Profilnine
Product Images NDC 68516-3208

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Profilnine (NDC 68516-3208). 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

10mlsterilewaterlabel

This is a sterile water for injection, USP, designed for reconstitution of an accompanying product. It comes in a nonpyrogenic, single-dose container and has not had any antimicrobial agents or other substances added. It should not be used for intravascular injection unless made approximately isotonic by the addition of a suitable solute. The unused portion should be discarded. The manufacturer is Laboratorios Grifols in Spain. The NDC code is 76297-002-12.*

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3210carton5ml500iu

This is a product description for Factor X Complex, sold under the brand name Profinine. The product is a sterile vial of Factor X Complex, used for intravenous administration. The package contains one vial, a transfer set, and directions for use. The reconstituted product contains no more than 5mL of polysorbate 80 and 0.40 pg Ui. The patient and physician should discuss the risks and benefits of this product. The package should be discarded if any contents are unused. The manufacturer is listed as Sifs Boloicals LT, located in El CASO032, USA.*

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3211carton10ml1000iu

This is a product description for a Factor IX Complex drug called Profilnine, administered through intravenous injections. It contains factors I, II, X, and low levels of Factor VI with no preservatives. The package also comes with directions of use, one via 10 L sterile water for injection, a Mi2Vial filter transfer set, and warnings and precautions containing information about dosage and storage temperatures. The product is administered within three hours of reconstitution, and the unused contents should be discarded. However, some of the text seems to be missing or not readable.*

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3211carton10ml1500iu

This is a product description of Factor X Complex Profilnine. The product comes in a vial and is used for intravenous administration. The contents of the package are Factor X Coplx, Pofiine. It is prepared from large pools and includes warnings and precautions. The storage temperature should not exceed 25°C. The product is intended for single-dose container use. The package includes 1500 1U FIX range. Unused contents should be discarded.*

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5mlsterilewaterlabel

This is a sterile water injection for reconstitution of other products. It is a single-dose container that should not be used if not clear and if it has antimicrobial agents or any substance added. This should not be used for intravascular injection without adding a suitable solute. The unused portion should be discarded. The manufacturer is Laboratorios Grifols, S. A. located in Parets del Valles, Barcelona. The product is indicated for prescription only.*

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68516 1001 Label

This is a single-dose container of sterile water for injection, USP, manufactured by Laboratorios Grifols S.A, and distributed by Grifols Biologicals LLC. This product is intended for reconstitution of accompanying medication and should only be used if clear without any addition of antimicrobial or other substance. This container is nonpyrogenic, and should not be used for intravascular injection without making approximately isotonic by addition of suitable solute. Unused portion of the product should be discarded.*

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68516 1002 2diluent

This is a single-dose container of sterile water for reconstitution of an accompanying product, with no added antimicrobial agents or other substances. It is nonpyrogenic and should not be used for intravascular injection without making it approximately isotonic by adding a suitable solute. The container should not be used if it is not clear, and any unused portion should be discarded. The manufacturer is Laboratorios Grifols in Spain, and it is manufactured for Grifols Biologicals Inc. in the US.*

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68516-3204-1-profilnine-500-iu (68516 3204 1 Label)

FDA Label Image

68516-3205-2-profilnine-1000-iu (68516 3205 2 Label)

Profilnine® 1000 is a Factor IX Complex used for intravenous administration only. The dosage range is 1U FIX. It is recommended to store the medicine at temperatures not exceeding 25°C (77°F). The manufacturer is Grifls Biologicals LLC, located in Los Angeles, California, USA. The product is Rx-only and contained in a single-dose container.*

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68516-3206-2-profilnine-1500-iu (68516 3206 2 Label)

This is a description of a medication called Profilnine, which is a Factor IX Complex used for intravenous administration. It has a 1500 1U FIX Range and comes in a single dose container of 10mL. It is manufactured by Grifols Biologicals LLC in Los Angeles, CA and it should be stored at temperatures no higher than 25 °C (77 °F). This medication is for prescription use only.*

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Figures 1-8 (Pro00 0010 01)

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