Extraneal
Product Images NDC 0941-0717

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Extraneal (NDC 0941-0717). 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

Extraneal Dhcp Letter 4 (Iamge 04)

A comparison table showing key differences between EXTRANEAL peritoneal dialysis solutions imported from Castlebar, Ireland and the US FDA approved product by Vantive US Healthcare LLC. The table covers product names, labeled fill volumes, container types, bags per carton, indications, active ingredients, electrolyte content per liter, pH, additional information, storage conditions, expiration dating, and container closure system differences, including photos of each container type.*

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Extraneal Dhcp Letter 1 (Image 01)

This document provides important prescribing information regarding the temporary importation of EXTRANEAL (icodextrin) Peritoneal Dialysis Solution from Ireland due to shortages in the US. It details the product descriptions, CAPD fill volumes (2000 mL and 2500 mL), product codes, packaging quantities, and corresponding NDC codes of imported EXTRANEAL solutions. The notice emphasizes the equivalence between European and US-manufactured products and regulatory information.*

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Extraneal Dhcp Letter 2 (Image 02)

Text document detailing differences in calcium and magnesium electrolyte concentrations and Luer-lock connector functions between EU/Ireland and U.S. versions of EXTRANEAL (icodextrin) Peritoneal Dialysis Solution. It includes notes on barcode registration issues, key differences in packaging and labeling, adverse event reporting instructions with contact information, and links for product feedback and prescribing information.*

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Extraneal Dhcp Letter 3 (Image 03)

This document features a signed letter from Geovana Basso, M.D., Director of Americas Medical Affairs at Baxter Healthcare Corporation. It references trademarks for Baxter, EXTRANEAL, and ULTRABAG, and notes attachments including Product Comparison Tables 1 and 2. The letterhead includes the Baxter logo and corporate address.*

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Extraneal Dhcp Letter 5 (Image 05)

Table comparing two EXTRANEAL (icodextrin) peritoneal dialysis solution container labels: an imported product label from Baxter Healthcare in Castlebear, Ireland, and the US FDA-approved product label by Baxter Healthcare Corporation, Deerfield, IL. The table details ingredient amounts, osmolarity, pH, usage instructions, and storage conditions for each label.*

FDA Label Image

Extraneal Dhcp Letter 6 (Image 06)

Label of EXTRANEAL Solution for Peritoneal Dialysis by Vantive US Healthcare LLC, showing formulation details for 1000 ml. It lists ingredients and their concentrations, osmolarity, and pH range. The label includes storage and usage instructions, manufacturer address in the UK, and volume of 2000 ml, marked as an imported product from Castlebar, Ireland.*

FDA Label Image

Extraneal Dhcp Letter 7 (Image 07)

EXTRANEAL solution for peritoneal dialysis, 2500 mL, labeled by Vantive US Healthcare LLC. The left panel shows the imported product from Castlebar, Ireland, listing ingredients like icodextrin 75 g per 1000 mL and electrolytes with osmolarity of 284 mOsm/L. The right panel displays the US FDA approved product label including preparation, usage instructions, and storage information, highlighting the active ingredient icodextrin and specifying it is for peritoneal dialysis use only.*

FDA Label Image

Extraneal Dhcp Letter 8 (Image 08)

Label for EXTRANEAL Solution for Peritoneal Dialysis by Vantive US Healthcare LLC, displaying a 2500 ml volume. The label includes a formula breakdown per 1000 ml with concentrations of Icodextrin, Sodium Chloride, Sodium (Si-lactate), Calcium Chloride, and Magnesium Chloride, plus osmolarity and pH range. It notes storage and usage instructions, and states the product is an imported version from Castlebar, Ireland by Vantive Limited.*

FDA Label Image

Representative Extraneal Container Label -fpb5268c.jpg (Image 09)

