NorOtic Ear Drops, Suspension for Dogs

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Clotrimazole, Dexamethasone, Marbofloxacin

זמין מ:

Norbrook Laboratories Limited

קוד ATC:

QS02CA06

INN (שם בינלאומי):

Clotrimazole, Dexamethasone, Marbofloxacin

טופס פרצבטיות:

Ear drops, suspension

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Dogs

איזור תרפויטי:

Antimicrobial

מצב אישור:

Expired

תאריך אישור:

2015-07-21

מאפייני מוצר

Issued: July 2015
AN: 01876/2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NorOtic Ear Drops, Suspension for Dogs
Canor vet (DK, FI)
Marbofloxacin/Clotrimazole/Dexamethasone Norbrook vet (SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCES:
Marbofloxacin ...................................................3.0
mg
Clotrimazole....................................................10.0
mg
Dexamethasone ...............................................0.9 mg
(equivalent to dexamethasone acetate ...........1.0 mg)
EXCIPIENTS
Propyl gallate (E310)……………………………………… 1.0
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, suspension
Homogenous beige to yellow oily suspension
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dogs
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of otitis externa of both bacterial and fungal origin
respectively due to
bacteria
sensitive
to
marbofloxacin,
and
fungi
especially
_Malassezia _
_pachydermatis_ sensitive to clotrimazole.
The product should be used based on susceptibility testing of isolated
bacteria.
Issued: July 2015
AN: 01876/2013
Page 2 of 6
4.3.
CONTRAINDICATIONS
Do not use in dogs suffering from perforation of the tympanic
membrane.
Do not use in case of hypersensitivity to the active substances or to
any of the
excipients. See section 4.7.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The
external
ear
canal
should
be
meticulously
cleaned
and
dried
before
treatment.
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
For external use only. Auricular use.
Avoid
contact
with
eyes
in
animals.
In
case
of
accidental
contact,
rinse
thoroughly with water.
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
fluoroquino