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

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: VMD (Veterinary Medicines Directorate)

Ingredjent attiv:

Florfenicol, Flunixin

Disponibbli minn:

MSD Animal Health UK Limited

Kodiċi ATC:

QJ01BA99

INN (Isem Internazzjonali):

Florfenicol, Flunixin

Għamla farmaċewtika:

Solution for injection

Tip ta 'preskrizzjoni:

POM-V - Prescription Only Medicine – Veterinarian

Grupp terapewtiku:

Cattle

Żona terapewtika:

Antimicrobial; Anti Inflammatory

L-istatus ta 'awtorizzazzjoni:

Authorized

Data ta 'l-awtorizzazzjoni:

2006-10-19

Karatteristiċi tal-prodott

Revised: October 2023
AN: 01790/2022 & 01371/2023
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 SUBSTANCES:
Flunixin 16.5 mg equivalent to 27.4 mg flunixin meglumine
Florfenicol 300 mg
EXCIPIENTS:
N-Methyl-2-Pyrrolidone
250.0 mg
Propylene Glycol (Antimicrobial Preservative) E1520
150.0 mg
For the 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
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: October 2023
AN: 01790/2022 & 01371/2023
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