B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Meloxoral 1.5 mg/ml oral suspension 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:

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Manufacturer for the batch release:

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer

THE NETHERLANDS

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Meloxoral 1.5 mg/ml oral suspension for dogs

Meloxicam

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

One ml contains:

Meloxicam 1.5 mg.

Yellow/ green suspension.

• 4. INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

• 5. CONTRAINDI­CATIONS

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

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

Do not use in dogs less than 6 weeks of age.

• 6. ADVERSE REACTIONS

Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

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 treated, including isolated reports).

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

Dogs

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

Oral use.

To be administered either mixed with food or directly into the mouth.

Dosage

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after > 4 days), the dose of Meloxoral can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

The suspension can be given using the Meloxoral measuring syringe provided in the package.

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.

After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The syringe should be stored in the carton box in between uses.

To avoid introduction of external contaminants during use, keep the provided syringes only for this product.

Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Shelf life after first opening the container: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals :

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Meloxoral 0.5 mg/ml oral suspension for cats should be used.

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

People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

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

Pregnancy and lactation :

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Do not use in pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxoral must not be administered in conjunction with other NSAIDs or glucocorticos­teroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Overdose (symptoms, emergency procedures, antidotes) :

In case of overdose symptomatic treatment should be initiated.

• 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

Bottle of 10, 25, 50, 125 or 180 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Meloxoral 1.5 mg/ml oral suspension 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:

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Manufacturer for the batch release:

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer

THE NETHERLANDS

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Meloxoral 1.5 mg/ml oral suspension for dogs

Meloxicam

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

One ml contains:

Meloxicam 1.5 mg.

Yellow/ green suspension.

• 4. INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

• 5. CONTRAINDI­CATIONS

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

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

Do not use in dogs less than 6 weeks of age.

• 6. ADVERSE REACTIONS

Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

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 treated, including isolated reports).

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

Dogs

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

Oral use.

To be administered either mixed with food or directly into the mouth.

Dosage

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after > 4 days), the dose of Meloxoral can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

The suspension can be given using the Meloxoral measuring syringe provided in the package.

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.

After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The syringe should be stored in the carton box in between uses.

To avoid introduction of external contaminants during use, keep the provided syringes only for this product.

Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Shelf life after first opening the container: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals :

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Meloxoral 0.5 mg/ml oral suspension for cats should be used.

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

People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

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

Pregnancy and lactation :

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Do not use in pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxoral must not be administered in conjunction with other NSAIDs or glucocorticos­teroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Overdose (symptoms, emergency procedures, antidotes) :

In case of overdose symptomatic treatment should be initiated.

• 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

Bottle of 10, 25, 50, 125 or 180 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Meloxoral 0.5 mg/ml oral suspension for cats

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Dechra Regulatory B.V.

Handelsweg 25

5531 AE BladelTHE NETHERLANDS

Manufacturer for the batch release:

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer

THE NETHERLANDS

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Meloxoral 0.5 mg/ml oral suspension for cats Meloxicam

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

One ml contains:

Meloxicam 0.5 mg.

Yellow/ green suspension.

• 4. INDICATION(S)

Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.

• 5. CONTRAINDI­CATIONS

Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

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

Do not use in cats less than 6 weeks of age.

• 6. ADVERSE REACTIONS

Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported. These adverse reactions are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

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 treated, including isolated reports).

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Cats

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

Oral use.

To be administered orally either mixed with food or directly into the mouth.

Dosage

Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight.

A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

• 9. ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

The suspension can be given using the Meloxoral measuring syringe provided in the package.

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.

After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The syringe should be stored in the carton box in between uses.

To avoid introduction of external contaminants during use, keep the provided syringes only for this product.

Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Shelf life after first opening the container: 6 months.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals:

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

Response to long-term therapy should be monitored at regular intervals by a veterinarian.

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

People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

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

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Do not use in pregnant or lactating animals.

Interaction with other medicinal products and other forms of interaction:

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxoral must not be administered in conjunction with other NSAIDs or glucocorticos­teroids. Concurrent administration of potential nephrotoxic veterinary medicinal products should be avoided.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Overdose (symptoms, emergency procedures, antidotes) :

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.

In case of overdose, adverse reactions, as listed in section 6 „Adverse reactions“, are expected to be more severe and more frequent. In the case of overdose symptomatic treatment should be initiated.

• 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