Meloxidyl

1 x 50 ml
Liquid for injection, solution
IM
IV
SC

Active substance

  • Meloxicam : 20 mg/ml
  • Species

    Cattle, pigs and horses

    Indications

    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.

    Dose to be administered and administration route

    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).

    Avoid introduction of contamination during use.

    Adverse reactions

    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).

    Dispensing

    POM-V - Prescription Only Medicine – Veterinarian

    1. NAME OF THE VETERINARY MEDICINAL PRODUCT

    Meloxidyl 20 mg/ml solution for injection for cattle, pigs and horses

    2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    One ml of Meloxidyl 20 mg/ml solution for injection contains:

    Active substance: Meloxicam 20 mg

    Excipient:

    Ethanol anhydrous 150 mg

    For the full list of excipients, see section 6.1

    3. PHARMACEUTICAL FORM

    Solution for injection

    Clear, colourless to yellowish solution.

    4. CLINICAL PARTICULARS

    4.1 Target species

    Cattle, pigs and horses

    4.2 Indications for use, specifying the target species

    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.

    4.3 Contraindications

    See also section 4.7.

    Do not use in horses less than 6 weeks of age.

    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.

    4.4 Special warnings for each target species

    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 adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

    4.5 Special precautions for use

    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.

    4.6 Adverse reactions (frequency and seriousness)

    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).

    4.7 Use during pregnancy, lactation or lay

    Cattle and pigs: Can be used during pregnancy and lactation.

    Horses:

    Do not use in pregnant or lactating mares.

    Do not use in horses producing milk for human consumption.

    See also section 4.3.

    4.8 Interaction with other medicinal products and other forms of interaction

    Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

    4.9 Amounts to be administered and administration route

    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).

    Avoid introduction of contamination during use.

    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

    In the case of overdose, symptomatic treatment should be initiated.

    4.11 Withdrawal period(s)

    Cattle:

    Meat and offal: 15 days

    Milk: 5 days

    Pigs:

    Meat and offal: 5 days

    Horses:

    Meat and offal: 5 days.

    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, anti-exudative, analgesic and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.

    5.2 Pharmacokinetic particulars

    Absorption

    After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.

    After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.

    Distribution

    More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

    Metabolism

    Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain 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. The metabolism in horses has not been investigated.

    Elimination

    Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.

    In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.

    In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

    Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

    6. PHARMACEUTICAL PARTICULARS

    6.1 List of excipients

    Ethanol, anhydrous

    Poloxamer 188

    Macrogol 300

    Glycine

    Sodium citrate

    Sodium hydroxide (for pH adjustment)

    Hydrochloric acid (for pH adjustment)

    Meglumine Water for injections

    6.2 Major incompatibilities

    None known.

    6.3 Shelf life

    Shelf life of the veterinary medicinal product as packaged for sale: 30 months. Shelf life after first opening the immediate packaging: 28 days.

    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

    Cardboard box containing 1 colourless glass vial of 50 ml, 100 ml or 250 ml.

    Each vial is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

    Not all pack sizes may be marketed.

    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

    7. MARKETING AUTHORISATION HOLDER

    Ceva Santé Animale

    10 avenue de la Ballastière

    33500 Libourne

    France

    8. MARKETING AUTHORISATION NUMBER(S)

    EU/2/06/070/005

    EU/2/06/070/006

    EU/2/06/070/007

    9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

    Date of first authorisation: 15.01.2007

    Date of last renewal: 19.12.2011

    10 DATE OF REVISION OF THE TEXT

    Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

    PROHIBITION OF SALE, SUPPLY AND/OR USE

    Not applicable.

    Pig icon
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    Product identification - 15052/5013
    Art. Nr. 15052/5013
    EAN 3411111946199
    PACKAGES
    Meloxidyl
    Ceva Animal Health
    1 x 50 ml
    15052/5013
    Meloxidyl
    Ceva Animal Health
    1 x 100 ml
    15052/5013

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    Meloxidyl (1 x 100 ml)

    Meloxidyl

    20 mg/ml Liquid for injection, solution
    1 x 50 ml, 1 x 100 ml
    Pig icon
    Cattle icon
    Horse icon
    Meloxidyl (1 x 100 ml)

    Meloxidyl

    20 mg/ml Liquid for injection, solution
    1 x 50 ml, 1 x 100 ml
    Pig icon
    Cattle icon
    Horse icon
    Meloxidyl (1 x 100 ml)

    Meloxidyl

    20 mg/ml Liquid for injection, solution
    1 x 50 ml, 1 x 100 ml
    Pig icon
    Cattle icon
    Horse icon
    Meloxidyl (1 x 100 ml)

    Meloxidyl

    20 mg/ml Liquid for injection, solution
    1 x 50 ml, 1 x 100 ml
    Pig icon
    Cattle icon
    Horse icon
    Meloxidyl (1 x 100 ml)

    Meloxidyl

    20 mg/ml Liquid for injection, solution
    1 x 50 ml, 1 x 100 ml
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