Posatex
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-06-2013
Produktets egenskaber
(SPC)
11-06-2013
Offentlige vurderingsrapport
(PAR)
23-02-2021
Aktiv bestanddel:
orbifloxacin, Mometasone furoate, posaconazole
Tilgængelig fra:
Intervet International BV
ATC-kode:
QS02CA91
INN (International Name):
orbifloxacin, mometasone furoate, posaconazole
Terapeutisk gruppe:
Dogs
Terapeutisk område:
Otologicals
Terapeutiske indikationer:
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.
Produkt oversigt:
Revision: 9
Autorisation status:
Authorised
Autorisation dato:
2008-06-23
Indlægsseddel
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET FOR:
POSATEX EAR DROPS SUSPENSION DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
Manufacturer for the batch release:
Vet Pharma Friesoythe
Sedelsberger Straße 2
26169 Friesoythe
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Posatex, ear drops suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Orbifloxacin
8.5 mg/mL
Mometasone furoate (as monohydrate)
0.9 mg/mL
Posaconazole
0.9 mg/mL
4.
INDICATIONS
Treatment of acute otitis externa and acute exacerbations of recurrent
otitis externa, associated with
bacteria susceptible to orbifloxacin and fungi susceptible to
posaconazole, in particular
_Malassezia _
_pachydermatis. _
5.
CONTRAINDICATIONS
Do not use if the eardrum is perforated.
Do not use in case of hypersensitivity to any of the ingredients of
the veterinary medicinal product, to
corticosteroids, to other azole antifungal agents or to other
fluoroquinolones.
6.
ADVERSE REACTIONS
Mild erythematous lesions have been observed.
The use of auricular preparations may be associated with hearing
impairment, usually temporary, and
primarily in geriatric dogs.
19
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Auricular use.
One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and
27 µg posaconazole.
Shake well before use.
With dogs weighing less than 2 kg, apply 2 drops to the ear once a
day.
With dogs weighing 2-15 kg, apply 4 drops to the ear once a day.
With dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Treatment should continue for 7 consecutive days.
9.
ADVICE ON CORRECT ADMINISTRATION
The external ear canal should be meticulously cl
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Posatex ear drops suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Orbifloxacin
8.5 mg/mL
Mometasone furoate (as monohydrate)
0.9 mg/mL
Posaconazole
0.9 mg/mL
EXCIPIENTS:
Paraffin liquid
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops suspension
White to off-white viscous suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of acute otitis externa and acute exacerbations of recurrent
otitis externa, associated with
bacteria susceptible to orbifloxacin and fungi susceptible to
posaconazole, in particular
_Malassezia _
_pachydermatis._
4.3
CONTRAINDICATIONS
Do not use if the eardrum is perforated.
Do not use in case of hypersensitivity to the active substances, to
any of the ingredients, to
corticosteroids, to other azole antifungal agents or to other
fluoroquinolones.
Do not use (during the whole or part of the pregnancy).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bacterial and fungal otitis is often secondary in nature. The
underlying cause should be identified and
treated.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
3
Heavy reliance on a single class of antibiotic may result in the
induction of resistance in a bacterial
population. It is prudent to reserve fluoroquinolones for the
treatment of clinical conditions, which
have responded poorly or are expected to respond poorly to other
classes of antibiotics.
Use of the product should be based on susceptibility testing of
isolated bacteria, and/or other
appropriate diagnostic tests.
_ _
Quinolone class veterinary medicinal products have been associated
with cartilage erosions in weight-
bearing joints and other forms of arthropathy in immature animals of
various species. Therefore do
not use in animals less than 4 months of age.
Prolonged and intensive use of topical corticosteroids preparation is
known to t
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