Inflacam - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Inflacam 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 and manufacturer responsible for batch release:

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway, Ireland.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 1.5 mg/ml oral suspension for dogs

Meloxicam

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

One ml contains: 1.5 mg of meloxicam, 5 mg of sodium benzoate.

• 4. INDICATION(S)

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

Do not use in pregnant or lactating animals.

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.

Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects 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 serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs.

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

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.

Method and route of administration

Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using the measuring syringe provided in the package. The syringe has a scale which corresponds to the volume required.

For initiation of the therapy on the first day, twice the maintenance dosage will be required.

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

ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing.

Please carefully follow the instructions of the veterinarian.

Avoid introduction of contamination during use.

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.

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

Shelf life after first opening the immediate packaging: 6 months.

Precaution 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,

Inflacam 0.5 mg/ml oral suspension for cats should be used.

Precautions to be taken by the person administering the product

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.

Use during pregnancy and lactation

See section "Contraindications".

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. Inflacam must not be administered in conjunction with other NSAIDs or glucocorticosteriods.

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

Overdose

In case of overdose symptomatic treatment should be initiated.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, 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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

To be supplied only on veterinary prescription.

• 15, 42, 100 or 200 ml bottle with two measuring syringes.

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.

Lietuva

OÜ ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel.: + 372 6 709 006

E-mail:

E-mail:

Ireland

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Slovenija

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

island

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Italia

VIRBAC S.r.l.

Via Ettore Bugatti, 15

I-20142 Milano

Tel: + 39 02 40 92 47 1

Kvnpog

Panchris Feeds (Veterinary) Ltd

Industrial Area Aradippou, 7100, Larnaca

(P.O.Box 40261, 6302 Larnaca)

Tel: + 357 24813333

Latvija

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail:

Romania

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Slovenská republika

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Suomi/Finland

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Sverige

Virbac Danmark A/S Filial Sverige, c/o

Incognito AB,

Box 1027,

SE-171 21 Solna

Tel: + 45 7552 1244

United Kingdom (Northern Ireland)

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: + 44 (0) 1359 243243

Hrvatska

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

PACKAGE LEAFLET:

Inflacam 20 mg/ml solution for injection for cattle, pigs and horses

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

Marketing authorisation holder

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway, Ireland

Manufacturers responsible for batch release :

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway, Ireland

and

Eurovet Animal Health B.V.

Handelsweg 25, 5531 AE Bladel, The Netherlands

and

Labiana Life Sciences, S.A., C/ Venus, 26, Pol. Ind. Can Parellada, Tarrasa, 08228 Barcelona

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 20 mg/ml solution for injection for cattle, pigs and horses

Meloxicam

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

One ml contains:

Meloxicam 20 mg,

Ethanol (96%) 159.8 mg.

Clear, yellow solution.

• 4. INDICATION(S)

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

Pigs

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic.

• 5. CONTRAINDICATIONS

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

Do not use in pregnant or lactating mares.

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

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

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

• 6. ADVERSE REACTIONS

A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

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

Cattle, pigs and horses

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

Cattle

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.

Horses

Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, Inflacam 15 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

Cattle: meat and offal: 15 days; milk: 5 days.

Pigs: meat and offal: 5 days.

Horses: meat and offal: 5 days.

Not authorised for use in horses 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 (EXP) stated on the carton and vial.

Shelf life after first opening the container: 28 days.

Treatment of calves with Inflacam 20 minutes before dehorning reduces post-operative pain. Inflacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

Special precautions for use in animals:

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

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.

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

Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

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

Use during pregnancy and lactation:

Cattle and pigs: Can be used during pregnancy and lactation.

Horses: See section "Contraindications".

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In the case of overdose, symptomatic treatment should be initiated.

• 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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ().

• 15. OTHER INFORMATION

Cardboard box containing one colourless glass injection vial of 20 ml, 50 ml, 100 ml or 250 ml.

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.

Eesti

OÜ ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa

Tel: + 372 6 709 006

E-mail:

EMáSa

Virbac Hellas AE

130 x^M- E.O. A0qvóv - AapíaZ,

14452, MsTagóppoon, Attik^

Tq!.: + 30 210 6219520

Fax.: + 30 210 8140900

E-mail:

Espana

VIRBAC ESPANA, S.A. Angel Guimera 179181, 08950 - Esplugues de Llobregat (Barcelona) Tel: + 34 93 470 79 40

Latvija

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail:

Romania

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73

PACKAGE LEAFLET:

Inflacam 15 mg/ml oral suspension for horses

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

Marketing authorisation holder and manufacturer responsible for batch release:

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway, Ireland.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 15 mg/ml oral suspension for horses

Meloxicam

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

One ml contains: 15 mg of meloxicam, 5 mg of sodium benzoate.

