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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



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1. NAME OF VETERINARY THE 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.
    3/33
    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 VETERINARY THE 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 VETERINARY THE 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 VETERINARY THE 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 VETERINARY THE 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 VETERINARY THE 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 VETERINARY THE 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 VETERINARY THE 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 VETERINARY THE 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 VETERINARY THE 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.
    25/33
     
    MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
    Blister
    1. NAME OF VETERINARY THE 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.
    26/33
     
    B. PACKAGE LEAFLET
    27/33
    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 VETERINARY THE 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
    28/33
    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).
    29/33
    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.
    30/33
     
    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.
    31/33
    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
    32/33
    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
    33/33


    Source: European Medicines Agency


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