Gamifant Injection
Product Images NDC 66658-522

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Product Visual Gallery

This gallery contains 3 technical images submitted to the FDA as part of the official labeling for Gamifant (NDC 66658-522). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Swedish Orphan Biovitrum Ab (publ), 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

Gam01 0001 01

Gam01 0001 01
This is a product description for Gamifant, an injection containing 10 mg emapalumab-Izsg, which comes in a single-dose vial of 2 mL solution. Each mL of Gamifant contains 5 mg emapalumab, L-Histidine (155 mg), Histidine monohydrochloride monohydrate (314 mg), Polysorbate 80 (0.05 mg), sodium chloride (731 mg), and water for injection. Gamifant should be refrigerated at 36°F to 46°F (2°C to 8°C) and protected from light. It should also not be frozen or shaken. This is for intravenous infusion only, and dilution is required before administration. The enclosed medication guide should be given to each patient. It is manufactured in the United Kingdom and distributed by Sobline.*
FDA Label Image

Gam01 0001 02

Gam01 0001 02
This is a medication called Gamifant which contains 100mg emapalumab-zsgin provided in a single-dose vial of 20mL solution. Each mL of the solution is made up of 5g emapalumab- s, L Histidine 1.55 ma), L Histidne monohyerocloride, monohyciate (314 ma), Polysorbate 80 (0.05 ma) sodium chloride 731 ma) and Water for Injection. It is for intravenous infusion only and requires dilution prior to administration. This medication should be refrigerated and protected from light. It is distributed by Sabiinc and its contents should be discarded after a single use. The enclosed medication guide must be given to each patient. The product is made in the United Kingdom.*
FDA Label Image

Gam01 0001 03

Gam01 0001 03
Gamifant® (emapalumab-lzsg) Injection is a medication used for intravenous infusion only, containing 50 mg emapalumab-zsg in 10 of solution. It is distributed by Sobi Inc, and its trademark belongs to Swedish Orphan Blovitrum AB. The enclosed medication guide must be dispensed to each patient, and it should not be frozen or shaken. Refrigeration is required at 36 to 46°F (2°C to 8°C) in the original carton to protect the product from light.*

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