Sevenfact Kit
Product Images NDC 71127-2000

35 FDA label images from Laboratoire Fran�ais Du Fractionnement Et Des Biotechnologies Soci�t� Anonyme (lfb S.a.) · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 35 technical images submitted to the FDA as part of the official labeling for Sevenfact (NDC 71127-2000). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Laboratoire Fran�ais Du Fractionnement Et Des Biotechnologies Soci�t� Anonyme (lfb S.a.), 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

FDA Label Image

The Vial Includes A Rubber Stopper Under The Plastic Cap. (Recombinant 01)

The Vial Includes A Rubber Stopper Under The Plastic Cap. (Recombinant 01)
An illustration of a vial showing a plastic cap covering a rubber stopper. The diagram labels the plastic cap on top and indicates the rubber stopper beneath the plastic cap on the vial.*
FDA Label Image

The Syringe Plunger Rod Has A Wide Top End And Threaded End. The Pre-filled Syringe With Water For Injection Diluent Has A Plastic Backstop, Rubber Stopper, Syringe Tip (luer Lock Top Under Syringe Cap), And Syringe Cap. (Recombinant 02)

The Syringe Plunger Rod Has A Wide Top End And Threaded End. The Pre-filled Syringe With Water For Injection Diluent Has A Plastic Backstop, Rubber Stopper, Syringe Tip (luer Lock Top Under Syringe Cap), And Syringe Cap. (Recombinant 02)
An instructional line drawing illustrating the parts of a syringe assembly for intravenous use. The diagram labels the wide top, thread, plastic backstop, rubber stopper, syringe tip (with a note about a Luer lock top under the syringe cap), and the syringe cap.*
FDA Label Image

The Sevenfact 1 mg And 2 mg Vial Adapter And Sevenfact 5 mg Vial Adapter Each Contain A Plastic Cover, Paper Protective Cover, And Spike (under Protective Paper). (Recombinant 03)

The Sevenfact 1 mg And 2 mg Vial Adapter And Sevenfact 5 mg Vial Adapter Each Contain A Plastic Cover, Paper Protective Cover, And Spike (under Protective Paper). (Recombinant 03)
An instructional illustration showing a syringe cap with a spike covered by protective paper, along with a plastic cover and paper protective cover. The diagram labels these components to clarify their arrangement and protective features for safe use.*
FDA Label Image

Lfb Logo (Recombinant 04)

Lfb Logo (Recombinant 04)
FDA Label Image

A Black And Blue Logoai-generated Content May Be Incorrect. (Recombinant 05)

A Black And Blue Logoai-generated Content May Be Incorrect. (Recombinant 05)
FDA Label Image

The Powdered Drug Vial Includes A Rubber Stopper Under The Plastic Cap. (Recombinant 06)

The Powdered Drug Vial Includes A Rubber Stopper Under The Plastic Cap. (Recombinant 06)
An instructional illustration depicting a powdered drug vial with labels identifying its components: a plastic cap and a rubber stopper beneath the plastic cap. The vial is shown in a labeled diagram format, useful for understanding packaging or preparation of the drug.*
FDA Label Image

The Syringe Plunger Rod Has A Wide Top End And Threaded End. The Pre-filled Syringe With Water For Injection Diluent Has A Plastic Backstop, Rubber Stopper, Syringe Tip (luer Lock Top Under Syringe Cap), And Syringe Cap. (Recombinant 07)

The Syringe Plunger Rod Has A Wide Top End And Threaded End. The Pre-filled Syringe With Water For Injection Diluent Has A Plastic Backstop, Rubber Stopper, Syringe Tip (luer Lock Top Under Syringe Cap), And Syringe Cap. (Recombinant 07)
An instructional illustration showing the components of a syringe plunger rod and a prefilled syringe with diluent. The syringe plunger rod is labeled with a wide top and thread. The prefilled syringe is labeled with a plastic backstop, rubber stopper, syringe tip (noting a Luer lock top under the syringe cap), and syringe cap.*
FDA Label Image

An Infusion Set, Plastic Syringe, Alcohol Swab, And Fda-approved Sharps Container. (Recombinant 08)

