Butasal-100, 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats
Butasal-100, 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats
Authorised
- Cyanocobalamin
- Butafosfan
Product identification
Medicine name:
Butasal-100, 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats
Butasal-100, 100 mg/mL + 0,05 mg/mL, otopina za injekciju, za konje, goveda, pse i mačke
Active substance:
- Cyanocobalamin
- Butafosfan
Target species:
-
Cattle
-
Horse
-
Dog
-
Cat
Route of administration:
-
Intravenous use
-
Intramuscular use
-
Subcutaneous use
Product details
Active substance and strength:
-
Cyanocobalamin0.05milligram(s)1.00millilitre(s)
-
Butafosfan100.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Cattle
-
Meat and offal0day
-
Milk0hour
-
- Horse
-
Meat and offal0day
-
Milk0hour
-
- Dog
- Cat
-
Intramuscular use
- Dog
- Cat
-
Subcutaneous use
- Dog
- Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QA12CX99
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Croatia
Package description:
- Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flipoff cap with polypropylene cover. Package size: Cardboard box of 6 carton boxes of 1 vial of 100 mL
- Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flipoff cap with polypropylene cover. Package size: Cardboard box of 1 vial of 100 mL.
- Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flip-off cap with polypropylene cover. Cardboard box of 6 carton boxes of 1 vial of 50 mL.
- Amber glass vial, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flip-off cap with polypropylene cover. Cardboard boxes of 1 vial of 50 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:
- Interchemie Werken De Adelaar Eesti AS
Marketing authorisation date:
Manufacturing sites for batch release:
- Interchemie Werken De Adelaar Eesti AS
Responsible authority:
- Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
- UP/I-322-05/21-01/284
Date of authorisation status change:
Reference member state:
-
Estonia
Procedure number:
- EE/V/0106/001
Concerned member states:
-
Austria
-
Belgium
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Finland
-
France
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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