DUPHAFRAL D3 1000 SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
COLECALCIFEROL
Available from:
Fort Dodge Animal Health Limited
ATC code:
QA11CC05
Dosage:
1000000 IU/ML
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Vitamins & Minerals
Therapeutic area:
Bovine
Authorization date:
1995-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphafral D
3
1000 Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Duphafral D
3
1000 is indicated for the prevention of milk fever in cows.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to injectable vitamin solutions.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Aseptic precautions must be observed when using the product. Ensure that site of injection is clean and swabbed with
iodine or spirit prior to administration.
Duphafral D3 1000 is a useful adjunct in the prevention of Milk Fever in cattle. However management and feeding
practices must also be adjusted in order to achieve optimum results.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
Each ml contains:
ACTIVE SUBSTANCE
Colecalciferol
1,000,000 I.U.
EXCIPIENTS
Benzyl alcohol
9 mg
Propylene glycol
100 mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/02/2011_
_CRN 7007809_
_page number: 1_
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Calcification of blood vessels has been observed following repeated high doses of Vitamin D
3
.
In the event of an allergic or anaphylactic reaction, immediate treatment should be given with a soluble glucocorticoid
intravenously (e.g. dexamethasone sodium phosphate) or epinephrine (adrenaline) intramuscularly.
The product contains a polyethoxylated castor oil as non-ionic surfactant and can provide severe an
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