• 4. INDICATION(S)

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

• 5. CONTRAINDICATIONS

Do not use in pregnant or lactating mares.

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

• 6. ADVERSE REACTIONS

Isolated cases of adverse reactions typically associated with non-steroidal anti-inflammatory drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.

In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically

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

Horses.

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

Dosage

Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.

This is equivalent to 1 ml of Inflacam per 25 kg body weight of horse. For example, a horse weighing 400 kg will receive 16 ml of Inflacam, a horse weighing 500 kg will receive 20 ml of Inflacam, and a horse weighing 600 kg will receive 24 ml of Inflacam.

Method and route of administration

Shake well before use. To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.

The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a 2 ml scale.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

Meat and offal: 3 days.

Not authorised for use in lactating 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.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

Do not use after the expiry date (EXP) stated on the carton and the bottle.

Shelf life after first opening of the container: 3 months.

Special precautions for use in animals:

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 is a potential risk of increased renal toxicity.

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.

Use during pregnancy and lactation:

See the section under “Contraindications”.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In the case of overdose symptomatic treatment should be initiated.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, 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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

To be supplied only on veterinary prescription. 100 or 250 ml bottle with a measuring syringe. 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.

Etnrapun

VIRBAC

1ère avenue 2065 m - LID

06516 Carros, France

E-mail:

Ísland

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Slovenská republika

VIRBAC

1ěre avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Italia

VIRBAC S.r.l.

Via Ettore Bugatti, 15

I-20142 Milano

Tel: + 39 02 40 92 47 1

Kvnpog

Panchris Feeds (Veterinary) Ltd

Industrial Area Aradippou, 7100, Larnaca

(P.O.Box 40261, 6302 Larnaca)

Tel: + 357 24813333

Latvija

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail:

Lietuva

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel.: + 372 6 709 006

E-mail:

Romania

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Suomi/Finland

VIRBAC

Pre avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Sverige

Virbac Danmark A/S Filial Sverige, c/o

Incognito AB,

Box 1027,

SE-171 21 Solna

Tel: + 45 7552 1244

United Kingdom (Northern Ireland)

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: + 44 (0) 1359 243243

Hrvatska

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

PACKAGE LEAFLET:

Inflacam 1 mg chewable tablets for dogs

Inflacam 2.5 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 and manufacturer responsible for batch release:

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea,

Co. Galway,

Ireland.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 1 mg chewable tablets for dogs

Inflacam 2.5 mg chewable tablets for dogs

Meloxicam

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

One chewable tablet contains:

Active substance

Meloxicam 1 mg

Meloxicam 2.5 mg

• 4. INDICATION(S)

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

• 5. CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

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 dogs less than 6 weeks of age or less than 4 kg body weight.

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

• 6. ADVERSE REACTIONS

Typical adverse drug reactions of non-steroidal anti-inflammatory drugs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects 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 serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs

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

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.

Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the animal.

Inflacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.

Dose scheme for the maintenance dose:

The use of Inflacam oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Inflacam oral suspension for dogs is recommended.

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

• 9. ADVICE ON CORRECT ADMINISTRATION

To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing or overdosing.

• 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.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals:

If adverse reactions 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 is a potential risk of renal toxicity.

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

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (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.

Use during pregnancy and lactation:

See section “Contraindications”.

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. Inflacam 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 drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic 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 MATERIAL, 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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION

Package sizes:

20 tablets

100 tablets

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.

E-mail:

Tel: + 372 6 709 006

E-mail:

PACKAGE LEAFLET:

Inflacam 5 mg/ml solution for injection for dogs and 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:

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Manufacturers responsible for the batch release :

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland and

Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, The Netherlands and

Labiana Life Sciences, S.A., C/ Venus, 26, Pol. Ind. Can Parellada, Tarrasa, 08228 Barcelona

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 5 mg/ml solution for injection for dogs and cats Meloxicam

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

One ml contains:

Meloxicam 5 mg,

Ethanol (96%) 159.8 mg.

Clear, yellow solution.

• 4. INDICATION(S)

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

• 5. CONTRAINDICATIONS

Do not use in animals 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 animals less than 6 weeks of age nor in cats of less than 2 kg.

