Product Specifications
| Specification | Details |
| Manufacturer / Brand | B. Braun Medical Inc. / Plenamine™ |
| Manufacturer # / SKU | S4500 |
| NDC # | 00264-4500-00 |
| Active Ingredient | Amino Acids 15% |
| Product Type | Rx Only / Parenteral Nutrition |
| Dosage Form | Injection, Solution (Pharmacy Bulk Package) |
| Volume | 1000 mL per Bag |
| Container Type | Flexible Bag (Not made with DEHP, PVC, or Natural Rubber Latex) |
| Packaging / Sold As | Case of 8 Bags |
| UNSPSC Code | 51191503 |
Key Features
-
High Concentration: The 15% concentration provides a dense nitrogen source, allowing for flexible compounding in parenteral nutrition bags while managing total fluid volume.
-
Pharmacy Bulk Package (PBP): Contains several single doses intended for use in a clean air compounding area (e.g., laminar flow hood) to prepare multiple IV containers.
-
Safe Materials: The flexible container is manufactured without DEHP, PVC, or natural rubber latex, reducing the risk of chemical leaching and allergic reactions.
-
Smart Packaging: Features an easy-to-spike port and an oxygen sensor to ensure product integrity and stability throughout its 18-month shelf life.
-
Comprehensive Nutrition: Includes a balanced profile of essential and nonessential amino acids to support protein synthesis and metabolic requirements.
Usage & Administration
-
Admixture Only: Must be compounded with other nutritional components (dextrose, lipids, electrolytes) in a pharmacy setting.
-
Dispensing Rule: Once the closure is penetrated, the transfer of contents must be completed within 4 hours.
-
Storage: Store at room temperature (25 Degrees Celsius). Protect from freezing and excessive heat. Protect from light if stored outside the original carton.
⚠️ Contraindications: Do not use in patients with hepatic coma, severe renal failure, metabolic disorders involving impaired nitrogen utilization, or hypersensitivity to one or more amino acids in the solution.
⚠️ Warning: Hyperammonemia is of special significance in infants; monitor blood ammonia levels closely. Administration of amino acid solutions without carbohydrates may result in the accumulation of ketone bodies in the blood.
