Sodium Phenylacetate and Sodium Benzoate (Page 5 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
Sodium Phenylacetate and Sodium Benzoate Injection, 10% per 10% is supplied in a sterile, non-pyrogenic, single-dose glass vial.
single-dose vial containing 50 mL of
sodium phenylacetate and sodium benzoate injection, 10% per 10%
Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
17 PATIENT COUNSELING INFORMATION
Physicians should advise patients and caregivers about the following for safe use of sodium phenylacetate and sodium benzoate injection:
- When plasma ammonia levels have normalized, dietary protein intake can usually be increased with the goal of unrestricted protein intake.
- The most common adverse reactions are vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment.
- Generally BUPHENYL is stopped during the time sodium phenylacetate and sodium benzoate injection is used.
Fosun Pharma USA Inc.
Princeton, NJ 08540
Made in India
Revised: Aug 2022
PRINCIPAL DISPLAY PANEL – 10%/10%
NDC 72266-247-01 50 mL
Sodium Phenylacetate and Sodium Benzoate Injection 10% / 10%
For IV Use Only
Warning: Administration must be through a central venous catheter.
Administration through a peripheral line may cause burns.
Must be diluted before IV administration
Rx only Single-Dose Vial
Dosage: See accompanying package insert.
Each mL contains: 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sterile, concentrated solution must be diluted with sterile dextrose injection, 10% (D10W) before intravenous administration.
Discard unused portion.
Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Keep out of reach of children.
| SODIUM PHENYLACETATE AND SODIUM BENZOATE |
sodium phenylacetate and sodium benzoate injection, solution, concentrate
|Labeler — FOSUN PHARMA USA INC (080920998)|
Revised: 05/2023 FOSUN PHARMA USA INC
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