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Trocoxil

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Summary for the public


What is Trocoxil?

Trocoxil contains the active substance mavacoxib, which belongs to a class of medicines with anti-inflammatory action. It is available as triangular chewable tablets, in five different strengths (6, 20, 30, 75 and 95 mg).


What is Trocoxil used for?

Trocoxil is used for the treatment of pain and inflammation associated with degenerative joint disease (disease involving damage to the joints, such as osteoarthritis) in dogs at least one year of age. It is used when continuous treatment for more than one month is needed.

Trocoxil is given at a dose of 2 mg per kilogram body weight, immediately before or with the dog’s main meal. There should be a gap of two weeks between the first and second doses, after which it is given once a month. The dose and duration of treatment (maximum 6.5 months) will depend on the weight and type of animal and condition to be treated. For details, please see the Package Leaflet.


How does Trocoxil work?

The active substance in Trocoxil, mavacoxib, belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking an enzyme called cyclo-oxygenase-2 (COX-2). This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation. By blocking the production of prostaglandins, Trocoxil reduces the pain and inflammation caused by damage to the joints.


How has Trocoxil been studied?

Trocoxil has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“clinical studies”).

Trocoxil chewable tablets for dogs were studied in one main study in dogs with osteoarthritis. The medicine was compared with carprofen (another NSAID) for up to 6.5 months and long term effects of treatment were also studied. Dogs of both sexes and various breeds were included in the study. The results showed an improvement in lameness score in dogs with established osteoarthritis. The product was shown to be comparable to the reference product (carprofen).


What benefit has Trocoxil shown during the studies?

Trocoxil tablets for dogs improved pain relief and inflammation. Administration of the product in accordance with the recommended monthly dosing schedule for a period of up to 6.5 months resulted in an improvement in lameness and quality of life in dogs with established osteoarthritis, as assessed by the dogs’ owners. Compliance to treatment was better with Trocoxil, possibly because it is given once a month rather than every day.


What are the side-effects associated with Trocoxil?

The side effects of Trocoxil are similar to those seen with other medicines in this product class (NSAIDs) and include loss of appetite, soft faeces/diarrhoea, vomiting, apathy (lack of interest in surroundings) and signs of kidney problems. If a dog experiences these side effects, treatment should be stopped and general supportive therapy should be given as appropriate for NSAID overdose.

Trocoxil must not be used in dogs aged less than one year or weighing less than 5 kg. It must not be used in dogs with problems affecting the stomach or gut, including ulcers or bleeding, or in dogs that have signs of bleeding problems. It must not be used in dogs with kidney or liver problems, or inadequate blood flow to the heart muscle, or in dogs that are pregnant, breeding or lactating. It must also not be used in dogs that are hypersensitive (allergic) to mavacoxib, any of the other ingredients in the tablet or sulphonamides. It must not be used with glucocorticosteroids or other NSAIDs.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Ingestion of Trocoxil may be harmful for children. To avoid accidental ingestion, give the tablet to the dog immediately after it is removed from the blister packaging. People with a known allergy to NSAIDs should avoid contact with Trocoxil.

Do not eat, drink, or smoke when handling Trocoxil. Wash hands after handling the medicine. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.


Why has Trocoxil been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Trocoxil exceed the risks for the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated, and recommended that Trocoxil be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Trocoxil

The European Commission granted a marketing authorisation valid throughout the European Union, for Trocoxil to Pfizer Ltd on 09/09/2008. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: Trocoxil
EMEA Product number: EMEA/V/C/000132
Active substance: mavacoxib
INN or common name: Mavacoxib
Species: Dogs
ATCvet Code: QM01AH 92
Marketing Authorisation Holder: Pfizer Limited
Revision: 3
Date of issue of Market Authorisation valid throughout the European Union: 09/09/2008
Contact address:
Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom



