Hemofil M Kit
Product Images NDC 0944-3944

The text is a product description of Antihemophilic Factor (Human). The product is Nanofiltered and Monoclonal Purified. It is administered through intravenous adm n only, and does not contain a preservative. It should be stored at 2° - 8°C (36° - 46°F) or room temperature, not to exceed 30°C (86°F) until the expiration date noted on the package. The text provides dosage and administration information as well as a lot number and NDC. The manufacturer is Baxalta US Inc.*

This product is a 10 mL bottle of dried Antihemophilic Factor (Human) called HEMOFIL M. It is purified by the monoclonal method and nanofiltered. The package includes a bottle of Sterile Water for Injection, USP, one double-ended needle, one filter needle, and a package insert. It is only for intravenous administration and must be kept at a temperature not exceeding 30°C (86°F) until the expiration date. It should be administered within three hours of reconstitution. The product contains stabilizing agents such as Albumin (Human), PEG, histidine, glycine, and organic solvent. There are also precautions in place regarding the transmission of infectious agents due to the product's origins in human plasma. Furthermore, a confidential patient notification system is available for enrollment. Overall, this is a medication for those with hemophilia and requires careful preparation and administration.*

This is a product description of Antihemophilic Factor (Human), which is available in 10mL size and is purified for intravenous administration only. This product does not contain preservatives and should be stored at 2° - 8°C until the expiration date noted on the package or at room temperature, not exceeding 30°C (86°F). The package insert should be read regarding dosage and administration. The manufacturer is Baxalta US Inc. The other text includes lot numbers and expiration dates, dosage information and manufacturing details.*

This is a package insert for a medication called HEMOFIL M that contains Antihemophilic Factor (Human) for intravenous administration. It's designed for individuals with hemophilia A (Factor VIII deficiency). The pack contains a dried 10 mL bottle, 10 mL sterile water for injection, one double-ended needle, one filter needle, and package insert. It's important to note that this product is prepared from large pools of human plasma, which means it can transmit infectious agents. Therefore, the patient and physician should discuss the risks and benefits of the product before use. It's also important to administer the medication within three hours of reconstitution.*

This appears to be a product label or information sheet for a medicine called "Antihemophilic Factor (Human)" that is used to treat a blood clotting disorder called Hemophilia A. The medication is sold in vials, and the lot and expiration date are listed. The medication should be stored at a temperature of 2-8°C or room temperature but not to exceed 30°C. The label also cautions the user to read the package insert for dosage and administration instructions.*

The text describes a product with the name "HEMOFIL M", which is Antihemophilic Factor (Human) that contains nanofiltered FVIII. The product comes in a 10 mL bottle and is administered through intravenous injection. It is essential to store the medication at a temperature not exceeding 30°C and within 3 hours after reconstitution. Additionally, it contains stabilizing agents such as human albumin, PEG, histidine, glycine, mouse protein, organic solvent, and detergent. The text also warns that the product is prepared from human plasma and may transmit infectious agents. Finally, the product contains a package insert along with one double-ended needle and one filter needle.*

This is a description of a medication for intravenous administration only. It is an Antihemophilic Factor (Human) with Method M, Monoclonal Purified called HEMOFIL M, which is a nanofiltered FVI. It is available in 10 mL size, dried form, packaged with 10 mL Sterile Water for Injection, USP, one double-ended needle, and one filter needle. The medication should be administered within 3 hours after reconstitution, and the dosage and administration should be read in full before using. The product does not contain any preservatives and should be stored at either 2° - 8°C (36° - 46°F) or in room temperature not to exceed 30°C (86°F) until the expiration date noted on the package. The product has stabilizing agents present in the following maximum amounts: 12.5 mg/mL Albumin (Human) and per AHF International Unit, 0.07 mg PEG, 0.39 mg histidine, and it also contains not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). The medication is manufactured by Baxalta US Inc. in Lexington, MA 02421 USA, and is licensed in the US with License No. 2020. It contains a warning that it is prepared from large pools of human plasma and its components may transmit infectious agents. The patient and physician should discuss the risks and benefits of the product.*

This is a description of a Nonpyrogenic Single-Dose Container with a capacity of 10 mL, containing sterile water for Injection, USP. It is meant for reconstitution of an accompanying product. The container should not be used if it is not clear, or if any antimicrobial agent or other substance has been added. It should not be used for nonvascular injection without making approximately isotonic by adding suitable solute. The unused portion should be discarded. The manufacturer is Baxter Healthcare Corporation and it is imported by Baxter Corporation. The Lot and the Exp information are not available.*