ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs
2.
Active substances:
Procox contains 0.9 mg/ml emodepside and 18 mg/ml toltrazuril.
Excipients:
0.9 mg/ml butylhydroxytoluene (E321; as antioxidant)
0.7 mg/ml sorbic acid (E200; as preservative)
For a full list of excipients, see section 6.1.
3.
Oral suspension.
White to yellowish suspension.
4.
Dogs.
For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following
species are suspected or demonstrated:
Roundworms (Nematodes)
:
-
Toxocara canis
(mature adult, immature adult, L4)
-
Uncinaria stenocephala
(mature adult)
-
Ancylostoma caninum
(mature adult)
Coccidia
:
-
Isospora ohioensis
complex
-
Isospora canis
Procox is effective against the replication of
Isospora
and also against the shedding of oocysts.
Although treatment will reduce the spread of infection, it will not be effective against the clinical signs
of infection in already infected animals.
Do not use in dogs/puppies which are under 2 weeks of age or weigh less than 0.4 kg.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
2
Procox is effective against the replication of coccidia and against the shedding of oocysts. Replication
of the parasite damages the dog’s intestinal mucosa, which may cause enteritis. Therefore, treatment
with Procox does not resolve clinical symptoms arising from mucosal damage (e.g., diarrhoea) that
have arisen before treatment. In such cases supportive treatment may be necessary.
Treatment against
Isospora
should aim to minimize the shedding of oocysts into the environment,
thereby reducing the risk for reinfection in groups/kennels with known and recurring
Isospora
infections.
A prevention strategy, including efforts to eliminate the infection, should be initiated. Treatment with
Procox is included as one of several measures necessary in such a strategy.
It is important that hygienic measures are implemented, in particular to ensure the environment is as
dry and clean as possible, in order to prevent reinfection from the environment.
Isospora
oocysts are
resistant to many disinfectants and can survive in the environment for extensive periods of time.
Prompt removal of faeces before oocyst sporulation (within 12 hours) reduces the likelihood of
transmission of infection. One administration of Procox to a litter/group is generally sufficient to
reduce the shedding of
Isospora
oocysts within it. In kennels with recurring outbreaks of clinical
disease due to
Isospora
infection, each litter should be treated for an extended period of time in order
to control, and gradually reduce, the level of infection. All dogs at risk of infection within the group
should be treated at the same time, including adult animals as they may be subclinically infected.
Diagnostic methods (faecal flotation) to determine the presence and level of oocyst shedding within
groups of animals could be useful at the end of a control program in order to monitor its success.
As with any parasiticide product, the frequent and long term use of anthelmintics or antiprotozoals
may lead to the development of resistance. An appropriate treatment regimen established by a
veterinarian will ensure adequate parasite control and reduce the likelihood of resistance developing.
Unnecessary use of the product should be avoided. Repeated treatment is indicated only if mixed
infection with coccidia and nematodes, as described in section 4.2, is still suspected or demonstrated.
Emodepside is a substrate for P-glycoprotein. Studies with emodepside indicate that the margin of
safety in certain dogs of Collie or related breeds may be less than in other breeds. The tolerance of
Procox in young puppies of these breeds has not been investigated, and the use of this veterinary
medicinal product is therefore not recommended in such dogs.
There is limited experience with severely debilitated dogs or dogs with seriously compromised kidney
or liver function. Therefore, the veterinary medicinal product should only be used in such animals
according to a benefit/risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Do not eat, drink or smoke while handling the veterinary medicinal product.
Wash hands after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into the eyes, they should be thoroughly flushed
with plenty of water.
In case of accidental ingestion, especially in the case of children, seek medical advice and show the
package leaflet or the label to the physician.
3
Slight and transient digestive tract disorders (e.g., vomiting or loose stools) may occur.
The safety of the veterinary medicinal product has not been investigated in pregnant dogs and lactating
dogs. Use in pregnant dogs and lactating dogs during the first two weeks of their lactation is therefore
not recommended.
Emodepside is a substrate for P-glycoprotein. Co-treatment with other drugs that are P-glycoprotein
substrates/inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones,
erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions.
The potential clinical consequences of such interactions have not been investigated.
