Figure A (Rixubis 01)
Rixubis Kit
Product Images NDC 0944-3034
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Product Visual Gallery
This gallery contains 32 technical images submitted to the FDA as part of the official labeling for Rixubis (NDC 0944-3034). 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.
Product Images & Figures Index
Figure B (Rixubis 02)
Figure C (Rixubis 03)
Figure D (Rixubis 04)
Figure E (Rixubis 05)
Figure F (Rixubis 06)
Image (Rixubis 07)
Image (Rixubis 08)
Image (Rixubis 09)
Image (Rixubis 10)
Image (Rixubis 11)
Figure (Rixubis 12)
Figure (Rixubis 13)
Figure (Rixubis 14)
Figure (Rixubis 15)
Figure (Rixubis 16)
Figure (Rixubis 17)
Figure (Rixubis 18)
Figure (Rixubis 19)
Figure (Rixubis 20)
Figure (Rixubis 21)
Principal Display Panel (Kit Carton)
This is a description of a medical product called RMIBIS, which is a single-dose vial containing dried Coagulation Factor IX with no preservatives, and it comes with a needleless transfer device, a package insert, and sterile water for injection. The product is meant for intravenous use only and contains lyophilized powder for solution with a variety of ingredients, all of which are listed. It can be stored at a refrigerated temperature of 2°C to 8°C for up to 36 months or at room temperature for up to 30°C for the same period. Discard any unused portion and use within 3 hours of reconstitution. The product is made by Baxalta Incorporated, a Takeda company, and the package insert should be consulted for dosage and instructions for use.*
Principal Display Panel (5 mL Vial Label)
Principal Display Panel (Kit Carton)
RIXUBIS is a sterile and nonpyrogenic product containing lyophilized powder for solution. It is used for intravenous use after reconstitution. The package includes one vial dried Coagulation Factor (X (Recombinant)), one vial with 5 mL sterile water for injection, and one BAXJECT Il Needleless Transfer Device. The reconstituted product contains several components, including L-histidine, sodium chloride, calcium chloride, mannitol, sucrose, and polysorbate 80. It should be stored at a refrigerated temperature of [2°C to 8°C (36°F to 46°F)] or room temperature [not o exceed 30°C (86°F)] for up to 36 months. RIXUBIS is a trademark of Baalt Incorporated, a Takeda company.*
Principal Display Panel (5 mL Vial Label)
Principal Display Panel (Kit Carton)
RIXUBIS is a sterile and non-pyrogenic product used for intravenous administration as a replacement therapy for individuals suffering from Hemophilia B. Each pack contains a vial with Coagulation Factor IX (recombinant), a vial of sterile water, a BAXJECT II Needleless Transfer device, and a package insert. It is not made with natural rubber latex and should be stored at refrigerated temperature (2°C to 8°C/36°F to 46°F) or room temperature (not exceeding 30°C/86°F) for up to 36 months. The product has to be reconstituted before use, and the reconstituted solution should be used within three hours, and any unused portion should be discarded. The product contains Lyophilized Powder for Solution, 20 mM L-histidine, 60 mM sodium chloride, 4 mM calcium chloride, 110 mM mannitol, 35 mM sucrose, and 5 0.005% polysorbate 80. The enclosed package provides instructions for use and dosage information. RIXUBIS and BAXJECT I device are products of the USA, and sterilized water for injection is a product of Germany. RIXUBIS and BAXJECT are trademarks of Baxalta Incorporated, a Takeda company. Shire and the Shire logo are trademarks or registered trademarks of members of the Shire group of companies, now part of Takeda.*
Principal Display Panel (5 mL Vial Label)
This is a description of RIXUBIS, which is a recombinant coagulation factor IX product used for intravenous use only. The package insert contains instructions for use and it is not made with natural rubber latex. The manufacturer is Baxalta US, located in Lexington, WA. The product has a US License No. 2020. No further information is available due to fragmented text.*
Principal Display Panel (Kit Carton)
RIXUBIS is a non-pyrogenic coagulation factor IX product, packaged as a single-dose vial containing lyophilized powder for solution along with 5 mL of sterile water for injection. It comes with an injection device, a BAXJECT II Needleless Transfer Device, and should be used intravenously after reconstitution. RIXUBIS should be stored at refrigerated temperature (2°C to 8°C or 36°F to 46°F) or room temperature (not to exceed 30°C or 86°F) for up to 36 months. It must not be frozen or used beyond the expiration date. RIXUBIS is a trademark of Baxalta Incorporated, a Takeda company, and the product is made in the USA along with the injection device (BAXJECT II Needleless Transfer Device). Sterile Water for Injection is made in Germany.*
Principal Display Panel (5 mL Vial Label)
RIXUBIS is a medication used for intravenous administration containing recombinant coagulation factor IX. It comes in a package with NDC number 0944-3031-01 and its use is described in the package insert. The product is manufactured by a company named "Baalta" located in Lexington, MA, USA. The text contains some unreadable characters, possibly due to scanning errors.*
Principal Display Panel (Kit Carton)
RIXUBIS is a medication used for intravenous use after reconstitution to treat patients with hemophilia B, which is caused by the deficiency of coagulation Factor IX. Each package of RIXUBIS comes with a vial of dried Coagulation Factor IX, a vial with 5mL of Sterile Water for Injection, and a BAXJECT II Needleless Transfer Device. The reconstituted product should be used within 3 hours and any unused portion should be discarded. The storage temperature should be refrigerated or within room temperature, but should not exceed 30°C (86°F). The product contains natural rubber latex and can be stored for up to 36 months.*
Principal Display Panel (5 mL Vial Label)
RIXUBIS is a medication that contains recombinant coagulation factor IX, and is intended for therapeutic use. It is advised to refer to the package insert for instructions on use since no directions are provided in the given text. The product does not contain natural rubber latex. The NDC number is 0944-3033-01.*
Principal Display Panel (5 mL Vial Label)
This text seems to be a product description for a single-dose container of sterile water used for reconstitution of another accompanying product. The container should only be used if it is clear and should not be used for intravascular injection unless an appropriate solute is added to achieve isotonicity. It is for single use only and is nonpyrogenic. The product is manufactured by NO COAT.*
* 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.
