Fenflor 300 mg/ml Solution for Injection for Cattle

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Florfenicol

Dostupné z:

Krka d.d., Novo Mesto

ATC kód:

QJ01BA90

INN (Medzinárodný Name):

Florfenicol

Forma lieku:

Solution for injection

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Cattle

Terapeutické oblasti:

Antimicrobial

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2007-07-04

Súhrn charakteristických

Revised: September 2015
AN: 01292/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenflor 300 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol
300 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A light yellow to yellow, clear, viscous liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Diseases caused by florfenicol susceptible bacteria.
Treatment and metaphylaxis of respiratory tract infections in cattle
due to
_Mannheimia haemolytica, Pasteurella multocida _and_ Histophilus
somni_, where the
presence of the disease in the herd has been established.
4.3
CONTRAINDICATIONS
Do not use in adult bulls intended for breeding purposes.
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in case of resistance to the active substance.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: September 2015
AN: 01292/2014
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Swab septum before removing each dose. Use a dry, sterile syringe and
needle.
The product should be used in conjunction with susceptibility testing
and take into
account official and local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to florfenicol and may decrease the
effectiveness of
treatment with other amfenicols, due to the potential for cross
resistance.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately
and show the
package leaflet or the label to the physician.
Do not use the product in known cases of sensitivity to propylene
glycol.
4.6
A