Flovuxin 300/16.5 mg/ml Solution for Injection for Cattle

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Florfenicol, Flunixin

Commercializzato da:

Krka d.d., Novo Mesto

Codice ATC:

QJ01BA99

INN (Nome Internazionale):

Florfenicol, Flunixin

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Cattle

Area terapeutica:

Antimicrobial; Anti Inflammatory

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2020-12-21

Scheda tecnica

Issued: December 2020
AN: 01637/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flovuxin 300/16.5 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Florfenicol
300.0 mg
Flunixin
16.5
mg
(as flunixin meglumine)
EXCIPIENTS:
Propylene glycol E1520
150.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellow to yellow or to greenish yellow solution or to
brownish yellow
solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of respiratory infections caused by _Mannheimia
haemolytica_, _Pasteurella _
_multocida_, _Mycoplasma bovis_ and _Histophilus somni_ associated
with pyrexia.
4.3
CONTRAINDICATIONS
Do not use in adult bulls intended for breeding purposes.
Do not use in animals suffering from hepatic and renal diseases.
Do not use if there is a risk of gastrointestinal bleeding or in cases
where there is
evidence of altered hemostasis.
Do not use in animals suffering from cardiac diseases.
Do not use in cases of known hypersensitivity to the active substances
or to any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Issued: December 2020
AN: 01637/2019
Page 2 of 7
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional,
farm level) epidemiological information about susceptibility of the
target bacteria.
Official and local antimicrobial policies should be taken into account
when the
product is used.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to florfenicol.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there
is a potential
risk of increased renal toxicity. Concurrent ad