SUROLAN VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MICONAZOLE NITRATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

متاح من:

EUROMAR LTD

الشكل الصيدلاني:

SUSPENSION

تركيب:

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

طريقة التعاطي:

DERMAL, OTIC

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ELANCO ANIMAL HEALTH, ELI LILLY REGIONAL OPERATIONS GMBH, AUSTRIA

الخصائص العلاجية:

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

تاريخ الترخيص:

2018-07-08

نشرة المعلومات

CONSUMER PACKAGE INSERT FOR VETERINARY MEDICINAL PRODUCT
THE MEDICINE IS DISPENSED WITH A VETERINARIAN'S PRESCRIPTION ONLY
FOR ANIMAL USE ONLY
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT:
Surolan Veterinary
Suspension drops
2.
ACTIVE INGREDIENTS:
Each 1 ml contains:
Miconazole nitrate
23mg
Prednisolone acetate
5mg
Polymixin B sulfate
0.5293mg (5500I.U.)
3.
WHAT IS THE MEDICINAL PRODUCT INTENDED FOR:
Surolan is used in dogs and cats for the treatment of otitis and skin
infections caused
by fungi, yeast, gram-negative and gram-positive bacteria, ear mites
(Otodectes
cynotis).
THERAPEUTIC GROUP:
Miconazole nitrate: Antifungal from the Imidazole family
Prednisolone acetate: Synthetic corticosteroid
Polymixin B sulfate: Antibiotics
4.
CONTRAINDICATIONS
Do not use in animals with perforated ear drums since Polymyxin B is
known to be a
potential ototoxic agent.
.
Do not use in cases of known hypersensitivity to the active substances
or to any of the
excipients.
.
5.
SIDE EFFECTS
Deafness and impaired hearing (mainly in elderly dogs) have been
reported very rarely.
If this occurs, treatment should be stopped. Decreased hearing or
deafness is generally
temporary in nature.
Prolonged use of topical 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).
The frequency of adverse reactions is defined using the following
convention:
•
very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
•
common (more than 1 but less than 10 animals in 100 animals treated)
•
uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
•
rare (more than 1 but less than 10 animals in 10,000 animals treated)
•
very rare (less than 1 animal in 10,000 animals treated, including
isolated
reports)
If you notice any serious effects or other effects not mentioned in
this leaflet, please
inform your veterinary surgeon.
Side effects can be repor

خصائص المنتج

Page 1 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Surolan Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MG/ML
ACTIVE SUBSTANCES:
Miconazole Nitrate
23
Prednisolone Acetate
5
Polymyxin B Sulfate
0.5293
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops suspension and cutaneous suspension.
White suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Surolan is used in dogs and cats for the treatment of otitis and skin
infections
caused by fungi, yeasts, gram negative and gram positive bacteria. ear
mites
4.3
CONTRAINDICATIONS
Do not use in animals with perforated ear drums since Polymyxin B is
known
to be a potential ototoxic agent.
Do not use in cases of known hypersensitivity to the active substances
or to any of
the excipients
listed in section 6.1
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As the product is a prescription only medicine, treatment should be
closely
supervised by a veterinary practitioner.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Page 2 of 6
For external use only.
Due to the likely variability (temporal, geographical) in the
emergence of
bacterial resistance to polymyxin B, bacteriological sampling and
sensitivity testing (antibiogram) is recommended during treatment.
If there is overgrowth of resistance bacteria and/or fungi, treatment
with
this product should be discontinued and treatment with an appropriate
alternative should be initiated.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Do not handle the product if you are allergic to the ingredients in
the
product.
Accidental spillage on the skin should be washed off immediately with
soap and water. Wash hands after use.
Corticosteroids may produce irreversible effects in the skin. They can
be
absorbed and may have harmful effects, especially with frequent and
extensive contact or in pregnancy. Always wear single use disposable
gloves whe