Equioxx - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET

EQUIOXX 8.2 mg/g oral paste for horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Marketing authorisation holder :

Audevard

37–39 rue de Neuilly

92110, Clichy

France

Manufacturer responsible for batch release :

Boehringer Ingelheim Animal Health France

4 chemin du Calquet

31000 Toulouse

France

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

EQUIOXX 8.2 mg/g oral paste for horses.

• 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Firocoxib 8.2 mg/g

• 4. INDICATION(S)

Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.

• 5. CONTRAINDI­CATIONS

Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders.

Do not use in breeding, pregnant or lactating animals.

Do not use concomitantly with corticosteroids or other NSAIDs.

• 6. ADVERSE REACTIONS

Lesions (erosion/ulce­ration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies. These lesions were mild and resolved without treatment. Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals, including isolated reports treated)

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Horses.

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

0.1 mg firocoxib per kg bodyweight, once daily for up to 14 days. Oral

use.

• 9. ADVICE ON CORRECT ADMINISTRATION

To administer EQUIOXX at the dose of 0.1 mg firocoxib/kg, set the syringe plunger to the appropriate dose division for the horse’s weight. Each full dose division on the syringe plunger delivers sufficient firocoxib to treat 100 kg body weight. The contents of one syringe will treat horses weighing up to 600 kg. To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid overdosing.

To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by rotating it % turn and slide it along the plunger shaft to the appropriate dose division for the horse’s weight. Rotate the plunger ring % turn to lock it in place and ensure it is locked.

Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the tongue.

• 10. WITHDRAWAL PERIOD(S)

Withdrawal period(s): Meat and offal: 26 days.

Not authorized for use in animals producing milk for human consumption.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Replace cap after use.

Do not use after the expiry date stated on the label.

Shelf-life after first opening the syringe: 3 months.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.

Do not use in animals less than 10 weeks.

The recommended treatment dose and duration should not be exceeded.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Avoid contact with eyes and skin. If it occurs, rinse affected area immediately with water. Wash hands after use of the product.

Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive should avoid contact with, or wear disposable gloves, when administering the product.

Pregnancy and lactation :

No data on use during pregnancy is available in horses. Therefore, do not use in breeding, pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.

Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed. The treatmentfree period should take into account the pharmacological properties of the products used previously.

Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk of renal toxicity.

• 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 veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION

Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.

The oral paste is available in the following pack sizes:

• – 1 carton box containing 1 syringe

• – 1 carton box containing 7 syringes

• – 1 carton box containing 14 syringes

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

EQUIOXX 20 mg/ml solution for injection for horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Marketing authorisation holder :

Audevard

37–39 rue de Neuilly

92110, Clichy

France

Manufacturer responsible for batch release :

Boehringer Ingelheim Animal Health France

4, Chemin du Calquet

31000 Toulouse

France

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

EQUIOXX 20 mg/ml solution for injection for horses.

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Firocoxib 20 mg/ml

• 4. INDICATION(S)

Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.

• 5. CONTRAINDI­CATIONS

Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders. Do not use in breeding, pregnant or lactating animals.

Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

• 6. ADVERSE REACTIONS

Mild injection site swellings associated with perivascular inflammation and pain.

Lesions (erosion/ulce­ration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies. These lesions were mild and resolved without treatment. Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals, including isolated reports treated)

At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and 2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate renal lesions were observed. If clinical signs occur, treatment should be discontinued and symptomatic treatment initiated.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Horses

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

The recommended dose is 0.09 mg firocoxib per kg bodyweight (equivalent to 1 ml of the solution per 225 kg bodyweight) once daily by intravenous injection.

EQUIOXX 8.2 mg/g Oral Paste may be used for continuation of treatment at a dosage of 0.1 mg firocoxib per kg bodyweight once daily.

The overall duration of treatment with EQUIOXX solution for injection or EQUIOXX oral paste will be dependent on the response observed, but should not exceed 14 days.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid the introduction of contamination during use.

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: 26 days.

Not authorized for use in animals producing milk for human consumption.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use after the expiry date stated on the label after EXP. Shelflife

after first opening the container : 1 month.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic medicinal drugs should be avoided.

Do not use in animals less than 10 weeks of age.

Do not exceed the recommended dose or duration of treatment.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Avoid contact with eyes and skin. If this occurs, rinse affected area immediately with water.