Dosage and Treatment Schedule
The recommended minimum dose is 0.5 ml/kg bodyweight (bw), equivalent to 0.45 mg emodepside /
kg bw and 9 mg toltrazuril / kg bw.
Recommended dose volumes are given in the table below:
Weight [kg] Dose [ml]
0.4
0.2
> 0.4 – 0.6*
0.3
> 0.6 – 0.8
0.4
> 0.8 – 1.0
0.5
> 1.0 – 1.2
0.6
> 1.2 – 1.4
0.7
> 1.4 – 1.6
0.8
> 1.6 – 1.8
0.9
> 1.8 – 2.0
1.0
> 2.0 – 2.2
1.1
> 2.2 – 2.4
1.2
> 2.4 – 2.6
1.3
> 2.6 – 2.8
1.4
> 2.8 – 3.0
1.5
> 3.0 – 3.2
1.6
> 3.2 – 3.4
1.7
> 3.4 – 3.6
1.8
> 3.6 – 3.8
1.9
> 3.8 – 4.0
2.0
4
> 4 – 5
2.5
> 5 – 6
3.0
> 6 – 7
3.5
> 7 – 8
4.0
> 8 – 9
4.5
> 9 – 10
5.0
> 10 kg:
Continue with dose of
0.5 ml / kg bw
*
= more than 0.4 and up to 0.6 kg
One administration is generally sufficient to reduce the shedding of
Isospora
oocysts. Repeated
treatment is indicated only if mixed infection with coccidia and nematodes, as described in section 4.2,
continues to be suspected or demonstrated. Depending on the infection pressure in the environment,
treatment strategies should be tailored to each kennel. See also section 4.4.
Method of administration
For oral use in dogs from 2 weeks of age and weighing at least 0.4 kg.
Shake well before use.
Remove screw cap. Use a standard disposable syringe with Luer nozzle for each treatment. To ensure
precise dosing when treating dogs up to 4 kg, use a syringe with 0.1 ml graduations. For dogs
weighing more than 4 kg, a syringe with 0.5 ml graduations can be used. Place the syringe nozzle
firmly into the opening of the bottle. Then turn the bottle upside down, and withdraw the necessary
volume. Turn the bottle back into an upright position before removing the syringe. Replace screw cap
after use. Administer the suspension into the mouth of the dog.
Dispose of the syringe after treatment (as it is not possible to clean it).
The safety of the recommended dose has been demonstrated in puppies treated every two weeks, on up
to five occasions.
Slight and transient digestive tract disorders such as loose faeces and vomiting occurred occasionally
when the veterinary medicinal product was administered at repeated doses of up to five times the
recommended dose.
Not applicable.
5.
Pharmacotherapeutic group: antiparasitic product, ATCvet code: QP52AX60
5.1 Pharmacodynamic properties
Emodepside
is a semi-synthetic compound belonging to the chemical group of depsipeptides. It is
active against roundworms (ascarids, hookworms and whipworms). In this product, emodepside is
5
responsible for the efficacy against
Toxocara canis, Uncinaria stenocephala
and
Ancylostoma
caninum
.
It acts at the neuromuscular junction by stimulating presynaptic receptors belonging to the secretin
receptor family which results in paralysis and death of the parasites.
Toltrazuril is a triazinon derivative. It acts against coccidia of the genera
Eimeria
and
Isospora
. It is
acting against all intracellular development stages of coccidia of the merogony (asexual multiplication)
and gamogony (sexual phase). All stages are destroyed, thus the mode of action is coccidiocidal.
5.2 Pharmacokinetic particulars
After oral application in the rat, emodepside is distributed to all organs. Highest concentration levels
are found in the fat. Unchanged emodepside and hydroxylated derivatives are the major excretion
products.
In mammals toltrazuril is absorbed slowly after oral administration. The main metabolite is
characterised as toltrazuril sulfone.
Kinetics of oral suspension:
After treatment of one year old dogs with a dose of approximately 0.45 mg emodepside and 9 mg
toltrazuril per kg bodyweight, geometric mean maximum serum concentrations of 39 µg emodepside/l
and 17.28 mg toltrazuril/l were observed. Maximum concentrations of emodepside and toltrazuril were
reached 2 hours and 18 hours after treatment respectively. Emodepside was eliminated from the serum
with a half-life of 10 hours while the half life of toltrazuril was 138 hours.