An Infusion Set, Plastic Syringe, Alcohol Swab, And Fda-approved Sharps Container. (Recombinant 08)
An instructional diagram showing two types of vial adapters for the Sevenfact kit: a 1 mg vial adapter and a 5 mg vial adapter. Each adapter includes a plastic cover, spike (under protective paper), and a paper protective cover. A syringe cap is also shown for the 1 mg adapter. A note indicates that the Sevenfact kit will contain only one vial adapter.*
FDA Label Image

Check The Expiration Date On The Side Of The Kit (figure A). (Recombinant 09)

Check The Expiration Date On The Side Of The Kit (figure A). (Recombinant 09)
Illustration showing components of a Sevenfact infusion kit, including an infusion set, a plastic syringe, an alcohol swab, and an FDA-approved sharps container labeled with a biohazard symbol.*
FDA Label Image

Wash Your Hands With Soap And Water And Dry Using A Clean Towel Or Air Dry (figure B). (Recombinant 0a)

Wash Your Hands With Soap And Water And Dry Using A Clean Towel Or Air Dry (figure B). (Recombinant 0a)
The packaging label for Sevenfact, a kit containing Coagulation Factor VIIa Recombinant Human for intravenous use. The label features the brand name Sevenfact prominently, with part of the generic name visible. There is a section marked with a magnified eye symbol highlighting a barcode area containing GTIN, serial number, lot number, and expiration date fields. The labeler is Laboratoire Français du Fractionnement et des Biotechnologies Société Anonyme (LFB S.A.).*
FDA Label Image

Take Out The Contents Of One Kit And One Alcohol Swab. Place Items On The Clean Surface (figure C). (Recombinant 0b)

Take Out The Contents Of One Kit And One Alcohol Swab. Place Items On The Clean Surface (figure C). (Recombinant 0b)
Illustration showing a hand being washed under running water from a faucet, with another hand rubbing the fingers, labeled with a black square containing the letter B. This instructional image likely demonstrates proper hand hygiene technique related to use or preparation of the product.*
FDA Label Image

Remove The Plastic Cap From The Vial (figure D). (Recombinant 0c)

Remove The Plastic Cap From The Vial (figure D). (Recombinant 0c)
Illustration showing the Sevenfact kit for intravenous use, including packaging and kit contents displayed on a table: a syringe, a vial, a small packet labeled 'Multi-Dose,' and a lancet device. The image emphasizes the individual components contained within the Sevenfact coagulation factor VIIa recombinant human kit by LFB S.A.*
FDA Label Image

Wipe The Rubber Stopper With An Alcohol Swab (figure E) And Allow It To Air Dry For A Few Seconds To Ensure That It Is As Germ Free As Possible. (Recombinant 0d)

Wipe The Rubber Stopper With An Alcohol Swab (figure E) And Allow It To Air Dry For A Few Seconds To Ensure That It Is As Germ Free As Possible. (Recombinant 0d)
An instructional illustration showing a hand holding a vial labeled Sevenfact. The image demonstrates how to grip the vial, likely as part of preparation or administration instructions for the Sevenfact coagulation factor VIIa recombinant human intravenous kit by LFB S.A.*
FDA Label Image

Peel Off The Paper Protective Cover From The Vial Adapter Package (figure F). (Recombinant 0e)

Peel Off The Paper Protective Cover From The Vial Adapter Package (figure F). (Recombinant 0e)
An instructional illustration showing a hand holding a vial while another hand peels off or cleans the vial's stopper with an alcohol wipe or similar cloth. The image is labeled with the letter "E" in a black box in the lower left corner.*
FDA Label Image

Firmly Press Down So The Vial Adapter Spike Breaks Through The Rubber Stopper (you May Hear/see It "snap" Into Place) (figure G). (Recombinant 0f)

Firmly Press Down So The Vial Adapter Spike Breaks Through The Rubber Stopper (you May Hear/see It "snap" Into Place) (figure G). (Recombinant 0f)
An instructional illustration labeled 'F' showing hands peeling back a peel-off plastic cover from a round vial or container, likely part of preparing a Sevenfact kit for intravenous use.*
FDA Label Image

