Meloxidyl
meloxicam
Marketing authorisation holder: Ceva Santé Animale
10 avenue de la Ballastière 33500 Libourne
France
Manufacturers responsible for batch release: Ceva Santé Animale
Z.I. Très le Bois 22600 Loudéac France
Vetem SpA
Lungomare Pirandello, 8 92014 Porto Empedocle (AG) Italy
Meloxidyl 1.5 mg/ml oral suspension for dogs. Meloxicam
Each ml contains:
1.5 mg of meloxicam
2 mg of sodium benzoate
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 animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product.
Do not use in dogs less than 6 weeks of age.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon
Dogs.
Oral use.
Shake well before use. To be administered mixed with food.
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.
The suspension can be given using the measuring syringes provided in the package. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1mg Meloxicam/kg body weight). Thus, for the first day, twice the maintenance volume will be required. Dosing procedure using the measuring syringe:
Shake bottle well. Push down and unscrew bottle top.
Attach the dosing syringe to the bottle by gently pushing the end onto the top of the bottle.
Turn the bottle and syringe upside down. Withdraw the plunger until the black line on the plunger corresponds to your dog’s bodyweight in kilograms.
Return the bottle and syringe upright and remove the syringe.
Depress the plunger to empty the contents of the syringe onto the food.
A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days after the latest if no clinical improvement is apparent.
To avoid introduction of external contaminants during use, do not remove the bottle insert and keep the provided syringes only for this product.
Particular care should be taken with regard to the accuracy of dosing.
The suspension could be administered using the smallest syringe for dogs less than 7 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 7 kg body weight (one graduation corresponding to 2.5 kg of body weight).
Not applicable.
Keep out of the sight and reach of children.
Shelf life after first opening the container: 6 months.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month.
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, if 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. Meloxidyl® must not be administered in conjunction with other NSAIDs or glucocortisosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse
effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
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.
In the case of overdosage, seek medical advice.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
10, 32 or 100 ml bottle with two syringes per presentation. Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale –10 avenue de la Ballastière – 33500 Libourne - France
Meloxidyl 5 mg/ml solution for injection for dogs, cats Meloxicam
Meloxicam 5 mg/ml Excipients: Ethanol 150 mg/ml
Clear, yellow solution.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.
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. In dogs, these side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon
Dogs and cats.
Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg). Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Dogs:
Musculo-skeletal disorders: single subcutaneous injection.
Meloxidyl 1.5 mg/ml oral suspension for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.
Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia. Avoid introduction of contamination during use.
Particular care should be taken with regard to the accuracy of dosing.
Not applicable.
Keep out of the sight and reach of children. Do not store above 25°C.
Do not use this veterinary medicinal product after the expiry date which is stated on the cardboard box
and the vial after EXP. The expiry date refers to the last day of that month. Shelf life after first opening the container: 28 days.
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.
Special precautions for use in animals:
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of
increased renal toxicity.
Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
Pregnancy and lactation:
See section “Contraindications”
Interaction with other medicinal products and other forms of interaction:
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxidyl®must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Overdose (symptoms, emergency procedures, antidotes):
In the case of overdose symptomatic treatment should be initiated.
Incompatibilities None known.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Pack size:
Cardboard box containing one 10 ml vial.
Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale –10 avenue de la Ballastière – 33500 Libourne - France
Meloxidyl 20 mg/ml solution for injection for cattle, pigs, horses Meloxicam
Meloxicam 20 mg/ml
Excipients: Ethanol anhydrous 150 mg/ml Clear, colourless to yellowish solution.
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. For the relief of post-operative pain following dehorning in calves.
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis- agalactia syndrome) with appropriate antibiotic therapy.
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo- skeletal disorders.
For the relief of pain associated with equine colic.
Do not use in horses less than 6 weeks of age. Do not use in pregnant or lactating mares.
Do not use in horses producing milk for human consumption.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in case of hypersensitivity to the active substance or to any of the excipients. For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolves without intervention. In very rare cases anaphylactoid reactions may occur and should be treated symptomatically. The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon .
Cattle, pigs and horses
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).
Avoid introduction of contamination during use.
Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Horses: meat and offal: 5 days
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the cardboard box and vial after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening the container: 28 days.
Treatment of calves with Meloxidyl 20 minutes before dehorning reduces post-operative pain. Meloxidyl alone will not provide adequate pain relief during dehorning procedure. To obtain pain relief during surgery co-medication with an appropriate analgesic is needed.
Special precautions for use in animals:
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of
the diagnosis should be made as this could indicate the need for surgical intervention.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.
Pregnancy and lactation:
Cattle and pigs: Can be used during pregnancy and lactation. Horses: See section "Contraindications".
Interaction with other medicinal products and other forms of interactions:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anti-coagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In the case of overdose, symptomatic treatment should be initiated.
Incompatibilities None known.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Cardboard box containing 1 colourless glass vial of 50 ml, 100 ml or 250 ml. Not all pack sizes may be marketed.
Marketing authorisation holder:
Ceva Santé Animale - 10 av. de La Ballastière - 33500 Libourne - France
Manufacturer responsible for batch release:
Ceva Santé Animale – Z.I. Très le Bois - 22600 Loudéac - France
Meloxidyl 0.5 mg/ml oral suspension for cats Meloxicam
One ml contains:
Meloxicam 0.5 mg
Sodium benzoate 2 mg
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.
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.
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 side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon
Cats.
Post-operative pain and inflammation following surgical procedures:
After initial treatment with meloxicam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with Meloxidyl 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg bodyweight. 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.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the measuring syringe provided in the package.
The syringe fits onto the bottle and has a kg-body weight scale (from 1 kg to 10 kg) which corresponds to the maintenance dose (i.e. 0.05 mg meloxicam/kg body weight). Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Avoid introduction of contamination during use.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.
Please carefully follow the instructions of the veterinarian.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the label and the cardboard box after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening the container: 6 months.
Special precautions for use in animals:
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Post-operative pain and inflammation following surgical procedures:
In case additional pain relief is required, multimodal pain therapy should be considered.
Chronic musculoskeletal disorders:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to 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.
Pregnancy and lactation:
See section “Contraindications”.
Interaction with other medicinal products and other forms of interaction:
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. The product must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs 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 drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Overdose (symptoms, emergengy procedures, antidotes):
Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
In case of overdose, adverse reactions, as listed in Section “Adverse reactions” are expected to be more severe and more frequent. In the case of overdose symptomatic treatment should be initiated.
Incompatibilities None known.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Pack sizes:
Cardboard box containing 15 ml high density polyethylene bottle with one measuring syringe. Cardboard box containing 5 ml glass bottle with one measuring syringe.
The measuring syringe has a kg-body weight scale for cats (1 to 10 kg). Not all pack sizes may be marketed.