CALCIUM GLUCONATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

Bimeda, Inc.

INN (International Name):

CALCIUM GLUCONATE

Composition:

CALCIUM GLUCONATE 23 g in 100 mL

Administration route:

INTRAPERITONEAL

Prescription type:

OTC

Therapeutic indications:

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
BIMEDA, 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._
----------
INDICATIONS: To be used as an aid in the treatment of parturient
paresis (milk fever) in cattle.
DOSAGE AND ADMINISTRATION:
CATTLE: 250 mL to 500 mL. Administer intravenously or
intraperitoneally. 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. Discard any
unused portion. Handle under
aseptic conditions.
If there is no apparent improvement in the animal's condition within
24 hours, consult a veterinarian.
EACH 100 ML CONTAINS:
Calcium Gluconate
(provides 2.14 grams Calcium)..........................23 grams
Water for
Injection...................................................q.s.
Contains boric acid as a solubilizing agent.
ELECTROLYTES PER 1000 mL:
Calcium 1069 mEq
Osmolarity (calc.) 6,947 m0smol/L
Hypertonic
STORAGE: Store between 15 C - 30 C (59 F - 86 F).
CALCIUM GLUCONATE
calcium gluconate injection
PRODUCT INFORMATION
PRODUCT T YPE
OTC ANIMAL DRUG
ITE M CODE (SOURCE )
NDC:6 1133-0 29 7
ROUTE OF ADMINISTRATION
INTRAPERITONEAL, INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CALCIUM GLUCO NATE (UNII: SQE6 VB453K) (CALCIUM CATION - UNII:2M8
3C4R6 ZB)
CALCIUM GLUCONATE 23 g in 10 0 mL
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 1133-0 29 7-7
50 0 mL in 1 BOTTLE
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 3/23/20 0 5
Bimeda, Inc.
LABELER -
Bimeda, Inc. (060492923)
REGISTRANT -
Bimeda, Inc. (060492923)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Bimeda-MTC
256 232216
ma nufa c ture
Revised: 11/2018