Lightly Squeeze The Plastic Cover And Lift Up To Remove It From The Vial Adapter (figure H). (Recombinant 10)

Lightly Squeeze The Plastic Cover And Lift Up To Remove It From The Vial Adapter (figure H). (Recombinant 10)
An instructional illustration showing hands preparing medication using a vial and a syringe or similar device. An inset diagram highlights placing the assembled syringe apparatus into a holder or stand, indicated by a black arrow. The illustration is labeled with a bold letter 'G' in the corner.*
FDA Label Image

Remove The Syringe Cap From The Pre-filled Syringe By Holding The Syringe Body With One Hand And Using The Other Hand To Unscrew The Syringe Cap (turn To The Left) (figure I). (Recombinant 11)

Remove The Syringe Cap From The Pre-filled Syringe By Holding The Syringe Body With One Hand And Using The Other Hand To Unscrew The Syringe Cap (turn To The Left) (figure I). (Recombinant 11)
An instructional illustration showing hands removing two tablets or capsules from a blister pack and holding a vial, likely demonstrating preparation steps for the Sevenfact kit containing Coagulation Factor VIIa Recombinant Human for intravenous use.*
FDA Label Image

While Holding The Edges Of The Vial Adapter, Screw On The Pre-filled Syringe (turn To The Right) A Few Turns Until It Starts To Tighten (figure J). (Recombinant 12)

While Holding The Edges Of The Vial Adapter, Screw On The Pre-filled Syringe (turn To The Right) A Few Turns Until It Starts To Tighten (figure J). (Recombinant 12)
An instructional illustration showing a step in preparation or assembly, where a hand is twisting and attaching a vial or cap to another component, indicated by arrows to guide the motion.*
FDA Label Image

Insert The Plunger Rod Into The Syringe, Then Screw A Few Turns (turn To The Right) So That The Plunger Rod Is Attached To The Gray Rubber Stopper In The Syringe (figure K). (Recombinant 13)

Insert The Plunger Rod Into The Syringe, Then Screw A Few Turns (turn To The Right) So That The Plunger Rod Is Attached To The Gray Rubber Stopper In The Syringe (figure K). (Recombinant 13)
An instructional illustration showing a hand using a syringe to withdraw medication from a vial. The image demonstrates the correct method to draw liquid from the vial into the syringe, with arrows indicating the motion and a label 'J' in the bottom left corner.*
FDA Label Image

Very Slowly Push Down On The Plunger Rod To The Bottom Of The Syringe, To Transfer All Of The Liquid From The Syringe Into The Drug Vial (figure L). (Recombinant 14)

Very Slowly Push Down On The Plunger Rod To The Bottom Of The Syringe, To Transfer All Of The Liquid From The Syringe Into The Drug Vial (figure L). (Recombinant 14)
An instructional illustration showing a close-up of two hands manipulating a syringe and vial. The upper hand is shown twisting or rotating the syringe plunger, with curved arrows indicating the direction of rotation. The vial is positioned below the syringe on a flat surface. A black square with the letter 'K' appears in the lower left corner of the image.*
FDA Label Image

Swirl The Vial Gently Or Roll Between Hands Until All Powder Is Dissolved (figure M). (Recombinant 15)

Swirl The Vial Gently Or Roll Between Hands Until All Powder Is Dissolved (figure M). (Recombinant 15)
An instructional diagram showing the use of a syringe to draw liquid from a vial labeled with an 'L' in a black square. The illustration depicts two hands, one holding the syringe needle inserted into the vial and the other steadying the vial, with a downward arrow indicating the drawing motion.*
FDA Label Image

Check The Mixed Solution (figure N). It Should Be Clear To Slightly Opaque. All Powder Should Be Dissolved With No Particles Floating In The Liquid. (Recombinant 16)

