ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Posatex, ear drops suspension for dogs
2.
Active substances:
Orbifloxacin 8.5 mg/mL
Mometasone furoate (as monohydrate) 0.9 mg/mL
Posaconazole
0.9 mg/mL
Excipients:
Paraffin liquid
For a full list of excipients, see section 6.1.
3.
Ear drops suspension
White to off-white viscous suspension
4.
Dogs
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with
bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular
Malassezia
pachydermatis.
Do not use if the eardrum is perforated.
Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to
corticosteroids, to other azole antifungal agents or to other fluoroquinolones. See section 4.7 (Use
during pregnancy, lactation) of this SPC.
Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and
treated.
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial
population. It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which
have responded poorly or are expected to respond poorly to other classes of antibiotics.
2
Use of the product should be based on susceptibility testing of isolated bacteria, and/or other
appropriate diagnostic tests.
Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other
forms of arthropathy in immature animals of various species. Therefore do not use in animals less than
4 months of age.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and
systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed
healing. See section 4.10 Overdose.
Before the veterinary medicinal product is applied, the external auditory canal must be examined
thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the
infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Wash hands carefully after applying the veterinary medicinal product. Avoid skin contact. In case of
accidental exposure, rinse the affected area with copious quantities of water.
Mild erythematous lesions have been observed.
The use of auricular preparations may be associated with hearing impairment, usually temporary, and
primarily in geriatric dogs.
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Pregnancy:
Do not use during the whole or part of the pregnancy.
Lactation:
The use of the veterinary medicinal product is not recommended during lactation.
Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of
orbifloxacin. Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Fertility:
Studies to determine the effect of orbifloxacin on fertility in dogs have not been conducted.
Do not use in breeding animals.
Compatibility with ear cleaners has not been demonstrated. Concurrent use with an ear cleaner with a
high pH is not recommended.
Auricular use.
One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and 27 µg posaconazole.
The external ear canal should be meticulously cleaned and dried before treatment. Excess hair around
the treatment area should be cut.
3
Shake well before use.
Dogs weighing less than 2 kg, apply 2 drops to the ear once a day.
Dogs weighing 2 - 15 kg, apply 4 drops to the ear once a day.
Dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Treatment should continue for 7 consecutive days.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to
penetrate the lower part of the ear canal.
Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to
dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after
adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test. Discontinuation of
treatment will result in a complete return to normal adrenal response.
Not applicable.
5.
Pharmacotherapeutic group: Otologic - Corticosteroids and anti-infectives in combination.
ATC vet code: QS02CA91
5.1 Pharmacodynamic properties
Orbifloxacin is a synthetic broad-spectrum bactericidal agent classified as a quinolone carboxylic acid
derivative, or more specifically, a fluoroquinolone. The bactericidal action of orbifloxacin results from
interference with the enzymes DNA topoisomerase II (DNA-gyrase) and DNA topoisomerase IV
which are needed for the synthesis and maintenance of bacterial DNA. Such impairment disrupts
replication of the bacterial cell, leading to rapid cell death. The rapidity and extent of killing are
directly proportional to the drug concentration. Orbifloxacin has
in vitro
activity against a wide range
of Gram-positive and Gram-negative organisms.
Mometasone furoate is a corticosteroid with high topical potency but little systemic effect. Like other
topical corticosteroids, it has anti-inflammatory and anti-pruritic properties.
Posaconazole is a broad-spectrum triazole antifungal agent. The mechanism by which posaconazole
exerts fungicidal action involves the selective inhibition of the enzyme lanosterol 14-demethylase
(CYP51) involved in ergosterol biosynthesis in yeasts and filamentous fungi. In in vitro tests,
posaconazole has shown fungicidal activity against most of the approximately 7,000 strains of yeast
and filamentous fungi tested. Posaconazole is 40 – 100 times more potent
in vitro
against
Malassezia
pachydermatis
than clotrimazole, miconazole and nystatin.
Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: Decrease of
the bacterial wall permeability, expression of efflux pump, or mutation of enzymes responsible for the
molecule’s binding site. Cross-resistance across the fluoroquinolone class of antibiotics is common.
Malassezia pachydermatis
resistance to azoles, including posaconazole, has not been reported.
The in vitro activity of orbifloxacin against pathogens isolated from clinical cases of canine otitis
externa in an EU field trial conducted in 2000 - 2001 was:
4
Minimum Inhibitory Concentrations vs. Orbifloxacin – Summary
Pathogen
N
Min
Max
MIC
50
MIC
90
E coli
10
0.06
0.5
0.125
0.5
Enterococci
19
0.250
16
4
8
Proteus mirabilis
9
0.5
8
1
8
Pseudomonas aeruginosa
18
1
> 16
4
8
Staphylococcus intermedius
96
0.25
2
0.5
1
Streptococcus
ß-
haemolyticus
G
19
2
4
2
4
5.2 Pharmacokinetic particulars
Systemic absorption of the active ingredients was determined in single-dose studies with [
14
C]-
orbifloxacin, [
3
H]-mometasone furoate and [
14
C]-posaconazole contained within the Posatex
formulation and placed into the ear canals of normal Beagle dogs. Most of the absorption occurred in
the first few days after administration. The extent of percutaneous absorption of topical medications is
determined by many factors including the integrity of the epidermal barrier. Inflammation can increase
the percutaneous absorption of veterinary medicinal products.
6.
6.1 List of excipients
Lauric acid
Paraffin, Liquid
Plasticised hydrocarbon gel (5% polyethylene in 95% mineral oil)
6.2 Incompatibilities
Not applicable.
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:
8.8 mL: 7 days
17.5 mL and 35.1 mL: 28 days
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Store in the original bottle and carton.
6.5 Nature and composition of immediate packaging
White HDPE bottle with a white LDPE cap, a natural or white LDPE applicator and a sheath.
Fill sizes: 8.8 mL (7.5 g), 17.5 mL (15 g) and 35.1 mL (30 g)
Not all pack sizes may be marketed.
5
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
7.
Intervet International BV
Wim de Körverstraat 35
5830 AN Boxmeer
The Netherlands
8.
EU/2/08/081/001 8.8 mL (corresponds to 7.5 g)
EU/2/08/081/002 17.5 mL (corresponds to 15 g)
EU/2/08/081/003 35.1 mL (corresponds to 30 g)
9.
23/06/2008
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
7
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Vet Pharma Friesoythe
Sedelsberger Straße 2
26169 Friesoythe
Germany
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Box 17.5 mL and 35.1 mL
1.
Posatex, ear drops suspension for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Orbifloxacin 8.5 mg/mL
Mometasone furoate (as monohydrate) 0.9 mg/mL
Posaconazole
0.9 mg/mL
3.
Ear drops suspension
4.
PACKAGE SIZE
17.5 mL
35.1 mL
5.
Dogs
6.
Treatment of acute external otitis, and acute exacerbations of recurrent external otitis.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For auricular use only.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
11
10. EXPIRY DATE
EXP {2 digits /year}
Once opened use within 28 days.
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
Store in the original bottle and carton.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Intervet International BV
Wim de Körverstraat 35
5830 AN Boxmeer
The Netherlands
EU/2/08/081/002 17.5 mL (corresponds to 15 g)
EU/2/08/081/003 35.1 mL (corresponds to 30 g)
17. MANUFACTURER’S BATCH NUMBER
<Batch> <Lot> <BN> {number}
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Box 8.8 mL
1.
Posatex, ear drops suspension for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Orbifloxacin 8.5 mg/mL
Mometasone furoate (as monohydrate) 0.9 mg/mL
Posaconazole
0.9 mg/mL
3.
PACKAGE SIZE
8.8 mL
4.
METHOD AND ROUTE(S) OF ADMINISTRATION
For auricular use only.
Read the package leaflet before use.
5.