• 6. ADVERSE REACTIONS

Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure, have occasionally been reported. In very rare cases elevated liver enzymes have been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis, and gastrointestinal ulceration have been reported.

These side effects 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.

In very rare cases, anaphylactoid reactions may occur and should be treated symptomatically.

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

Dogs and cats.

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

Dosage for each species

Dogs: single administration of 0.2 mg meloxicam /kg body weight (i.e. 0.4 ml/10 kg).

Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).

Method and routes of administration

Dogs:

Musculo-skeletal disorders: single subcutaneous injection.

Inflacam 1.5 mg/ml oral suspension for dogs or Inflacam 1 mg and 2.5 mg chewable tablets for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example, at the time of induction of anaesthesia.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example, at the time of induction of anaesthesia.

• 9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

Maximum number of piercings is 42 for all presentations.

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Keep the vial in the outer carton.

Do not use after the expiry date (EXP) stated on the carton and vial.

Shelf life after first opening the container: 28 days.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals:

If adverse reactions 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 is a potential risk of renal toxicity.

During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

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

Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

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

Use 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, anti-coagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Inflacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g., aged animals), intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

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 the case of overdose, symptomatic treatment should be initiated.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, 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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ().

• 15. OTHER INFORMATION

Carton box containing one colourless glass injection vial of 10 ml, 20 ml or 100ml, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

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.

Lietuva

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel.: + 372 6 709 006

E-mail:

Efc^rapufl

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Luxembourg/Luxemburg

VIRBAC BELGIUM N.V.

Esperantolaan 4 3001 Leuven, Belgium Tel: + 32 (0) 16 38 72 60

Česká republika

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Magyarország

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding

Tel: + 45 7552 1244

Malta

VIRBAC

1ere avenue 2065 m - L.I.D

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

E-mail:

Kvnpog

Panchris Feeds (Veterinary) Ltd

Industrial Area Aradippou, 7100, Larnaca

(P.O.Box 40261, 6302 Larnaca)

Tel: + 357 24813333

Latvija

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail:

Romania

VIRBAC

Ure avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Sverige

Virbac Danmark A/S Filial Sverige, c/o

Incognito AB,

Box 1027,

SE-171 21 Solna

Tel: + 45 7552 1244

United Kingdom (Northern Ireland)

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: + 44 (0) 1359 243243

Hrvatska

VIRBAC

Ure avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

PACKAGE LEAFLET:

Inflacam 5 mg/ml solution for injection for cattle and pigs

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

Marketing authorisation holder:

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway, Ireland

Manufacturers responsible for batch release :

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway, Ireland

and

Eurovet Animal Health B.V.

Handelsweg 25, 5531 AE Bladel, The Netherlands

and

Labiana Life Sciences, S.A., C/ Venus, 26, Pol. Ind. Can Parellada, Tarrasa, 08228 Barcelona

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 5 mg/ml solution for injection for cattle and pigs

Meloxicam

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

One ml contains:

Meloxicam 5 mg,

Ethanol (96%) 159.8 mg.

Clear, yellow solution.

• 4. INDICATION(S)

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For the relief of post-operative pain following dehorning in calves.

Pigs

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For the relief of post-operative pain associated with minor soft tissue such as castration.

• 5. CONTRAINDICATIONS

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

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

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

Do not use in pigs less than 2 days old.

• 6. ADVERSE REACTIONS

A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.

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

Cattle (calves and young cattle) and pigs.

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

Cattle

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.

10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs

Locomotor disorders:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of bodyweight.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

• 10. WITHDRAWAL PERIOD(S)

Cattle: meat and offal: 15 days.

Pigs: meat and offal: 5 days.

• 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 (EXP) stated on the carton and vial.

Shelf life after first opening the container: 28 days.

• 12. SPECIAL WARNING(S)

Treatment of calves with Inflacam 20 minutes before dehorning reduces post-operative pain. Inflacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

Treatment of piglets with Inflacam before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.

To obtain the best possible relieving effect post-surgery Inflacam should be administered 30 minutes before surgical intervention.

Special precautions for use in animals:

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

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

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

Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

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

Use during pregnancy and lactation:

Cattle: Can be used during pregnancy.

Pigs: Can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In the case of overdose symptomatic treatment should be initiated.

• 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

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency ().

• 15. OTHER INFORMATION

Cardboard box containing 1 colourless glass injection vial of 20 ml, 50 ml or 100 ml.

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.