Check The Mixed Solution (figure N). It Should Be Clear To Slightly Opaque. All Powder Should Be Dissolved With No Particles Floating In The Liquid. (Recombinant 16)
An instructional illustration showing hands gently swirling a vial with a syringe. The image emphasizes a gentle swirling motion, indicated by curved arrows, to probably mix or dissolve the contents without shaking. The letter 'M' appears in a black square on the lower left corner.*
FDA Label Image

Without Withdrawing Any Drug Back Into The Syringe, Unscrew The Syringe From The Vial Adapter (turn To The Left) Until It Is Completely Detached (figure O). (Recombinant 17)

Without Withdrawing Any Drug Back Into The Syringe, Unscrew The Syringe From The Vial Adapter (turn To The Left) Until It Is Completely Detached (figure O). (Recombinant 17)
An instructional illustration showing a vial with a dropper or syringe attached at the top. An arrow points downward into the vial, with an eye icon beside it, indicating to visually inspect the vial's contents. The letter "N" is present in a black box at the lower left corner.*
FDA Label Image

Throw Out Empty Syringe Into An Fda-approved Sharps Container (figure P). (Recombinant 18)

Throw Out Empty Syringe Into An Fda-approved Sharps Container (figure P). (Recombinant 18)
An instructional illustration showing the hands performing a step in medication preparation. One hand holds a vial or container while the other hand is removing or inserting a syringe or similar device vertically above it, with arrows indicating upward and rotational movement.*
FDA Label Image

Sevenfact® Must Be Infused Within 4 Hours Of Reconstitution (figure Q). (Recombinant 19)

Sevenfact® Must Be Infused Within 4 Hours Of Reconstitution (figure Q). (Recombinant 19)
An instructional illustration showing a hand disposing of a syringe into a biohazard sharps container labeled with a biohazard symbol and the words 'SHARPS CONTAINER.' This image is likely part of patient or healthcare provider guidance for safe injection waste disposal.*
FDA Label Image

After Reconstitution And Infusion, Safely Dispose Of The Vial With Vial Adapter Attached, The Infusion Syringe, And Any Other Waste Materials Into An Fda-approved Sharps Container (figure R). (Recombinant 1a)

After Reconstitution And Infusion, Safely Dispose Of The Vial With Vial Adapter Attached, The Infusion Syringe, And Any Other Waste Materials Into An Fda-approved Sharps Container (figure R). (Recombinant 1a)
An instructional illustration depicting a clock showing 3:00 with the accompanying text 'Infuse within 4 Hours,' indicating the time frame for infusion after preparation.*
FDA Label Image

Ndc 71127-1000-1sevenfact® 1 mgcoagulation Factor Viia (recombinant)-jncw For Intravenous Use Onlydosage And Administration: Read Package Insertcontents:one 1 mg Vial Of Sevenfactone 1.1 mL Pre-filled Syringe Of Sterile Water For Injectionone Plunger Rodone Sterile Vial Adapternot Made With Natural Rubber Latexrx Onlylfbhema Biologics (Recombinant 1b)

Ndc 71127-1000-1sevenfact® 1 mgcoagulation Factor Viia (recombinant)-jncw For Intravenous Use Onlydosage And Administration: Read Package Insertcontents:one 1 mg Vial Of Sevenfactone 1.1 mL Pre-filled Syringe Of Sterile Water For Injectionone Plunger Rodone Sterile Vial Adapternot Made With Natural Rubber Latexrx Onlylfbhema Biologics (Recombinant 1b)
An instructional illustration showing a hand safely disposing of a syringe or vial into a rectangular sharps container labeled 'SHARPS CONTAINER' with a biohazard symbol. The image includes a bold letter 'R' in the lower left corner.*
FDA Label Image

Ndc 71127-2000-1sevenfact® 2 mgcoagulation Factor Viia (recombinant)-jncw For Intravenous Use Onlydosage And Administration: Read Package Insertcontents:one 2 mg Vial Of Sevenfactone 2.2 mL Pre-filled Syringe Of Sterile Water For Injectionone Plunger Rodone Sterile Vial Adapternot Made With Natural Rubber Latexrx Onlylfbhema Biologics (Recombinant 1c)