Drug label for EXTRANEAL Solution for Peritoneal Dialysis by Baxter. It lists the formula per 1000 ml, including amounts of icodextrin, sodium chloride, sodium (S)-lactate, calcium chloride dihydrate, magnesium chloride hexahydrate, water for injections, and pH adjusters. Electrolyte content and osmolarity are specified, with instructions for intraperitoneal use and storage conditions. Manufacturer and distribution information is provided for UK, Ireland, and the Netherlands.*

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Representative Extraneal Carton Label (FPB5268C)

EXTRANEAL solution for peritoneal dialysis in a 2000 ml x 5 package from Vantive US Healthcare LLC. The label lists active ingredients including 75 g Icodextrin, 5.4 g Sodium Chloride, and others per 1000 ml, and includes storage instructions and manufacturer addresses in the UK and Netherlands.*

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Vantive Representative Extraneal Container Label (FPB5268C)

Drug facts panel for EXTRANEAL Solution for Peritoneal Dialysis by Vantive. It lists formula components per 1000 ml and their mmol/l concentrations, including Icodextrin, Sodium Chloride, Sodium (S)-lactate, Calcium Chloride, Magnesium Chloride, and electrolytes such as Na+, Ca++, Mg++, and Cl-. Instructions indicate intraperitoneal use only and storage recommendations. Manufacturer address in Liverpool, UK, is noted.*

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Vantive Representative Extraneal Carton Label (FPB5268C)

Label for EXTRANEAL solution for peritoneal dialysis, showing product details including contents per 1000 ml: Icodextrin 75 g, Sodium Chloride 5.4 g, Sodium (S)-lactate 4.5 g, Calcium Chloride 2H2O 0.257 g, Magnesium Chloride 6H2O 0.051 g, and water for injections. The label indicates a twin bag with Luer connector, pack size 2000 ml x 5, by Vantive Limited, Liverpool, UK, with storage instructions and safety warnings.*

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Representative Extraneal Container Label (FPB5270)

EXTRANEAL Solution for Peritoneal Dialysis by Vantive US Healthcare LLC, presented in a 2500 ml container. The label lists formulation details per 1000 ml, including Icodextrin 75 g, Sodium Chloride 5.4 g, Sodium (S)-lactate 4.5 g, Calcium Chloride 2H2O 0.257 g, Magnesium Chloride 6H2O 0.051 g, and Water for Injections, with electrolytes concentrations and osmolarity. It includes usage and storage instructions and manufacturer information from Baxter Healthcare Ltd.*

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Representative Extraneal Carton Label (FPB5270)

Label for EXTRANEAL solution for peritoneal dialysis by Vantive US Healthcare LLC. The label details formulation ingredients per 1000 ml including icodextrin 75 g, sodium chloride 5.4 g, sodium (S)-lactate 4.5 g, calcium chloride dihydrate 0.257 g, and magnesium chloride hexahydrate 0.051 g. It is a twin bag with luer connector, not for intravenous use, and has storage instructions below 4°C. Package size indicated is 2500 ml x 4.*

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Vantive Representative Extraneal Container Label (FPB5270)

This image shows the formulation and usage instructions for EXTRANEAL Solution for Peritoneal Dialysis by Vantive US Healthcare LLC. It lists ingredient amounts per 1000 ml and their concentrations in mmol/l, including Icodextrin, sodium chloride, sodium (S)-lactate, calcium chloride, magnesium chloride, and ions like Na+, Ca++, Mg++, Cl-, and C3H5O3-. Also included are osmolarity and pH range values, and detailed instructions for intraperitoneal use, storage, and disposal.*

FDA Label Image

Vantive Representative Extraneal Carton Label (FPB5270)

Label for EXTRANEAL FPB5270, a solution for peritoneal dialysis in a 2500 ml x 4 pack. The label lists active ingredients per 1000 ml including Icodextrin 75 g, Sodium Chloride 5.4 g, Sodium (S)-lactate 4.5 g, Calcium Chloride 2H2O 0.257 g, and Magnesium Chloride 6H2O 0.051 g. It instructs storage above 4°C, use in intraperitoneal dialysis only, and features a twin bag with Luer connector. Manufactured by Vantive Limited, 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.