DURCALCIPHOS injection, solution

DurCalciPhos by

Drug Labeling and Warnings

DurCalciPhos by is a Animal medication manufactured, distributed, or labeled by VETTEK, 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 hypocalcemia 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

Dura-Ster TS

Terminally Sterilized

INFORMATION FOR OWNERS/CAREGIVERS

Manufactured for:

VetTek

Blue Springs, MO 64014

NDC: 60270-129-17

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DURCALCIPHOS 
durcalciphos injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 60270-129
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: 60270-129-17	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 - VETTEK (056387798)

Registrant - VETTEK (056387798)

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