SUROLAN EAR DROPS AND CUTANEOUS SUSPENSION

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QD01AC52
INN (International Name):
MICONAZOLE NITRATE, POLYMYXIN B SULFATE, PREDNISOLONE ACETATE
Dosage:
23 Mg/Ml
Pharmaceutical form:
Cutaneous Suspension
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Dogs, Cats
Therapeutic area:
miconazole, combinations
Therapeutic indications:
Antifungal
Authorization status:
Authorised
Authorization number:
VPA10047/043/001
Authorization date:
2012-08-17

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Surolan Ear Drops and Cutaneous Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Cats and dogs

4.2 Indications for use, specifying the target species

the topical

treatment

otitis externa and skin infections caused by Gram-negative bacteria e.g.

Staphylococcus aureus,

Streptococcus spp., and Gram-negative bacteria Escherichia coli and Pseudomonas aeruginosa.

For the topical treatment of otitis externa and skin infections caused by fungi and yeasts: Trichophyton spp.,

Microsporum spp.,

Malassezia pachydermatis, Candida spp.

For the topical treatment of otitis externa caused by the ear mite Otodectes cynotis.

The product also has anti-inflammatory and anti-pruritic activity.

4.3 Contraindications

Do not use in animals with perforated ear drums since polymixin B is known to be a potential ototoxic agent.

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.

Active substances:

Miconazole Nitrate

mg/ml

Prednisolone Acetate

mg/ml

Polymixin B Sulfate

0.5293 mg/ml

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

3

1

/

0

1

/

2

0

1

7

C

R

N

7

0

2

5

6

1

1

p

a

g

e

n

u

m

b

e

r

:

1

4.5 Special precautions for use

i) Special precautions for use in animals

For external use only.

Due to likely variability (time, geographical) in the occurance of resistance of bacteria for Polymyxin B, bacteriological sampling

and susceptibility testing are recommended.

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 when applying the product to animals.

4.6 Adverse reactions (frequency and seriousness)

Long -term use of topical steroids may cause skin thinning and delay wound healing.

4.7 Use during pregnancy, lactation or lay

Corticosteroids are not recommended for use in pregnant animals.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

This product is for topical administration. Shake the bottle vigorously and ensure the product is fully resuspended before use.

At the beginning of treatment, hair surrounding or covering the lesions must be clipped; this should be repeated during treatment if

necessary.

Ears

Clean the auditory canal and place a few drops of Surolan into the ear twice daily.

For infections caused by Otodectes

cynotis, instill five drops twice daily for 14 days. Massage the ear and the auditory canal gently but thoroughly to ensure proper

distribution.

Skin

Having ensured the area to be treated is clean, apply a few drops of the product (depending on lesion size) twice a day and

rub well.

Treatment should be continued until a few days after complete disappearance of the clinical symptoms. In some obstinate cases,

treatment may be required for 2 to 3 weeks (see also 4.6).

Where ear mite infection is present, consideration should be given to treating both ears even if infestation is only apparent in one

ear.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The product is applied topically.

No toxic side effects have been observed after accidental intake by licking.

4.11 Withdrawal Period(s)

Not applicable.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Otologicals, Corticosteroids and antiinfectives in combination.

ATC Vet Code: QS02CA01

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

3

1

/

0

1

/

2

0

1

7

C

R

N

7

0

2

5

6

1

1

p

a

g

e

n

u

m

b

e

r

:

2

5.1 Pharmacodynamic properties

Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity and a potent activity against Gram-

positive bacteria. Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of

yeast and fungi.

Polymyxin B sulfate is a polypeptide antibiotic with bactericidal activity against Gram- negative bacteria. It binds to

phospholipids in the cytoplasmic membrane, whereby the membrane permeability is disturbed. This results in lysis of the bacteria.

Prednisolone acetate is a glucocorticoid with strong anti-inflammatory activity which results from its reduction of the permeability

of capillaries and vascular proliferation and from the inhibition of fibroblast action.

5.2 Pharmacokinetic properties

After topical application of miconazole nitrate, virtually no systemic absorption takes place through the skin or mucous

membranes.

Systemic absorption of prednisolone on normal or abraded skin is minimal. Absorption of polymyxin B via the skin is also

negligible. Excretion is almost completely via the kidneys.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silica colloidal anhydrous

Liquid paraffin

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 3 months.

6.4 Special precautions for storage

Do not store above 25

6.5 Nature and composition of immediate packaging

Bottle: 15ml or 30ml white low-density polyethylene squeeze dropper bottle.

Closure: White, opaque high-density polyethylene child resistant cap (screw fit) with tamper evident ring or white, opaque high-

density polyethylene tamper evident (screw fit) cap.

Dropper (Dosing Device): White, low-density polyethylene and thermoplastic elastomer or white, low density polyethylene.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused product or waste material should be disposed of in accordance with national requirements.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

3

1

/

0

1

/

2

0

1

7

C

R

N

7

0

2

5

6

1

1

p

a

g

e

n

u

m

b

e

r

:

3

7 MARKETING AUTHORISATION HOLDER

Eli Lilly & Company Limited

Elanco Animal Health

Lilly House

Priestly Road

Basingstoke

Hampshire

RG24 9NL

8 MARKETING AUTHORISATION NUMBER(S)

VPA: 10047/043/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

September 2008

10 DATE OF REVISION OF THE TEXT

August 2012

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

3

1

/

0

1

/

2

0

1

7

C

R

N

7

0

2

5

6

1

1

p

a

g

e

n

u

m

b

e

r

:

4

Similar products

Search alerts related to this product

View documents history

Share this information