Product Characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS


1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 6 mg chewable tablets for dogs
Trocoxil 20 mg chewable tablets for dogs
Trocoxil 30 mg chewable tablets for dogs
Trocoxil 75 mg chewable tablets for dogs
Trocoxil 95 mg chewable tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Mavacoxib
20 mg
Mavacoxib
30 mg
Mavacoxib
75 mg
Mavacoxib
95 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Chewable tablets
Triangular tablet with mottled brown appearance embossed with the tablet strength on one side and the
word “Pfizer” on the other.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs aged 12 months or more.
4.2 Indications for use, specifying the target species
For the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases
where continuous treatment exceeding one month is indicated.
4.3 Contraindications
Do not use in dogs less than 12 months of age and/or less than 5 kg body weight.
Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding.
Do not use where there is evidence of a haemorrhagic disorder.
Do not use in cases of impaired renal or hepatic function.
Do not use in cases of cardiac insufficiency.
Do not use in pregnant, breeding or lactating animals.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in case of known hypersensitivity to sulphonamides.
Do not use concomitantly with glucocorticoids or other NSAIDs (see section 4.8).
4.4 Special warnings
Do not administer other NSAIDs within 1 month of the last administration of Trocoxil.
2/33
Mavacoxib
6 mg
4.5 Special precautions for use
Special precautions for use in animals
Mavacoxib exhibits an extended plasma half life (up to > 80 days, see Section 5.2) due to its low rate of
elimination. This corresponds to duration of effect of 1-2 months after administration of the second dose
(and following doses). Care should be taken to avoid treatment of animals that might not tolerate
prolonged NSAID exposure. A maximum treatment administration of 6.5 months continuous therapy is
recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination.
Animals should undergo a thorough clinical examination before commencing treatment with Trocoxil.
Animals with evidence of impaired renal or hepatic function, or with evidence of a protein or blood losing
enteropathy are not suitable for treatment with Trocoxil. It is recommended to repeat the clinical
examination one month after commencing treatment with Trocoxil and prior to administration of the third
dose.
Mavacoxib is excreted via bile and in dogs with hepatic disorders reduced elimination and thus excessive
accumulation could occur. For this reason dogs with hepatic disorders should not be treated.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased
renal toxicity. Concurrent administration of potentially nephrotoxic medicinal products should be avoided.
Ensure appropriate hydration and haemodynamic status when animals receiving Trocoxil undergo
anaesthesia and/or surgical procedures or develop conditions which may result in dehydration or
compromised haemodynamic status. The key aim of intervention is to maintain renal perfusion. (See also
section 4.6)
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
In case of accidental self-administration, seek medical advice immediately and show the package
leaflet or the label to the physician.
Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to
e.g. gastrointestinal disorders may be observed. To avoid accidental ingestion administer the tablet to
the dog immediately after removal from the blister packaging.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
Do not eat, drink, or smoke when handling the product. Wash hands after handling the product.
4.6 Adverse reactions (frequency and seriousness)
Adverse reactions of NSAIDs such as loss of appetite, diarrhoea, vomiting, apathy and degradation of
renal biochemistry parameters and impaired renal function have occasionally been reported. In rare
cases these may be fatal.
If an adverse reaction to the administration of Trocoxil occurs, no further tablets should be
administered and general supportive therapy, as applied to clinical overdosage with NSAIDs, should be
applied. Particular attention should be paid to maintaining haemodynamic status. Veterinarians should be
aware that clinical signs of adverse reactions may continue when supportive therapy (such as gastro
protectants) is discontinued.
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant, breeding, or lactating animals. The safety of Trocoxil has not been established
during pregnancy and lactation. However, studies in laboratory animals administered other NSAIDs
have shown increased pre- and post-implantation loss, embryo-foetal lethality, and malformations.
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4.8 Interaction with other medicinal products and other forms of interaction
No drug interaction studies have been performed. In common with other NSAIDs, Trocoxil should not be
administered simultaneously with other NSAIDs or glucocorticosteroids. Risks for interactions have to be
accounted for throughout the effect period i.e. 1-2 months after administration of Trocoxil. Dogs should
be carefully monitored if Trocoxil is administered simultaneously with an anticoagulant.
NSAIDs are highly bound to plasma proteins and may compete with other highly bound substances, such
that concomitant administration may result in toxic effects.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse
effects. To avoid such effects when Trocoxil is to be administered in replacement of another NSAID,
ensure an appropriate treatment-free period of at least 24 hours before administering the first dose of
Trocoxil. The treatment-free period should however, take into account the pharmacology of the medicinal
products used previously. Should another NSAID be administered after Trocoxil treatment, a
treatment-free period of at least ONE MONTH should be ensured to avoid adverse effects.
4.9 Amounts to be administered and administration route
Oral use.
THIS IS NOT A DAILY NSAID. The dose is 2 mg mavacoxib per kg body weight given immediately
before or with the dog’s main meal. Care should be taken to ensure that the tablet is ingested. The
treatment should be repeated 14 days later, thereafter the dosing interval is ONE MONTH. A treatment
cycle should not exceed 7 consecutive doses (6.5 months).
Bodyweight
(kg)
Number and Strength of Tablets to be Administered
6 mg
20 mg 30 mg 75 mg 95 mg
5-6
2
7-10
1
11-15
1
16-20
2
21-23
1
1
24-30
2
31-37
1
38-47
1
48-52
1
1
53-62
1
1
63-75
2
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In the overdose studies, in common with other NSAIDs, adverse pharmacodynamic events occur affecting
the gastrointestinal system. Similarly adverse reactions occurring at the use dose in the animal population
principally involved the gastrointestinal system.
In overdose safety studies, repeated doses of 5 mg/kg and 10 mg/kg were not associated with adverse
clinical events, abnormal clinical chemistry or significant histological abnormalities. At 15 mg/kg there
was evidence of vomiting, and softened/mucoid faeces and an increase in clinical chemistry parameters
reflecting renal function. At 25 mg/kg there was evidence of gastrointestinal ulceration.
4/33
 
