RESFLOR VETERINARY

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

FLORFENICOL; FLUNIXIN MEGLUMINE

Disponibil de la:

INTERVET ( ISRAEL) LTD

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

FLORFENICOL 300 MG/ML; FLUNIXIN MEGLUMINE 27.4 MG/ML

Calea de administrare:

S.C

Tip de prescriptie medicala:

Required

Produs de:

VET PHARMA FRIESOYTHE GMBH, GERMANY

Indicații terapeutice:

Therapeutic treatment of febrile respiratory tract infections caused by Mannheimia haemolytica , Pasteurella multocida , Mycoplasma bovis or histophilus somni in cattle.

Data de autorizare:

2016-06-30

Prospect

PATIENT PACKAGE INSERT FOR A VETERINARY PRODUCT
The medicine is only dispensed with a veterinarian’s prescription
For veterinary use only
1. NAME OF THE VETERINARY MEDICINAL PRODUCT, ITS DOSAGE FORM AND
CONCENTRATION
RESFLOR VETERINARY
SOLUTION FOR INJECTION FOR CATTLE
2. ACTIVE INGREDIENT(S)
Each 1 ml of solution contains the active ingredients:
Florfenicol 300 mg
Flunixin meglumine 27.4 mg (equivalent to 16.5 mg of free flunixin)
3
. WHAT IS THE MEDICINE INTENDED FOR
Treatment of respiratory infections in cattle caused by _ _
_Mannheimia haemolytica_, _Pasteurella multocida, Mycoplasma bovis,_
_Histophilus somni_
accompanied by fever.
THERAPEUTIC GROUP:
FLORFENICOL IS A BROAD SPECTRUM ANTIBIOTIC
FLUNIXIN MEGLUMINE IS A NON-STEROIDAL ANTI-INFLAMMATORY AGENT
4
. 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.
And do not use in cases where there is evidence of altered hemostasis.
Do not use in animals known to be hypersensitive to one of the
ingredients of the medicine.
Do not use in animals suffering from cardiac diseases.
5. ADVERSE REACTIONS
Subcutaneous administration of the product may result in injection
site swellings that become
palpable 2-3 days after injection.
This swelling may last from 15 to 36 days following the injection.
This reaction may be
associated with minimal to mild irritation of the subcutis. Extension
into the underlying muscle
has been noted in only a few instances.
After 56 days, no skin effects were observed that would require any
trim-out
at slaughter.
Side effects can be reported to the Ministry of Health by clicking on
the link “Report Side
Effects of Drug Treatment” found on the Ministry of Health homepage
(www.health.gov.il) that
directs you to the online form for reporting side effects, or by
entering the link:
https://sideeffects.health.gov.il/
6. TARGET SPECIES
Cattle
7. METHOD OF ADMINISTRATION AND DOSAGE
Only by subcutan

Caracteristicilor produsului

Page 1 of 6
_This leaflet format has been determined by the Ministry of Health and
the content has been checked and _
_approved on May 2019_
SUMMARY OF PRODUCT CHARACTERISTCS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Resflor Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains
Active substance:
Florfenicol
300.0 mg
Flunixin meglumine 27.4 mg (equivalent to 16.5 mg of free flunixin)
Excipients:
Propylene glycol (Antimicrobial Preservative) 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
Therapeutic treatment of febrile respiratory tract infections caused
by Mannheimia
haemolytica, Pasteurella multocida, Mycoplasma bovis or histophilus
somni in
cattle.
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.
Do not use in the case of known hypersensitivity to active substances
or to any of
the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Page 2 of 6
(i)
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
incre