Open menu Close menu Open Search Close search

AMERICAN DRUGS | ANATOMY | HEALTH TOPICS | HIV/AIDS GLOSSARY | DISEASES | HEALTH ARTICLES | GENOME | OCCUPATIONS

Zubrin

Spanish Simplified Chinese French German Russian Hindi Arabic Portuguese















Summary for the public


What is Zubrin?

Zubrin is an oral lyophilisate, i.e. a kind of tablet that will quickly disintegrate upon contact with moisture e.g. when placed on your dog’s tongue. Zubrin contains the active substance tepoxalin.


What is Zubrin used for?

Zubrin is used in dogs to reduce inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.

Zubrin is given to the dog once a day within 1-2 hours after feeding until the dog gets better. However, since side effects might occur, any treatment exceeding 1 – 2 weeks should be under regular veterinary supervision.


How does Zubrin work?

Zubrin contains tepoxalin, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). Zubrin acts by blocking enzymes, cyclooxygenase-1 and cyclooxygenase-2. When these enzymes are blocked, less prostaglandin is produced. As the prostaglandins are substances that trigger inflammation, tepoxalin reduces the inflammation and the swelling of muscles or joints and the pain associated with this.


How has the effectiveness of Zubrin been studied?

Zubrin has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices/clinics in the USA and in a number of countries in Europe (“clinical studies”). In these clinical studies, the animal owners gave Zubrin to their dogs, once daily at a dose of 10 mg per kg dog’s bodyweight with or without food. The best results were achieved when Zubrin was adminstered 1-2 hours after feeding. The animals were treated until they got better; however, since side effects might occur, any treatment exceeding 1 – 2 weeks should be under regular veterinary supervision. Zubrin was as effective as other medicines of the same class and showed significant improvement in dogs with muscle or joint disease.


What are the side effects of Zubrin?

The side effects of Zubrin are those seen with other NSAIDs, such as vomiting, soft faeces or diarrhoea, blood in faeces, reduced appetite and tiredness. Vomiting or diarrhoea has been observed in one out of 10 dogs. In rare cases, particularly in older or in sensitive dogs, these effects may become very serious. Occasionally, loss of hair or red patches on the skin might occurr.

When such undesirable effects are seen in the dog, you should discontinue giving Zubrin to your dog. Also, before you start using Zubrin, inform the veterinarian if your dog receives any other medication since some medicines might influence each other’s effectiveness.


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

Zubrin has a special pharmaceutical form (lyophilisate) that will quickly dissolve upon contact with moisture and might get very slippery or sticky when kept in your fingers. Therefore, you should make sure to administer the medicine with dry hands. If the lyophilisate disintegrates prematurely in your hands, wash your hands thoroughly.

Zubrin should be placed directly into the dog’s mouth and you should try to keep the mouth of the dog closed for a short while.

Zubrin should not be used in people. However, if a number of tablets are accidentially consumed by a person, the advice of a doctor should be sought immediately.


Why has Zubrin been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Zubrin are greater than any risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Zubrin should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Zubrin

The European Commission granted a marketing authorisation valid throughout the European Union, for Zubrin to S-P Veterinary on 13 March 2001. Information on the prescription status of this product may be found on the label of the carton.

Authorisation details
Name: Zubrin
EMEA Product number: EMEA/V/C/000057
Active substance: tepoxalin
INN or common name: tepoxalin
Species: Dogs
ATCvet Code: QM01AE92
Marketing Authorisation Holder: Intervet International B. V.
Revision: 13
Date of issue of Market Authorisation valid throughout the European Union: 13/03/2001
Contact address:
Intervet International B. V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands



