ADVOCIN INJECTABLE SOLUTION 2.5 % VETERINARY

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
02-07-2020

Aktivni sastojci:

DANOFLOXACIN AS MESYLATE

Dostupno od:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

Farmaceutski oblik:

SOLUTION FOR INJECTION

Sastav:

DANOFLOXACIN AS MESYLATE 25 MG/ML

Administracija rute:

I.M, S.C

Tip recepta:

Required

Proizveden od:

FAREVA AMBOISE, FRANCE

Terapijske indikacije:

For the treatment of cattle (calves, beef cattle and non-lactating dairy cattle) with respiratory infections caused by Pasteurella haemolytica and Pasteurella multocida, enteric infections caused by e.coli and salmonela spp.Only after sensitivity to danofloxacin has been confirmed by laboratory tests and after no alternative treatment was found effective (proved resistence to other treatments).

Datum autorizacije:

2019-01-31

Svojstava lijeka

                                Advocin 2.5% Veterinary LPD
.2020
2
20.0
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Advocin Injectable Solution 2.5% Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Danofloxacine (as mesylate) equivalent to
danofloxacine 25.0 mg/ml
For the full list of all other excipients see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, light yellow solution
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cattle.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of cattle (calves, beef cattle and non-lactating
dairy
cattle) with respiratory infections caused by _Pasteurella
haemolytica_ and
_Pasteurella multocida_, enteric infections caused by _E.coli_ and
_Salmonela_
spp. Only after sensitivity to danofloxacin has been confirmed by
laboratory tests and after no alternative treatment was found
effective
(proved resistance to other treatments).
4.3.
CONTRAINDICATIONS
None
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not applicable
4.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Fluoroquinolones
should
be
reserved
for
the
treatment
of
clinical
conditions which have responded poorly, or are expected to respond
poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on
susceptibility testing.
Use of the product deviating from the instructions given in the SPC
may
increase the prevalence of bacteria resistant to the fluoroquinolones
and
Advocin 2.5% Veterinary LPD
.2020
2
20.0
2
may decrease the effectiveness of treatment with other quinolones due
to the potential for cross resistance.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Wash hands after use.
4.6.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
Reporting suspected adverse reactions after authorization of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product. Any suspected a
                                
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