Nuflor Minidose (Flomac)
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
13-04-2013
Summary of Product characteristics
(SPC)
13-04-2013
Active ingredient:
florfenicol 450 mg/ml
Available from:
Intervet Deutschland GmbH
ATC code:
QJ01BA90
Pharmaceutical form:
Solution for injection
Therapeutic group:
florfenicol
Therapeutic area:
Cattle Food
Authorization date:
2011-10-13
Patient Information leaflet
Page 1 of 16
_[TEM-006 Version 01/2006] _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nuflor Minidose 450 mg/ml solution for injection for cattle
ES: Flomac 450 mg/ml solution for injection for cattle
FI: Nuflor vet Minidose 450 mg/ml solution for injection for cattle
FR: Nuflor 450 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol…………………………..450.00 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear colourless to yellow solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Preventive and therapeutic treatment of respiratory tract infections in cattle due to _Mannheimia _
_haemolytica_, _Pasteurella multocida_ and _Histophilus somni_ susceptible to florfenicol. The
presence of the disease in the herd should be confirmed before administering preventive
treatment.
4.3
CONTRAINDICATIONS
Not for use in adult bulls intended for breeding purposes.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product should be used in conjunction with susceptibility testing and take into account official
and local antimicrobial policies.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
3
Care should be taken to avoid accidental self-injection. In case of self-injection, seek medical
advice immediately and show the pack
Read the complete document
Summary of Product characteristics
Page 1 of 16
_[TEM-006 Version 01/2006] _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nuflor Minidose 450 mg/ml solution for injection for cattle
ES: Flomac 450 mg/ml solution for injection for cattle
FI: Nuflor vet Minidose 450 mg/ml solution for injection for cattle
FR: Nuflor 450 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol…………………………..450.00 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear colourless to yellow solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Preventive and therapeutic treatment of respiratory tract infections in cattle due to _Mannheimia _
_haemolytica_, _Pasteurella multocida_ and _Histophilus somni_ susceptible to florfenicol. The
presence of the disease in the herd should be confirmed before administering preventive
treatment.
4.3
CONTRAINDICATIONS
Not for use in adult bulls intended for breeding purposes.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product should be used in conjunction with susceptibility testing and take into account official
and local antimicrobial policies.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
3
Care should be taken to avoid accidental self-injection. In case of self-injection, seek medical
advice immediately and show the pack
Read the complete document
