Metacam
meloxicam
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial 08228 Terrassa, Barcelona
SPAIN
Metacam 5 mg/ml solution for injection for cattle and pigs Meloxicam
One ml contains: Meloxicam 5 mg
Ethanol 150 mg
Clear yellow solution.
Cattle:
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 the relief of post-operative pain following dehorning in calves.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For the relief of post operative pain associated with minor soft tissue surgery such as castration.
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 cases 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.
Do not use in pigs less than 2 days old.
In cattle, 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.
Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience 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 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).
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 (calves and young cattle) and pigs
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.
Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.
Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.
Avoid introduction of contamination during use.
Cattle: meat and offal: 15 days Pigs: 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. Shelf life after first opening the container: 28 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle after EXP.
Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.
Treatment of piglets with Metacam before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.
To obtain the best possible pain relieving effect post-surgery Metacam should be administered 30 minutes before surgical intervention.
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.
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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
Pregnancy and lactation:
Cattle: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml. Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Metacam 1.5 mg/ml oral suspension for dogs Meloxicam
One ml contains:
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop) Yellowish viscous oral suspension with a green tinge.
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 cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs 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, lethargy and renal failure have very rarely been reported from post-marketing safety experience.
Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience.
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.
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).
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
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 Metacam 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.
Shake well before use. To be administered orally either mixed with food or directly into the mouth. The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.
Dosing procedure using the drop dispenser of the bottle: Initial dose: 4 drops/kg body weight
Maintenance dose: 2 drops/kg body weight.
Dosing procedure using the measuring syringe:
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.
Shake bottle well.
Push down and unscrew bottle top. Attach the dosing syringe to the drop dispenser of the bottle by
gently pushing.
Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to your dog´s body weight in kilograms.
Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.
By pushing the plunger in empty the contents of the syringe onto the food or directly into the mouth.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.
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.
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.
Avoid introduction of contamination during use.
Not applicable.
Keep out of the sight and reach 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 this veterinary medicinal product after the expiry date which is stated on the carton and the
bottle after EXP.
Special precautions for use in animals:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 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 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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
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. Metacam 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.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
10 ml, 32 ml, 100 ml or 180 ml bottle. Not all pack sizes may be marketed.
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
GERMANY
Manufacturers responsible for batch release Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial 08228 Terrassa, Barcelona
SPAIN
Metacam 5 mg/ml solution for injection for dogs and cats Meloxicam
One ml contains: Meloxicam 5 mg
Ethanol 150 mg
Clear yellow solution.
Dogs:
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.
Cats:
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 cases 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, lethargy and renal failure have very rearely been reported from post-marketing safety experience.
Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience. 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.
Anaphylactoid reactions have been observed very rarely from post-marketing safety experience and should be treated symptomatically.
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).
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).
Musculo-skeletal disorders: single subcutaneous injection.
Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets 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.
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.
Particular care should be taken with regard to the accuracy of dosing. Avoid introduction of contamination during use.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions. Shelf life after first opening the container: 28 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the
bottle after EXP.
Special precautions for use in animals:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity. During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
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. Metacam 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 subcutaneaous 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 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.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
10 ml or 20 ml injection vial.
Not all pack sizes may be marketed.
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
GERMANY
Manufacturers responsible for batch release Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial 08228 Terrassa, Barcelona
SPAIN
Metacam 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam
One ml contains: Meloxicam 20 mg
Ethanol 150 mg
Clear yellow solution.
Cattle:
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.
Pigs:
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.
Horses:
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 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 cases 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, 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 was observed in isolated cases in clinical studies, but resolved without intervention.
Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience 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 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).
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
Cattle:
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.
Pigs:
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.
Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
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.
Not authorised to use in horses producing milk for human consumption.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions. Shelf life after first opening the container: 28 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after EXP.
Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate 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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
Pregnancy and lactation:
Cattle and pigs: Can be used during pregnancy and lactation. Horses: Do not use in pregnant or lactating mares.
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose, symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Cardboard box with either 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml. Cardboard box with either 1 or 6 colourless glass injection vial(s) of 250 ml.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Metacam 15 mg/ml oral suspension for horses Meloxicam
One ml contains: Meloxicam 15 mg
Yellowish viscous oral suspension with a green tinge.
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
Do not use in pregnant or lactating mares.
Do not use in horses 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 horses less than 6 weeks of age.
