ULTIGENE- electrolyte solution withdextrose injection, solution 
Vedco
Reference Label Set Id: c67c10cb-141e-496e-8ba8-64054bcf9ad1

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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ELECTROLYTE SOLUTION WITH DEXTROSE

Composition

Each 500 mL of sterile aqueous solution contains:

Dextrose.H2O                             12.50g

Sorbitol                                      12.50g

Sodium Lactate                            3.95g

Sodium Chloride                           2.40g

Potassium Chloride                       0.37g

Magnesium Chloride.6H2O            0.21g

Calcium Chloride.2H2O                 0.19g

Milliequivalents per liter

Cations                                      

Sodium                                        153mEq/L

Potassium                                        9mEq/L

Calcium                                            6mEq/L

Magnesium                                       4mEq/L

Anions

Chloride                                        101 mEq/L

Lactate                                           71 mEq/L

Osmolarity (calc.)                          602 mOsmol/L

Indications

For use in conditions associated with fluid and electrolyte loss such as dehydration, shock, vomitting, and diarrhea, particularly when an immediate source of energy is also indicated

Contradictions

Do not administer intraperitoneally to horses

Dosage and Administration

This product contains no preservatives. Use entire contents when first opened. Discard any unused solution.

Warm solution to body temperature and administer slowly (10 to 30 mL per minute) by intravenous or intraperitoneal injections, using strict aseptic procedures.

Adult Cattles and Horses - 1000 to 2000 mL

Calves, Ponies, and Foals - 500 to 1000 mL

Adult, Sheep and Swine - 500 to 1000 mL

These are suggested dosages. The actual amount and rate of fluid administration must be judged by the veterinarian in relation to the condition being treated and the clinical response of the animal, being careful to avoid overhydration

FOR ANIMAL USE ONLY

Warning

KEEP OUT OF REACH OF CHILDREN

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian

Storage

Store between 15oC and 30oC (59oF - 86oF)

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Distributed By:

VEDCO INC

St. Joseph, MO, 64507

Made in El Salvador

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Principal Display Panel

NDC 50989-886-16

ULTIGIENETM​ TERMINALLY STERILIZED

ELECTROLYTE SOLUTION WITH DEXTROSE

NET CONTENTS: 500 mL (16.9 fl. oz.)

VEDCO

Label

NDC 50989-886-17

ULTIGIENETM TERMINALLY STERILIZED

ELECTROLYTE SOLUTION WITH DEXTROSE

NET CONTENTS: 1000 mL (33.8 fl. oz.)

VEDCO

Label 1

ULTIGENE 
electrolyte solution withdextrose injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-886
Route of AdministrationINTRAVENOUS, INTRAPERITONEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate12.50 g  in 500 mL
Sorbitol (UNII: 506T60A25R) (Sorbitol - UNII:506T60A25R) Sorbitol12.50 g  in 500 mL
Sodium Lactate (UNII: TU7HW0W0QT) (Sodium Cation - UNII:LYR4M0NH37) Sodium Lactate3.95 g  in 500 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride2.40 g  in 500 mL
Potassium Chloride (UNII: 660YQ98I10) (Potassium Cation - UNII:295O53K152) Potassium Chloride0.37 g  in 500 mL
Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Chloride0.21 g  in 500 mL
Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Chloride0.19 g  in 500 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-886-16500 mL in 1 BOTTLE, PLASTIC
2NDC:50989-886-171000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/05/2019
Labeler - Vedco (021634266)
Registrant - Vedco (021634266)

Revised: 8/2019
Document Id: 9e03fd0a-bc59-4c49-baab-cc1cc9875478
Set id: f3848cd4-42ad-4133-b7ce-fb5aeb2e99d6
Version: 2
Effective Time: 20190809
 
Vedco