B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Onsior 6 mg tablets 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 :

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Manufacturer responsible for the batch release :

Elanco France S.A.S

26 Rue de la Chapelle

68330 Huningue

FRANCE

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Onsior 6 mg tablets for cats

Robenacoxib

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

Each tablet contains 6 mg robenacoxib.

Tablets are round, beige to brown, non-divisible and with imprints “NA” on one side and “AK” on the other side.

Onsior tablets are easy to administer and well accepted by most cats.

4. INDICATION(S)

For the treatment of pain and inflammation associated with acute and chronic musculoskeletal disorders in cats.

For the reduction of moderate pain and inflammation associated with orthopaedic surgery in cats.

5. CONTRAINDICATIONS

Do not use in cats suffering from ulceration in the digestive tract.

Do not use together with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies.

Do not use in case of hypersensitivity to robenacoxib or to any of the constituents of the tablets.

Do not use in pregnant or lactating cats or cats used for breeding because the safety of this product has not been established in these animals.

6. ADVERSE REACTIONS

Mild and transient diarrhoea, soft faeces or vomiting were commonly reported in clinical trials with treatment up to 6 days. Lethargy may be observed in very rare cases. In addition, elevated renal parameters (creatinine, BUN and SDMA), and renal insufficiency have been reported very rarely in post marketing safety experience, more commonly in older cats and with concomitant use of anaesthetic or sedative agents (see also Sections: Special precautions for use, Interaction with other medicinal products and forms of interaction, and dosage for each species, route(s) and method of administration).

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

Cats.

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

For oral use.

The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2.4 mg/kg. The following number of tablets should be given once daily at the same time every day.

Body weight (kg)	Number of tablets
2.5 to < 6	1 tablet
6 to 12	2 tablets

Acute musculoskeletal disorders : treat for up to 6 days.

Chronic musculoskeletal disorders: Duration of treatment should be decided on an individual basis.

A clinical response is normally seen within 3–6 weeks. Treatment should be discontinued after 6 weeks if no clinical improvement is apparent.

Orthopaedic surgery: Give as a single oral treatment prior to orthopaedic surgery.

Premedication should only be carried out in combination with butorphanol-analgesia. The tablet(s) should be administered without food at least 30 minutes prior to surgery.

After surgery, once daily treatment may be continued for up to two further days. If necessary, additional analgesic treatment with opioids is recommended.

The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in a target animal safety study and was shown to be well tolerated by the cats.

For cats, Onsior solution for injection or tablets may be used interchangeably in accordance with the indications and duration of use approved for each pharmaceutical form. Treatment should not exceed one dose (either tablet or injection) per day. Please note that the recommended doses for the two formulations are different.

9. ADVICE ON CORRECT ADMINISTRATION

Give either without food or with a small amount of food. Onsior tablets are easy to administer and well accepted by most cats. The tablets should not be divided or broken.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Store below 25 °C. Do not use after the expiry date stated on the label or blister after EXP.

12. SPECIAL WARNING(S)

Special precautions for use in animals :

The safety of this veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.

Use in cats with impaired function of the heart, kidneys or liver or in cats that are dehydrated, have low volume of circulating blood or have low blood pressure may involve additional risks. If use cannot be avoided, these cats require careful monitoring.

Response to long-term treatment should be monitored at regular intervals by a veterinary surgeon. Clinical field studies showed that robenacoxib was well-tolerated by most cats for up to 12 weeks.

Use this veterinary medicinal product under strict veterinary monitoring in cats at risk of stomach ulcer or if the animal previously displayed intolerance to other NSAIDs.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash hands after use of the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In small children, accidental ingestion increases the risk for NSAID adverse effects.

For pregnant women, particularly near term pregnant women, prolonged dermal exposure may increase the risk to the foetus.

Pregnancy and lactation :

Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats used for breeding.

Interaction with other medicinal products and other forms of interaction:

Onsior must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.

Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensinconverting enzyme (ACE) inhibitors, should be subject to clinical monitoring.

In healthy cats treated with or without the diuretic furosemide, concomitant administration of Onsior with the ACE inhibitor benazepril for 7 days was not associated with any negative effects on plasma aldosterone concentrations, plasma renin activity or glomerular filtration rate. No safety data in the target population and no efficacy data in general exist for the combined treatment of robenacoxib and benazepril.

As anaesthetics may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.

Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity.

Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Overdose (symptoms, emergency procedures, antidotes):

In healthy young cats aged 7–8 months, oral robenacoxib administered at high overdoses (4, 12 or 20 mg/kg/day for 6 weeks) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.

