Ibaflin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
24-06-2010
Charakterystyka produktu
(SPC)
24-06-2010
Sprawozdanie z oceny publicznego
(PAR)
29-11-2007
Składnik aktywny:
ibafloxacin
Dostępny od:
Intervet International BV
Kod ATC:
QJ01MA96
INN (International Nazwa):
ibafloxacin
Grupa terapeutyczna:
Dogs; Cats
Dziedzina terapeutyczna:
Antibacterials for systemic use
Wskazania:
Dogs:Ibaflin is indicated for the treatment of the following conditions in dogs:dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible strains of Staphylococci, Escherichia coli and Proteus mirabilis;acute, uncomplicated urinary-tract infections, caused by susceptible strains of Staphylococci, Proteus species, Enterobacter spp., E. coli and Klebsiella spp.;respiratory-tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.Ibaflin gel is indicated in dogs for the treatment of the following conditions:dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and P. mirabilis.Cats:Ibaflin gel is indicated in cats for treatment of the following conditions:dermal infections (soft-tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli, Proteus spp. and Pasteurella spp.;upper respiratory-tract infections caused by susceptible pathogens such as Staphylococcus spp., E. coli, Klebsiella spp. and Pasteurella spp.
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-06-13
Ulotka dla pacjenta
B. PACKAGE INSERT
25/35
Medicinal product no longer authorised
P
ACKAGE INSERT FOR INCLUSION WITH THE
I
BAFLIN
T
ABLETS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE
FOR BATCH RELEASE
Intervet GesmbH.
Siemensstraße 107
1210 Vienna
Austria
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ibaflin 30 mg tablets for dogs
Ibaflin 150 mg tablets for dogs
Ibaflin 300 mg tablets for dogs
Ibaflin 900 mg tablets for dogs
3.
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
Ibaflin 30 mg: ibafloxacin 30 mg
Ibaflin 150 mg: ibafloxacin 150 mg
Ibaflin 300 mg: ibafloxacin 300 mg
Ibaflin 900 mg: ibafloxacin 900 mg
4.
INDICATIONS
Ibaflin is indicated for the treatment of the following conditions in
dogs:
Dermal infections (pyoderma – superficial and deep, wounds,
abscesses) caused by susceptible strains
such as S
_taphylococci, E. coli, Proteus mirabilis_
.
Acute, uncomplicated urinary tract infections
_, _
caused by susceptible strains such as S
_taphylococci, _
_Proteus spp., Enterobacter spp., E. coli _
and
_ Klebsiella spp. _
Respiratory tract infections (upper tract)
_ _
caused by susceptible strains of S
_taphylococci, E. coli, _
and
_ _
_Klebsiella spp_
.
5.
CONTRAINDICATIONS
Do not use in dogs during the period of growth as articular cartilage
may be affected. This period depends
on the breed. For the majority of breeds the use of ibafloxacin is
contra-indicated in dogs less than 8
months of age, and in giant breeds less than 18 months.
Do not use in combination with nonsteroidal anti-inflammatory drugs
(NSAIDs) in dogs with a history of
seizures.
26/35
Medicinal product no longer authorised
6.
UNDESIRABLE EFFECTS
Diarrhoea, soft faeces, vomiting, dullness and anorexia have been
observed with low frequency. These
effects
Przeczytaj cały dokument
Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1/35
Medicinal product no longer authorised
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ibaflin 30 mg tablets for dogs
Ibaflin 150 mg tablets for dogs
Ibaflin 300 mg tablets for dogs
Ibaflin 900 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Ibaflin contains:
ACTIVE SUBSTANCE(S)
Ibafloxacin 30 mg
Ibafloxacin 150 mg
Ibafloxacin 300 mg
Ibafloxacin 900 mg
EXCIPIENTS
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE
Ibaflin is indicated for the treatment of the following conditions in
dogs:
Dermal infections (pyoderma – superficial and deep, wounds,
abscesses) caused by susceptible strains
of
_Staphylococci, E. coli, _
and
_Proteus mirabilis_
.
Acute, uncomplicated urinary tract infections
_, _
caused by susceptible strains of
_Staphylococci, Proteus _
_spp., Enterobacter spp., E. coli _
and
_ Klebsiella spp. _
Respiratory tract infections (upper tract)
_ _
caused by susceptible strains of
_Staphylococci, E. coli, _
and
_ _
_Klebsiella spp_
.
4.3
CONTRAINDICATIONS
Do not use in dogs during the period of growth as articular cartilage
may be affected. This period
depends on the breed. For the majority of breeds the use of
ibafloxacin is contra-indicated in dogs less
than 8 months of age and in giant breeds less than 18 months.
Do not use in combination with non-steroidal anti-inflammatory drugs
(NSAIDs) in dogs with a
history of seizures.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in dogs with known quinolone hypersensitivity.
2/35
Medicinal product no longer authorised
4.5
SPECIAL PRECAUTIONS FOR USE
Heavy reliance on a single class of antibiotic may result in the
induction of resistance in a bacterial
population. It is prudent to reserve the fluoroquinolones for the
treatment of clinical conditions which
have responded poorly, or are expected to respond poorly, to other
classes of antibiotic. Ibaflin should
only be used based on s
Przeczytaj cały dokument
