MULTIPLE ELECTROLYTES PH 5.5- sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride injec

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM GLUCONATE (UNII: R6Q3791S76) (GLUCONIC ACID - UNII:R4R8J0Q44B, SODIUM CATION - UNII:LYR4M0NH37), SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNI

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is indicated as a source of water and electrolytes or as an alkalinizing agent. Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is contraindicated in patients with a known hypersensitivity to the product. See WARNINGS . For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION. Check solution container composition, lot number, and expiry date. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use solution containers in series connections. Do not remove solution container from its overwrap until immediately before use. The intact port caps provide visual tamper evidence. Do not use if a port cap is prematurely removed. Maintain strict aseptic technique during handling. TO OPEN - Always inspect the solution container before and after removal from the overwrap. - Place the solution container on a clean, flat surface. Using the

Product summary:

Multiple Electrolytes Injection, Type 1, USP, pH 5.5 in free flex ® plastic containers is available as shown below: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MULTIPLE ELECTROLYTES PH 5.5- SODIUM CHLORIDE, SODIUM GLUCONATE,
SODIUM
ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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MULTIPLE ELECTROLYTES INJECTION, TYPE 1, USP, PH 5.5
IN FREEFLEX PLASTIC CONTAINER
DESCRIPTION
Multiple Electrolytes Injection, Type 1, USP, pH 5.5 is a sterile,
nonpyrogenic isotonic
solution in a single dose container for intravenous administration.
Each 100 mL contains
526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C H
NaO ); 368
mg of Sodium Acetate Trihydrate, USP (C H NaO •3H O); 37 mg of
Potassium Chloride,
USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl
•6H O). It contains no
antimicrobial agents. The pH is adjusted with hydrochloric acid. The
pH is 5.5 (4.0 to
8.0).
Multiple Electrolytes Injection, Type 1, USP, pH 5.5 administered
intravenously has value
as a source of water, electrolytes, and calories. One liter has an
ionic concentration of
140 mEq sodium, 5 mEq potassium, 3 mEq magnesium, 98 mEq chloride, 27
mEq
acetate, and 23 mEq gluconate. The osmolarity is 294 mOsmol/L (calc).
Normal
physiologic osmolarity range is approximately 280 to 310 mOsmol/L. The
caloric content
is 21 kcal/L.
The flexible plastic container is fabricated from a specially
formulated non-plasticized,
film containing polypropylene and thermoplastic elastomers (FREE_flex_
bag). 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. 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
Multiple Electrolytes Injection, Type 1, USP, pH 5.5 has value as a
source of water and
electrolytes. It is capable of inducing diuresis depending on the
clinical condition o