  • Drugs Alphabetically





    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Zubrin 50 mg oral lyophilisates for dogs
    Zubrin 100 mg oral lyophilisates for dogs
    Zubrin 200 mg oral lyophilisates for dogs
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance
    Tepoxalin
    50 mg / oral lyophilisate
    Tepoxalin
    100 mg / oral lyophilisate
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Oral lyophilisates
    4.
    CLINICAL PARTICULARS
    4.1 Target species
    Dogs
    4.2 Indications for use
    Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
    4.3 Contraindications
    Do not use in pregnant or lactating dogs or in bitches intended for breeding.
    Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history
    of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product.
    Do not use in dehydrated, hypovolaemic or hypotensive dogs, as there is an increased risk of renal
    toxicity.
    4.4 Special warnings
    Special care should be taken when treating dogs with marked renal insufficiency.
    4.5 Special precautions for use
    Special precautions for use in animals
    Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve
    additional risk. If such use cannot be avoided, close veterinary supervision to monitor for
    gastrointestinal blood loss is necessary.
    If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should
    be sought.
    The recommended dose should not be exceeded.
    2
    Tepoxalin
    200 mg / oral lyophilisate
    Special precautions to be taken by the person administering the medicinal product to animals
    Tepoxalin is not water-soluble and becomes very sticky upon wetting. If the oral lyophilisate
    disintegrates prematurely, wash hands thoroughly.
    In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be
    sought immediately.
    4.6 Adverse reactions (frequency and seriousness)
    Vomiting or diarrhoea may occur due to treatment. Alopecia and erythema may also occur
    occasionally.
    Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in
    faeces, reduced appetite, lethargy and renal disorders. If there are such undesirable effects, treatment
    should be discontinued immediately. In rare cases, particularly in older or in sensitive dogs, these
    undesirable effects may be serious or fatal.
    During clinical trial testing of the product, the incidence of gastrointestinal reactions
    (diarrhoea/vomiting) was 10%.
    4.7 Use during pregnancy, lactation or lay
    Do not use in pregnant or lactating bitches.
    4.8 Interaction with other medicinal products and other forms of interaction
    Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Other
    NSAIDs, diuretics, anticoagulants and substances with high plasma protein binding may compete for
    binding leading to potentially toxic effects.
    4.9 Amounts to be administered and administration route
    10 mg tepoxalin per kg bodyweight once daily. The duration of treatment is dependent on
    clinical response. After a treatment period of 7-10 days, the condition of the dog should be re-
    evaluated in order to establish the need for continuation of treatment. Long term treatment should be
    under regular veterinary supervision.
    The weight of the animal should be accurately determined before start of treatment.
    Peel back foil to reveal a single oral lyophilisate in the form of a round tablet. Ensure hands are dry to
    prevent the tablet from sticking to fingers. Push the bottom of the blister and the tablet will pop out.
    Place the tablet in the dog’s mouth. The tablet will disintegrate upon contact with moisture. Keep the
    mouth of the dog closed for a few seconds to ensure complete tablet wetting. Administer to dogs
    within 1-2 hours after feeding. When this is not possible, or when dogs resist having the product
    placed directly into the mouth, put the tablet immediately before administration into a small amount of
    moistened food, or in a moist treat. Ensure the food or treat containing the medication is completely
    consumed.
    4.10 Overdose (symptoms, emergency procedures, antidotes)
    At doses of 30 mg/kg and above, oral administration of tepoxalin is associated with discoloured faeces
    ranging in colour from white to yellow, which is the result of unabsorbed drug.
    NSAID overdosage is characterised by vomiting, soft faeces/diarrhoea, blood in faeces, reduced
    appetite and lethargy. In the case of overdosage discontinue therapy. If gastrointestinal bleeding is
    suspected, administer gastric protectants. If vomiting continues, administer anti-emetics. Monitor the
    hematocrit frequently. Maintain the animal on intravenous fluids and, if necessary, administer whole
    blood.
    4.11 Withdrawalperiod
    Not applicable
    3
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Anti-inflammatory Products, Non Steroids
    ATCvet code: QM01AE92
    5.1 Pharmacodynamic properties
    Tepoxalin is a dual cyclooxygenase / 5-lipoxygenase inhibitor with anti-inflammatory activity.
    Oral administration of 10 mg tepoxalin / kg bodyweight results in inhibition of prostaglandin and
    leukotriene synthesis.
    5.2 Pharmacokinetic properties
    Tepoxalin is rapidly (T max of approximately 2 hours) absorbed after oral administration in dogs. At a
    therapeutic dose of 10 mg/kg, the C max of tepoxalin was 1.08 ± 0.37 μg/ml in dogs fed a low fat meal
    and 1.19 ± 0.29 μg/ml in dogs fed a high fat meal. Absorption of tepoxalin is facilitated via
    administration to dogs in a fed state. Tepoxalin is extensively converted to its acid metabolite. The
    acid metabolite is a potent, active cyclooxygenase inhibitor and prolongs the activity of the parent
    compound. Plasma concentrations of the acid metabolite are higher than those of the parent compound
    in the dog. No accumulation of tepoxalin or its acid metabolite was detected after multiple dosing over
    a broad dose range. Tepoxalin and its metabolites are highly protein-bound, more than 98%. Tepoxalin
    and its metabolites are excreted in the faeces (99%).
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Gelatin
    Mannitol
    6.2 Incompatibilities
    Not applicable
    6.3 Shelf life
    3 years
    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
    Zubrin oral lyophilisates are supplied in boxes with foil blisters. Each blister contains 10 oral
    lyophilisates.
    The oral lyophilisates are available in the following pack sizes:
    50 mg, 100 mg:
    1 box containing 1, 3 or 6 blisters.
    Not all pack sizes may be marketed.
    4
    200 mg:
    1 box containing 1 or 3 blisters.
    6.6 Special precautions for the disposal of unused veterinary medicinal products 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 the local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    Intervet International B. V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/028/002-008
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    13 March 2001
    10. DATE OF REVISION OF THE TEXT
    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
    5
    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
    6
    A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer responsible for batch release
    S-P Veterinary Ltd
    Breakspear Road South
    Harefield
    Uxbridge UB9 6LS
    United Kingdom
    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
    7
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    8
    A. LABELLING
    9
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    {50 mg oral lyophilisate}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Zubrin 50 mg oral lyophilisates for dogs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Tepoxalin
    50 mg / oral lyophilisate
    3.
    PHARMACEUTICAL FORM
    Oral lyophilisates
    4.
    PACKAGE SIZE
    10 oral lyophilisates (EU/2/00/028/002)
    30 oral lyophilisates (EU/2/00/028/003)
    5.
    TARGET SPECIES
    Dogs
    6.
    INDICATION(S)
    Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    10 mg/kg of body weight once daily.
    The duration of treatment is dependent on clinical response. After a treatment period of 7-10 days, the
    condition of the dog should be re-evaluated in order to establish the need for continuation of treatment.
    Long term treatment should be under regular veterinary supervision.
    The weight of the animal should be accurately determined before start of treatment.
    Administer to dogs within 1-2 hours after feeding. When this is not possible, or when dogs resist
    having the product placed directly into the mouth, put the tablet immediately before administration
    into a small amount of moistened food, or in a moist treat. Ensure the food or treat containing the
    medication is completely consumed.
    Read the package leaflet before use.
    10
     
