POSATEX VETERINARY

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

MOMETASONE FUROATE (AS MONOHYDRATE); ORBIFLOXACIN; POSACONAZOLE

Dostupno od:

INTERVET ( ISRAEL) LTD

Farmaceutski oblik:

EAR DROPS SUSPENSION

Sastav:

ORBIFLOXACIN 8.5 MG/ML; MOMETASONE FUROATE (AS MONOHYDRATE) 0.9 MG/ML; POSACONAZOLE 0.9 MG/ML

Administracija rute:

OTIC

Tip recepta:

Required

Proizveden od:

VET PHARMA FRIESOYTHE GMBH, GERMANY

Terapijske indikacije:

Dogs: 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

Datum autorizacije:

2021-01-31

Uputa o lijeku

The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in February 2016
Requires a veterinarian’s prescription
For veterinary use only
1.
POSATEX VETERINARY
Ear drops suspension for dogs
2.
COMPOSITION:
Active substences:
Orbifloxacin 8.5 mg/ml
Mometasone furoate (as monohydrate) 0.9 mg/ml
Posaconazole 0.9 mg/ml
Therapeutic group: A combination of a corticosteroid, fluoroquinolones
and
azole antifungal agent.
3.
PHARMACEUTICAL FORM:
Ear drops suspension for dogs.
Homogenous, white to off-white viscous suspension.
4.
CLINICAL PARTICULARS:
4.1
TARGET SPECIES: Dogs
4.2
INDICATION:
Treatment of acute otitis externa and acute exacerbation of recurrent
otitis
externa, associated with bacteria susceptible to orbifloxacin and
fungi
susceptible to posaconazole, in particular, the _Malassezia
pachydermatis_
yeast.
4.3
CONTRAINDICATIONS:
Do not use if the eardrum is perforated.
Do not use in case of sensitivity to any of the ingredients of the
medicine, to
corticosteroids, to other azole antifungal medicines, or to
fluoroquinolones.
Do not use during part of or the whole pregnancy.
Do not use in breeding animals.
Do not use in dogs under 4 months of age.
4.4
SPECIAL WARNINGS:
Fungal or bacterial otitis is usually secondary in nature. The primary
cause of
inflammation must be identified and treated.
4.5
PRECAUTIONS FOR USE:
PRECAUTIONS FOR USE IN ANIMALS:
Heavy reliance on a single class of antibiotic may cause resistance of
the
bacterial population; exercise caution when using fluoroquinolones and
reserve them for treating clinical conditions that have not responded
or are not
expected to respond to other types of antibiotics.
Use of this product should be based on bacterial susceptibility
testing and
bacterial cultures, 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. Therefore, do not use in animals under 4

Svojstava lijeka

1
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and _
_approved on _
February 2016
_ _
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Posatex Veterinary
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:
Mineral oil/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 in animals less than 4 months of age.
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.
2
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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
weightbearing joints and other forms of arthropathy in immature
animals of various species. Therefore
do not use in animals less than 4 months of age.
Prol