CALCICURE- calcicure injection, solution 
VEDCO, INC.

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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ULTIGIENE™ TERMINALLY STERILIZED CALCICURE®​ STERILE SOLUTION

Parenteral Solution

INDICATIONS:

For intravenous use in milk fever, and in calcium, phosphorous, magnesium and glucose deficiency in animals.

Note:

Intravenous administration is always preferable.  If used subcutaneously, always distribute dose in several places and massage to facilitate absorption.

Dosage:

Cattle, 500 mL.  For milk fever prophylaxis, give 200-500 mL at time of calving.  Horses, 250-500 mL; Sheep, 50-125 mL.  Repeat in 2 to 6 hours if needed.  This product contains no preservative.  Unused portion remaining in bottle must be discarded.

CAUTION:

Large doses administered intravenously may have toxic action on heart if the blood level of calcium is raised excessively.  Doses should be carefully regulated according to severity of hypo-calcemia and injected slowly so that administration may be stopped if toxic action becomes evident.

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION:

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

CONTAINS:

Calcium borogluconate, dextrose, magnesium borogluconate, calcium hypophosphite and base. Total calcium chemically equivalent to

Calcium borogluconate .......  26.0% w/v

Dextrose • H2O .................. 15.0% w/v

Magnesium borogluconate ... 6.0% w/v

Total phosphorus in amounts chemically equivalent to elemental phosphorus .......... 0.5% w/v

Store between 15°C and 30°C (59°F-86°F)

TAKE TIME OBSERVE LABEL DIRECTIONS

Terminally Sterilized

Distributed By

VEDCO, INC

St. Joseph,

MO 64507

Made in El Salvador

NDC 50989-879-16

Net Contents: 500 mL (16.9 fl. oz.)

500 mL label

CALCICURE 
calcicure injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:50989-879
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM BOROGLUCONATE (UNII: 6915G2PQI0) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION26 g  in 100 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE15 g  in 100 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM GLUCONATE6 g  in 100 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS0.5 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50989-879-16500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2020
Labeler - VEDCO, INC. (021634266)
Registrant - VEDCO, INC. (021634266)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Biogalenic851259507manufacture, api manufacture

Revised: 7/2020
Document Id: 7000f675-a466-4ce6-9b9c-b3d8a45fd884
Set id: 71a2e41a-5cae-439e-a524-0601eff46b9d
Version: 2
Effective Time: 20200703
 
VEDCO, INC.