There is no specific antidote for mavacoxib overdosage, but general supportive therapy, as applied to
clinical overdosage with NSAID’s, should be given.
4.11 Withdrawal period
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, Coxibs.
ATCvet code: QM01AH92.
5.1 Pharmacodynamic properties
Mavacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. Mavacoxib is
4-[5-(4-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide. It is a
diarylsubstituted pyrazole. The principal mode of action is inhibition of cyclooxygenase (COX).
COX is a key enzyme in pathways of arachidonic acid metabolism. Its activity culminates in the
synthesis of local hormones and inflammatory mediators, termed eicosanoids, which include several
prostaglandins. There are two isoforms of COX, COX-1 and COX-2. COX-1 is a widely distributed
constitutive enzyme, primarily involved in maintaining organ and tissue function, whilst COX-2 is
inducible at sites of tissue damage but in some organs it is also constitutive. COX-2 exerts the major
role in synthesising prostaglandins which have pivotal roles as mediators of pain, inflammation and
fever. Mavacoxib acts by preferential inhibition of COX-2-mediated prostaglandin synthesis. It
therefore possesses analgesic and anti-inflammatory properties. The products of COX-2 metabolism
are also involved in ovulation, implantation and closure of the ductus arteriosus . Both COX-1 and
COX-2 are present constitutively in the kidney and are assumed to possess protective roles in adverse
physiological circumstances.
Based on the results of canine whole blood assays, plasma concentrations producing 20 % COX-1
inhibition and 80 % COX-2 inhibition were 2.46 µg/mL and 1.28 µg/mL, respectively, so that the
IC 20 COX-1:IC 80 COX-2 potency ratio is approximately 2:1, whilst the IC 80 COX-1:IC 80 COX-2 potency
ratio is approximately 40:1. These IC concentrations may be compared with mean trough
concentrations of mavacoxib in plasma in clinical subjects of 0.52 and 1.11 µg/mL, respectively, after
the first and fifth doses. Therefore, clinical doses are predicted to produce low level inhibition of
COX-1 and high level inhibition of COX-2.
5.2 Pharmacokinetic particulars
Mavacoxib is well absorbed after oral administration; bioavailability was 87 % in fed dogs and 46 %
in fasted conditions and the recommended dose is based on administration with food. Therapeutic
concentrations in fed dogs are reached rapidly and peak concentrations are obtained in less than 24
hours after administering a dose. Mavacoxib is approximately 98 % bound to plasma proteins. It is
extensively distributed throughout the body and almost all the mavacoxib-related residues in plasma
comprise parent drug. The rate of body clearance of mavacoxib is slow and the major route of
elimination is by biliary excretion of the parent drug.
Multiple-dose pharmacokinetic studies provided no evidence that mavacoxib produces autoinhibition
or autoinductive changes in its clearance, and it exhibits linear pharmacokinetics with oral doses
ranging from 2 to 50 mg/kg. In laboratory studies with young adult dogs, mean elimination half-life
values ranged from 13.8 to 19.3 days. Mavacoxib possessed a longer elimination half-life in client-
owned animals. Population pharmacokinetic data derived from studies in dogs with a predominately
older population with heavier dogs as compared to the experimental studies (mean 9 years of age)
showed that the mean elimination half-life was 39 days with a small sub-population (<5 %) having a
5/33
elimination half-life of more than 80 days and correspondingly an increased exposure was recorded in
these individuals. The reason for this longer half-life is unknown. Steady state pharmacokinetics was
attained by the fourth treatment in most animals.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Silicified microcrystalline cellulose
Artificial powdered beef flavour
Croscarmellose sodium
Sodium lauryl sulfate
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
The veterinary medicinal product does not require any special storage conditions.
Store in the original package.
6.5 Nature and composition of immediate packaging
Carton boxes containing one blister. Each blister contains two tablets of 6 mg, 20 mg, 30 mg, 75 mg or
95 mg mavacoxib, respectively.
-Blister foil base: PVC film /aluminium foil/ nylon
-Blister backing: vinyl heat seal coating /aluminium foil/polyester film/printable paper
Not all pack sizes may be marketed.
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.
7. MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/08/084/001 6 mg
6/33
EU/2/08/084/002 20 mg
EU/2/08/084/003 30 mg
EU/2/08/084/004 75 mg
EU/2/08/084/005 95 mg
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/09/2008
10. DATE OF REVISION OF THE TEXT
03/12/2010
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.
7/33
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
8/33
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) responsible for batch release
Pfizer (Heinrich Mack Nachf)
Heinrich-Mack-Str. 35, Illertissen
Germany
Alternate site
Pfizer Italia s.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
Italy
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
Risk Management Plan
Pfizer Ltd commits to performing the studies and additional pharmacovigilance activities detailed in
version 1 of the Risk Management Plan (RMP) presented in the Marketing Authorisation and any
subsequent updates of the RMP agreed by the CVMP.
The updated RMP should be submitted at the same time as the next Periodic Safety Update Report
(PSUR) or at the request of EMA.
D. STATEMENT OF THE MRLs
Not applicable.
9/33
 
