ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Melosus 1.5 mg/ml oral suspension for dogs
2.
One ml contains:
Active substance:
Meloxicam
1.5 mg
Excipient:
Sodium benzoate
1.75 mg
For a full list of excipients, see section 6.1.
3.
Oral suspension.
Yellow/ green suspension.
4.
Dogs
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
2
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased
renal toxicity.
Special precautions to be taken by the person administering the veterinary
medicinal product to
animals
People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. These adverse reactions occur generally within
the first treatment week and are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Melosus must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacokinetic properties of the products used previously.
Oral use.
To be administered either mixed with food or directly into the mouth.
Shake well before use.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Melosus
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.
Particular care should be taken with regard to the accuracy of dosing.
The suspension can be given using the measuring syringe provided in the package.
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to
the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
3
A clinical response is normally seen within 3 - 4 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
In case of overdose symptomatic treatment should be initiated.
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code:
QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.
4
6.
6.1 List of excipients
-
Sodium benzoate
-
Sorbitol
-
Glycerol
-
Polysorbate 80
-
Disodium phosphate dodecahydrate
-
Silica, colloidal anhydrous
-
Hydroxyethylcellulose
-
Citric acid monohydrate
-
Sodium cyclamate
-
Sucralose
-
Anise aroma
-
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
6 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Polyethylene bottle containing 10 ml, 25 ml, 50 ml or 125 ml with a tamper proof child resistant closure
and a polypropylene measuring syringe.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products 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.
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
5
Shelf-life after first opening the immediate packaging:
3 years
8.
EU/2/10/116/005 10 ml
EU/2/10/116/001 25 ml
EU/2/10/116/002 50 ml
EU/2/10/116/003 125 ml
9.
21.02.2011
12.05.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
6
1.
Melosus 0.5 mg/ml oral suspension for cats
2.
One ml contains:
Active substance:
Meloxicam
0.5 mg
Excipient:
Sodium benzoate
1.75 mg
For a full list of excipients, see section 6.1.
3.
Oral suspension.
Yellow/ green suspension.
4.
Cats
Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
7
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Melosus 0.5 mg/ml oral suspension for cats should not be used following parenteral injection of
meloxicam or any other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) as appropriate dosage
regimens for such follow-up treatments have not been established in cats.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. These adverse reactions are in most cases
transient and disappear following termination of the treatment but in very rare cases may be serious or
fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Melosus must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products should be avoided.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacokinetic properties of the products used previously.
Oral use.
To be administered either mixed with food or directly into the mouth.
Shake well before use.
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg
meloxicam/kg body weight.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not
be exceeded.
The suspension can be given using the measuring syringe provided in the package. The syringe fits onto
the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance
dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the
latest if no clinical improvement is apparent.
8
Avoid introduction of contamination during use.
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at
relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more
frequent. In case of overdose symptomatic treatment should be initiated.
Not applicable.
5.
Pharmacotherapeutic group:
Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code:
QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately
3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine. Due to the loading dose, steady state is reached after 2
days (48h).
9
6.
6.1 List of excipients
-
Sodium benzoate
-
Glycerol
-
Polysorbate 80
-
Disodium phosphate dodecahydrate
-
Silica, colloidal anhydrous
-
Hydroxyethylcellulose
-
Citric acid monohydrate
-
Sodium cyclamate
-
Sucralose
-
Anise aroma
-
Water, purified
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening the immediate packaging: 6 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Polyethylene bottle containing 10 ml or 25 ml with a tamper proof child resistant closure and a
polypropylene measuring syringe
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products 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.
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
10
-
Sorbitol
8.
EU/2/10/116/006 10 ml
EU/2/10/116/004 25 ml
9.
21.02.2011
12.05.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
12
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
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.
13
ANNEX III
LABELLING AND PACKAGE LEAFLET
14
A. LABELLING
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Melosus 1.5 mg/ml oral suspension for dogs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains:
Meloxicam 1.5 mg
Sodium benzoate 1.75 mg
3.
Oral suspension
4.
PACKAGE SIZES
10 ml
25 ml
50 ml
125 ml
5.
Dogs
6.
INDICATION(S)
Acute and chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered with food or directly into the mouth. Read the package leaflet before use.
8.
Not applicable.
16
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP {month/year}
Shelf-life of opened bottle: 6 months.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Read the package leaflet before use
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.
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/10/116/005 10 ml
EU/2/10/116/001 25 ml
EU/2/10/116/002 50 ml
EU/2/10/116/003 125 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
17
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Melosus 1.5 mg/ml oral suspension for dogs
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
1.5 mg/ml
3.
CONTENT BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
10 ml
25 ml
50 ml
4.
ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once opened, use within 6 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
18
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
1.
Melosus 1.5 mg/ml oral suspension for dogs
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam
1.5 mg/ml
3.
Oral suspension
4.
PACKAGE SIZES
125 ml
5.
Dogs
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Oral use.
Read the package leaflet before use.
8.
Not applicable.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
19
10. EXPIRY DATE
EXP {month/year}
Once opened use within 6 months.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Read the package leaflet before use.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Read the package leaflet before use.
CP-Pharma Handelsgesellschaft mbH, Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/10/116/003
125 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
20
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Melosus 0.5 mg/ml oral suspension for cats
Meloxicam
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains:
Meloxicam 0.5 mg
Sodium benzoate 1.75 mg
3.
Oral suspension
4.
PACKAGE SIZES
10 ml
25 ml
5.
Cats
6.
INDICATION(S)
Chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Shake well before use.
To be administered with food or directly into the mouth.Read the package leaflet before use.
8.
Not applicable.
21
9.
SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP {month/year}
Once opened, use within 6 months.
11. SPECIAL STORAGE CONDITIONS
Read the package leaflet before use.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Read the package leaflet before use.
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.
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
16. MARKETING AUTHORISATION NUMBERS
EU/2/10/116/006 10 ml
EU/2/10/116/004 25 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
22
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Melosus 0.5 mg/ml oral suspension for cats
Meloxicam
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam
0.5 mg/ml
3.
CONTENTS BY WEIGHT; BY VOLUME OR BY NUMBER OF DOSES
10 ml
25 ml
4.
ROUTE OF ADMINISTRATION
Oral use.
5.
Not applicable.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once opened, use within 6 months.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET FOR:
Melosus 1.5 mg/ml oral suspension for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
Manufacturer for the batch release:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
2.
Melosus 1.5 mg/ml oral suspension for dogs
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Meloxicam
1.5 mg/ml
4.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs .
5.
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.
6.
Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite,
vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. These
adverse reactions occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.
25
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
To be administered either mixed with food or directly into the mouth.
Shake well before use.
Dosage
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Melosus
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.
Method and route of administration
The suspension can be given using the Melosus measuring syringe provided in the package.
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to
the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
A clinical response is normally seen within 3 - 4 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.
After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The
syringe should be stored in the carton box in between uses.
To avoid introduction of external contaminants during use, keep the provided syringes only for this
product.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the
instructions of the veterinarian.
10. WITHDRAWAL PERIOD
Not applicable.
26
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the container: 6 months.
Do not use after the expiry date stated on the carton and the bottle after EXP.
12. SPECIAL WARNING(S)
Precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased
renal toxicity.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Melosus must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.
In case of overdose symptomatic treatment should be initiated.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label
to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
12.05.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
10, 25, 50 or 125 ml bottle.
Not all pack sizes may be marketed.
27
PACKAGE LEAFLET FOR:
Melosus 0.5 mg/ml oral suspension for cats
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
Manufacturer for the batch release:
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
2.
Melosus 0.5 mg/ml oral suspension for cats
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Meloxicam
0.5 mg/ml
4.
Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.
5.
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
6.
Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite,
vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. These
adverse reactions are in most cases transient and disappear following termination of the treatment but in
very rare cases may be serious or fatal.
28
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cats
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
To be administered orally either mixed with food or directly into the mouth.
Shake well before use.
Dosage
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg
meloxicam/kg body weight.
Method and route of administration
The suspension can be given using the Melosus measuring syringe provided in the package.
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to
the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the
latest if no clinical improvement is apparent.
After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The
syringe should be stored in the carton box in between uses.
To avoid introduction of external contaminants during use, keep the provided syringes only for this
product.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the
instructions of the veterinarian.
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf-life after first opening the container: 6 months.
29
Do not use after the expiry date stated on the carton and the bottle after EXP.
12. SPECIAL WARNING(S)
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of
increased renal toxicity.
Response to long-term therapy should be monitored at regular intervals by a veterinarian.
Melosus should not be used following parenteral injection of meloxicam or any other NSAIDs as
appropriate dosage regimens for such follow-up treatments have not been established in cats.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Melosus must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products should be avoided.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at
relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 6 "Adverse reactions", are expected to be more
severe and more frequent. In the case of overdose symptomatic treatment should be initiated.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label
to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
12.05.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu/
.
15 OTHER INFORMATION
10 or 25 ml bottle.
30
Source: European Medicines Agency
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