KEFLORIL 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
KEFLORIL 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Authorised
- Florfenicol
Product identification
Medicine name:
KEFLORIL 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Kefloril 300 mg/ml injektionsvæske, opløsning
Active substance:
- Florfenicol
Target species:
-
Cattle
-
Pig
Route of administration:
-
Intramuscular use
-
Subcutaneous use
Product details
Active substance and strength:
-
Florfenicol300.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Milkno withdrawal periodMilk: Not permitted for use in lactating animals producing milk for human consumption.
-
Meat and offal30dayby IM (at 20 mg/kg bodyweight, twice): 30 days
-
-
Pig
-
Meat and offal18day
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offal44dayby SC (at 40 mg/kg bodyweight, once): 44 days
-
Milkno withdrawal periodMilk: Not permitted for use in lactating animals producing milk for human consumption.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01BA90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Denmark
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Vetoquinol Scandinavia AB
Marketing authorisation date:
Manufacturing sites for batch release:
- Vetoquinol S.A.
Responsible authority:
- Danish Medicines Agency
Authorisation number:
- 45756
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0216/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Germany
-
Ireland
-
Italy
-
Netherlands
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Danish (PDF)
Published on: 7/04/2025