ANNEX III
LABELLING AND PACKAGE LEAFLET
10/33
A. LABELLING
11/33
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 6 mg chewable tablets for dogs
Mavacoxib
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 tablet contains 6 mg of mavacoxib.
3. PHARMACEUTICAL FORM
Chewable tablets
4. PACKAGE SIZE
2 tablets
5. TARGET SPECIES
Dogs
6. INDICATION(S)
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
9. SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
12/33
 
11. SPECIAL STORAGE CONDITIONS
Store in the original package.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of 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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/08/084/001
17. MANUFACTURER’S BATCH NUMBER
Lot
13/33
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 20 mg chewable tablets for dogs
Mavacoxib
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 tablet contains 20 mg of mavacoxib.
3. PHARMACEUTICAL FORM
Chewable tablets
4. PACKAGE SIZE
2 tablets
5. TARGET SPECIES
Dogs
6. INDICATION(S)
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
9. SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
14/33
 
11. SPECIAL STORAGE CONDITIONS
Store in the original package.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of 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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/08/084/002
17. MANUFACTURER’S BATCH NUMBER
Lot
15/33
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 30 mg chewable tablets for dogs
Mavacoxib
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 tablet contains 30 mg of mavacoxib.
3. PHARMACEUTICAL FORM
Chewable tablets
4. PACKAGE SIZE
2 tablets
5. TARGET SPECIES
Dogs
6. INDICATION(S)
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
9. SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
16/33
 
11. SPECIAL STORAGE CONDITIONS
Store in the original package.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of 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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/08/084/003
17. MANUFACTURER’S BATCH NUMBER
Lot
17/33
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 75 mg chewable tablets for dogs
Mavacoxib
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 tablet contains 75 mg of mavacoxib.
3. PHARMACEUTICAL FORM
Chewable tablets
4. PACKAGE SIZE
2 tablets
5. TARGET SPECIES
Dogs
6. INDICATION(S)
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
9. SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
18/33
 
