Hemofil M Kit
Product Images NDC 0944-3946

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Hemofil M (NDC 0944-3946). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Takeda Pharmaceuticals America, 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

Hemofil 01

Label for HEMOFIL M kit containing antihemophilic factor human, Method M, monoclonal purified, nanofiltered. The label shows dosage form as a dried 10 mL size vial with factor VIII (FVIII) indicated. Manufacturer is Baxalta US Inc., Lexington, MA, with Shire logo and storage instructions at 2°-8°C or room temperature not to exceed 30°C. The label includes fields for FVIII IU per vial, date and time of dose, lot number, and expiration date.*

FDA Label Image

Hemofil 02

Packaging label for HEMOFIL M, a kit containing antihemophilic factor (human) Method M, monoclonal purified, nanofiltered. The label includes dosage form as a kit with one 10 mL bottle dried antihemophilic factor and accompanying sterile water for injection and needles. Labeler is Takeda Pharmaceuticals America, Inc., with references to storage instructions, warnings about plasma origin, and trademarks of Baxalta and Shire. The label is predominately white with blue and pink text and logos.*

FDA Label Image

Hemofil 03

HEMOFIL M kit label showing antihemophilic factor (human), Method M, Monoclonal Purified, nanofiltered. The label includes dosing information fields for FVIII IU/vial, date, lot number, and time of dose. It specifies intravenous administration only with storage instructions and no preservatives. The label indicates the product is from Baxalta US Inc., Lexington, MA, and is marked with the Shire logo.*

FDA Label Image

Hemofil 04

Packaging label for HEMOFIL M, a kit containing Antihemophilic Factor (Human) Method M, Monoclonal Purified, nanofiltered. The label includes the brand Shire and indicates a 10 mL dried size with storage instructions, warnings, contents, and manufacturing details by Baxalta US Inc. The label also provides handling, administration, and patient notification information.*

FDA Label Image

Hemofil 05

Label for HEMOFIL M, antihemophilic factor (human) Method M, monoclonal purified, nanofiltered. It is a plasma derivative in kit form with FVIII IU dosing indicated. The label includes storage instructions, lot and dosing information fields, manufacturer is Baxalta US Inc., Lexington, MA, and features the Shire logo. It specifies intravenous administration only and notes no preservative content.*

FDA Label Image

Hemofil 06

Packaging label for HEMOFIL M, antihemophilic factor (human) Method M, monoclonal purified, nanofiltered, FVIII. The label indicates a 10 mL size dried dosage form in a kit format. It includes storage instructions, warnings about human plasma origin, and product contents. The label features Takeda Pharmaceuticals America's branding under Shire, with detailed product codes and regulatory information.*

FDA Label Image

Hemofil 07

The label for HEMOFIL M, containing antihemophilic factor (human) Method M, Monoclonal Purified, nanofiltered. It is for intravenous administration and displays the product strength as FVIII IU per vial. The label includes dosage form details as a 10 mL dried vial, storage instructions between 2° to 8°C and not exceeding 30°C, and manufacturer information for Takeda Pharmaceuticals America, Inc. (previously Baxalta US Inc.). It prominently states "NO COAT" and includes fields for date, lot number, and time of dose.*

FDA Label Image

Hemofil 08

Packaging label for HEMOFIL M antihemophilic factor (human) Method M, monoclonal purified, nanofiltered. This is a kit dosage form, featuring the FVIII designation. The label includes administration instructions, storage conditions (2°-8°C or room temperature up to 30°C), and warnings regarding human plasma origin. It also states the contents include a 10 mL dried antihemophilic factor bottle, sterile water for injection, double-ended needle, filter needle, and package insert. Manufactured and labeled by Takeda Pharmaceuticals America, Inc. under the Shire brand.*

FDA Label Image

Hemofil 09

Label for Sterile Water for Injection, USP, 10 mL single-dose container. It is intended for reconstitution of accompanying products and is nonpyrogenic. Manufactured by Baxter Healthcare Corporation, Deerfield, IL, and imported by Baxter Corporation, Toronto, Ontario. Includes usage instructions and regulatory information.*

* 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.