Sodium Phenylacetate And Sodium Benzoate Injection, Solution, Concentrate
Product Images NDC 70511-101
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Product Visual Gallery
This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Sodium Phenylacetate And Sodium Benzoate (NDC 70511-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Maia Pharmaceuticals, 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.
Product Images & Figures Index
Chemical Structure (Structure)
Table 1
This is a table describing the dosage and administration of a medication called Tafusion. The table provides information on the components of Tafusion and their dilution requirements. It also gives instructions for dosage based on patient population and their medical conditions. The table includes a list of abbreviations and their corresponding meanings.*
Table 3
Table 3 shows the baseline characteristics and diagnoses of the study population. The gender distribution of the 310 patients included 56% females. The mean age was 62 years with a standard deviation of 8.54 years. The patients were divided into age groups, including greater than 2-12 years, greater than 12-16 years, and greater than 16 years. The table includes data on enzyme deficiencies, including omithine transcarbamylase deficiency, argininosuccinate synthetase deficiency, carbamyl phosphate synthetase deficiency, argininosuccinate lyase deficiency, and arginase deficiency, as well as transient hyperammonemia of the newborn. The table also includes information on specific diagnoses, such as acidemia and HHH syndrome, as well as suspected deficiencies and valproic-acid-induced hyperammonemia.*
Vial Jan2021
This is a prescription-only solution called Sodium Phenylacetate and Sodium Benzoate Injection that is intended for intravenous use only after being diluted. It is available in a 50mL, sterile, single-dose vial that must be administered through a central venous catheter. Due to its concentrated composition, it causes burns when administered via a peripheral line, hence must be diluted with sterile, dextrose injection (D10W) before use. Each mL of the solution contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, along with water for injection. It also contains sodium hydroxide and/or hydrochloric acid to adjust the pH. This medication should be stored within the 59° to 86°F temperature range and outside the reach of children. The packaging includes dosage instructions, and all unused portions must be discarded. The manufacturer is MAIA Pharmaceuticals, and it is produced by Gland Pharma in Hyderabad, India. The lot and expiration date are provided but not applicable in this case.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.