11. SPECIAL STORAGE CONDITIONS
Store in the original package
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of 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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/08/084/004
17. MANUFACTURER’S BATCH NUMBER
Lot
19/33
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 95 mg chewable tablets for dogs
Mavacoxib
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 tablet contains 95 mg of mavacoxib.
3. PHARMACEUTICAL FORM
Chewable tablets
4. PACKAGE SIZE
2 tablets
5. TARGET SPECIES
Dogs
6. INDICATION(S)
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
9. SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
20/33
 
11. SPECIAL STORAGE CONDITIONS
Store in the original package.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of 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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/08/084/005
17. MANUFACTURER’S BATCH NUMBER
Lot
21/33
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 6 mg chewable tablets for dogs
Mavacoxib
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer
3. EXPIRY DATE
<EXP {month/year}>
4. BATCH NUMBER
Lot
5. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
22/33
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 20 mg chewable tablets for dogs
Mavacoxib
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer
3. EXPIRY DATE
<EXP {month/year}>
4. BATCH NUMBER
Lot
5. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
23/33
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 30 mg chewable tablets for dogs
Mavacoxib
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer
3. EXPIRY DATE
<EXP {month/year}>
4. BATCH NUMBER
Lot
5. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
24/33
 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 75 mg chewable tablets for dogs
Mavacoxib
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer
3. EXPIRY DATE
<EXP {month/year}>
4. BATCH NUMBER
Lot
5. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 95 mg chewable tablets for dogs
Mavacoxib
2. NAME OF THE MARKETING AUTHORISATION HOLDER
Pfizer
3. EXPIRY DATE
<EXP {month/year}>
4. BATCH NUMBER
Lot
5. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
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B. PACKAGE LEAFLET
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PACKAGE LEAFLET
Trocoxil 6 mg chewable tablets for dogs
Trocoxil 20 mg chewable tablets for dogs
Trocoxil 30 mg chewable tablets for dogs
Trocoxil 75 mg chewable tablets for dogs
Trocoxil 95 mg chewable tablets for dogs
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer for the batch release:
Pfizer (Heinrich Mack Nachf)
Heinrich-Mack-Str. 35, Illertissen
Germany
Alternate site
Pfizer Italia s.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
Italy
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Trocoxil 6 mg chewable tablets for dogs
Trocoxil 20 mg chewable tablets for dogs
Trocoxil 30 mg chewable tablets for dogs
Trocoxil 75 mg chewable tablets for dogs
Trocoxil 95 mg chewable tablets for dogs
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
Mavacoxib
6 mg
Mavacoxib
20 mg
Mavacoxib
30 mg
Mavacoxib
95 mg
Tablets also contain the following ingredients:
Sucrose
Silicified microcrystalline cellulose
Artificial powdered beef flavour
Croscarmellose sodium
Sodium lauryl sulfate
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Mavacoxib
75 mg
 