Lietuva

OÜ ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel.: + 372 6 709 006

E-mail:

Efc^rapufl

VIRBAC

1ère avenue 2065 m - LID

06516 Carros, France

Česká republika

VIRBAC

1ěre avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding

Tel: + 45 7552 1244

Deutschland

VIRBAC Tierarzneimittel GmbH

Rögen 20

23843 Bad Oldesloe

Tel: + 49 (4531) 805 111

Luxembourg/Luxemburg

VIRBAC BELGIUM N.V.

Esperantolaan 4

3001 Leuven, Belgium

Tel: + 32 (0) 16 38 72 60

Magyarorszag

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Malta

VIRBAC

1ere avenue 2065 m - L.I.D

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Nederland

VIRBAC NEDERLAND BV

Hermesweg 15-NL

3771 ND-Barneveld

Tel: + 31 (0) 342 427 127

Latvija

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail:

Romania

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

PACKAGE LEAFLET: Inflacam 330 mg granules for horses

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

Marketing authorisation holder and manufacturer responsible for batch release :

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

IRELAND.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 330 mg granules for horses.

Meloxicam

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

One sachet contains: 330 mg of meloxicam.

Pale yellow granules.

• 4. INDICATION(S)

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in horses weighing between 500 and 600 kg.

• 5. CONTRAINDICATIONS

Do not use in pregnant or lactating mares.

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

Isolated cases of adverse reactions typically associated with non-steroidal anti-inflammatory drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

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

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

• 7. TARGET SPECIES

Horses.

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

In-feed use.

To be administered mixed with food at a dose of 0.6 mg/kg body weight, once daily, up to 14 days.

The product should be added to 250 g of muesli feed, prior to feeding.

Each sachet contains one dose for a horse weighing between 500 kg and 600 kg and the dose must not be divided into smaller doses.

• 9. ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination during use.

WITHDRAWAL PERIOD(S)

Meat and offal: 3 days.

Not authorised for use in lactating animals producing milk for human consumption.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Shelf life after incorporation into muesli feed: use immediately.

• 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.

In order to minimise risk of intolerance, the product should be mixed into muesli feed.

This product is only for use in horses weighing between 500 and 600 kg.

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

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (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:

Do not use in pregnant or lactating mares.

Interaction with other medicinal products and other forms of interaction:

Do not administer concurrently with glucocorticoids, other NSAIDs or with anti-coagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In the case of overdose symptomatic treatment should be initiated.

Incompatibilities:

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 MATERIAL, 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

Detailed information on this product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION

Pack size: 20 and 100 sachets.

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.

E-mail:

Tel: + 32 (0) 16 38 72 60

E-mail:

Ísland

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Slovenská republika

VIRBAC

1ěre avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Italia

VIRBAC S.r.l.

Via Ettore Bugatti, 15

I-20142 Milano

Tel: + 39 02 40 92 47 1

Suomi/Finland

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Kvnpog

Panchris Feeds (Veterinary) Ltd

Industrial Area Aradippou, 7100, Larnaca

(P.O.Box 40261, 6302 Larnaca)

Tel: + 357 24813333

Latvija

OÜ ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail:

Romania

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Sverige

Virbac Danmark A/S Filial Sverige, c/o

Incognito AB,

Box 1027,

SE-171 21 Solna

Tel: + 45 7552 1244

United Kingdom (Northern Ireland)

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: + 44 (0) 1359 243243

Hrvatska

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

PACKAGE LEAFLET:

Inflacam 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 and manufacturer responsible for batch release :

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway,

IRELAND.

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Inflacam 0.5 mg/ml oral suspension for cats. meloxicam

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

One ml contains:

Active substance

Meloxicam 0.5 mg.

Excipient

Sodium benzoate 1.5 mg.

Smooth light yellow suspension

• 4. INDICATION(S)

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

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

• 5. CONTRAINDICATIONS

Do not use in pregnant or lactating animals.

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, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases.

These side effects 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 reactions)

• - 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

Cats.

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

Oral use.

Post-operative pain and inflammation following surgical procedures:

After initial treatment with Inflacam 5 mg/ml solution for injection for cats, continue treatment

24 hours later with Inflacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight (0.1 ml /kg). The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to 4 days.

Acute musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight (0.4 ml/kg) on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight (0.1 ml /kg) for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight (0.2 ml/kg) 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 (0.1 ml /kg).

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.

Route and method of administration

A one ml syringe is provided with the product. The precision of the syringe is not suitable for the treatment of cats below 1 kg.

