CALCIUM GLUCONATE- calcium gluconate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Calcium Gluconate (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

Durvet

Administration route:

INTRAVENOUS

Prescription type:

OTC

Therapeutic indications:

To be used as an aid in the treatment of parturient paresis (milk fever) in cattle.

Authorization status:

unapproved drug other

Summary of Product characteristics

CALCIUM GLUCONATE- CALCIUM GLUCONATE INJECTION, SOLUTION
DURVET
_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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CALCIUM GLUCONATE 23% SOLUTION
FOR USE IN ANIMALS ONLY
EACH 100 ML CONTAINS: ACTIVE INGREDIENTS:
Calcium Gluconate
(provides 2.14 grams
Calcium) ................................................... 23 grams
Water for Injection .................................................
q.s.
INACTIVE INGREDIENTS:
Boric acid (as a solubilizing
agent) .....................................................3.5 grams
INDICATIONS:
To be used as an aid in the treatment of parturient paresis (milk
fever) in cattle.
Store between 15 degrees C and 30 degrees C (59 degrees F and 86
degrees F).
Keep from freezing.
KEEP OUT OF REACH OF CHILDREN
DOSAGE AND ADMINISTRATION:
Cattle: 250 to 500 mL
Administer intravenously. Solution should be warmed to body
temperature and administered slowly.
This product is sterile in unopened container. It contains no
preservative. Use entire contents when
first opened. It should be handled under aseptic conditions. If there
is no apparent improvement in the
animal's condition within 24 hours; consult a veterinarian.
TAKE TIME OBSERVE LABEL DIRECTIONS
CALCIUM GLUCONATE
calcium gluconate injection, solution
PRODUCT INFORMATION
PRODUCT T YPE
OTC ANIMAL DRUG
ITE M CODE (SOURCE )
NDC:30 79 8 -117
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CA LCIUM GLUCO NA TE (UNII: SQE6 VB453K) (CALCIUM CATION - UNII:2M8
3C4R6 ZB)
Calcium Gluco nate
23 g in 10 0 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:30 79 8 -117-17
50 0 mL in 1 BOTTLE
Durve t
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 6 /15/20 11
LABELER -
Durvet (056387798)
REGISTRANT -
Durv