoneal Dialysis. It includes the composition of the solution, cautionary instructions, and handling guidelines. The solution is intended for intraperitoneal infusion only and not for intravenous use. It must be used only if clear and the container is undamaged. It should be used immediately after removal from the overpouch and any unused solution should be discarded. Storage guidelines include not storing above 25°C, no refrigeration or freezing. Additionally, it should be kept out of sight and reach of children. The manufacturer details for Baxter Holding B.V. are provided at the end of the text.*

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Representative Dianeal Carton Label (Image 18)

This text provides information about a 5000 ml x 2 solution of Dianeal with Glucose for Peritoneal Dialysis. It lists the composition of the solution, including ingredients like Anhydrous Glucose, Sodium Chloride, Sodium Lactate, Calcium Chloride, and Magnesium Chloride. The text includes instructions for use, storage conditions, and warnings against intravenous use. It also mentions contact details for the manufacturer, Baxter Healthcare Limited, in the United Kingdom and Netherlands, along with lot number details.*

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Representative Dianeal Container Label (Image 19)

This text appears to be a description of a solution for Peritoneal Dialysis named "DIANEAL iE Glucose 1.36%". The solution contains various components such as CH0, NaCl, CHNaO, CaCl2H2O, and more. It is mentioned that the solution is free from Bacterial Endotoxins and is meant for intraperitoneal infusion only. The text includes instructions such as not using the solution if it's not clear, for single use only, discarding unused solution, storing below 25°C, not refrigerating or freezing, and keeping out of reach of children. Additionally, information about the manufacturer, Waverres Technology Park located at Waverre Boulevard in Liverpool, United Kingdom, is provided along with a product code (PL 5871170002).*

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Representative Dianeal Carton Label (Image 20)

This is a description of a medical solution for Peritoneal Dialysis, containing Anhydrous Glucose, Sodium Chloride, Sodium Lactate, Calcium Chloride, and Magnesium Chloride. The solution is free from bacterial endotoxins and is intended for intraperitoneal infusion. It is for single use only, to be used if clear and undamaged. The solution should be discarded if unused, kept away from children, and used immediately after removing from the overpouch. The product should not be stored above 25°C, refrigerated, or frozen. The solution comes in a single bag with a Luer connector. The manufacturer is listed as Vanive Limited, located in Wavertree Technology Park, Liverpool, United Kingdom.*

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Representative Dianeal Container Label (Image 21)

This is a description of "Dianeal Solution for Peritoneal Dialysis" by Wantive FPB5225R 5000. The solution contains glucose and various electrolytes essential for peritoneal dialysis. It is free from Bacterial Endotoxins and is designed for intraperitoneal infusion only. Directions include using the solution immediately after removing it from the overpouch, discarding unused solution, not storing above 25°C, and keeping out of reach of children. The product is intended for single-use and must not be refrigerated or frozen.*

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Representative Dianeal Carton Label (Image 22)

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Representative Dianeal Container Label (Image 23)

This text provides information on a solution for Peritoneal Dialysis called DIANEAL. It contains ingredients such as Glucose, Sodium chloride, Calcium chloride, and Magnesium chloride. The solution is free from Bacterial Endotoxins and is intended for Intraperitoneal infusion only, not for intravenous infusion. Instructions include using the solution immediately after removal from the packaging, discarding unused solution, and not storing above 25°C. The product is from Vantive Limited in the United Kingdom.*

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Representative Dianeal Carton Label (Image 24)

This text is a description of a peritoneal dialysis solution called Dianeal Glucose 3.86%. It provides a list of ingredients, usage instructions, storage recommendations, and contact information for the production company. It is indicated for intraperitoneal infusion only and should be used once. The solution should be clear, the container undamaged, and discarded if unused. It also specifies not to store above 25°C, refrigerate, or freeze. However, for more detailed information, please refer to the original document.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.