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Premasol
  • Professionals
  • FDA PI

Premasol

Generic name:amino acid injection
Dosage form: injection
Drug class:Intravenous nutritional products

Medically reviewed by Drugs.com. Last updated on May 23, 2022.

PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

Rx Only

Premasol Description

6% and 10% Premasol - sulfite-free (Amino Acid) Injections are sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period (e.g., di-2-ethylhexyl phthalate, DEHP, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers.

Each 100 mL contains:

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Cardiology
Pediatrics
Diabetes Care
Pre-natal Care
Ultrasound Echocardiogram