Summary of medicine characteristics - Melosus
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Meloxicam 1.5 mg
Excipient:
Sodium benzoate 1.75 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension.
Yellow/green suspension.
4. CLINICAL PARTICULARS4.1 Target species
Dogs
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4.2 Indications for use, specifying the target species
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
4.3 Contraindications
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.
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4.4 Special warnings for each target species
None.
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4.5 Special precautions for use
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Melosus 0.5 mg/ml oral suspension for cats should be used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to 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.
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4.6 Adverse reactions (frequency and seriousness)
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reactions)
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in pregnant or lactating animals (See section 4.3).
4.8 Interaction with other medicinal products and other forms of interaction
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. 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.
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4.9 Amounts to be administered and administration route
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.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose symptomatic treatment should be initiated.
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4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATC vet 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).
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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.
6. PHARMACEUTICAL PARTICULARS6.1 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 Major 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.
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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.
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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 product should be disposed of in accordance with local requirements.
7.
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
8. 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)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21/02/2011
Date of last renewal: 07/01/2016
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXTDetailed information on this veterinary medicinal product is available on the website of the
European Medicines Agency.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Meloxicam 0.5 mg
Excipient:
Sodium benzoate 1.75 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension.
Yellow/green suspension.
4. CLINICAL PARTICULARS4.1 Target species
Cats and guinea pigs
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4.2 Indications for use, specifying the target species
Cats:
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.
Guinea pigs:
Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.
4.3 Contraindications
Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
Do not use in guinea pigs less than 4 weeks of age.
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4.4 Special warnings for each target species
None.
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4.5 Special precautions for use
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Post-operative use in cats and guinea pigs:
In case additional pain relief is required, multimodal pain therapy should be considered.
Chronic musculoskeletal disorders in cats:
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.
-
4.6 Adverse reactions (frequency and seriousness)
In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported.
These adverse reactions are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
-
– very common (more than 1 in 10 animals treated displaying adverse reactions)
-
– common (more than 1 but less than 10 animals in 100 animals treated)
-
– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
-
– rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
-
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in pregnant or lactating animals (See section 4.3).
4.8 Interaction with other medicinal products and other forms of interaction
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. 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.
-
4.9 Amounts to be administered and administration route
Oral use.
To be administered either mixed with food or directly into the mouth.
Shake well before use.
Avoid introduction of contamination during use.
Cats:
Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with meloxicam solution for injection for cats, continue treatment 24 hours later with Melosus 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.
Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight.
A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.
Route and method of administration
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.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.
Guinea pigs:
Dosage
Post-operative pain associated with soft tissue surgery :
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery). Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg meloxicam/kg body weight on day 2 to day 3 (post-surgery).
The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.
Route and method of administration
The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.
Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight
Use a small container (e.g. a teaspoon) and drop Melosus oral suspension into the container (it is advised to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw up Melosus according to the bodyweight of the guinea pig. Administer Melosus with the syringe directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next use.
Do not use the cat syringe with the kg-body weight scale for guinea pigs.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
In guinea pigs, an overdose of 0.6 mg/kg body weight administered during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.
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4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATC vet 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
Cats:
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).
Guinea pigs:
No data available.
6. PHARMACEUTICAL PARTICULARS6.1 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 Major 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 5 ml, 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 product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
D-31303 Burgdorf
Germany
8. MARKETING AUTHORISATION NUMBERS
EU/2/10/116/007 (5 ml)
EU/2/10/116/006 (10 ml)
EU/2/10/116/004 (25 ml)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 21/02/2011
Date of last renewal: 07/01/2016