Nuflor Minidose (Flomac)
Krajina: Maďarsko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
Príbalový leták
(PIL)
13-04-2013
Súhrn charakteristických
(SPC)
13-04-2013
Aktívna zložka:
florfenicol 450 mg/ml
Dostupné z:
Intervet Deutschland GmbH
ATC kód:
QJ01BA90
Forma lieku:
Solution for injection
Terapeutické skupiny:
florfenicol
Terapeutické oblasti:
Cattle Food
Dátum Autorizácia:
2011-10-13
Príbalový leták
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
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Súhrn charakteristických
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
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