Lacellate Solution – 250

LACELLATE SOLUTION — 250- sodium chloride, sodium lactate, potassium chloride and calcium chloride injection, solution
IT3 Medical LLC

DESCRIPTION

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.

Table 1

Composition (g/L)

Ionic Composition (mEq/L)

Size (mL)

Sodium Chloride, USP, (NaCl)

Sodium Lactate,
(C3 H5 NaO3 )

Potassium Chloride, USP, (KCl)

Calcium Chloride, USP
(CaCl2 ·2H2 O)

Osmolarity (mOsmol/L) (calc)

pH

Sodium

Potassium

Calcium

Chloride

Lactate

Caloric Content (kcal/L)

Lactated Ringer’s Injection, USP

250

500

1000

6

3.1

0.3

0.2

273


6.5
(6.0 to 7.5)

130

4

2.7

109

28

9

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.

CLINICAL 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.

INDICATIONS AND USAGE

Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent.

CONTRAINDICATIONS

As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Lactated Ringer’s Injection, USP is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream).

In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Lactated Ringer’s Injection, USP, through the same infusion line (e.g., via Y-connector).
If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.

Lactated Ringer’s Injection, USP is contraindicated in patients with a known hypersensitivity to sodium lactate.

WARNINGS

Although Lactated Ringer’s Injection, USP has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it should not be used for this purpose.

Lactated Ringer’s Injection, USP is not for use for the treatment of lactic acidosis or severe metabolic acidosis.

Lactated Ringer’s Injection, USP should not be administered simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation.

The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Hypersensitivity reactions are reported more frequently during pregnancy.

Depending on the volume and the rate of infusion, 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, pulmonary edema or acid-base imbalance. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with hyperkalemia or conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns) and in patients with cardiac disease.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis. Because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium and/or potassium retention, fluid overload, or edema.

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