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
    Do not use in pregnant or lactating dogs or in bitches intended for breeding.
    The recommended dose should not be exceeded.
    If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should
    be sought.
    9.
    EXPIRY DATE
    EXP {month/year}
    10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with the local requirements.
    11. 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.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Marketing Authorisation Holder
    Intervet International B. V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/028/002 (1 blister)
    EU/2/00/028/003 (3 blisters)
    15. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    11
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    {100 mg oral lyophilisate}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Zubrin 100 mg oral lyophilisates for dogs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Tepoxalin
    100 mg / oral lyophilisate
    3.
    PHARMACEUTICAL FORM
    Oral lyophilisates
    4.
    PACKAGE SIZE
    10 oral lyophilisates (EU/2/00/028/004)
    30 oral lyophilisates (EU/2/00/028/005)
    5.
    TARGET SPECIES
    Dogs
    6.
    INDICATION(S)
    Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    10 mg/kg of body weight once daily.
    The duration of treatment is dependent on clinical response. After a treatment period of 7-10 days, the
    condition of the dog should be re-evaluated in order to establish the need for continuation of treatment.
    Long term treatment should be under regular veterinary supervision.
    The weight of the animal should be accurately determined before start of treatment.
    Administer to dogs within 1-2 hours after feeding. When this is not possible, or when dogs resist
    having the product placed directly into the mouth, put the tablet immediately before administration
    into a small amount of moistened food, or in a moist treat. Ensure the food or treat containing the
    medication is completely consumed.
    Read the package leaflet before use.
    12
     