EXPIRY DATE
EXP {2 digits /year}
Once opened use within 7 days.
6.
SPECIAL STORAGE CONDITIONS
Store in the original bottle and carton.
7.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
8.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
13
9.
Intervet International BV
Wim de Körverstraat 35
5830 AN Boxmeer
The Netherlands
EU/2/08/081/001 8.8 mL (corresponds to 7.5 g)
11. MANUFACTURER’S BATCH NUMBER
<Batch> <Lot> <BN> {number}
14
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle 17.5 mL and 35.1 mL
1.
Posatex, ear drops suspension for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Orbifloxacin 8.5 mg/mL
Mometasone furoate (as monohydrate) 0.9 mg/mL
Posaconazole
0.9 mg/mL
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
17.5 mL
35.1 mL
4.
BATCH NUMBER
Batch {number}
5.
EXPIRY DATE
EXP {2 digits/year}
Once opened use within 28 days.
6.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
15
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle 8.8 mL
1.
Posatex, ear drops suspension for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Orbifloxacin
Mometasone furoate (as monohydrate)
Posaconazole
3.
BATCH NUMBER
Batch {number}
4.
EXPIRY DATE
EXP {2 digits /year}
Once opened use within 7 days.
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET
Posatex, ear drops suspension dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Intervet International BV
Wim de Körverstraat 35
5830 AN Boxmeer
The Netherlands
Manufacturer for the batch release
:
Vet Pharma Friesoythe
Sedelsberger Straße 2
26169 Friesoythe
Germany
2.
Posatex, ear drops suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Orbifloxacin 8.5 mg/mL
Mometasone furoate (as monohydrate) 0.9 mg/mL
Posaconazole
0.9 mg/mL
4.
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with
bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular
Malassezia
pachydermatis.
5.
Do not use if the eardrum is perforated.
Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to
corticosteroids, to other azole antifungal agents or to other fluoroquinolones.
6.
Mild erythematous lesions have been observed.
The use of auricular preparations may be associated with hearing impairment, usually temporary, and
primarily in geriatric dogs.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
18
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Auricular use.
One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and 27 µg posaconazole.
Shake well before use.
With dogs weighing less than 2 kg, apply 2 drops to the ear once a day.
With dogs weighing 2-15 kg, apply 4 drops to the ear once a day.
With dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Treatment should continue for 7 consecutive days.
9.
ADVICE ON CORRECT ADMINISTRATION
The external ear canal should be meticulously cleaned and dried before treatment. Excess hair around
the treatment area should be cut.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to
penetrate the lower part of the ear canal.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date, which is stated on the label.
Shelf-life after first opening the bottle:
8.8 mL: Once opened use within 7 days.
17.5 and 35.1 mL: Once opened use within 28 days.
12. SPECIAL WARNING(S)
Bacterial and fungal otitis is often secondary in nature. The underlying cause should be identified and
treated.
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial
population. It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which
have responded poorly or are expected to respond poorly to other classes of antibiotics.
19
Use of the product should be based on susceptibility testing of isolated bacteria, and/or other
appropriate diagnostic tests.
Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other
forms of arthropathy in immature animals of various species. Therefore do not use in animals less than
4 months of age.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and
systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed
healing.
Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to
dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after
adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test. Discontinuation of
treatment will result in a complete return to normal adrenal response.
Before the veterinary medicinal product is applied, the external auditory canal must be examined
thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the
infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of
orbifloxacin. Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Studies to determine the effect of orbifloxacin on fertility in dogs have not been conducted.
Do not use in breeding animals.
Compatibility with ear cleaners has not been demonstrated. Concurrent use with an ear cleaner with a
high pH is not recommended.
Wash hands carefully after applying the veterinary medicinal product. Avoid skin contact. In case of
accidental exposure, rinse the affected area with copious quantities of water.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
/.
15. OTHER INFORMATION
Not all pack sizes may be marketed.
20
Source: European Medicines Agency
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