Wash hands after use of the product.

Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive should avoid contact with, or wear disposable gloves, when administering the product.

Pregnancy and lactation:

The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated. Therefore, do not use in breeding, pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretics and substances that have a high degree of protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs. Pretreatment with other anti-inflammatory substances may result in additional or increased adverse reactions and a treatment-free period with such products should therefore be observed. The treatmentfree period should take into account the pharmacological properties of the products used previously.

Concurrent administration of potentially nephrotoxic drugs should be avoided, as there might be an increased risk of renal toxicity. Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring.

In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.

• 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 veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION

Mode of action:

Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis. COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. In in-vitro equine whole blood assays, firocoxib exhibited 222 to 643 fold selectivity for COX-2 over COX-1.

The injection vials are available in the following pack sizes: – carton containing one vial of 25 ml.

– carton containing 6 vials of 25 ml

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

EQUIOXX 57 mg chewable tablets for horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Marketing authorisation holder :

Audevard

37–39 rue de Neuilly

92110, Clichy

France

Manufacturer responsible for batch release :

Boehringer Ingelheim Animal Health France

4 chemin du Calquet

31000 Toulouse

France

EYLIO

9 rue des Tuileries

67460 Souffel­weyersheim

France

PROVET SA

Thesi Vrago

Aspropyrgos Attiki, 19300

Greece

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

EQUIOXX 57 mg chewable tablets for horses.

firocoxib

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Firocoxib 57 mg

Brown, round, convex, scored tablets.

Tablets are engraved on one side with “M” above the score and “57” below the score.

• 4. INDICATION(S)

Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses weighing between 450 kg and 600 kg bodyweight.

• 5. CONTRAINDI­CATIONS

Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, cardiac or renal function and bleeding disorders.

Do not use in breeding, pregnant or lactating animals.

Do not use concomitantly with corticosteroids or other NSAIDs.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

• 6. ADVERSE REACTIONS

Lesions (erosion/ulce­ration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies. These lesions were mild and resolved without treatment. Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals, including isolated reports treated)

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Horses (450–600 kg).

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Oral use.

Administer one tablet once daily for horses weighing 450–600 kg bodyweight.

Duration of treatment will be dependent on the response observed, but should not exceed 14 days.

• 9. ADVICE ON CORRECT ADMINISTRATION

One tablet should be administered with a small amount of food in a bucket or direct by hand, presenting the tablet combined with a small amount of food or with a treat in the palm of the hand. After administration, it is recommended to examine the buccal cavity to ensure that the tablet has been adequately swallowed.

Do not exceed the recommended dosage.

For safe and effective use, this product should only be administered to horses in the weight range 450600 kg. For horses weighing under 450 kg or over 600 kg, and where firocoxib is the treatment of choice, use of other firocoxib-containing formulations that allow for accurate dosing is advised.

• 10. WITHDRAWAL PERIOD(S)

Withdrawal period(s): Meat and offal: 26 days.

Not authorized for use in animals producing milk for human consumption.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 30 °C.

Store in the original package.

Do not use this veterinary medicinal product after the expiry date stated on the label after EXP.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there may be potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.

The recommended treatment dose and duration should not be exceeded.

Special precautions to be taken by the person administering the veterinary medicinal product to animals.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use of the veterinary medicinal product.

Like other medicinal products that inhibit COX-2, pregnant women or women attempting to conceive should avoid contact with, or wear disposable gloves, when administering the product.

Pregnancy and lactation :

No data on use during pregnancy is available in horses. Therefore, do not use in breeding, pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteroids or other NSAIDs.

Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed. The treatmentfree period should take into account the pharmacological properties of the products used previously.

Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk of renal toxicity.

• 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 veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION

Mode of action:

Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) mediated prostaglandin synthesis. COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. In in-vitro equine whole blood assays, firocoxib exhibited 222 to 643 fold selectivity for COX-2 over COX-1.

The 57 mg chewable tablets are available in the following pack sizes:

• – 1 cardboard box containing 10 tablets in blisters

• – 1 cardboard box containing 30 tablets in blisters

• – 1 cardboard box containing 180 tablets in blisters

• – 1 cardboard box containing 60 tablets in a 30 ml bottle