In healthy young cats aged 7– 8 months, oral robenacoxib administered at overdoses of up to 5 times the maximum recommended dose (2.4 mg, 7.2 mg, 12 mg robenacoxib/kg bodyweight) for 6 months was well tolerated. A reduction in body weight gain was observed in treated animals. In the high dose group kidney weights were decreased and sporadically associated with renal tubular degeneration/ regeneration but not correlated with evidence of renal dysfunction on clinical pathology parameters.

The interchangeable use of Onsior tablets and Onsior solution for injection in 4-month old cats at overdoses of up to 3 times the maximum recommended dose (2.4 mg, 4.8 mg, 7.2 mg robenacoxib/kg orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg subcutaneously) resulted in a dose-dependent increase of sporadic oedema at the injection site and minimal to mild subacute/chronic inflammation of the subcutaneous tissue. A dose-dependent increase in the QT interval, a decreased heart rate and corresponding increased respiratory rate were observed in laboratory studies. No relevant effects on body weight, bleeding time or evidence of any gastrointestinal, kidney or liver toxicity were observed.

In overdose studies conducted in cats, there was a dose-dependent increase in the QT interval. The biological relevance of increased QT intervals outside of normal variations observed following overdose of robenacoxib is unknown. No changes in the QT interval were observed after a single intravenous administration of 2 or 4 mg/kg robenacoxib to anaesthetised healthy cats.

As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised cats. There is no specific antidote. Symptomatic, supportive therapy is recommended and should consist of administration of gastrointestinal protective agents and infusion of isotonic saline.

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 product is available on the website of the European Medicines Agency ).

15. OTHER INFORMATION

Onsior tablets for cats are available in cardboard boxes containing 6 × 1, 12 × 1, 30 × 1 or 60 × 1 tablets in Alu/Alu perforated unit dose blisters. Not all pack sizes may be marketed.

Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID). It selectively inhibits the cyclooxygenase 2 enzyme (COX-2), which is responsible for pain, inflammation or fever. The cyclooxygenase 1 enzyme (COX-1) which has protective functions, e.g. in the digestive tract and kidneys, is not inhibited by robenacoxib. In clinical trials in cats this product reduced pain and inflammation associated with acute musculoskeletal disorders and reduced the need for rescue treatment when given as premedication in case of orthopaedic surgery, in combination with opioids. In two clinical trials in (mainly indoor) cats with chronic musculoskeletal disorder (CMSD), robenacoxib increased the activity and improved subjective scores of activity, behaviour, quality of life, temperament and happiness of the cats. Differences between robenacoxib and placebo were significant (P<0.05) for the client specific outcome measures, but did not reach significance (P=0.07) for the feline musculoskeletal pain index.

In a clinical study, 10 of 35 CMSD cats were assessed to be significantly more active when treated with robenacoxib for three weeks compared to these same cats when they received a placebo treatment. Two cats were more active when given placebo and for the remaining 23 cats no significant difference in activity could be detected between robenacoxib and placebo treatment.

For any information about this veterinary medicinal product, please contact the marketing authorisation holder.

PACKAGE LEAFLET:

Onsior 5 mg tablets for dogs

Onsior 10 mg tablets for dogs

Onsior 20 mg tablets for dogs

Onsior 40 mg 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 :

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Manufacturer responsible for the batch release :

Elanco France S.A.S

26 Rue de la Chapelle

68330 Huningue

FRANCE

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Onsior 5 mg tablets for dogs

Onsior 10 mg tablets for dogs

Onsior 20 mg tablets for dogs

Onsior 40 mg tablets for dogs Robenacoxib

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

Each tablet contains the following amount of robenacoxib and bears the imprint “NA” on one side and the following imprint on the other side:

Robenacoxib/tablet

Imprints

5 mg

10 mg

20 mg

40 mg

AK

BE CD BCK

Tablets are round, beige to brown and non-divisible. Onsior tablets are flavoured and are taken voluntarily by most dogs.

4.

INDICATION(S)

For the treatment of pain and inflammation of chronic osteoarthritis in dogs.

For the treatment of pain and inflammation associated with soft tissue surgery in dogs.

5. CONTRAINDICATIONS

Do not use in dogs suffering from stomach ulcer or with liver disease.

Do not use together with other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies.

Do not use in case of hypersensitivity to robenacoxib or to any of the ingredients of the tablets.

Do not use in pregnant or lactating bitches because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.

6. ADVERSE REACTIONS

Adverse reactions of the digestive tract were reported very commonly, but most cases were mild and recovered without treatment. Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon.

In dogs treated up to 2 weeks no increases in liver enzyme activities were observed. However, with long-term treatment increases in liver enzyme activities were common. In most cases the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with symptoms of anorexia, apathy or vomiting were uncommon. In very rare cases, lethargy may be observed.

