Koate Kit
Product Images NDC 76125-250

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Koate (NDC 76125-250). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kedrion Biopharma, Inc., 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

13533 000 04

Label for Sterile Water for Injection, USP, 5 mL single-dose container for reconstitution of accompanying product. The label states it is nonpyrogenic, for injection only after making isotonic by adding suitable solute, with no antimicrobial agent added. Manufactured by Baxter Healthcare Corporation, Deerfield, IL, for Grifols Therapeutics LLC, Research Triangle Park, NC.*

FDA Label Image

13533 200 05

Label for Sterile Water for Injection, USP 5 mL vial used for reconstitution of an accompanying product. It is a single-dose, nonpyrogenic container with instructions against use unless clear. Manufactured by Laboratorios Grifols S. A. in Spain and Grifols Therapeutics LLC in the USA.*

FDA Label Image

76125 250 20

Packaging label for Koate Antihemophilic Factor (Human) 250 IU FVIII Range kit. The label indicates the product is a plasma derivative, solvent/detergent treated and heat-treated at 80°C. The package size is 5 mL, for intravenous use, and is labeled Rx only. Manufactured by Kedrion Biopharma, Inc. The label includes warnings about infectious agents, storage instructions, and a list of kit contents.*

FDA Label Image

76125 252 21

Koate Antihemophilic Factor (Human) plasma derivative kit label for intravenous use. The label states the product is solvent/detergent treated and heat-treated at 80°C. Manufactured for Kedrion Biopharma Inc. and by Grifols Therapeutics LLC. It includes storage instructions, administration route, and preservative information.*

FDA Label Image

76125 667 30

Packaging label for Koate Antihemophilic Factor (Human) 500 IU FVIII Range, a plasma derivative kit for intravenous use. The label indicates it is solvent/detergent treated and heat-treated at 80°C, supplied as a 5 mL kit, Rx only. Manufactured by Kedrion Biopharma, Inc. with additional manufacturing by Grifols Therapeutics LLC. Contains one bottle of Koate, sterile water for injection, sterile needles, and administration set; sterile and nonpyrogenic with no preservative.*

FDA Label Image

76125 669 31

Koate Antihemophilic Factor (Human) intravenous kit, a plasma derivative labeled by Kedrion Biopharma, Inc. The label includes handling instructions such as storage temperatures, reconstitution with sterile water, and a reminder that the product contains no preservatives and is for intravenous use only. Manufacturing information by Grifols Therapeutics LLC is also shown.*

FDA Label Image

76125 672 50

The image shows packaging for Koate Antihemophilic Factor (Human) 1000 IU FVIII Range, a plasma derivative kit for intravenous use. The front panel highlights the product name, strength, and that it is solvent/detergent treated and heat-treated at 80°C. The package includes warnings, storage instructions, and contents: one bottle of Koate, 10 mL sterile water for injection, sterile filter needle, sterile double-ended transfer needle, and a sterile administration set. Manufactured by Kedrion Biopharma, Inc. and Grifols Therapeutics LLC.*

FDA Label Image

76125 673 51

Label for Koate Antihemophilic Factor (Human) intravenous kit, a plasma derivative. The product is solvent/detergent treated and heat-treated at 80°C. Manufactured for Kedrion Biopharma Inc. and by Grifols Therapeutics LLC. The label includes storage instructions, reconstitution directions, and a barcode.*

FDA Label Image

76297 002 02

Sterile Water for Injection, USP label for 5 mL single-dose vial. The label includes usage instructions, manufacturing details by Laboratorios Grifols, S. A. in Spain, and warnings about the solution's use for reconstitution only, not for direct intravascular injection without proper dilution. It is marked Rx Only and includes barcodes and a space for lot and expiration information.*

FDA Label Image

Figures A-f (Koate Dvi 02)

An instructional diagram showing step-by-step preparation of an intravenous kit, likely for Koate Antihemophilic Factor (Human). Steps include removing cap from vial, inserting a syringe or diluent bottle, mixing by shaking or swirling, and drawing liquid into a syringe for administration.*

* 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.