MITEX VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MICONAZOLE NITRATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

متاح من:

VETMARKET LTD, ISRAEL

الشكل الصيدلاني:

SUSPENSION

تركيب:

POLYMYXIN B SULFATE 5500 IU / 1 ML; PREDNISOLONE ACETATE 5 MG / 1 ML; MICONAZOLE NITRATE 23 MG / 1 ML

طريقة التعاطي:

OTIC, TOPICAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

RICHTER PHARMA AG, AUSTRIA

الخصائص العلاجية:

For the treatment of otitis and skin infections caused by fungi, yeasts, gram-negative and gram-positive bacteria in dogs and cats. Ear mites

تاريخ الترخيص:

2020-02-19

نشرة المعلومات

CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1. NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH
MITEX VETERINARY
Suspension for otic or dermal use
2. ACTIVE INGREDIENTS AND QUANTITY PER UNIT DOSE
Each mL contains:
Miconazole nitrate 23 mg
Polymyxin B sulfate 0.5293 mg (5500 IU)
Prednisolone acetate 5 mg
For the list of inactive excipients, see section 13
“Additional information”
.
3. WHAT IS THE MEDICINE INTENDED FOR
For the treatment of inflammation of the external ear and cutaneous
inflammations of
cats and dogs caused by fungi, yeasts and Gram-negative and Gram-
positive
bacteria sensitive to the drug. Inflammation of the ear caused by Ear
mites.
THERAPEUTIC GROUP:
Miconazole nitrate: Antifungal substance of the imidazole family
Prednisolone acetate: Synthetic corticosteroid
Polymyxin B sulfate: Antibiotic
4. CONTRAINDICATIONS
Do not use in animals if the eardrum is damaged, Polymyxin B can cause
hearing
problems.
Do not use in cases of known hypersensitivity to the active
ingredients listed above or
to any of the excipients included in the product as detailed in
section 13.
5. SIDE EFFECTS
Dogs and cats:
Very rare (occur in less than 1 in 10,000 treated animals, including
isolated
reports)
- Deafness
1
- Impaired hearing
1
1
Mainly in elderly dogs. If this occurs, treatment should be stopped.
Decreased
hearing or deafness is generally temporary in nature.
Prolonged use of topically administered steroids can cause skin
discoloration and
delay wound healing.
The conventional adverse effects of corticosteroids can occur
(disturbance of
biochemical parameters, such as increased cortisol and hepatic enzyme
levels).
Side effects can be reported to the Ministry of Health by clicking on
the link "Side
Effects Report" that appears on the home page of the Ministry of
Health web site
(www.health.gov.il),
which
leads
to
an
online
form
for
reporting
side
effects.
Alternatively, you can use the following link:
https://sidee