Ndc 71127-2000-1sevenfact® 2 mgcoagulation Factor Viia (recombinant)-jncw For Intravenous Use Onlydosage And Administration: Read Package Insertcontents:one 2 mg Vial Of Sevenfactone 2.2 mL Pre-filled Syringe Of Sterile Water For Injectionone Plunger Rodone Sterile Vial Adapternot Made With Natural Rubber Latexrx Onlylfbhema Biologics (Recombinant 1c)
Sevenfact 1 mg kit carton label for coagulation factor VIIa (recombinant) - jncw. The packaging indicates room temperature stability with instructions not to freeze. Labeler is Laboratoire Français du Fractionnement et des Biotechnologies Société Anonyme (LFB S.A.) with distribution by HEMA Biologics. The label includes usage directions and storage warnings, barcodes, and manufacturer details.*
FDA Label Image

Ndc 71127-5000-1sevenfact® 5 mgcoagulation Factor Viia (recombinant)-jncw For Intravenous Use Onlydosage And Administration: Read Package Insertcontents:one 5 mg Vial Of Sevenfactone 5.2 mL Pre-filled Syringe Of Sterile Water For Injectionone Plunger Rodone Sterile Vial Adapternot Made With Natural Rubber Latexrx Onlylfbhema Biologics (Recombinant 1d)

Ndc 71127-5000-1sevenfact® 5 mgcoagulation Factor Viia (recombinant)-jncw For Intravenous Use Onlydosage And Administration: Read Package Insertcontents:one 5 mg Vial Of Sevenfactone 5.2 mL Pre-filled Syringe Of Sterile Water For Injectionone Plunger Rodone Sterile Vial Adapternot Made With Natural Rubber Latexrx Onlylfbhema Biologics (Recombinant 1d)
Sevenfact 5 mg packaging label for coagulation factor VIIa (recombinant) intravenous kit. The label shows the proprietary name Sevenfact with strength 5 mg, details on the recombinant factor VIIa, warnings including 'Room temperature stable. Do not freeze.', and reconstitution instructions. The labeler is Laboratoire Français du Fractionnement et des Biotechnologies Société Anonyme (LFB S.A.), with HEMA Biologics mentioned as distributor.*
FDA Label Image

Ndc 71127-1100-1sevenfact® 1 mgcoagulation Factor Viia (recombinant)-jncwreconstitute With 1.1 mL Sterile Water For Injectionfor Intravenous Administration Onlystore Between 2-30°c (36-86°f). Rx Onlymanufactured By Lfb S.a. U.s. License No. 2061 (Recombinant 1e)

Ndc 71127-1100-1sevenfact® 1 mgcoagulation Factor Viia (recombinant)-jncwreconstitute With 1.1 mL Sterile Water For Injectionfor Intravenous Administration Onlystore Between 2-30°c (36-86°f). Rx Onlymanufactured By Lfb S.a. U.s. License No. 2061 (Recombinant 1e)
Sevenfact 1 mg kit containing coagulation factor VIIa (recombinant). The label indicates reconstitution with 1.1 mL sterile water for injection and specifies intravenous administration only. Storage instructions are to keep between 2-30°C (36-86°F). Manufactured by Laboratoire Français du Fractionnement et des Biotechnologies S.A. (LFB S.A.).*
FDA Label Image

Ndc 71127-2100-1sevenfact® 2 mgcoagulation Factor Viia (recombinant)-jncwreconstitute With 2.2 mL Sterile Water For Injectionfor Intravenous Administration Onlystore Between 2-30°c (36-86°f). Rx Onlymanufactured By Lfb S.a. U.s. License No. 2061 (Recombinant 1f)

Ndc 71127-2100-1sevenfact® 2 mgcoagulation Factor Viia (recombinant)-jncwreconstitute With 2.2 mL Sterile Water For Injectionfor Intravenous Administration Onlystore Between 2-30°c (36-86°f). Rx Onlymanufactured By Lfb S.a. U.s. License No. 2061 (Recombinant 1f)
Sevenfact 2 mg kit label showing coagulation factor VIIa (recombinant) for intravenous use. The label instructs reconstitution with 2.2 mL sterile water for injection, storage between 2-30°C, and indicates Rx only. Manufactured by Laboratoire Français du Fractionnement et des Biotechnologies (LFB S.A.). The NDC number is 71127-2100-1.*
FDA Label Image