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

Osteoarthritis: The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2 mg/kg. Administer once daily at the same time every day according to the table below.

Number of Tablets by Strength and Body Weight for Osteoarthritis

Body Weight (kg)	Number of Tab		ets by Strength
Body Weight (kg)	5 mg	10 mg	20 mg	40 mg
2.5 to < 5	1 tablet
5 to < 10		1 tablet
10 to<20			1 tablet
20 to < 40				1 tablet
40 to 80				2 tablets

A clinical response is normally seen within a week. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

For long-term treatment, once a clinical response has been observed, the dose of Onsior can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time. Regular monitoring should be undertaken by the veterinarian.

Soft tissue surgery: The recommended dose of robenacoxib is 2 mg/kg body weight with a range of 2–4 mg/kg. Give as a single oral treatment prior to soft tissue surgery.

The tablet(s) should be administered without food at least 30 minutes prior to surgery.

After surgery, once daily treatment may be continued for up to two further days.

Number of Tablets by Strength and Body Weight for Soft Tissue Surgery

Body Weight (kg)	Number of Tablets by Strength
	5 mg	10 mg	20 mg	40 mg
2.5	1 tablet
> 2.5 to < 5		1 tablet
5 to < 10			1 tablet
10 to<20				1 tablet
20 to < 40				2 tablets
40 to < 60				3 tablets
60 to 80				4 tablets

The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in a target animal safety study and was shown to be well tolerated by dogs.

For dogs, Onsior solution for injection or tablets may be used interchangeably in accordance with the indications and directions of use approved for each pharmaceutical form. Treatment should not exceed one dose (either tablet or injection) per day. Please note that the recommended doses for the two formulations may be different.

9. ADVICE ON CORRECT ADMINISTRATION

Give orally. Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib for osteoarthritis when administered without food or at least 30 minutes before or after a meal. Soft Tissue Surgery: Administer the first dose at least 30 minutes prior to surgery. Onsior tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or broken.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Store below 25 °C. Do not use after the expiry date stated on the label or blister after EXP.

12. SPECIAL WARNING(S)

Special warnings for each target species:

In clinical studies in dogs with osteoarthritis, inadequate response to treatment was seen in 10–15% of the dogs.

Special precautions for use in animals :

The safety of this veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.

For long term therapy, liver enzymes should be monitored at the start of therapy, e.g. after 2, 4 and 8 weeks. Thereafter it is recommended to continue regular monitoring, e.g. every 3–6 months. Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows symptoms such as anorexia, apathy or vomiting in combination with elevated liver enzymes.

Use in dogs with impaired function of the heart, kidneys or liver or in dogs that are dehydrated, have low volume of circulating blood or have low blood pressure may involve additional risk. If use cannot be avoided, these dogs require careful monitoring.

Use this veterinary medicinal product under strict veterinary monitoring in dogs at risk of stomach ulcer or if the animal previously displayed intolerance to other NSAIDs.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash hands after use of the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In small children, accidental ingestion increases the risk for NSAID adverse effects.

For pregnant women, particularly near term pregnant women, prolonged dermal exposure might increase the risk to the foetus.

Interaction with other medicinal products and other forms of interaction:

Onsior must not be administered in conjunction with other NSAIDs or glucocorticoids. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.

Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin-converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. In healthy dogs treated with and without the diuretic furosemide, concomitant administration of Onsior with the ACE inhibitor benazepril for 7 days was not associated with any negative effects on urine aldosterone concentrations, plasma renin activity or glomerular filtration rate. No safety data in the target population and no efficacy data in general exist for the combined treatment of robenacoxib and benazepril.

Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity.

Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Overdose (symptoms, emergency procedures, antidotes):

In healthy young dogs aged 5–6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Robenacoxib also had no detrimental effects on cartilages or joints.

As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

The interchangeable use of Onsior tablets and Onsior solution for injection in mongrel dogs at overdoses of up to 3 times the maximum recommended dose (2.0, 4.0 and 6.0 plus 4.0, 8.0 and 12.0 mg robenacoxib/kg orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg subcutaneously) resulted in dose-related oedema, erythema, thickening of the skin and skin ulceration at the subcutaneous injection site and inflammation, congestion or haemorrhage in the duodenum, jejunum and caecum. No relevant effects on body weight, bleeding time or evidence of any kidney or liver toxicity were observed.

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 product is available on the website of the European Medicines Agency ).

15. OTHER INFORMATION

Onsior tablets for dogs are available in cardboard boxes containing 7, 14, 28 or 70 tablets in Alu/Alu blisters, 30 × 1 tablets in Alu/Alu perforated unit dose blisters or 60 × 1 tablets in Alu/Alu perforated unit dose blisters. Not all pack sizes may be marketed.

Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID). It selectively inhibits the cyclooxygenase 2 enzyme (COX-2), which is responsible for pain, inflammation or fever. The cyclooxygenase 1 enzyme (COX-1) which has protective functions, e.g. in the digestive tract and kidneys, is not inhibited by robenacoxib.

In artificially induced inflammation in dogs, robenacoxib reduced pain and inflammation with single oral doses ranging from 0.5 to 8 mg/kg and a rapid onset of action (0.5 h). In clinical trials this product reduced the lameness and inflammation of dogs with chronic osteoarthritis and pain, inflammation and the need for rescue treatment in dogs undergoing soft tissue surgery.

For any information about this veterinary medicinal product, please contact the marketing authorisation holder.

PACKAGE LEAFLET:

Onsior 5 mg tablets for dogs

Onsior 10 mg tablets for dogs

Onsior 20 mg tablets for dogs

Onsior 40 mg 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 :

Elanco GmbH

Heinz-Lohmann-Str. 4

27472 Cuxhaven

Germany

Manufacturer responsible for the batch release :

Elanco France S.A.S

26 Rue de la Chapelle

68330 Huningue

FRANCE

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Onsior 5 mg tablets for dogs

Onsior 10 mg tablets for dogs

Onsior 20 mg tablets for dogs

Onsior 40 mg tablets for dogs Robenacoxib

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

Each tablet contains the following amount of robenacoxib and bears the imprint “NA” on one side and the following imprint on the other side:

Robenacoxib/tablet

Imprints

5 mg

10 mg

20 mg

40 mg

AK

BE CD BCK

Tablets are round, beige to brown and non-divisible. Onsior tablets are flavoured and are taken voluntarily by most dogs.

4.

INDICATION(S)

For the treatment of pain and inflammation of chronic osteoarthritis in dogs.

For the treatment of pain and inflammation associated with soft tissue surgery in dogs.

5. CONTRAINDICATIONS

Do not use in dogs suffering from stomach ulcer or with liver disease.

Do not use together with other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies.

Do not use in case of hypersensitivity to robenacoxib or to any of the ingredients of the tablets.

Do not use in pregnant or lactating bitches because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.

6. ADVERSE REACTIONS

Adverse reactions of the digestive tract were reported very commonly, but most cases were mild and recovered without treatment. Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon.

In dogs treated up to 2 weeks no increases in liver enzyme activities were observed. However, with long-term treatment increases in liver enzyme activities were common. In most cases the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with symptoms of anorexia, apathy or vomiting were uncommon. In very rare cases, lethargy may be observed.

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

Osteoarthritis: The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2 mg/kg. Administer once daily at the same time every day according to the table below.

Number of Tablets by Strength and Body Weight for Osteoarthritis

Body Weight (kg)	Number of Tab		ets by Strength
Body Weight (kg)	5 mg	10 mg	20 mg	40 mg
2.5 to < 5	1 tablet
5 to < 10		1 tablet
10 to<20			1 tablet
20 to < 40				1 tablet
40 to 80				2 tablets

A clinical response is normally seen within a week. Treatment should be discontinued after 10 days if no clinical improvement is apparent.

For long-term treatment, once a clinical response has been observed, the dose of Onsior can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time. Regular monitoring should be undertaken by the veterinarian.

Soft tissue surgery: The recommended dose of robenacoxib is 2 mg/kg body weight with a range of 2–4 mg/kg. Give as a single oral treatment prior to soft tissue surgery.

The tablet(s) should be administered without food at least 30 minutes prior to surgery.

After surgery, once daily treatment may be continued for up to two further days.

Number of Tablets by Strength and Body Weight for Soft Tissue Surgery

Body Weight (kg)	Number of Tablets by Strength
	5 mg	10 mg	20 mg	40 mg
2.5	1 tablet
> 2.5 to < 5		1 tablet
5 to < 10			1 tablet
10 to<20				1 tablet
20 to < 40				2 tablets
40 to < 60				3 tablets
60 to 80				4 tablets

The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in a target animal safety study and was shown to be well tolerated by dogs.

For dogs, Onsior solution for injection or tablets may be used interchangeably in accordance with the indications and directions of use approved for each pharmaceutical form. Treatment should not exceed one dose (either tablet or injection) per day. Please note that the recommended doses for the two formulations may be different.

9. ADVICE ON CORRECT ADMINISTRATION

Give orally. Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib for osteoarthritis when administered without food or at least 30 minutes before or after a meal. Soft Tissue Surgery: Administer the first dose at least 30 minutes prior to surgery. Onsior tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or broken.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Store below 25 °C. Do not use after the expiry date stated on the label or blister after EXP.

12. SPECIAL WARNING(S)