Koate Kit
Product Images NDC 76125-672

NDC 13533-000-04 is a nonpyrogenic single-dose container of sterile water for injection, USP, that comes in a 5ml container. It is intended for reconstituting the accompanying product but should not be used unless clear. No antimicrobial agent or other substances have been added. It should not be used for intravascular use unless made approximately isotonic. Any unused portion should be discarded. Manufactured by Grifols Therapeutics LLC for Baxter Healthcare Corporation, Deerfield, IL 60015 USA. It is intended for placement purposes only.*

This is a description of a sterile water solution for injection, provided in a single-dose container. The NDC code associated with the solution is 13533-200-05. It is manufactured by Laboratorios Grifols, based in Spain, and distributed by Grifols Therapeutics LLC in the US. The solution is for reconstitution of accompanying products and requires testing for clarity prior to usage. It is nonpyrogenic and should not be used for intravascular injection unless adjusted to an isotonic state. Unused portions should be discarded.*

This appears to be a product description for a drug called Antihemoph Factor (Human). It comes in a 500 IU FVIII range and is Solvent/Detergent Treated and Heat-Treated at 80°C. The document provides information on dosage and administration, storage, and sterile instructions. The drug is manufactured by Kedrion Biopharma Inc. and Grifls Therapeuties LLC.*

This is a product description of Koate, an antihemophilic factor treated with solvent/detergent and heat. It is manufactured by Grifols Therapeutics LLC and distributed by Kedrion Biopharma Inc. This product should be administered intravenously and should only be used after discussing the benefits and risks with a physician. The product does not contain preservatives, and it should be reconstituted with 5 mL of sterile water for injection, USP. It can be stored at 2-8°C for up to 6 months before expiration, and the package insert should be read before administration. Any other additional information is not available.*

This appears to be a product insert for Kedrion Blopharma Inc's Factor (Human) product, with dosage and administration information provided in the text. The product is sterile and nonpyrogenic, but there is a warning about the risk of transmitting infectious agents since it is prepared from large pools of human plasma. The content of one vial of Koite should be reconstituted with either 10 ml of Sterile Water for Injection or 10 ml of Saline Water for Injection, and the reconstituted product should be used within three hours. The text also mentions the presence of 1500 µg/ml polyethylene glycol, among other ingredients. The product is not returnable for credit or exchange.*

This appears to be a description of a medication in the form of a Koal Antihemophilic Factor (Human). The medication has been treated with Solvent/Detergent and Heat at 80°C. It does not contain any preservatives and should only be administered intravenously. Reconstitution requires sterile water and storage temperature should be maintained at 2-8°C (36-46°F), and no more than 6 months at room temperature. The manufacturer is Kedrion Blopharma Inc in Fort Lee, NJ and manufactured by Grifols Therapeutics LLC in NC. The dosage and administration details are available in the package insert. No information is given on the date removed from refrigeration.*

This is a single-dose container of Sterile Water for Injection, which is used to reconstitute the accompanying product. It should not be used if it is not clear, and no antimicrobial agent or other substance has been added. It should not be used for intravascular injection without making it approximately isotonic by adding a suitable solute. The unused portion should be discarded. The manufacturer is Laboratorios Grifls, S.A., based in Parets del Valkes, Barcelona, Spain, with product number NDC 76297-002-02.*