CALCICURE injection, solution

CALCICURE by

Drug Labeling and Warnings

CALCICURE by is a Animal medication manufactured, distributed, or labeled by VEDCO, INC., Laboratorios Biogalenic. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

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.

PRECAUTIONS

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

STORAGE AND HANDLING

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

WARNINGS AND PRECAUTIONS

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS

Terminally Sterilized

INFORMATION FOR OWNERS/CAREGIVERS

Distributed By

VEDCO, INC

St. Joseph,

MO 64507

Made in El Salvador

NDC: 50989-879-16

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALCICURE 
calcicure injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 50989-879
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM BOROGLUCONATE (UNII: 6915G2PQI0) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	26 g  in 100 mL
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	15 g  in 100 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM GLUCONATE	6 g  in 100 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	0.5 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50989-879-16	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2020

Labeler - VEDCO, INC. (021634266)

Registrant - VEDCO, INC. (021634266)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Biogalenic		851259507	manufacture, api manufacture