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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Florfenicol, Flunixin

Available from:

Krka d.d., Novo Mesto

ATC code:

QJ01BA99

INN (International Name):

Florfenicol, Flunixin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antimicrobial; Anti Inflammatory

Authorization status:

Authorized

Authorization date:

2020-12-21

Summary of Product characteristics

Revised: August 2023
AN: 00849/2023
Page 1 of 8
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:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS_ _
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Propylene glycol E1520
150.0 mg
N-methylpyrrolidone
250.0 mg
Citric acid
Macrogol 300
Solution for injection is a clear, slightly yellow to yellow or to
greenish yellow solution
or to brownish yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of respiratory infections caused by _Mannheimia
haemolytica_, _Pasteurella _
_multocida_, _Mycoplasma bovis_ and _Histophilus somni_ associated
with pyrexia.
Revised: August 2023
AN: 00849/2023
Page 2 of 8
3.3
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 hypersensitivity to the active substances or to
any of the
excipients.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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 t