6.
6.1 List of excipients
Butylhydroxytoluene (E321)
Sorbic acid (E200)
Sunflower oil
Glyceryl dibehenate
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: 10 weeks
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Amber glass bottle with a polyethylene Luer adapter and a tamper-proof polypropylene child resistant
closure containing 7.5 ml or 20 ml.
Not all pack sizes may be marketed.
6
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
products should be disposed of in accordance with local requirements. The product should not be allowed
to enter water courses as this may be dangerous for fish and other aquatic organisms.
7.
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
8.
EU/2/11/123/001-002
9.
20/04/2011
20/04/2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
7
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER 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
8
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
D-24106 Kiel
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.
9
ANNEX III
LABELLING AND PACKAGE LEAFLET
10
A. LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Outer Carton, 7.5 ml (or 20 ml) bottle
1.
Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
0.9 mg/ml emodepside + 18 mg/ml toltrazuril.
3.
Oral suspension
4.
PACKAGE SIZE
7.5 ml
20 ml
5.
For dogs
6.
For use against mixed infections of roundworms and coccidia.
For the complete indication, read the package leaflet.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Read the package leaflet before use.
Oral use.
8.
12
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once opened, use within 10 weeks.
11. SPECIAL STORAGE CONDITIONS
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read package leaflet.
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.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
EU/2/11/123/001 7.5 ml
EU/2/11/123/002 20 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle label, 7.5 (or 20ml) bottle
1.
Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
0.9 mg/ml emodepside + 18 mg/ml toltrazuril.
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
7.5 ml
20 ml
4.
ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use.
5.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once opened, use by…
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET for:
Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
Manufacturer for the batch release
:
KVP Pharma + Veterinär Produkte GmbH
Projensdorfer Str. 324
D-24106 Kiel
Germany
2.
Procox 0.9 mg/ml + 18 mg/ml oral suspension for dogs
Emodepside / Toltrazuril
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Active substances:
Procox contains 0.9 mg/ml emodepside and 18 mg/ml toltrazuril.
Excipients:
0.9 mg/ml butylhydroxytoluene (E321; as antioxidant)
0.7 mg/ml sorbic acid (E200; as preservative)
4.
INDICATIONS
For dogs, when mixed parasitic infections caused by roundworms and coccidia of the following
species are suspected or demonstrated:
Roundworms (Nematodes)
:
-
Toxocara canis
(mature adult, immature adult, L4)
-
Uncinaria stenocephala
(mature adult)
-
Ancylostoma caninum
(mature adult)
Coccidia
:
-
Isospora ohioensis
complex
-
Isospora canis
Treatment will reduce the spread of
Isospora
infection but will not be effective against symptoms in
already infected animals.
16
5.
Do not use in dogs/puppies which are under 2 weeks of age or weigh less than 0.4 kg.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
6.
Slight and transient digestive tract disorders (e.g., vomiting or loose stools) may occur.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform
your veterinary surgeon.
7.
Dogs.
8.
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
For oral use in dogs from 2 weeks of age and weighing at least 0.4 kg.
Shake well before use.
Dosage and Treatment Schedule
The recommended minimum dose is 0.5 ml/kg bodyweight (bw), equivalent to 0.45 mg emodepside /
kg bw and 9 mg toltrazuril / kg bw.
Recommended dose volumes are given in the table below:
Weight [kg] Dose [ml]
0.4
0.2
> 0.4 – 0.6*
0.3
> 0.6 – 0.8
0.4
> 0.8 – 1.0
0.5
> 1.0 – 1.2
0.6
> 1.2 – 1.4
0.7
> 1.4 – 1.6
0.8
> 1.6 – 1.8
0.9
> 1.8 – 2.0
1.0
> 2.0 – 2.2
1.1
> 2.2 – 2.4
1.2
> 2.4 – 2.6
1.3
> 2.6 – 2.8
1.4
> 2.8 – 3.0
1.5
> 3.0 – 3.2
1.6
> 3.2 – 3.4
1.7
> 3.4 – 3.6
1.8
> 3.6 – 3.8
1.9
17
> 3.8 – 4.0
2.0
> 4 – 5
2.5
> 5 – 6
3.0
> 6 – 7
3.5
> 7 – 8
4.0
> 8 – 9
4.5
> 9 – 10
5.0
> 10 kg:
Continue with dose of
0.5 ml / kg bw
*
= more than 0.4 and up to 0.6 kg
One treatment is generally sufficient to reduce the spread of
Isospora
infection. Repeated treatment is
indicated only if mixed infections with coccidia and roundworms continue to be suspected (by the
veterinarian) or demonstrated.
