"On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport"...
Lactated Ringer's Injection, USP
in AVIVA Plastic Container
Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.
|Size (mL)||Composition (g/L)||Osmolarity (mOsmol/L) (calc)||pH||Ionic Concentration (mEq/L)||Caloric Content (kcal/L)|
|Sodium Chloride, USP, (NaCl)||Sodium Lactate, (C3H5NaO3)||Potassium Chloride, USP, (KCl)||Calcium Chloride, USP (CaCl2·2H2O)||Sodium||Potassium||Calcium||Chloride||Lactate|
|Lactated||250||6||3.1||0.3||0.2||273|| 6.5 |
(6.0 to 7.5)
The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or other plasticizers.
The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system.
The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.
The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (See Directions for Use). The primary function of the overwrap is to protect the container from the physical environment.
Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Lactated Ringer's Information
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