Prolastin-c Kit
Product Images NDC 13533-706

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Prolastin-c (NDC 13533-706). 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

Diluent (13533 200 20 Label)

Diluent (13533 200 20 Label)
This is a description of a product called Sterile Water for Injection, used only for reconstitution of an accompanying product. It is a single-dose container that is nonpyrogenic, meaning it doesn't cause fever. The container should not be used if it is not clear and no antimicrobial agent or other substance has been added. The product should also not be used for intravascular injection without making it isotonic by adding a suitable solute. The unused portion of the product should be discarded. The product is manufactured by Laboratorios Grifols in Spain and is distributed by Grifols Therapeutics LLC in the USA.*
FDA Label Image

Prolastin Vial (13533 702 11 Label)

FDA Label Image

Carton (13533 703 10 Carton)

Carton (13533 703 10 Carton)
This is a description of a medical product called PROLASTIN'C manufactured by Grifols. The product is a solvent detergent treated Nanofiltered Alpha-Proteinase Inhibitor (Human) for intravenous administration only. It is prepared from pools of human plasma that may contain infectious agents. The package insert contains warnings for risks to the patient. The product must be reconstituted with 20 mL of diluent within 3 hours after reconstitution with specified contents of chloride and sodium phosphate. Dosage and administration information is included in the package. The product does not contain preservatives and must be kept at temperatures not exceeding 25°C.*
FDA Label Image

76297 002 22

76297 002 22
This is a single-dose container of sterile water for injection, which is used for reconstitution of a medicinal product. It is nonpyrogenic and free from antimicrobial agents or other substances. However, it should not be used for intravascular injection without adding a suitable solute to make it isotonic. The manufacturer is Laboratorios Grifols in Spain.*
FDA Label Image

Prolastin-c Figure 1 (Prolastinc Figure 1)

Prolastin-c Figure 1 (Prolastinc Figure 1)
The text is a graph showing the mean plasma Alpha-Proteinase Inhibitor (API) concentration over time after treatment with PROLASTIN-C or PROLASTIN, with different dosages represented on the x-axis and time on the y-axis.*
FDA Label Image

Prolastin-c Reconstitution Method (Prolastincfigureaandb)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.