Sykes Calcium Gluconate 23%: Product Information

SYKES CALCIUM GLUCONATE 23%- calcium gluconate solution
Sypharma Pty Ltd

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.

STERILE NONPYROGENIC SOLUTION
For Animal Use Only

KEEP OUT OF REACH OF CHILDREN

500 mL

Each 100mL contains:

CALCIUM GLUCONATE (PROVIDES 2.14 grams OF CALCIUM) 23 grams
WATER FOR INJECTION q.s.
BORIC ACID (AS A SOLUBILIZING AGENT) 3.5 grams

mEq/L CALCIUM 1069, HYPERTONIC, pH: 2.5 to 4.5, OSMOLARITY: 6,782 mOsmol/L (calc)

INDICATIONS

FOR USE IN CATTLE AS AN AID IN TREATING UNCOMPLICATED MILK FEVER (PARTURIENT PARESIS).

DOSAGE AND ADMINISTRATION

FOR INTRAVENOUS ADMINISTRATION ONLY.
CATTLE 250 – 500 mL
DOSAGE MAY BE REPEATED AT 8 TO 12 HOUR INTERVALS IF REQUIRED.

CAUTION

SOLUTION SHOULD BE WARMED TO BODY TEMPERATURE AND ADMINISTERED SLOWLY. ENTIRE CONTENTS SHOULD BE USED UPON ENTERING, AS THIS PRODUCT CONTAINS NO PRESERVATIVE. DISCARD ANY UNUSED PORTION. DO NOT USE IF SOLUTION IS CLOUDY OR CONTAINS PRECIPITATE. MONITOR ANIMAL’S CONDITION CLOSELY. RE-TREATMENT MAY BE NECESSARY. IF THERE IS NO NOTICEABLE IMPROVEMENT WITHIN 24 HOURS FOLLOWING TREATMENT, CONSULT YOUR VETERINARIAN. ASEPTIC PRECAUTIONS SHOULD BE OBSERVED.

STORAGE

STORE BETWEEN 59°F-86°F/15°C-30°C IN BARRIER OVER-POUCH UNTIL READY FOR USE. PROTECT FROM FREEZING.

Made in Australia

MANUFACTURED AND DISTRIBUTED BY: SYPHARMA PTY LTD, 27 HEALEY ROAD, DANDENONG VICTORIA 3175 AUSTRALIA.

FOR CUSTOMER SERVICE EMAIL: CUSTOMERSERVICE@SYPHARMA.COM.AU

NDC NUMBER: 86043-1004-2 BARCODE: 9317643192506

BATCH NUMBER:

EXPIRY:

500mL Sykes Calcium Gluconate 23% Solution

CalciumGluconate23
(click image for full-size original)
CalciumGluconate23
(click image for full-size original)

SYKES CALCIUM GLUCONATE 23%
calcium gluconate solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86043-1004
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE (CALCIUM CATION) CALCIUM GLUCONATE 23 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86043-1004-2 500 mL in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/22/2016
Labeler — Sypharma Pty Ltd (753786292)
Establishment
Name Address ID/FEI Operations
Sypharma Pty Ltd 753786292 manufacture, pack, sterilize

Revised: 12/2017 Sypharma Pty Ltd

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