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

Introduction

Company name: Ceva Animal Health Ltd

Address: Unit 3, Anglo Office Park

White Lion Road

Amersham, Bucks

HP7 9FB

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.com

Presentation

A clear colourless to yellowish solution containing 20 mg/ml meloxicam for injection for cattle, pigs and horses.

Uses

Cattle:

For use in acute respiratory infection with appropriate antimicrobial therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral rehydration 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 antimicrobial therapy.

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 antimicrobial 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.

Dosage and administration

Cattle:

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg bodyweight (i.e. 2.5 ml/100 kg bodyweight) in combination with antimicrobial therapy or with oral rehydration therapy, as appropriate.

Pigs:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg bodyweight (i.e. 2.0 ml/100 kg bodyweight) in combination with antimicrobial therapy, as appropriate. If required, a second administration of Meloxidyl® can be given after 24 hours.

Horses:

Single intravenous injection at a dosage of 0.6 mg meloxicam/kg bodyweight (i.e. 3.0 ml/100 kg bodyweight).

Avoid introduction of contamination during use.

Contra-indications, warnings, etc

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.

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 reevaluation 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.

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.

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.

Overdose:

In case of overdose symptomatic treatment should be initiated.

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.

Withdrawal period(s)

Cattle: Meat and offal: 15 days

Milk: 5 days

Pigs: Meat and offal: 5 days

Horses: Meat and offal: 5 days.

Pharmaceutical precautions

After first opening, the product should be used within 28 days. If any unused product remains after this time, it should be disposed of in accordance with national regulations.

This veterinary medicinal product does not require any special storage conditions.

Legal category

POM-V

Packaging Quantities

50ml, 100ml or 250ml glass vial.

Not all pack sizes may be marketed.

Further information

Nil

Marketing authorisation number

EU/2/06/070/005

EU/2/06/070/006

EU/2/06/070/007

Significant Changes

GTIN

Meloxidyl 20mg 50ml:

03411111946199

Meloxidyl 20mg 100ml:

03411111946267