RESFLOR 300/16.5 mg/mL Solution for Injection for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flunixin meglumine; Florfenicol

Available from:

Intervet Ireland Limited

ATC code:

QJ01BA99

INN (International Name):

Flunixin meglumine; Florfenicol

Dosage:

300/16.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

amphenicols, combinations

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2007-09-14

Summary of Product characteristics

1
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 PRODUC
t
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.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
3.4
SPECIAL WARNINGS
None
.
2
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 florfenicol.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there
is a potential risk of increased
renal toxicity. Concurrent adm