ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Onsior 6 mg tablets for cats
2.
Each tablet contains:
Active substance:
Robenacoxib
6 mg
For a full list of excipients see section 6.1.
3.
Tablet.
Round, beige to brown tablets with imprints “NA” on one side and “AK” on the other side.
4.
4.1
Cat
4.2
For the treatment of acute pain and inflammation associated with musculo-skeletal disorders in cats.
4.3
Do not use in cats suffering from gastrointestinal ulceration.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs
(NSAIDs).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
See section 4.7 (pregnancy and lactation).
4.4
None.
4.5
The safety of the 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 cardiac, renal or hepatic function or in cats that are dehydrated,
hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these cats require
careful monitoring.
Use this veterinary medicinal product under strict veterinary monitoring in cats with a risk of
gastrointestinal ulcers, or if the cat previously displayed intolerance to other NSAIDs.
2
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 small children, accidental ingestion increases the risk for NSAID adverse effects.
In case of
accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the
physician.
For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases
the risk for premature closure of the ductus arteriosus in the foetus.
Mild and transient diarrhoea, soft faeces or vomiting were commonly reported.
*
The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
not known (frequency cannot be estimated from the available data).
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.
Onsior must not be administered in conjunction with other NSAIDs. 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.
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.
4.9
For oral use.
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.
The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1-2.4 mg/kg. Administer
once daily at the same time every day, for up to 6 days according to the table below.
3
Body weight (kg)
Number of tablets
2.5 to < 6
1 tablet
6 to < 12
2 tablets
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.
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.
4.11 Withdrawalperiods
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs.
ATCvet code: QM01AH91.
5.1
Pharmacodynamic properties
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and
selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is
present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g.
in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme which is
responsible for the production of mediators including PGE
2
which induce pain, inflammation or fever.
In the
in vitro
whole blood assay in cats, robenacoxib was approximately 500
fold selective for COX-2
(IC
50
0.058 µM) as compared to COX-1 (IC
50
28.9 µM). 1-2 mg/kg robenacoxib tablets produced a
marked inhibition of COX-2 activity in cats and had no effect on COX-1 activity. In an inflammation
model in cats, robenacoxib injection had analgesic, anti-inflammatory and anti-pyretic actions and a
rapid onset of action (0.5 h). In clinical trials in cats, robenacoxib tablets reduced pain and
inflammation associated with musculoskeletal disorders.
5.2
Pharmacokinetic particulars
Absorption
After oral administration of robenacoxib tablets at approximately 2 mg/kg without food, peak blood
concentrations are attained rapidly with a T
max
of 0.5 h, a C
max
of 1159 ng/ml and an AUC of 1337
ng.h/ml. Co-administration of robenacoxib tablets with one third of the daily food ration produced no
change in T
max
(0.5 h), C
max
(1201 ng/ml) or AUC (1383 ng.h/ml). Co-administration of robenacoxib
tablets with the entire daily food ration produced no delay in T
max
(0.5 h), but a lower C
max
(691 ng/ml)
and a slightly lower AUC (1069 ng.h/ml). The systemic bioavailability of robenacoxib tablets was
49% without food.
Distribution
Robenacoxib has a relatively small volume of distribution (Vss 190 ml/kg) and is highly bound to
plasma proteins (>99%).
4
Biotransformation
Robenacoxib is extensively metabolised by the liver in cats Apart from one lactam metabolite, the
identity of other metabolites is not known in cats
Elimination
Robenacoxib is rapidly cleared from blood (CL 0.44 L/kg/h) with an elimination t
1/2
of 1.1 h after
intravenous administration. After oral administration of tablets, the terminal half-life from blood was
1.7 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood.
Robenacoxib is excreted predominantly via the biliary route (
∼
70 %) rather than via the kidneys
(
∼
30%). The pharmacokinetics of robenacoxib do not differ between male and female cats.
6.
6.1 List of excipients
Yeast powder
Cellulose, microcrystalline
Povidone (K-30)
Crospovidone
Silica, colloidal anhydrous
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
6.4. Specialprecautionsforstorage
Store below 30°C.
6.5 Nature and composition of immediate packaging
Cardboard box containing 1, 2, 5 or 10 Alu/Alu blisters. Each blister contains 6 tablets.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Novartis Animal Health UK Ltd
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
5
8.
