Sodium chloride, sodium lactate, potassium chloride, calcium chloride.
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 as follows. (See table.)
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The Viaflex plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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), up to 5 parts 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.
Pharmacology: Lactated Ringer's Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.
Lactated Ringer's Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.
Lactated Ringer's Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent.
As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
All injections in Viaflex plastic containers are intended for intravenous administration using sterile equipment.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
Lactated Ringer's Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
Lactated Ringer's Injection, USP should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.
Lactated Ringer's Injection, USP should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.
Lactated Ringer's Injection, USP should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation.
The intravenous administration of Lactated Ringer's Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.
In patients with diminished renal function, administration of Lactated Ringer's Injection, USP may result in sodium or potassium retention.
Lactated Ringer's Injection, USP is not for use in the treatment of lactic acidosis.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Lactated Ringer's Injection, USP should be used with caution. Excess administration may result in metabolic alkalosis.
Caution must be exercised in the administration of Lactated Ringer's Injection, USP to patients receiving corticosteroids or corticotropin.
Do not administer unless solution is clear and seal is intact.
Use in Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Lactated Ringer's Injection, USP. It is also not known whether Lactated Ringer's Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lactated Ringer's Injection, USP should be given to a pregnant woman only if clearly needed.
Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Lactated Ringer's Injection, USP. It is also not known whether Lactated Ringer's Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lactated Ringer's Injection, USP should be given to a pregnant woman only if clearly needed.
Allergic reactions or anaphylactoid symptoms such as localized or generalized urticaria and pruritus; periorbital, facial, and/or laryngeal edema; coughing, sneezing, and/or difficulty with breathing have been reported during administration of Lactated Ringer's Injection, USP. The reporting frequency of these signs and symptoms is higher in women during pregnancy.
Reactions which may occur because of the solution or the technique of administration, include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Directions for use of Viaflex plastic container: WARNING: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
To Open: Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions as follows.
Preparation for Administration: 1. Suspend container from eyelet support.
2. Remove plastic protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set.
To Add Medication: WARNING: Additives may be incompatible.
To add medication before solution administration: 1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture medication port and inject.
3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
To add medication during solution administration: 1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by squeezing them while container is in the upright position.
6. Mix solution and medication thoroughly.
7. Return container to in use position and continue administration.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at temperature not exceeding 30° C: brief exposure up to 40°C does not adversely affect the product.
B05BB01 - electrolytes ; Belongs to the class of solutions affecting the electrolyte balance used in I.V. solutions.
Soln for inj 500 mL, 1,000 mL.