Ndc 71127-5100-1sevenfact® 5 mgcoagulation Factor Viia (recombinant)-jncwreconstitute With 5.2 mL Sterile Water For Injectionfor Intravenous Administration Onlystore Between 2-30°c (36-86°f). Rx Onlymanufactured By Lfb S.a. U.s. License No. 2061 (Recombinant 20)

Ndc 71127-5100-1sevenfact® 5 mgcoagulation Factor Viia (recombinant)-jncwreconstitute With 5.2 mL Sterile Water For Injectionfor Intravenous Administration Onlystore Between 2-30°c (36-86°f). Rx Onlymanufactured By Lfb S.a. U.s. License No. 2061 (Recombinant 20)
Label for Sevenfact 5 mg, containing coagulation factor VIIa (recombinant). The label includes instructions for reconstitution with 5.2 mL Sterile Water for Injection and mentions intravenous administration only. Storage conditions specify 2-30°C (36-86°F). Manufactured by Laboratoire Français du Fractionnement et des Biotechnologies (LFB S.A.) under U.S. License No. 2061.*
FDA Label Image

Ndc 71127-1200-1sterile Water For Injection 1.1 mLfor Reconstitution Of Sevenfact® 1 mg/viallot 000000000aexp Mmm0000manufactured By Lfb S.a.puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f)rx Onlyexp Mmm0000manufactured By Lfb S.a.puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f)rx Only (Recombinant 21)

Ndc 71127-1200-1sterile Water For Injection 1.1 mLfor Reconstitution Of Sevenfact® 1 mg/viallot 000000000aexp Mmm0000manufactured By Lfb S.a.puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f)rx Onlyexp Mmm0000manufactured By Lfb S.a.puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f)rx Only (Recombinant 21)
Label for Sterile Water for Injection 1.1 mL, intended for reconstitution of Sevenfact 1 mg/vial. The label includes lot number, expiration date, storage instructions (2-30°C), and manufacturer information (LFB S.A., Puteaux, France). The product is Rx only and includes a barcode and U.S. License No. 2061.*
FDA Label Image

Ndc 71127-2200-1sterile Water For Injection 2.2 mLfor Reconstitution Of Sevenfact® 2 mg/viallot 000000000abexp Mmm0000manufactured By Lfb S.a. Puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f). Rx Only (Recombinant 22)

Ndc 71127-2200-1sterile Water For Injection 2.2 mLfor Reconstitution Of Sevenfact® 2 mg/viallot 000000000abexp Mmm0000manufactured By Lfb S.a. Puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f). Rx Only (Recombinant 22)
Sterile Water for Injection 2.2 mL vial label for reconstitution of Sevenfact 2 mg/vial. The label includes lot number, expiration date, manufacturer Laboratoire Français du Fractionnement et des Biotechnologies (LFB S.A.) in France, U.S. license number, storage instructions between 2-30°C (36-86°F), and a barcode.*
FDA Label Image

Ndc 71127-5200-1sterile Water For Injection 5.2 mLfor Reconstitution Of Sevenfact® 5 mg/viallot 000000000abexp Mmm0000manufactured By Lfb S.a. Puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f)rx Only (Recombinant 23)

Ndc 71127-5200-1sterile Water For Injection 5.2 mLfor Reconstitution Of Sevenfact® 5 mg/viallot 000000000abexp Mmm0000manufactured By Lfb S.a. Puteaux, 92800, Franceu.s. License No. 2061store Between 2-30°c(36-86°f)rx Only (Recombinant 23)
Label for Sterile Water for Injection 5.2 mL vial, used for reconstitution of Sevenfact 5 mg kit. Manufactured by Laboratoire Français du Fractionnement et des Biotechnologies S.A. (LFB S.A.), with storage instructions and lot/expiration placeholders visible.*

* 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.