EU/2/08/089/001-003
EU/2/08/089/021
9.
16.12.2008
10
06/2009
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA)
http://www.emea.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
1.
Onsior 5 mg tablets for dogs
Onsior 10 mg tablets for dogs
Onsior 20 mg tablets for dogs
Onsior 40 mg tablets for dogs
2.
Each tablet contains:
Active substance:
5 mg tablets: Robenacoxib 5 mg
10 mg tablets: Robenacoxib 10 mg
20 mg tablets: Robenacoxib 20 mg
40 mg tablets: Robenacoxib 40 mg
For a full list of excipients see section 6.1.
3.
Tablet
Round, beige to brown tablets with the imprint “NA” on one side and the following imprint on the
other side:
5 mg tablet: AK
10 mg tablet: BE
20 mg tablet: CD
40 mg tablet: BCK
4.
4.1
Dog
4.2
For the treatment of pain and inflammation associated with chronic osteoarthritis in dogs.
4.3
Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs
(NSAIDs).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
See section 4.7 (pregnancy and lactation).
4.4
In clinical studies, inadequate response to treatment was seen in 10-15% of the dogs.
7
4.5
The safety of the 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 clinical signs
such as anorexia, apathy or vomiting in combination with elevated liver enzymes.
Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or
hypotensive may involve additional risks. If use cannot be avoided, these dogs require careful
monitoring.
Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if
the dog 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 increases
the risk of premature closure of the ductus arteriosus in the foetus.
Gastrointestinal adverse events 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 there were no
clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment.
Increases in liver enzyme activities associated with clinical signs of anorexia, apathy or vomiting were
uncommon.
*
The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
not known (frequency cannot be estimated from the available data).
Do not use in pregnant or lactating dogs because the safety of robenacoxib has not been established
during pregnancy and lactation or in dogs used for breeding.
8
Onsior must not be administered in conjunction with other NSAIDs. 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.
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.
4.9
For oral use.
Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib when
administered without food or at least 30 minutes before or after a meal.
Onsior tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided
or broken.
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.
Body weight (kg)
Number of tablets
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 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
.
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.
9
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs.
ATCvet code: QM01AH91.
5.1
Pharmacodynamic properties
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and
selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is
present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g.
in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible
for the production of mediators including PGE
2
which induce pain, inflammation or fever.
In an
in vitro
whole blood assay in dogs, robenacoxib was approximately 140 fold selective for COX-
2 (IC
50
0.04 µM) as compared to COX-1 (IC
50
7.9 µM). Robenacoxib produced marked inhibition of
COX-2 activity and had no effect on COX-1 activity in dogs at oral doses ranging from 0.5 to 4
mg/kg. Robenacoxib tablets are therefore COX-1 sparing at recommended doses in dogs. Robenacoxib
had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses
ranging from 0.5 to 8 mg/kg, with an ID
50
of 0.8 mg/kg and a rapid onset of action (0.5 h). In clinical
trials robenacoxib tablets reduced the lameness and inflammation of dogs with chronic osteoarthritis.
5.2
Pharmacokinetic particulars
Absorption
After oral administration of robenacoxib flavoured tablets at 1 mg/kg without food, peak blood
concentrations are attained rapidly with a T
max
of 0.5 h, a C
max
of 1124 ng/ml and an AUC of 1249
ng.h/ml. Co-administration of robenacoxib non-flavoured tablets with food produced no delay in T
max
,
but slightly lower values for C
max
(832 ng/ml) and AUC (782 ng.h/ml). The systemic bioavailability of
robenacoxib tablets in dogs was 62% with food and 84% without food.
Distribution
Robenacoxib has a relatively small volume of distribution (Vss 240 ml/kg) and is highly bound to
plasma proteins (>99%).
Biotransformation
Robenacoxib is extensively metabolised by the liver in dogs. Apart from one lactam metabolite, the
identity of other metabolites is not known in dogs.
Elimination
Robenacoxib is cleared rapidly from blood (CL 0.81 L/kg/h) with an elimination t
1/2
of 0.7 h after
intravenous administration
.
After oral administration of the tablets, the terminal half-life in blood was
1.2 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood.