9.
ADVICE ON CORRECT ADMINISTRATION
1.
Shake well before use.
2.
Remove screw cap. Use a standard disposable syringe with Luer nozzle for each treatment. To
ensure precise dosing when treating dogs up to 4 kg, use a syringe with 0.1 ml graduations. For
dogs weighing more than 4 kg a syringe with 0.5 ml graduations can be used. Place the syringe
nozzle firmly into the opening of the bottle.
3.
Then turn the bottle upside down, and withdraw the necessary volume. Turn the bottle back into an
upright position before removing the syringe. Replace screw cap after use.
4.
Give Procox into the mouth of the dog. Dispose of the syringe after treatment (as it is not possible
to clean it).
1.
Shake well before
use.
2.
Place syringe nozzle
firmly into opening
of the bottle.
3.
Turn bottle upside
down and withdraw
necessary volume.
4.
Give Procox into the
dog's mouth.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not use after the expiry date (EXP) printed on the label and carton.
Shelf-life after first opening the bottle: 10 weeks.
This veterinary medicinal product does not require any special storage conditions.
18
12. SPECIAL WARNINGS
Treatment will prevent the spread of
Isospora
infection but will not be effective against symptoms
(e.g., diarrhoea) in already infected animals. Additional treatment (by a veterinarian) may be needed in
animals with diarrhoea.
It is important to take hygienic measures to ensure the environment is as dry and clean as possible, in
order to prevent reinfection from the environment.
Isospora
oocysts are resistant to many disinfectants and can survive in the environment for a long
time. The prompt removal of faeces (within 12 hours) reduces the risk of transmission of infection. All
dogs at risk of infection within the group should be treated at the same time.
The safety of the veterinary medicinal product has not been investigated in pregnant dogs and lactating
dogs. Use in pregnant dogs and lactating dogs during the first two weeks of lactation is therefore not
recommended.
There is limited experience with severely debilitated dogs or dogs with seriously compromised kidney
or liver function. Please tell your veterinary surgeon if your dog has any of these.
The tolerance of Procox in young puppies of Collie or related breeds has not been investigated,
therefore the use of this veterinary medicinal product is not recommended in such puppies.
As with any antiparasitic product, the frequent and long term use of anthelmintics or antiprotozoals
may lead to the development of resistance. An appropriate treatment regimen established by a
veterinarian will ensure adequate parasite control and reduce the likelihood of resistance developing.
To the user
:
Do not eat, drink or smoke while handling the veterinary medicinal product.
Wash hands after use.
In case of accidental spillage onto skin, wash off immediately with soap and water.
If the veterinary medicinal product accidentally gets into the eyes, they should be thoroughly flushed
with plenty of water.
In case of accidental ingestion, especially in the case of children, seek medical advice and show the
package leaflet or the label to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements. Medicines should not be disposed
of via wastewater. These measures should help to protect the environment. The product should not be
allowed to enter water courses as this may be dangerous for fish and other aquatic organisms.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
20/04/2011
19
15. OTHER INFORMATION
Procox oral suspension is supplied in two different pack sizes containing 7.5 or 20 ml.
Not all pack sizes may be marketed.
Other information for the veterinary surgeon:
Emodepside may interact with other drugs using the same drug transport system (e.g. macrocyclic
lactones). The potential clinical consequences of such interactions have not been investigated.
Slight and transient digestive tract disorders such as loose faeces and vomiting occurred occasionally
when the veterinary medicinal product was administered at repeated doses of up to five times the
recommended dose.
20
Source: European Medicines Agency
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