Gamunex-c Injection
Product Images NDC 13533-800

16 FDA label images from Grifols Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Gamunex-c (NDC 13533-800). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Grifols Usa, Llc, 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

Carton

Carton
Gamunex-C 10 g/100 mL Immune Globulin Injection (Human), 10% solution for infusion, is shown in a carton label for intravenous or subcutaneous administration. The label includes brand and generic names, strength, dosage form, administration route, and manufacturer Grifols USA, LLC. Warnings about storage and usage, absence of preservatives, and product identification details are also visible.*
FDA Label Image

Figure 7 (Gamunex C Img2)

Figure 7 (Gamunex C Img2)
A line graph depicting plasma total IgG concentration (mg/mL) over time (days) post start of infusion for Gamunex-C administered intravenously (IV) and subcutaneously (SC). The graph shows measured and projected values for SC administration and measured values for IV administration.*
FDA Label Image

Figure 8: Outcome Of Randomized Withdrawal Period (Gamunex Img 01)

Figure 8: Outcome Of Randomized Withdrawal Period (Gamunex Img 01)
A Kaplan-Meier curve showing time to relapse over 27 weeks comparing patients treated with Gamunex (n=31) versus placebo (n=26). The y-axis represents the percentage of patients who have not relapsed, and the plot indicates a higher percentage of non-relapsing patients in the Gamunex group versus placebo, with a p-value of 0.011 noted on the graph.*
FDA Label Image

Pi Administration (Pi Admin2)

Pi Administration (Pi Admin2)
Instructional diagram with six illustrations showing steps for subcutaneous injection and placement of an infusion pump. Figures depict opening packaging, recommended injection sites on torso and thighs, preparing the insertion area, inserting the needle, connecting tubing, and attaching the infusion pump to a belt.*
FDA Label Image

Step 1 (Step1)

Step 1 (Step1)
An instructional illustration showing a pair of hands being washed under a running faucet with water flowing over them, with visible soap suds indicating handwashing.*
FDA Label Image

Step 11 (Step11)

Step 11 (Step11)
An instructional illustration showing a hand holding a small electronic device against a person's lower abdomen where multiple electrode pads are attached on wires. This likely demonstrates the application of a medical or monitoring device with electrodes positioned on the skin.*
FDA Label Image

Step 2 (Step2)

Step 2 (Step2)
An instructional illustration showing hands removing a cap from a small vial, then peeling back the label or stopper from the vial, demonstrating preparation steps for a medication injection.*
FDA Label Image

Step 3 (Step3)

Step 3 (Step3)
Illustration showing hands removing a protective cap from a syringe tip, preparing the syringe for use. The image demonstrates the correct method for detaching the cap by gripping and pulling it off.*
FDA Label Image

Step 4 (Step4)

Step 4 (Step4)
Instructional illustration showing three steps for preparing an injection: drawing liquid into a syringe, inserting the syringe into a vial to withdraw medication, and holding the syringe upright to expel air bubbles. The images demonstrate proper technique for intravenous or subcutaneous injection preparation.*
FDA Label Image

Step 5 (Step5)

Step 5 (Step5)
An illustration showing a medical infusion pump device with a digital display and control buttons, connected to multiple long IV tubing lines. The image depicts equipment typically used for controlled administration of intravenous medications or fluids.*
FDA Label Image

Step 6 (Step6)

Step 6 (Step6)
An anatomical illustration showing front and back views of a human figure with shaded areas indicating preferred injection sites for Gamunex-C immune globulin injection. The front view highlights upper arms, upper thighs, and abdomen areas, while the back view highlights the upper back and lower back areas.*
FDA Label Image

Step 7 (Step7)

Step 7 (Step7)
An illustration showing a person's hand applying a cotton ball or gauze pad to a spot on the abdomen, likely demonstrating the post-injection care of a subcutaneous injection site.*
FDA Label Image

Step 8 (Step8)

Step 8 (Step8)
An instructional illustration showing a person holding and adjusting a subcutaneous injection device attached to their abdomen, demonstrating administration technique consistent with subcutaneous injection route for products like Gamunex-C immune globulin.*
FDA Label Image

Step 9a (Step9a)

Step 9a (Step9a)
An instructional illustration showing a person holding and preparing a syringe connected to an intravenous catheter or line inserted into the abdomen area. The image depicts the hands manipulating the syringe plunger, likely demonstrating administration technique for an intravenous or subcutaneous injection.*
FDA Label Image

Step 9b (Step9b)

Step 9b (Step9b)
An instructional illustration showing a person holding a syringe connected to tubing, with one hand holding the syringe and the other adjusting the connection, demonstrating assembly or preparation for intravenous or subcutaneous injection.*
FDA Label Image

Vial

Vial
Gamunex-C 10 g per 100 mL Immune Globulin Injection (Human), 10% solution. The label indicates it is chromatography purified and intended for intravenous or subcutaneous administration. The product is a single-dose vial labeled by Grifols USA, LLC in Research Triangle Park, NC. It includes storage instructions and cautions about use, including to not use if turbid.*

* 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.