Robenacoxib is excreted predominately via the biliary route (
∼
10
65 %) and the remainder via the
kidneys. Repeated oral administration of robenacoxib to dogs at dosages of 2 -10 mg/kg for 6 months
produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme
induction. Accumulation of metabolites has not been tested. The pharmacokinetics of robenacoxib do
not differ between male and female dogs, and are linear over the range 0.5-8 mg/kg.
6.
6.1 List of excipients
Yeast powder
Cellulose, microcrystalline
Flavour, artificial beef
Cellulose, powdered
Povidone (K-30)
Crospovidone
Silica, colloidal anhydrous
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months
6.4. Specialprecautionsforstorage
Do not store above 25°C.
6.5 Nature and composition of immediate packaging
Cardboard box containing 1, 2, 4 or 10 Alu/Alu blisters. Each blister contains 7 tablets.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Novartis Animal Health UK Ltd
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
8.
EU/2/08/089/004-019
9.
16.12.2008
11
10
06/2009
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA)
http://www.emea.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
12
1.
Onsior 20 mg/ml solution for injection for cats and dogs
2.
Each ml contains :
Active substance:
Robenacoxib 20 mg
Excipient:
Sodium metabisulphite (E 223): 1 mg
For a full list of excipients see section 6.1.
3.
Solution for injection.
Clear, colourless to slightly coloured (pink) liquid
4.
4.1
Cats and dogs.
4.2
For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs.
For the treatment of pain and inflammation associated with soft tissue surgery in cats.
4.3
Do not use in animals suffering from gastrointestinal ulceration.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs
(NSAIDs).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
See section 4.7 (pregnancy and lactation).
4.4
None.
4.5
The safety of the veterinary medicinal product has not been established in cats less than 4 months of
age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Use in animals with impaired cardiac, renal or hepatic function or that are dehydrated, hypovolaemic
or hypotensive may involve additional risks. If use cannot be avoided, these animals require careful
monitoring and fluid therapy.
13
Use this veterinary medicinal product under strict veterinary monitoring in cases at risk of
gastrointestinal ulceration, 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 and exposed skin immediately after use of the product
In case of accidental ingestion or self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
For pregnant women, particularly near term pregnant women, accidental injection and prolonged
dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus.
Cats:
Gastrointestinal adverse events (such as vomiting) were very commonly reported, but most cases were
mild and recovered without treatment. Diarrhoea or vomiting with blood were uncommon..
Slight pain at injection was very commonly reported. Moderate or severe pain at injection was
commonly reported.
Dogs:
Gastrointestinal adverse events (such as vomiting) were commonly reported but most cases were mild
and recovered without treatment. Diarrhoea, soft and dark faeces or reduced appetite were uncommon.
Slight pain at injection was commonly reported. Moderate or severe pain at injection was uncommon.
*
The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
not known (frequency cannot be estimated from the available data).
Do not use in pregnant and lactating animals because the safety of robenacoxib has not been
established during pregnancy and lactation or in cats and dogs used for breeding.
Onsior must not be administered in conjunction with other NSAIDs. 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.
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.
14
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.
4.9
Subcutaneous use.
Administer subcutaneously to cats or dogs approximately 30 minutes before the start of surgery, for
example around the time of induction of general anaesthesia, at a dose of 1 ml per 10 kg of body
weight (2 mg/kg).
In healthy young dogs aged 6 months, once daily subcutaneous administration of robenacoxib at doses
of 2 (recommended therapeutic dose; RTD), 6 (3 times RTD), and 20 mg/kg (10 times RTD) for 9
administrations over a 5 week period (3 cycles of 3 consecutive once daily injections) did not produce
any signs of toxicity, including no gastrointestinal, kidney or liver toxicity and no effect on bleeding
time
.
Reversible inflammation at the injection site was noted in all groups (including controls) and was
more severe in the 6 and 20 mg/kg dose groups.
In healthy young cats aged 10 months, once daily subcutaneous administration of robenacoxib at doses
of 4 mg/kg (twice RTD) for 2 consecutive days and 10 mg/kg (5 times RTD) for 3 consecutive days
did not produce any signs of toxicity, including no signs of gastrointestinal, kidney or liver toxicity
and no effect on bleeding time. Reversible, minimal injection site reactions were noted in both dose
groups.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or
compromised animals. There is no specific antidote. Symptomatic, supportive therapy is
recommended consisting of administration of gastrointestinal protective agents and infusion of
isotonic saline.
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs.
ATCvet code: QM01AH91.
5.1
Pharmacodynamic properties
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and
selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is
present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g.
in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible
for the production of mediators including PGE
2
which induce pain, inflammation or fever.
In
cats
, using an
in vitro
whole blood assay , robenacoxib was approximately 500 fold selective for
COX-2 (IC
50
0.058 µM) as compared to COX-1 (IC
50
28.9 µM).
In vivo,
robenacoxib solution for
injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity. At the
recommended dosage (2 mg/kg), analgesic, anti-inflammatory and anti-pyretic effects were
demonstrated in an inflammation model, and in clinical trials, robenacoxib reduced pain and
inflammation in cats undergoing soft tissue surgery.
15
In
dogs
, robenacoxib was
in vitro
approximately 140 fold selective for COX-2 (IC
50
0.04 µM) as
compared to COX-1 (IC
50
7.9 µM).
In vivo
, robenacoxib solution for injection produced marked
inhibition of COX-2 activity and had no effect on COX-1 activity. At dosages ranging from 0.25 to 4
mg/kg, robenacoxib had analgesic, anti-inflammatory and anti-pyretic effects in an inflammation
model with a rapid onset of action (1 h). In clinical trials at the recommended dose (2 mg/kg),
robenacoxib reduced pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery.
5.2
Pharmacokinetic particulars
Absorption
Peak blood concentrations of robenacoxib are attained rapidly after subcutaneous injection in cats and
dogs. After a dosage of 2 mg/kg a T
max
of 1 h (cats and dogs), a C
max
of 1464 ng/ml (cats) and 615
ng/ml (dogs), and an AUC of 3128 ng.h/ml (cats) and 2180 ng.h/ml (dogs) is obtained. After a
subcutaneous administration of 1 mg/kg the systemic bioavailability is 69% in cats and 88% in dogs.
Distribution
Robenacoxib has a relatively small volume of distribution (Vss of 190 ml/kg in cats and 240 ml/kg in
dogs) and is highly bound to plasma proteins (>99%).
Biotransformation
Robenacoxib is extensively metabolised by the liver in cats and dogs. Apart from one lactam
metabolite, the identity of other metabolites is not known in cats or dogs.
65 %) and the
remainder via the kidneys. Repeated subcutaneous administration at dosages of 2 -20 mg/kg produced
no change in the blood profile, with neither bioaccumulation of robenacoxib nor enzyme induction.
Bioaccumulation of metabolites has not been tested. The pharmacokinetics of robenacoxib injection
do not differ between male and female cats and dogs, and are linear over the range of 0.25-4 mg/kg in
dogs.
∼
70 %) and dogs (
∼
6.
6.1 List of excipients
Macrogol 400
Ethanol, anhydrous
Poloxamer 188
Citric acid monohydrate
Sodium metabisulphite (E 223)
Sodium hydroxide
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
16
Elimination
After intravenous administration robenacoxib was rapidly cleared from blood (CL of 0.44 L/kg/h in
cats and 0.81 L/kg/h in dogs) with an elimination t
1/2
of 1.1 h in cats and 0.8 h in dogs
.
After
subcutaneous administration, the terminal half-life from blood was 1.1 h in cats and 1.2 h in dogs.
Robenacoxib persists longer and in higher concentrations at sites of inflammation than in blood.
Robenacoxib is excreted predominately via the biliary route in cats (
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first broaching of the vial: 28 days.
6.4. Specialprecautionsforstorage
Store in a refrigerator (2° C-8° C). Avoid introduction of contamination. Keep the vial in the outer carton.
6.5 Nature and composition of immediate packaging
Multi-dose amber glass vial containing 20 ml solution for injection, closed with a rubber stopper and
sealed with an aluminium cap. One vial packed in a cardboard box.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Novartis Animal Health UK Ltd
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
8.
EU/2/08/089/020
9.
16.12.2008
10
06/2009
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA)
http://www.emea.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
17
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
18
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) responsible for batch release
Tablets:
Novartis Santé Animale S.A.S.
26 Rue de la Chapelle
F-68330 Huningue
France.
Solution for injection:
Vericore Ltd., Kinnoull Road
Kingsway West
Dundee DD2 3XR
United Kingdom
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D.
STATEMENT OF THE MRLs
Not applicable.
19
ANNEX III
LABELLING AND PACKAGE LEAFLET
20
A. LABELLING
21
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
NATURE/TYPE: Cardboard box
1.
Onsior 6 mg tablets for cats
Robenacoxib
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 6 mg Robenacoxib
3.
Tablet
4.
PACKAGE SIZE
6 tablets
12 tablets
30 tablets
60 tablets
5.
Cat
6.
Not applicable
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
22
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store below 30
°
C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: Read Package leaflet.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Novartis Animal Health UK Ltd.
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
EU/2/08/089/001 (6 tablets)
EU/2/08/089/002 (12 tablets)
EU/2/08/089/021 (30 tablets)
EU/2/08/089/003 (60 tablets)
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
23
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURE/TYPE: Blister foil
1.
Onsior 6 mg tablets for cats
Robenacoxib
2.
Novartis Animal Health
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
24
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
NATURE/TYPE: Cardboard box
1.
Onsior 5 mg tablets for dogs
Robenacoxib
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 5 mg Robenacoxib
3.
Tablet
4.
PACKAGE SIZE
7 tablets
14 tablets
28 tablets
70 tablets
5.
Dog
6.
Not applicable
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use
25
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store below 25
°
C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: Read Package leaflet
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Novartis Animal Health UK Ltd.
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
EU/2/08/089/004 (7 tablets)
EU/2/08/089/005 (14 tablets)
EU/2/08/089/006 (28 tablets)
EU/2/08/089/007 (70 tablets)
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
26
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
NATURE/TYPE: Cardboard box
1.
Onsior 10 mg tablets for dogs
Robenacoxib
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 10 mg Robenacoxib
3.
Tablet
4.
PACKAGE SIZE
7 tablets
14 tablets
28 tablets
70 tablets
5.
Dog
6.
Not applicable
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use
27
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store below 25
°
C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: Read Package leaflet
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Novartis Animal Health UK Ltd.
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
EU/2/08/089/008 (7 tablets)
EU/2/08/089/009 (14 tablets)
EU/2/08/089/010 (28 tablets)
EU/2/08/089/011 (70 tablets)
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
28
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
NATURE/TYPE: Cardboard box
1.
Onsior 20 mg tablets for dogs
Robenacoxib
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 20 mg Robenacoxib
3.
Tablet
4.
PACKAGE SIZE
7 tablets
14 tablets
28 tablets
70 tablets
5.
Dog
6.
Not applicable
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use
29
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store below 25
°
C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: Read Package leaflet
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Novartis Animal Health UK Ltd.
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
EU/2/08/089/012 (7 tablets)
EU/2/08/089/013 (14 tablets)
EU/2/08/089/014 (28 tablets)
EU/2/08/089/015 (70 tablets)
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
30
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
NATURE/TYPE: Cardboard box
1.
Onsior 40 mg tablets for dogs
Robenacoxib
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 40 mg Robenacoxib
3.
Tablet
4.
PACKAGE SIZE
7 tablets
14 tablets
28 tablets
70 tablets
5.
Dog
6.
Not applicable
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use
31
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store below 25
°
C.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: Read Package leaflet
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Novartis Animal Health UK Ltd.
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
EU/2/08/089/016 (7 tablets)
EU/2/08/089/017 (14 tablets)
EU/2/08/089/018 (28 tablets)
EU/2/08/089/019 (70 tablets)
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
32
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURE/TYPE: Blister foil
1.
Onsior 5 mg tablets for dogs
Robenacoxib
2.
Novartis Animal Health
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
33
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURE/TYPE: Blister foil
1.
Onsior 10 mg tablets for dogs
Robenacoxib
2.
Novartis Animal Health
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
34
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURE/TYPE: Blister foil
1.
Onsior 20 mg tablets for dogs
Robenacoxib
2.
Novartis Animal Health
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
35
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
NATURE/TYPE: Blister foil
1.
Onsior 40 mg tablets for dogs
Robenacoxib
2.
Novartis Animal Health
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
36
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
NATURE/TYPE: Cardboard box
1.
Onsior 20 mg/ml solution for injection for cats and dogs
Robenacoxib
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
20 mg/ml Robenacoxib
1 mg/ml Sodium metabisulphite (E 223)
3.
Solution for injection
4.
PACKAGE SIZE
20 ml
5.
Cats and dogs
6.
Not applicable
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use. Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use
37
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 28 days by…
11. SPECIAL STORAGE CONDITIONS
Store in a refrigerator (2° C – 8° C). Keep the vial in the outer carton.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: Read Package leaflet
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Novartis Animal Health UK Ltd.
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
EU/2/08/089/020
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
38
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
NATURE/TYPE: Glass vial
1.
Onsior 20 mg/ml solution for injection for cats and dogs
Robenacoxib
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
20 mg/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
20 ml
4.
ROUTE(S) OF ADMINISTRATION
Subcutaneous use
5.
Not applicable
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use by…
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET FOR:
Onsior 6 mg tablets for cats
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Novartis Animal Health UK Ltd
Frimley Business Park
Frimley/Camberley
Surrey, GU16 7SR
United Kingdom
Manufacturer for the batch release
:
Novartis Santé Animale S.A.S.
26 Rue de la Chapelle
F-68330 Huningue
France
2.
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.
For the treatment of acute pain and inflammation associated with musculo-skeletal disorders in cats.
5.
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, lactating or cats used for breeding because the safety of this product has not
been established in these animals.
41
6.
ADVERSE REACTIONS*
Mild and transient diarrhoea, soft faeces or vomiting were commonly reported.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
*
The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
not known (frequency cannot be estimated from the available data).
7.
Cat
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. Administer
once daily at the same time every day, for up to 6 days according to the table below.
Body weight (kg)
Number of tablets
2.5 to less than 6
1 tablet
6 to less than 12
2 tablets
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
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children. Store below 30°C. Do not use after the expiry date stated
on the blister after EXP.
42
12. SPECIAL WARNING(S)
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.
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.
Onsior must not be administered in conjunction with other NSAIDs. 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 angiotensin
converting enzyme (ACE) inhibitors, should be subject to clinical monitoring.
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.
For 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.
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.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
06/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA)
http://www.emea.europa.eu
/.
43
15. OTHER INFORMATION
Onsior tablets for cats are available in cardboard boxes containing 1, 2, 5 or 10 blisters. Each blister
contains 6 tablets. 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. This product reduced pain and inflammation associated with
musculoskeletal disorders in clinical trials in cats.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Luxembourg/Luxemburg
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Република България
Novartis Animal Health d.o.o.
Teл: + 386 1 580 2884
Magyarország
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Česká republika
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Malta
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Danmark
Novartis Healthcare A/S,
Tlf: +45-39 16 84 00
Nederland
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Deutschland
Novartis Tiergesundheit GmbH
Tel: +49-(0)89 7877 713
Norge
Novartis Healthcare A/S,
Tlf: +45-39 16 84 00
Eesti
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Österreich
Novartis Animal Health GmbH
Tel: +43-(0) 5338 2000
Ελλάδα
Premier Shukuroglou Hellas SA
Tηλ: +39-210 6538-061/181
Polska
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
España
Novartis Sanidad Animal, S.L.
Tel: +34-93 306 4700
Portugal
Novartis Farma-Produtos Farmacêuticos, S.A.
Tel: +351-21 000 86 00
France
Novartis Santé Animale S.A.S.
Tél: +33)-(0)1 55 47 87 47
România
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Ireland
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Slovenija
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Ísland
Novartis Healthcare A/S
Sími: +45-39 16 84 00
Slovenská republika
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Italia
Novartis Animal Health S.p.A.
Tel: +39-02 96542205
Suomi/Finland
Novartis Healthcare A/S,
Puh/Tel: +45-39 16 84 00
Κύπρος
Premier Shukuroglou Ltd
Tηλ: +357 22 81 53 53
Sverige
Novartis Healthcare A/S
Tel: +45-39 16 84 00
Latvija
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
United Kingdom
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
44
Lietuva
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
45
PACKAGE LEAFLET FOR:
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.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Novartis Animal Health UK Ltd
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
Manufacturer for the batch release
:
Novartis Santé Animale S.A.S.
26 Rue de la Chapelle
F-68330 Huningue
France
2.
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
AK
10 mg
BE
20 mg
BCK
Tablets are round, beige to brown and non-divisible. Onsior tablets are flavoured and are taken
voluntarily by most dogs.
4.
For the treatment of pain and inflammation of chronic osteoarthritis in dogs.
46
40 mg
CD
5.
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.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
*
The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
not known (frequency cannot be estimated from the available data).
7.
Dog
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
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.
Body weight (kg)
Number of tablets by size
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.
47
For long-term treatment, once 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 osteoartritis may vary over time. Regular monitoring should be undertaken by the
veterinarian
.
9.
ADVICE ON CORRECT ADMINISTRATION
Give orally. Do not administer with food since clinical trials demonstrated better efficacy of
robenacoxib when administered without food or at least 30 minutes before or after a meal. Onsior
tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or
broken.
10. WITHDRAWAL PERIOD
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children. Store below 25°C. Do not use after the expiry date stated
on the blister after EXP.
12. SPECIAL WARNING(S)
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.
Onsior must not be administered in conjunction with other NSAIDs. 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.
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.
48
For 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.
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.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
06/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA)
http://www.emea.europa.eu
/.
15. OTHER INFORMATION
Onsior tablets for dogs are available in cardboard boxes containing 1, 2, 4 or 10 blisters. Each blister
contains 7 tablets. 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). This product reduced in
clinical trials the lameness and inflammation of dogs with chronic osteoarthritis.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Luxembourg/Luxemburg
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Република България
Novartis Animal Health d.o.o.
Teл: + 386 1 580 2884
Magyarország
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Česká republika
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Malta
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Danmark
Novartis Healthcare A/S,
Tlf: +45-39 16 84 00
Nederland
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
49
Deutschland
Novartis Tiergesundheit GmbH
Tel: +49-(0)89 7877 713
Norge
Novartis Healthcare A/S,
Tlf: +45-39 16 84 00
Eesti
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Österreich
Novartis Animal Health GmbH
Tel: +43-(0) 5338 2000
Ελλάδα
Premier Shukuroglou Hellas SA
Tηλ: +39-210 6538-061/181
Polska
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
España
Novartis Sanidad Animal, S.L.
Tel: +34-93 306 4700
Portugal
Novartis Farma-Produtos Farmacêuticos, S.A.
Tel: +351-21 000 86 00
France
Novartis Santé Animale S.A.S.
Tél: +33)-(0)1 55 47 87 47
România
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Ireland
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Slovenija
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Ísland
Novartis Healthcare A/S
Sími: +45-39 16 84 00
Slovenská republika
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Italia
Novartis Animal Health S.p.A.
Tel: +39-02 96542205
Suomi/Finland
Novartis Healthcare A/S,
Puh/Tel: +45-39 16 84 00
Κύπρος
Premier Shukuroglou Ltd
Tηλ: +357 22 81 53 53
Sverige
Novartis Healthcare A/S
Tel: +45-39 16 84 00
Latvija
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
United Kingdom
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Lietuva
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
50
PACKAGE LEAFLET FOR:
Onsior 20 mg/ml solution for injection for cats and dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Novartis Animal Health UK Ltd
Frimley Business Park
Frimley/Camberley, Surrey, GU16 7SR
United Kingdom
Manufacturer for the batch release
:
Vericore Ltd.
Kinnoull Road
Kingsway West
Dundee DD2 3XR
United Kingdom
2.
Onsior 20 mg/ml solution for injection for cats and dogs
Robenacoxib
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains 20 mg robenacoxib as active substance and 1 mg sodium metabisulphite (E 223) as
an antioxidant.
The solution for injection is a clear, colourless to slightly coloured (pink) liquid.
4.
For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs.
For the treatment of pain and inflammation associated with soft tissue surgery in cats.
5.
Do not use in animals suffering from gastrointestinal ulceration.
Do not use together with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Do not use in case of hypersensitivity to robenacoxib or to any ingredients of the solution.
Do not use in pregnant or lactating animals because the safety of robenacoxib has not been established
during pregnancy and lactation or in cats and dogs used for breeding.
6.
ADVERSE REACTIONS*
Cats:
Adverse reactions of the digestive tract (such as vomiting) were very commonly reported, but most
cases were mild and recovered without treatment. Diarrhoea or vomiting with blood were uncommon..
Slight pain at injection was very commonly reported. Moderate or severe pain at injection was
commonly reported.
51
Dogs:
Adverse reactions of the digestive tract (such as vomiting) were commonly reported but most cases
were mild and recovered without treatment. Diarrhoea, soft and dark faeces or reduced appetite were
uncommon.
Slight pain at injection was commonly reported. Moderate or severe pain at injection was uncommon.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
*
The frequency of possible adverse effects is defined using the following convention:
very common (affects more than 1 animal in 10)
common (affects 1 to 10 animals in 100)
uncommon (affects 1 to 10 animals in 1,000)
rare (affects 1 to 10 animals in 10,000)
very rare (affects less than 1 animals in 10,000)
not known (frequency cannot be estimated from the available data).
7.
Cat and dog
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administer the solution subcutaneously to cats or dogs approximately 30 minutes before the start of
surgery, for example around the time of induction of general anaesthesia, at a dose of 1 ml per 10 kg
of body weight (2 mg/kg).
9.
ADVICE ON CORRECT ADMINISTRATION
None
10. WITHDRAWAL PERIOD
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in a refrigerator (2° C-8° C).
Avoid introduction of contamination.
Keep the vial in the outer carton.
Do not use after the expiry date stated on the label after EXP. After first broaching of the vial, the
product may be stored for 28 days.
52
12. SPECIAL WARNING(S)
The safety of this veterinary medicinal product has not been established in cats less than 4 months of
age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.
Use in animals with impaired function of the heart, kidneys or liver or in animals that are dehydrated,
have low volume of circulating blood or have low blood pressure may involve additional risks. If use
cannot be avoided, these animals require careful monitoring and fluid therapy.
Use this veterinary medicinal product under strict veterinary monitoring in animals at risk of
ulceration of the digestive tract, or if the animal previously displayed intolerance to other NSAIDs.
Onsior must not be administered in conjunction with other NSAIDs. 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.
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.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.
For the person administering the veterinary medicinal product to animals
Wash hands and exposed skin immediately after use of the veterinary medicinal product.
In case of accidental ingestion or self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
For pregnant women, particularly near term pregnant women, accidental injection and prolonged
dermal exposure might increase the risk to the foetus.
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.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
06/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA)
http://www.emea.europa.eu
/.
53
15. OTHER INFORMATION
Onsior solution for injection for cats and dogs is available in a cardboard box containing 1 vial with 20
ml solution for injection.
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 cats and dogs, robenacoxib reduced pain, inflammation and
fever at the recommended doses with a rapid onset of action (1 h).
This product reduced in clinical trials pain and inflammation in cats undergoing soft tissue surgery and
pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Luxembourg/Luxemburg
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Република България
Novartis Animal Health d.o.o.
Teл: + 386 1 580 2884
Magyarország
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Česká republika
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Malta
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Danmark
Novartis Healthcare A/S,
Tlf: +45-39 16 84 00
Nederland
Novartis Consumer Health B.V.
Tel /Tél: +31-76 533 00 20
Deutschland
Novartis Tiergesundheit GmbH
Tel: +49-(0)89 7877 713
Norge
Novartis Healthcare A/S,
Tlf: +45-39 16 84 00
Eesti
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Österreich
Novartis Animal Health GmbH
Tel: +43-(0) 5338 2000
Ελλάδα
Premier Shukuroglou Hellas SA
Tηλ: +39-210 6538-061/181
Polska
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
España
Novartis Sanidad Animal, S.L.
Tel: +34-93 306 4700
Portugal
Novartis Farma-Produtos Farmacêuticos, S.A.
Tel: +351-21 000 86 00
France
Novartis Santé Animale S.A.S.
Tél: +33)-(0)1 55 47 87 47
România
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Ireland
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Slovenija
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Ísland
Novartis Healthcare A/S
Sími: +45-39 16 84 00
Slovenská republika
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
Italia
Novartis Animal Health S.p.A.
Tel: +39-02 96542205
Suomi/Finland
Novartis Healthcare A/S,
Puh/Tel: +45-39 16 84 00
Κύπρος
Premier Shukuroglou Ltd
Tηλ: +357 22 81 53 53
Sverige
Novartis Healthcare A/S
Tel: +45-39 16 84 00
54
Latvija
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
United Kingdom
Novartis Animal Health UK Ltd.
Tel: +44-(0) 1276 69 4402
Lietuva
Novartis Animal Health d.o.o.
Tel: + 386 1 580 2884
55
Source: European Medicines Agency
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