Diarrhoea, typically associated with non-steroidal anti-inflammatory drugs (NSAIDs), was very rarely observed in clinical trials . The clinical sign was reversible.
Loss of appetite, lethargy, abdominal pain, colitis and urticaria have been reported very rarely from post- marketing safety experience.
Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from
post-marketing safety experience and should be treated symptomatically.
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).
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.
Horses
Dosage
Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Method and route of administration
Shake well before use. To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.
After administration of the drug, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Avoid introduction of contamination during use.
Meat and offal: 3 days.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions. Shelf life after first opening of 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.
Special precautions for use in animals:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
Pregnancy and lactation
See section "Contraindications".
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
100 ml or 250 ml bottle.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Metacam 0.5 mg/ml oral suspension for dogs Meloxicam
One ml contains:
Meloxicam 0.5 mg (equivalent to 0.02 mg per drop) Yellowish viscous oral suspension with a green tinge.
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 cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs 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, lethargy and renal failure have very rarely been reported from post-marketing safety experience.
Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience.
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.
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).
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
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 Metacam 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.
Shake well before use. To be administered orally either mixed with food or directly into the mouth. The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.
Dosing procedure using the drop dispenser of the bottle: Initial dose: 10 drops/kg body weight
Maintenance dose: 5 drops/kg body weight.
Dosing procedure using the measuring syringe:
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.
Shake bottle well.
Push down and unscrew bottle top. Attach the dosing syringe to the drop dispenser of the bottle by
gently pushing.
Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to your dog´s body weight in kilograms.
Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.
By pushing the plunger in empty the contents of the syringe onto the food or directly into the mouth.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.
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.
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.
Avoid introduction of contamination during use.
Not applicable.
Keep out of the sight and reach 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 this veterinary medicinal product after the expiry date which is stated on the carton and the
bottle after EXP.
Special precautions for use in animals:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
This product for dogs should not be used in cats due to the different dosing devices. In cats, Metacam
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 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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
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. Metacam 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.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
15 ml or 30 ml bottle.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Metacam 1 mg chewable tablets for dogs Metacam 2.5 mg chewable tablets for dogs Meloxicam
One tablet contains: Meloxicam 1 mg
Meloxicam 2.5 mg
Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or "M25" on one side. The tablet can be divided into equal halves.
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 dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported from post-marketing safety experience.
Very rare cases of haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported from post-marketing safety experience.
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.
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).
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
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.
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.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.
Each chewable tablet can be halved for accurate dosing according to the individual body weight of the
dog. Metacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
Dose scheme for the maintenance dose:
Body weight (kg) | Number of chewable tablets | mg/kg | |
1 mg | 2.5 mg | ||
4.0–7.0 | ½ | 0.13–0.1 | |
7.1–10.0 | 1 | 0.14–0.1 | |
10.1– 15.0 | 1½ | 0.15–0.1 | |
15.1–20.0 | 2 | 0.13–0.1 | |
20.1–25.0 | 1 | 0.12–0.1 | |
25.1–35.0 | 1½ | 0.15–0.1 | |
35.1–50.0 | 2 | 0.14–0.1 | |
The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.
A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.
Instructions for opening the child-resistant blisters:
Push the tablet for release from the blister.
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 carton and the blister after EXP.
Special precautions for use in animals:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 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 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 carton 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. Metacam 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.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon
how to dispose of medicines no longer required. These measures should help to protect the environment.
Package sizes:
Metacam 1 mg chewable tablets for dogs Blisters: 7, 84 or 252 tablets.
Metacam 2.5 mg chewable tablets for dogs Blisters: 7, 84 or 252 tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Metacam 0.5 mg/ml oral suspension for cats and guinea pigs Meloxicam
One ml contains:
Meloxicam 0.5 mg (equivalent to 0.017 mg per drop). Yellowish viscous oral suspension with a green tinge.
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 acute and 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.
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.
In cats, typical adverse reactions of non-steroidal anti-inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported from post-marketing safety experience.
Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases from post- marketing safety experience.
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.
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 during)
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 and guinea pigs
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with Metacam 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 4 days.
Acute musculo-skeletal disorders:
Initial treatment is a single oral 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 dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.
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.
To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight. Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the
package can be used.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.
Dosing procedure using the drop dispenser of the bottle:
Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight
Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.
Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the dose of 0.05 mg meloxicam/kg bodyweight. Thus for initiation of the treatment of chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be required.
For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.
Shake bottle well.