Magnesium stearate.
Triangular tablet with mottled brown appearance embossed with the tablet strength on one side and the
word “Pfizer” on the other.
4. INDICATION(S)
Trocoxil chewable tablets are indicated for the treatment of pain and inflammation associated with
degenerative joint disease in dogs where treatment for more than one month is needed.
Trocoxil belongs to a group of medicines called Non-steroidal Anti-inflammatory drugs (NSAIDs)
which are used to treat pain and inflammation.
5. CONTRAINDICATIONS
Do not use in dogs less than 12 months of age and/or less than 5 kg body weight.
Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding.
Do not use where there is evidence of a haemorrhagic disorder.
Do not use in cases of impaired kidney or liver function.
Do not use in cases of heart insufficiency.
Do not use in pregnant, breeding or lactating animals.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in case of known hypersensitivity to sulphonamides.
Do not use concomitantly with glucocorticoids or other NSAIDs.
6. ADVERSE REACTIONS
Typical adverse drug reactions of NSAIDs such as loss of appetite, diarrhoea, vomiting, apathy and a
change in kidney biochemistry parameters and impaired kidney function have occasionally been
reported. In rare cases these may be fatal. If these reactions occur, stop using the product and contact
your veterinarian. Note that Trocoxil has an extended effect of duration (up to 2 months after
administration of the second dose and following doses). Adverse reactions could occur at any time
point during this period.
If you notice any serious effects or other effect not mentioned in this leaflet, please inform your
veterinary surgeon.
7. TARGET SPECIES
Dogs aged 12 months or more.
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
Use the dose prescribed by the veterinarian. The dose of Trocoxil chewable tablets is 2 mg/kg of body
weight (see table below).
THIS IS NOT A DAILY TREATMENT.
The initial treatment should be repeated 14 days later, thereafter the dosing interval is one month. A
treatment cycle with Trocoxil should not exceed 7 consecutive doses (6.5 months).
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Bodyweight
(kg)
Number and Strength of Tablets to be Administered
6 mg
20 mg 30 mg 75 mg 95 mg
5-6
2
7-10
1
11-15
1
16-20
2
21-23
1
1
24-30
2
31-37
1
38-47
1
48-52
1
1
53-62
1
1
63-75
2
9. ADVICE ON CORRECT ADMINISTRATION
Trocoxil should be given immediately before or during the animal’s main meal.
Care should be taken to ensure that the tablet is ingested.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
The veterinary medicinal product does not require any special storage conditions.
Store in the original package.
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton and blister after Exp.
12. SPECIAL WARNING(S)
Advice for dog owner
Before prescribing Trocoxil and during treatment with Trocoxil, your veterinarian will check your dog
for kidney and liver problems as well as for diseases of the intestines.
Trocoxil should not be used in dehydrated dogs.
If your dog needs surgery, inform the surgeon that the dog is using Trocoxil.
Do not administer other NSAIDs or glucocorticoids concurrently or within at least 1 month of the last
administration of Trocoxil.
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Trocoxil has extended effect duration (up to 2 months after administration of the second dose and
following doses). Adverse reactions could occur at any time point during this period.
If an adverse reaction to the administration of Trocoxil occurs, stop using the product, and seek
medical advice from your veterinarian immediately.
Trocoxil must not be used in pregnant, breeding or lactating animals.
Tell your veterinarian if your dog is using a blood-thinning agent.
Do not exceed the stated dose prescribed by your veterinarian.
In case of accidental self-administration, seek medical advice immediately and show the package
leaflet or the label to the physician.
If you have a known hypersensitivity to NSAIDs you should avoid contact with the veterinary
medicinal product.
Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to
e.g. gastrointestinal disorders may be observed. To avoid accidental ingestion administer the tablet to
the dog immediately after removal from the blister packaging.
Do not eat, drink, or smoke when handling the product. Wash hands after handling the product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
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
03/12/2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
Blister packs containing two tablets of the same strength per pack, each tablet containing 6 mg, 20 mg,
30 mg, 75 mg or 95 mg of mavacoxib.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
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België/Belgique/Belgien
Pfizer Animal Health s.a.,
Tél.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a.,
Tél.: + 32 (0)2 554 62 11
Република България
Pfizer Luxembourg SARL
Tel: + 359 2 970 43 21
Magyarország
Pfizer Kft.
Tel: +361 488 3695
Česká republika
Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited
Tel: +356 21 465 797
Danmark
Pfizer Oy Animal Health
Tlf: +358 (0)9 4300 40
Nederland
Pfizer Animal Health B.V.,
Tel: +31 (0)10 4064 600
Deutschland
Pfizer GmbH
Tel: +49 30-5500 5501
Norge
Pfizer Oy Animal Health
Tlf: +358 (0)9 4300 40
Eesti
Pfizer Animal Health
Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Polska
Pfizer Trading Polska Sp. z.o.o.
Tel: +48 22 335 61 00
España
Pfizer S.A.
Tel: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 55 00
France
Pfizer
Tél: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as:
Pfizer Animal Health
Tel: +353 (0) 1 467 6500
Slovenija
Pfizer Luxembourg SARL
Tel: +386 (0) 1 52 11 670
Ìsland
Pfizer Oy Animal Health
Tel: +358 (0)9 4300 40
Slovenská republika
Pfizer Luxembourg SARL o.z.
Tel: + 421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Suomi/Finland
Pfizer Oy Animal Health,
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Sverige
Pfizer Oy Animal Health
Tel: +358 (0)9 4300 40
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Latvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel.: +370 5 269 17 96
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Source: European Medicines Agency



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