Dicural
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
30-10-2015
Karatteristiċi tal-prodott
(SPC)
30-10-2015
Rapport ta 'Valutazzjoni Pubblika
(PAR)
30-10-2015
Ingredjent attiv:
difloxacin
Disponibbli minn:
Pfizer Limited
Kodiċi ATC:
QJ01MA94
INN (Isem Internazzjonali):
difloxacin
Grupp terapewtiku:
Turkeys; Dogs; Cattle; Chicken
Żona terapewtika:
Antibacterials for systemic use, Antiinfectives for systemic use
Indikazzjonijiet terapewtiċi:
Chickens:for the treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.Turkeys:For the treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.Also for the treatment of infections caused by Pasteurella multocida.Dogs:For the treatment of acute uncomplicated urinary-tract infections caused by Escherichia coli or Staphylococcus spp. and superficial pyoderma caused by Staphylococcus intermedius.Cattle:For the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida and / or Mycoplasma spp.
Sommarju tal-prodott:
Revision: 7
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
1998-01-16
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
42
B. PACKAGE LEAFLET
Medicinal product no longer authorised
43
PACKAGE LEAFLET FOR
DICURAL 100 MG/ML ORAL SOLUTION FOR CHICKENS AND TURKEYS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
MANUFACTURER FOR THE BATCH RELEASE
Pfizer Olot, S.L.U.
Ctra. Camprodón, s/n°, Finca La Riba,
Vall de Bianya, 17813 Girona
Spain
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dicural 100 mg/ml oral solution for chickens and turkeys
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCE
Difloxacin (as hydrochloride)
100 mg
EXCIPIENTS
Other excipients, including benzyl alcohol, in an aqueous formulation
to 1 ml
4.
INDICATIONS
In chickens and turkeys:
Dicural oral solution is indicated for treatment of chronic
respiratory
infections caused by sensitive strains of
_Escherichia coli_
and
_Mycoplasma gallisepticum_
.
In turkeys:
Dicural oral solution is also indicated for the treatment of
infections caused by
_Pasteurella _
_multocida._
Dicural oral solution should only be used based on susceptibility
testing
5.
CONTRAINDICATIONS
Since no studies were performed in clinically lame birds, Dicural
oral solution should not be used in
birds with existing leg-weakness or in birds suffering from
osteoporosis.
Medicinal product no longer authorised
44
6.
ADVERSE REACTIONS
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Chickens (broilers and future breeders)
Turkeys (young turkeys up to 2 kg body weight).
8.
DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION
Dicural oral solution must be administrated daily via the drinking
water in such a concentration that
the dose is 10 mg/kg bodyweight. The administration must be continued
for 5 days.
For oral administration in drinking water.
Taki
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dicural 100 mg/ml oral solution for chickens and turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Difloxacin (as hydrochloride)
100 mg
EXCIPIENTS:
Benzyl alcohol
100 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers and future breeders)
Turkeys (young turkeys up to 2 kg body weight).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In chickens and turkeys:
Dicural oral solution is indicated for treatment of chronic
respiratory
infections caused by sensitive strains of
_Escherichia coli_
and
_Mycoplasma gallisepticum_
.
In turkeys
: Dicural oral solution is also indicated for the treatment of
infections caused by
_Pasteurella _
_multocida_
.
4.3
CONTRAINDICATIONS
Since no studies were performed in clinically lame birds, Dicural
should not be used in birds with
existing leg-weakness or in birds suffering from osteoporosis.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Heavy reliance on a single class of antibiotics may result in the
induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the
treatment of clinical conditions that
have responded poorly, or are expected to respond poorly, to other
classes of antibiotics.
Official and local antimicrobial policies should be taken into account
when the product is used
.
Whenever possible, fluoroquinolones should only be used based on
susceptibility testing.
Medicinal product no longer authorised
3
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of
bacteria resistant to the fluoroquinolones and may decrease the
effectiveness of treatment with other
quinolones due to the potential of cross resistance
Aqra d-dokument sħiħ
