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

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Florfenicol, Flunixin

Disponível em:

MSD Animal Health UK Limited

Código ATC:

QJ01BA99

DCI (Denominação Comum Internacional):

Florfenicol, Flunixin

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Cattle

Área terapêutica:

Antimicrobial; Anti Inflammatory

Status de autorização:

Authorized

Data de autorização:

2006-10-19

Características técnicas

Revised: November 2020
AN: 01042/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTCS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
RESFLOR 300/16.5 mg/mL Solution for Injection for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains
Active substance:
Florfenicol
300.0 mg
Flunixin
16.5
mg
(as flunixin meglumine)
Excipients:
Propylene glycol (Antimicrobial Preservative)
E 1520
150.0 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, light yellow to straw coloured liquid
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
CONTRA-INDICATIONS
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.
Revised: November 2020
AN: 01042/2020
Page 2 of 7
Do not use in the case of known hypersensitivity to active substances
or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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 administration of potentiall