Push down and unscrew bottle top. Attach the dosing syringe to the drop dispenser of the bottle by gently pushing.
Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to your cat´s body weight in kilograms.
Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.
By pushing the plunger in empty the contents of the syringe onto the food or directly into the mouth.
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.
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 Metacam 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 Metacam according to the bodyweight of the guinea pig. Administer Metacam 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 and the cat pictogram for guinea pigs.
Shake bottle well.
Push down and unscrew bottle top.
Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is
Use the 1 ml standard syringe and draw up the required volume of Metacam oral suspension which
By pushing the plunger in empty the contents of the syringe directly into the mouth of the guinea pig.
advised to dispense a few drops more than required into the small container).
corresponds to the body weight of the guinea pig.
Please carefully follow the instructions of the veterinarian. Shake well before use.
Avoid introduction of contamination during use.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Shelf life after first opening the container: 3 ml bottle: 14 days
10 ml, 15 ml and 30 ml bottles: 6 months.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
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.
Special precautions to be taken by the person administering the veterinany 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 this package leaflet or the label to the physician.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
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. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided.
In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for injection for cats at a single dose of 0.2 mg/kg 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.
Overdose (symptoms, emergency 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 case of overdose symptomatic treatment should be initiated.
In guinea pigs, an overdose of 0.6 mg/kg body weight administred 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.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
3 ml, 10 ml, 15 ml or 30 ml bottle. Not all pack sizes may be marketed.
Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
GERMANY
Manufacturers responsible for batch release Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial 08228 Terrassa, Barcelona
SPAIN
Metacam 2 mg/ml solution for injection for cats Meloxicam
One ml contains: Meloxicam 2 mg
Ethanol 150 mg
Clear yellow solution.
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
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 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, lethargy and renal failure have very rarely been reported from post-marketing safety experience.
Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases from post- marketing safety-experience.
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.
Anaphylactoid reactions have been observed very rarely from post-marketing safety experience 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 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).
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
Single subcutaneous injection of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
To continue treatment for up to five days, this initial dose may be followed 24 hours later by administration of Metacam 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 for up to a total of four doses at 24 hour intervals.
Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation. This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible
e.g. feral cats. In this case do not use oral follow up treatment.
Particular care should be taken with regard to the accuracy of dosing. Avoid introduction of contamination during use.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions. Shelf life after first opening the container: 28 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
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 cat, as there is a potential risk of renal toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
In case additional pain relief is required, multimodal pain therapy should be considered.
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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
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. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products 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 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.
Overdose (symptoms, emergency procedures, antidotes):
In the case of overdose symptomatic treatment should be initiated.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
10 ml or 20 ml injection vial.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Metacam 15 mg/ml oral suspension for pigs Meloxicam
One ml contains: Meloxicam 15 mg
Yellowish viscous oral suspension with a green tinge.
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 MMA) with appropriate antibiotic therapy.
Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
None.
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.
Pigs
Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.
In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam
20 mg/ml solution for injection is recommended. Shake well before use.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.
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. Shelf life after first opening of 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.
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 pigs which require parenteral
rehydration, as there may be a potential risk of 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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with
water.
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose symptomatic treatment should be initiated.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
100 ml or 250 ml bottle.
Not all pack sizes may be marketed.
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
GERMANY
Manufacturers responsible for batch release Labiana Life Sciences S.A.
Venus, 26
Can Parellada Industrial 08228 Terrassa, Barcelona
SPAIN
Metacam 40 mg/ml solution for injection for cattle and horses Meloxicam
One ml contains:
Meloxicam 40 mg
Ethanol 150 mg
Clear yellow solution.
Cattle:
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.
Horses:
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 (see section “Pregnancy and lactation”).
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 cases 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, 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 was observed in isolated cases in clinical studies, but resolved without intervention.
Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience 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 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).
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 and horses.
Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Horses:
Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 1.5 ml/100 kg body weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo- skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dose of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Avoid introduction of contamination during use.
Cattle: meat and offal: 15 days; milk: 5 days. Horses: meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions. Shelf life after first opening the container: 28 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Special warnings for each target species:
Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate 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 the package leaflet or the label to the physician.
In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Pregnancy and lactation:
Cattle: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares (see section “Contraindications”).
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In case of overdose, symptomatic treatment should be initiated.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Pack sizes of 1 or 12 colourless glass injection vial(s) of 50 ml or 100 ml. Not all pack sizes may be marketed.