Truleva Flow, 50 mg/ml, Suspension for Injection for Pigs and Cattle

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Ceftiofur

Saatavilla:

Continental Farmaceutica

ATC-koodi:

QJ01DD90

INN (Kansainvälinen yleisnimi):

Ceftiofur

Valtuutuksen tilan:

Expired

Valmisteyhteenveto

Revised: August 2015
AN: 01536/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
IT:
TRULEVA Fluid suspension, 50 mg/ml, suspension for injection for pigs
and cattle
DE, FR and UK:
TRULEVA Flow, 50 mg/ml, suspension for injection for pigs and cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ceftiofur (as hydrochloride)
50.0 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
Opaque suspension, white to off-white.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections associated with bacteria sensitive to ceftiofur:
In pigs:
For the treatment of bacterial respiratory disease associated with
_Pasteurella multocida_,
_Actinobacillus pleuropneumoniae _and _Streptococcus suis_.
In cattle:
For the treatment of bacterial respiratory disease associated with
_Mannheimia haemolytica _
_(former Pasteurella haemolytica), Pasteurella multocida and
Histophilus somni (former _
_Haemophilus somnus)._
For the treatment of acute interdigital necrobacillosis (panaritium,
foot rot), associated with
_Fusobacterium necrophorum _and _Bacteroides melaninogenicus
_(_Porphyromonas _
_asaccharolytica_).
For treatment of the bacterial component of acute post-partum
(puerperal) metritis within 10
days after calving associated with _Escherichia coli_,
_Arcanobacterium pyogenes _and
Page 1 of 7
Revised: August 2015
AN: 01536/2014
_Fusobacterium necrophorum_, sensitive to ceftiofur, where treatment
with another
antimicrobial has failed_. _
4.3
CONTRAINDICATIONS
Do not administer to an animal previously found to be hypersensitive
to ceftiofur and other

-lactam antibiotics.
Do not inject intravenously.
Do not use in cases where resistance to other cephalosporins or
beta-lactam antibiotics
has occurred.
Do not use in poultry (including eggs) due to risk of spread of
antimicrobial resistance to
humans.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPE