Neptra

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

florfenicol, Terbinafine hydrochloride, Mometasone furoate

Available from:

Bayer Animal Health GmbH

ATC code:

QS02CA91

INN (International Name):

florfenicol, terbinafine hydrochloride, mometasone furoate

Therapeutic group:

Dogs

Therapeutic area:

Otologicals, Corticosteroids and antiinfectives in combination

Therapeutic indications:

For the treatment of acute canine otitis externa or acute exacerbations of recurrent otitis caused by mixed infections of susceptible strains of bacteria sensitive to florfenicol (Staphylococcus pseudintermedius) and fungi sensitive to terbinafine (Malassezia pachydermatis).

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2019-12-10

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
NEPTRA EAR DROPS SOLUTION FOR 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:
Bayer Animal Health GmbH
51368 Leverkusen
Germany
Manufacturer responsible for batch release:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324,
24106 Kiel
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Neptra ear drops solution for dogs
florfenicol/terbinafine hydrochloride/mometasone furoate
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
One dose (1 ml) contains 16.7 mg florfenicol, 16.7 mg terbinafine
hydrochloride (equivalent to 14.9
mg terbinafine base) and 2.2 mg mometasone furoate.
Clear, colourless to yellow, slightly viscous liquid.
4.
INDICATION(S)
For the treatment of acute canine otitis externa or acute
exacerbations of recurrent otitis caused by
mixed infections of susceptible strains of bacteria sensitive to
florfenicol (
_Staphylococcus _
_pseudintermedius_
) and fungi sensitive to terbinafine (
_Malassezia pachydermatis_
).
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances, to
other corticosteroids or to any of the
excipients.
Do not use if the ear drum is perforated.
Do not use in dogs with generalised demodicosis.
Do not use in pregnant or breeding animals.
6.
ADVERSE REACTIONS
18
Vocalisation, head shaking and application site pain shortly after
product application have been
reported very rarely in spontaneous (pharmacovigilance) reports.
Ataxia, internal ear disorder,
nystagmus, emesis, application site erythema, hyperactivity, anorexia
and application site
inflammation and eye disorders (such as eye irritation, blepharospasm,
conjunctivitis, corneal ulcer,
keratoconjunctivitis sicca) were reported very rarely in spontaneous
(pharmacovigilance) reports.
.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treate

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Neptra ear drops solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1 ml) contains:
ACTIVE SUBSTANCES:
Florfenicol: 16.7 mg
Terbinafine hydrochloride: 16.7 mg, equivalent to terbinafine base:
14.9 mg
Mometasone furoate: 2.2 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, solution.
Clear, colourless to yellow, slightly viscous liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute canine otitis externa or acute
exacerbations of recurrent otitis caused by
mixed infections of susceptible strains of bacteria sensitive to
florfenicol (
_Staphylococcus _
_pseudintermedius_
) and fungi sensitive to terbinafine (
_Malassezia pachydermatis_
).
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances, to
other corticosteroids or to any of the
excipients.
Do not use if the ear drum is perforated.
Do not use in dogs with generalised demodicosis.
Do not use in pregnant or breeding animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bacterial and fungal otitis is often secondary to other conditions. In
animals with a history of recurrent
otitis externa, the underlying causes of the condition such as allergy
or anatomical conformation of the
ear must be addressed in order to avoid ineffective treatment with a
veterinary medicinal product.
In cases of parasitic otitis, an appropriate acaricidal treatment
should be implemented.
Ears must be cleaned before administration of the product. It is
recommended not to repeat ear
cleaning until 28 days after administration of the product. In
clinical trials, only saline was used for ear
cleaning before treatment initiation with the veterinary medicinal
product.
3
This combination is intended for the treatment of acute otitis when
mixed infections caused by
_Staphylococcus pseudintermedius _
susceptible to florfenicol a