Gammaked Injection
Product Images NDC 76125-900

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Gammaked (NDC 76125-900). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kedrion Biopharma, 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

Figure 7 (Figure7)

A line graph depicting plasma total IgG concentration (mg/mL) over time in days after infusion start comparing intravenous (IV) and subcutaneous (SC) administration. IV administration shows a higher initial concentration with a gradual decline, while SC administration maintains a steadier concentration. The graph includes measured data for both routes and projected data for SC administration.*

FDA Label Image

Figure 8 (Figure8)

A Kaplan-Meier curve graph showing the time to relapse during a randomized withdrawal period for patients treated with GAMMAKED versus placebo. The y-axis represents the percentage of patients who relapsed, and the x-axis shows time to relapse in weeks. The graph indicates a statistically significant difference (p=0.011) favoring GAMMAKED over placebo.*

FDA Label Image

100 mL Carton (Gammakedcarton)

GAMMAKED Immune Globulin (Human) 10% Injection, 10 grams protein per 100 mL, solution for infusion. The label includes storage instructions, product contents, and manufacturer details. Labeler is Kedrion Biopharma, Inc. The packaging is a carton with clear labeling for intravenous or subcutaneous administration and no preservatives.*

FDA Label Image

Administration (Pi Admin2)

Instructional diagram showing six figures illustrating the preparation and administration steps for subcutaneous injection of a medication. Figures depict hands preparing the injection, body areas suitable for injection marked on front and back views, and attaching the infusion set and device to the abdominal area near the belt line.*

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Step 11 (Step11bw)

An instructional illustration showing a person holding a handheld medical device or sensor against their lower back or waist area. The person has two adhesive electrode pads attached to their abdomen, each connected by wires to the device, demonstrating setup or usage guidance for a medical monitoring or therapeutic device.*

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Step 1 (Step1bw)

An instructional illustration showing two cupped hands positioned under running water from a faucet, indicating handwashing or rinsing. The grayscale image emphasizes proper hygiene or cleaning technique relevant to medication handling.*

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Step 2 (Step2bw)

An instructional illustration showing hands handling a vial and a cap. The first image demonstrates holding a vial, and the second depicts the removal of a cap or seal from a small container, indicative of preparation steps for an injection.*

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Step 3 (Step3bw)

An instructional illustration showing two steps of preparing an injection. The first step shows a hand inserting a needle cap over the syringe needle, and the second step shows a hand twisting and removing the needle cap from the syringe. The syringe is held horizontally in both steps.*

FDA Label Image

Step 4 (Step4bw)

Three-step instructional diagram showing hands preparing an injection syringe: drawing fluid from a vial, expelling air bubbles, and finalizing the syringe for use. The black-and-white illustrations demonstrate safe syringe handling and preparation technique for intravenous or subcutaneous administration.*

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Step 5 (Step5bw)

An illustration showing a medical infusion pump device with attached tubing, likely used for controlled intravenous or subcutaneous administration of medications such as immune globulin.*

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Step 6 (Step6bw)

An anatomical illustration showing front and back views of a human figure with shaded areas on shoulders, upper arms, abdomen, upper thighs, and lower back, likely indicating recommended injection sites for intravenous or subcutaneous administration.*

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Step 7 (Step7bw)

An illustration showing a hand using a cotton ball to press on an injection site on the abdomen, just above the beltline. This image visually demonstrates care after administering a subcutaneous injection.*

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Step 8 (Step8bw)

An instructional illustration depicting hands administering a subcutaneous injection into the abdomen area. The image shows the placement of the needle and tubing attached to the injection site, indicating proper technique for subcutaneous delivery of a medication.*

FDA Label Image

Step 9a (Step9abw)

An instructional line drawing showing a person preparing an intravenous or subcutaneous injection using a syringe. One hand holds the syringe while the other hand adjusts the plunger, with a visible needle and tubing connected to the syringe, likely depicting the administration technique for an immune globulin injection.*

FDA Label Image

Step 9b (Step9bbw)

An instructional black-and-white illustration showing hands preparing a syringe connected to an infusion set for subcutaneous injection. The setup is positioned against a person's abdomen, demonstrating the proper technique for administering a subcutaneous injection, relevant for products like GAMMAKED (Immune Globulin [Human]) injection.*

FDA Label Image

100 mL Vial (Vial)

Label for GAMMAKED Immune Globulin Injection (Human), 10% (10 g/100 mL) solution for infusion. The label states it is caprylate/chromatography purified, for intravenous and subcutaneous administration. Manufactured by Grifols Therapeutics LLC and distributed by Kedrion Biopharma, Inc. Additional text includes storage conditions, single dose vial indication, 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.