Alphanate Kit
Product Images NDC 68516-4612

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Alphanate (NDC 68516-4612). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Grifols Usa, 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

10ml1500iucartonlablel

This text seems to be a combination of text fragments and codes. There is no coherent information available.*

FDA Label Image

10mlsterilewaterlablel

This is a single dose container of sterile water for injection with the purpose of reconstituting an accompanying product. It is nonpyrogenic and should not be used unless clear. No additional substances have been added to this product. It is important to note that it shouldn't be used for intravascular injection without being made approximately isotonic by adding a suitable solute. The unused portion should be discarded. This product has been manufactured by Laboratorios Brifols, S.A. in Spain.*

FDA Label Image

10mll1000iucartonlablel

This is a label for a medical product called "Alphanate." It contains Antihemophilic Factor/von Willebrand Factor Complex (Human) and is used for intravenous administration. The product comes in a 10mL container and features a warning about the potential transmission of infectious agents due to its origin from human plasma. Also included on the label are instructions for use and storage guidelines.*

FDA Label Image

10mll1000iuviallablel

This is a product description for Antihemophilic Factor/von Willebrand Factor Complex (Human) Alphanate®, which is a medication for intravenous administration. It is stored at temperatures not exceeding 25°C and comes in a single-dose container. The medication is produced by Grifols Biologicals LLC and is solvent detergent / heat treated. The product contains no preservatives and the accompanying pamphlet should be consulted for dosage and directions for administration. Unused contents should be discarded.*

FDA Label Image

10mll1500iuviallablel

Antihemophilic Factor/von Willebrand Factor Complex (Human) Alphanate is a medication used for intravenous administration. It is made by Grifols Biologicals LLC and comes in a single-dose container. The medication is reconstituted with 10 mL of sterilized water and contains no preservatives. This medication carries potential benefits but also risks, which should be discussed between the patient and physician before administering. The text may contain errors as there are characters that appear to be misplaced.*

FDA Label Image

10mll2000iucartonlablel

This document contains information about a product called "Antihemophilic Factor/von Willebrand Factor Complex (Human) Alphanate". It provides details about the contents, composition, and instructions for usage and storage. The product is a single-dose container meant for intravenous administration only. It is made from human plasma and may carry infectious agents. The document advises patients and physicians to discuss the benefits and risks of the product before usage.*

FDA Label Image

10mll2000iuviallablel

Antihemophilic Factor/von Willebrand Factor Complex (Human) Alphanate® is a medicine that comes with a single dose container containing 10 mL of solvent detergent/heat treated solution for intravenous administration only. It has FVIII range 2000 1U and should be stored at temperatures not exceeding 25°C. Reconstitution should be done with 10mL of Steri and should not be refrigerated after reconstitution. Unused contents should be discarded, and dosage and administration should follow physician instructions. The medicine is produced by Grifols Biologicals LLC and has NDC 68516-4610-2.*

FDA Label Image

5mlsterilewaterlablel

This is a single-dose container of sterile water for injection used for reconstitution of accompanying products. It is nonpyrogenic and does not contain any antimicrobial agent or other substance. It should not be used for intravascular injection without making it approximately isotonic by adding a suitable solute. The unused portion should be discarded. This container is manufactured by Laboratorios Grifols in Spain. The NDC code is 76297-002-02.*

FDA Label Image

5mll250iucartonlablel

This is a document related to the medicine Antihemophilic Factor/von Willebrand Factor Complex (Human) Alphanate®. It contains information on the product's composition, usage directions and storage instructions. The medicine is for intravenous administration and is solvent detergent/heat treated. The text contains some errors making some words unclear.*

FDA Label Image

5mll250iuviallablel

FDA Label Image

5mll500iucartonlablel

This document appears to be a package insert for a medical product called Alphanate. It is a complex of Antihemophilic Factor and Von Willebrand factor, intended for intravenous administration to treat bleeding disorders. The product is derived from human plasma and is treated with a solvent detergent and heat process. The document provides instructions for administration and storage, and contains warnings about the potential for infections from human blood and its components. The manufacturer's address is listed at the end of the document.*

FDA Label Image

5mll500iuviallablel

This is a product description for Alphanate, an antihemophilic factor/von Willebrand factor complex used for intravenous administration. It has been solvent detergent/heat treated and contains 500 U LELC. The product is manufactured by Grifols Biologicals LLC and is stored at temperatures not exceeding 25 °C (77 °F). The NDC code is 68516-4606-1 and the product is a single dose container. The provided text includes some artifacts, but the description is readable.*

FDA Label Image

68516 1001

This is a description of a single-dose container of sterile water for injection (Lot number NDC 68516-10011) used for the reconstitution of a medication indicated for intravascular injection. The container is non-pyrogenic, meaning it does not contain substances that can cause fever when administered. The manufacturer is Laboratorios Grifols, S.A., located in Barcelona, Spain, and the product is distributed by Grifols Biologicals LLC in Los Angeles, CA. The unused portion of the injection should be discarded and the water should not be used for intravascular injection without the addition of a suitable solute to make it approximately isotonic.*

FDA Label Image

68516 1002

This is a label of Sterile Water for Injection, a single-dose container used for reconstitution of accompanying product. It should not be used for intravascular injection without making approximately isotonic by addition of suitable solute. The unused portion of the product should be discarded. The manufacturer is Laboratorios Grifols of Spain and it is distributed in the USA by Grifols Biologicals LLC.*

FDA Label Image

Figures 1-8 (Alp03 0009 01)

* 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.