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
    Do not use in pregnant or lactating dogs or in bitches intended for breeding.
    The recommended dose should not be exceeded.
    If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should
    be sought.
    9.
    EXPIRY DATE
    EXP {month/year}
    10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with the local requirements.
    11. 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.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Marketing Authorisation Holder
    Intervet International B. V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/028/004 (1 blister)
    EU/2/00/028/005 (3 blisters)
    15. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    13
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    {200 mg oral lyophilisate}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Zubrin 200 mg oral lyophilisates for dogs
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Tepoxalin
    200 mg / oral lyophilisate
    3.
    PHARMACEUTICAL FORM
    Oral lyophilisates
    4.
    PACKAGE SIZE
    10 oral lyophilisates (EU/2/00/028/006)
    30 oral lyophilisates (EU/2/00/028/007)
    60 oral lyophilisates (EU/2/00/028/008)
    5.
    TARGET SPECIES
    Dogs
    6.
    INDICATION(S)
    Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
    7.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    10 mg/kg of body weight once daily.
    The duration of treatment is dependent on clinical response. After a treatment period of 7-10 days, the
    condition of the dog should be re-evaluated in order to establish the need for continuation of treatment.
    Long term treatment should be under regular veterinary supervision.
    The weight of the animal should be accurately determined before start of treatment.
    Administer to dogs within 1-2 hours after feeding. When this is not possible, or when dogs resist
    having the product placed directly into the mouth, put the tablet immediately before administration
    into a small amount of moistened food, or in a moist treat. Ensure the food or treat containing the
    medication is completely consumed.
    Read the package leaflet before use.
    14
     
    8.
    SPECIAL WARNING(S), IF NECESSARY
    Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers
    Do not use in pregnant or lactating dogs or in bitches intended for breeding.
    The recommended dose should not be exceeded.
    If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should
    be sought.
    9.
    EXPIRY DATE
    EXP {month/year}
    10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with the local requirements.
    11. 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
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Marketing Authorisation Holder
    Intervet International B. V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/00/028/006 (1 blister)
    EU/2/00/028/007 (3 blisters)
    EU/2/00/028/008 (6 blisters)
    15. MANUFACTURER’S BATCH NUMBER
    Batch {number}
    15
     
    MINIMUM PARTICULARS TO APPEAR ON BLISTER
    {50 mg}{100 mg}{200 mg}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Zubrin 50 mg oral lyophilisates for dogs
    Zubrin 100 mg oral lyophilisates for dogs
    Zubrin 200 mg oral lyophilisates for dogs
    Tepoxalin
    2.
    NAME OF THE MARKETING AUTHORISATION HOLDER
    Intervet International B. V.
    3.
    EXPIRY DATE
    EXP {month/year}
    4.
    BATCH NUMBER
    Batch {number}
    5.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only
    16
     
