KELACYL 100 mg/ml solution for injection for cattle and pigs
KELACYL 100 mg/ml solution for injection for cattle and pigs
Authorised
- Marbofloxacin
Product identification
Medicine name:
Kelbomar 100 mg/ml Solution injectable pour bovins et porcins
Kelbomar 100 mg/ml Injektionslösung für Rinder und Schweine
KELACYL 100 mg/ml solution for injection for cattle and pigs
Active substance:
- Marbofloxacin
Target species:
-
Cattle
-
Pig (sow)
Route of administration:
-
Intramuscular use
-
Intravenous use
-
Subcutaneous use
Product details
Active substance and strength:
-
Marbofloxacin100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: Respiratory: 3 Days (8 mg/kg (IV/SC/IM)) 6 Days (2 mg/kg (IM)) / Mastitis 3 Days (2 mg/kg (IV/IM/SC)); Milk: Respiratory: 72 Hours (8 mg/g (IM) and 36 Hours (2 mg/g (IV / SC / IM)) / Mastitis: 36 Hours 2 mg/g (IV / IM / SC)
-
-
Pig (sow)
-
Meat and offal4day
-
-
Cattle
-
Milkno withdrawal periodMeat and offal: Respiratory: 3 Days (8 mg/kg (IV/SC/IM)) 6 Days (2 mg/kg (IM)) / Mastitis 3 Days (2 mg/kg (IV/IM/SC)); Milk: Respiratory: 72 Hours (8 mg/g (IM) and 36 Hours (2 mg/g (IV / SC / IM)) / Mastitis: 36 Hours 2 mg/g (IV / IM / SC)
-
-
-
Intravenous use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: Respiratory: 3 Days (8 mg/kg (IV/SC/IM)) 6 Days (2 mg/kg (IM)) / Mastitis 3 Days (2 mg/kg (IV/IM/SC)); Milk: Respiratory: 72 Hours (8 mg/g (IM) and 36 Hours (2 mg/g (IV / SC / IM)) / Mastitis: 36 Hours 2 mg/g (IV / IM / SC)
-
-
Cattle
-
Milkno withdrawal periodMeat and offal: Respiratory: 3 Days (8 mg/kg (IV/SC/IM)) 6 Days (2 mg/kg (IM)) / Mastitis 3 Days (2 mg/kg (IV/IM/SC)); Milk: Respiratory: 72 Hours (8 mg/g (IM) and 36 Hours (2 mg/g (IV / SC / IM)) / Mastitis: 36 Hours 2 mg/g (IV / IM / SC)
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: Respiratory: 3 Days (8 mg/kg (IV/SC/IM)) 6 Days (2 mg/kg (IM)) / Mastitis 3 Days (2 mg/kg (IV/IM/SC)); Milk: Respiratory: 72 Hours (8 mg/g (IM) and 36 Hours (2 mg/g (IV / SC / IM)) / Mastitis: 36 Hours 2 mg/g (IV / IM / SC)
-
-
Cattle
-
Milkno withdrawal periodMeat and offal: Respiratory: 3 Days (8 mg/kg (IV/SC/IM)) 6 Days (2 mg/kg (IM)) / Mastitis 3 Days (2 mg/kg (IV/IM/SC)); Milk: Respiratory: 72 Hours (8 mg/g (IM) and 36 Hours (2 mg/g (IV / SC / IM)) / Mastitis: 36 Hours 2 mg/g (IV / IM / SC)
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01MA93
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Luxembourg
Available in:
-
Luxembourg
Package description:
- box containing 12 vials of 250 ml individually packed in a carton box
- box containing 12 vials of 100 ml individually packed in a carton box
- box containing 10 vials of 250 ml individually packed in a carton box
- box containing 10 vials of 100 ml individually packed in a carton box
- box containing 6 vials of 250 ml individually packed in a carton box
- box containing 6 vials of 100 ml individually packed in a carton box
- cardboard box containing 1 vial of 250 ml
- cardboard box containing 1 vial of 100 ml
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:
- KELA Kempisch Laboratorium Kela Laboratoria
Marketing authorisation date:
Manufacturing sites for batch release:
- KELA Kempisch Laboratorium Kela Laboratoria
Responsible authority:
- Ministry Of Health And Social Security
Authorisation number:
- V 188/13/11/1332
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0189/001
Concerned member states:
-
Belgium
-
Germany
-
Luxembourg
-
Poland
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
eu-PUAR-esv0189001-dcp-kelacyl-100-mg-ml-en.pdf
English (PDF)
Download Published on: 22/12/2023
