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

Држава: Велика Британија

Језик: Енглески

Извор: VMD (Veterinary Medicines Directorate)

Активни састојак:

Florfenicol, Flunixin

Доступно од:

MSD Animal Health UK Limited

АТЦ код:

QJ01BA99

INN (Међународно име):

Florfenicol, Flunixin

Фармацеутски облик:

Solution for injection

Тип рецептора:

POM-V - Prescription Only Medicine – Veterinarian

Терапеутска група:

Cattle

Терапеутска област:

Antimicrobial; Anti Inflammatory

Статус ауторизације:

Authorized

Датум одобрења:

2006-10-19

Карактеристике производа

Amended pages: November 2023
AN: 01789/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
N-Methyl-2-Pyrrolidone
250.0 mg
Propylene Glycol (Antimicrobial
Preservative) E1520
150.0 mg
Citric acid, anhydrous
Macrogol 300
Clear, light yellow to straw coloured liquid.
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.
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.
Amended pages: November 2023
AN: 01789/2022
Page 2 of 7
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 to flor