    B. PACKAGE LEAFLET
    17
    PACKAGE LEAFLET
    Zubrin oral lyophilisates 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:
    Intervet International B. V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Manufacturer for the Batch Release:
    S-P Veterinary Ltd
    Breakspear Road South
    Harefield
    Uxbridge UB9 6LS
    United Kingdom
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Zubrin 50 mg oral lyophilisates for dogs
    Zubrin 100 mg oral lyophilisates for dogs
    Zubrin 200 mg oral lyophilisates for dogs
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
    Active substance
    Tepoxalin
    50 mg / oral lyophilisate
    Tepoxalin
    100 mg / oral lyophilisate
    4.
    INDICATIONS
    Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders.
    5.
    CONTRAINDICATIONS
    Do not use if your dog
    • is pregnant or lactating or in bitches intended for breeding
    • has cardiac or hepatic disease
    • has had gastrointestinal ulceration or bleeding
    • is hypersensitive to the product
    • is dehydrated, hypovolaemic or hypotensive, as there is an increased risk of renal toxicity.
    18
    Tepoxalin
    200 mg / oral lyophilisate
    6.
    ADVERSE REACTIONS
    Vomiting or diarrhoea may occur due to treatment. Alopecia and erythema may also occur
    occasionally.
    Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in
    faeces, reduced appetite, lethargy and renal disorders. If there are such undesirable effects, treatment
    should be discontinued immediately. In rare cases, particularly in older or in sensitive dogs, these
    undesirable effects may be serious or fatal.
    During clinical trial testing of the product, the incidence of gastrointestinal reactions
    (diarrhoea/vomiting) occurred in 1 out of 10 animals.
    If you notice any other side effects, please inform your veterinary surgeon.
    7.
    TARGET SPECIES
    Dogs
    8.
    DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
    10 mg/kg once daily.
    The weight of the animal should be accurately determined before start of treatment.
    Peel back foil to reveal a single oral lyophilisate in the form of a round tablet. Push the bottom of the
    blister and the tablet will pop out. Place the tablet in the dog’s mouth. The tablet will disintegrate upon
    contact with moisture. Keep the mouth of the dog closed for a few seconds to ensure complete tablet
    wetting. Administer to dogs within 1-2 hours after feeding. When this is not possible, or when dogs
    resist having the product placed directly into the mouth, put the tablet immediately before
    administration into a small amount of moistened food, or in a moist treat. Ensure the food or treat
    containing the medication is completely consumed.
    9.
    ADVICE ON CORRECT ADMINISTRATION
    The duration of treatment is dependent on clinical response. After a treatment period of 7-10 days, the
    condition of the dog should be re-evaluated in order to establish the need for continuation of treatment.
    Long term treatment should be under regular veterinary supervision.
    Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers. Tepoxalin is not water-
    soluble and becomes very sticky upon wetting. If the oral lyophilisate disintegrates prematurely, wash
    hands thoroughly.
    10. WITHDRAWAL PERIOD
    Not applicable
    11. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    This veterinary medicinal product does not require any special storage conditions.
    Do not use after the expiry date, which is stated on the blister.
    19
    12. SPECIAL WARNINGS
    The recommended dose should not be exceeded.
    Use in animals less than 6 months of age, with a weight below 5 kg, or in aged animals, may involve
    additional risk. If such use cannot be avoided, close veterinary supervision to monitor for
    gastrointestinal blood loss is necessary.
    Special care should be taken when treating dogs with marked renal insufficiency
    Tepoxalin must not be administered in conjunction with other NSAIDs or glucocorticosteroids,
    diuretics or anticoagulants.
    If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should
    be sought.
    In case of ingestion of a number of oral lyophilisates by a person, the advice of a doctor should be
    sought immediately.
    13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help
    to protect the environment.
    14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    Detailed information on this product is available on the website of the European Medicines Agency
    http://www.ema.europa.eu
    15. OTHER INFORMATION
    Not all pack sizes may be marketed.
    20


    Source: European Medicines Agency


    - Please bookmark this page (add it to your favorites).
    - If you wish to link to this page, you can do so by referring to the URL address below this line.

    https://theodora.com/drugs/eu/zubrin_veterinary.html

    Copyright © 1995-2021 ITA all rights reserved.