GMS ELECTROLYTE SOLUTION COMPOUND SODIUM LACTATE HARTMANNS- sodium chloride, potassium chloride, sodium lactate and calcium chlo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37)

Available from:

GM Scientific, LLC

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 600 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

GMS Electrolyte Solution Compound Sodium Lactate (Hartmann’s Solution) is indicated as a source of water and electrolytes for all species. It is also used as an alkalinizing agent. GMS Electrolyte Solution Compound Sodium Lactate (Hartmann’s Solution) is contraindicated in patients with a known hypersensitivity to sodium lactate; congestive heart failure or severe impairment of renal function; clinical states in which the administration of sodium and chloride is detrimental.

Authorization status:

unapproved drug other

Summary of Product characteristics

GMS ELECTROLYTE SOLUTION COMPOUND SODIUM LACTATE HARTMANNS -
SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM
CHLORIDE SOLUTION
GM SCIENTIFIC, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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GMS ELECTROLYTE SOLUTION COMPOUND SODIUM LACTATE HARTMANNS
STERILE NONPYROGENIC SOLUTION
FOR ANIMAL USE ONLY
DES CRIPTION
GMS Electrolyte Solution Compound Sodium Lactate (Hartmanns Solution)
is a sterile, non-pyrogenic
solution intended for fluid and electrolyte replenishment in single
dose containers. May be administered
intravenously, subcutaneously or intraperitoneally (except in horses)
using aseptic technique. It contains
no antimicrobial agents. Discard any unused portion. Composition,
osmolarity, pH and ionic
concentration are shown in Table 1.
TABLE 1
*Sodium Lactate USP _(S)_-enantiomer
Osmolarity (mOsmol/L) (calc): 280mOsmol per litre
pH: 6.5 (limit 6.0 7.0)
The container is free of PVC and phthalates. It is fabricated from 5
layer polyolefin based co-extrusion
material. The container meets the requirements of USP (Class VI).
CLINICAL PHARMACOLOGY
A multiple electrolyte intravenous solution is intended to restore the
electrolyte balance and water for
hydration. A combination of multiple electrolytes and sodium lactate,
an alkalinizing agent, will provide
electrolyte balance and normalize the pH of the acid-base of the
physiological system.
INDICATIONS
GMS Electrolyte Solution Compound Sodium Lactate (Hartmann’s
Solution) is indicated as a source of
water and electrolytes for all species. It is also used as an
alkalinizing agent.
CONTRAINDICATIONS
GMS Electrolyte Solution Compound Sodium Lactate (Hartmann’s
Solution) is contraindicated in
patients with a known hypersensitivity to sodium lactate; congestive
heart failure or severe impairment
of renal function; clinical states in which the administration of
sodium and chloride is detrimental.
WARNIN