Shake well before use. To be administered orally either mixed with food or directly into the mouth.

• 9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.

Please carefully follow the instructions of the veterinarian.

Avoid introduction of contamination during use.

• 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.

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

Shelf life after first opening of the container:

3 ml and 5 ml bottles: 14 days

10 ml and 15 ml bottles: 6 months.

• 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.

Post-operative pain and inflammation following surgical procedures:

In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders:

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

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

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (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. See section "Contraindications".

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. Inflacam 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 "Adverse reactions", are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

Incompatibilities:

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

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, 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

Pack size: 1 x 3 ml, 1 x 5 ml, 1 x 10 ml or 1 x 15 ml bottle with a measuring syringe.

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.

België/Belgique/Belgien

VIRBAC BELGIUM N.V.

Esperantolaan 4

3001 Leuven

Tel: + 32 (0) 16 38 72 60




Efc^rapufl

VIRBAC

1ère avenue 2065 m - LID

06516 Carros, France




Česká republika

VIRBAC

1ěre avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding

Tel: + 45 7552 1244




Lietuva

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel.: + 372 6 709 006

E-mail:

Luxembourg/Luxemburg

VIRBAC BELGIUM N.V.

Esperantolaan 4

3001 Leuven, Belgium

Tel: + 32 (0) 16 38 72 60

Magyarorszag

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Malta

VIRBAC

1ere avenue 2065 m - L.I.D

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00




Deutschland VIRBAC Tierarzneimittel GmbH Rögen 20 23843 Bad Oldesloe Tel: + 49 (4531) 805 111	Nederland VIRBAC NEDERLAND BV Hermesweg 15-NL 3771 ND-Barneveld Tel: + 31 (0) 342 427 127
Eesti OÜ ZOOVETVARU Uusaru 5 76505 Saue/Harjumaa Tel: + 372 6 709 006 E-mail:	Norge Virbac Norge c/o Premium Pet Products Vollaveien 20 A 0614 Oslo Tel: + 45 7552 1244
EMäöa Virbac Hellas AE 130 x^M- E.O. A0t|v6jv - AapiaZ, 14452, MsTapoppooq, Attik^ Tq!.: + 30 210 6219520 Fax.: + 30 210 8140900 E-mail:	Österreich VIRBAC Österreich GmbH Hildebrandgasse 27 1180 Wien Tel: + 43 (0) 1 21 834 260

España VIRBAC ESPAÑA, S.A. Angel Guimera 179181, 08950 - Esplugues de Llobregat (Barcelona) Tel: + 34 93 470 79 40	Polska VIRBAC Sp. o.o. ul. Pulawska 314 02-819 Warszawa
France VIRBAC France 13e rue - LID -06517 Carros Cedex	Portugal VIRBAC DE Portugal LABORATÓRIOS LDA Ed13-Piso 1- Esc.3 Quinta da Beloura 2710-693 Sintra Tel.: + 351 219 245 020
Ireland VIRBAC 1ere avenue 2065 m - LID 06516 Carros, France	Slovenija VIRBAC 1ere avenue 2065 m - LID 06516 Carros, France Tel: + 33 (0) 4 92 08 73 00
Ísland VIRBAC 1ere avenue 2065 m - LID 06516 Carros, France Tel: + 33 (0) 4 92 08 73 00	Slovenská republika VIRBAC 1ere avenue 2065 m - LID 06516 Carros, France Tel: + 33 (0) 4 92 08 73 00
Italia VIRBAC S.r.l. Via Ettore Bugatti, 15 I-20142 Milano Tel: + 39 02 40 92 47 1	Suomi/Finland VIRBAC 1ere avenue 2065 m - LID 06516 Carros, France Tel: + 33 (0) 4 92 08 73 00

Kvnpog

Panchris Feeds (Veterinary) Ltd

Industrial Area Aradippou, 7100, Larnaca

(P.O.Box 40261, 6302 Larnaca)

Tel: + 357 24813333

Sverige

Virbac Danmark A/S Filial Sverige, c/o

Incognito AB,

Box 1027,

SE-171 21 Solna

Tel: + 45 7552 1244

Latvija

OU ZOOVETVARU

Uusaru 5

76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail:

United Kingdom (Northern Ireland)

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: + 44 (0) 1359 243243

Romania

VIRBAC

Ure avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

Hrvatska

VIRBAC

1ere avenue 2065 m - LID

06516 Carros, France

Tel: + 33 (0) 4 92 08 73 00

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