Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

A clear colourless solution for injection containing dexamethasone (as dexamethasone sodium phosphate) 2.0 mg/ml and benzyl alcohol 15.0 mg/ml as a preservative.

Uses

Rapidexon® may be used whenever a parenteral corticosteroid preparation giving a medium duration of activity is required. It can be used as an anti-inflammatory and anti-allergic agent in horses, cattle, pigs, dogs and cats, and for the treatment of primary ketosis in cattle. Rapidexon® can also be used to induce parturition in cattle. Rapidexon® is suitable for intravenous use in horses, and is thus of particular benefit in cases needing emergency treatment.

Dosage and administration

Rapidexon® may be administered by intravenous or intramuscular injection in horses, and by intramuscular injection in cattle, pigs, dogs and cats. The product may also be given by intra-articular injection in horses. Normal aseptic technique should be observed.

For the treatment of inflammatory or allergic conditions, the following average doses are advised. However, the severity of the signs and the length of time for which they have been present should determine the actual dose used.

Species	Dosage
Horses, cattle, pigs	1.5 ml/50 kg
Dog, cat	0.5 ml/10 kg

Doses may be repeated once at 24-48 hour intervals if required.

For the treatment of primary ketosis in cattle (acetonaemia), a dose of 5-10 ml given by intramuscular injection is advocated dependent on the size of the cow and the duration of the signs. Care should be taken not to overdose Channel Island breeds. Larger doses will be required if the signs have been present for some time or if relapsed animals are being treated. In most early cases, a single dose will affect a cure but the dose may be repeated at 48 hour intervals if necessary.

For the induction of parturition (to avoid foetal oversize and mammary oedema in cattle)

A single intramuscular injection of 10 ml after day 260 of pregnancy.

Parturition will normally occur within 48-72 hours. If calving does not occur within this period then dose may be repeated.

For the treatment of arthritis, bursitis or tenosynovitis by intra-articular injection in the horse Dosage1-5 ml

These quantities are not specific and are quoted purely as a guide. Injections into joint spaces or bursae should be preceded by the removal of an equivalent volume of synovial fluid. Strict asepsis is essential.

To measure small volumes of less than 1 ml a suitably graduated syringe should be used to ensure accurate administration of the correct dose.

Contra-indications, warnings, etc

Except in emergency situations, do not use in animals suffering from diabetes, chronic nephritis, renal disease, congestive heart failure, or osteoporosis.

Do not use in viral infections during the viraemic stage.

For animal treatment only. Keep out of reach and sight of children.

Undesirable effects

Anti-inflammatory corticosteroids are known to exert a wide range of side-effects. Whilst single high doses are generally well tolerated, they may induce severe adverse reactions with long-term use, and when esters possessing a long duration of action are administered. Dosage in medium to long-term use should therefore generally be kept to the minimum necessary to control the clinical signs.

Steroids themselves, during treatment, may cause cushinoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism (e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result).

During therapy, effective doses suppress the hypothalamo-pituitreal adrenal axis. Following cessation of treatment, signs of adrenal insufficiency extending to adrenocortical atrophy can arise, and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. dosing to coincide with the time of endogenous cortisol peak (i.e. in the morning with regard to dogs and the evening with regard to cats) and a gradual reduction of dosage (for further information see standard texts).

Systemically administered corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalaemia in long-term use. Systemic corticosteroids have caused deposition of calcium in the skin (calcinosis cutis).

Corticosteroid use may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections. In the presence of bacterial infection, concurrent antibacterial therapy is usually required. In the presence of viral infections, corticosteroids may worsen or hasten the progress of the disease. It is recommended that corticosteroids are not administered to animals with mycotic infections.

Gastrointestinal ulceration has been reported in animals treated with corticosteroids and gastro intestinal tract ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in animals with spinal cord trauma.

Corticosteroid use may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes and may increase the risk of acute pancreatitis. Other possible adverse reactions associated with corticosteroid use include changes in blood biochemical and haematological parameters.

Special precautions for use in animals

Care should be taken when the product is used for the treatment of laminitis in horses, where there is the possibility that such treatment could worsen the condition. The use of the product in horses for other conditions could induce laminitis and careful observation during the treatment period should be made.

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Use of corticosteroids in horses has been reported to induce laminitis. Therefore, horses treated with such preparations should be monitored frequently during the treatment period. When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper. Only the 25 ml or 30 ml vial should be used for treating cats, dogs or small piglets.

Special precautions to be taken by the person administering the medicinal product to animals

Care should be taken to avoid self-injection.

Use during pregnancy and lactation

Apart from the use of Rapidexon® to induce parturition in cattle, corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy is likely to cause abortion or early parturition in ruminants, and may have a similar effect in other species.

If the product is used for induction of parturition in cattle, then a high incidence of retained placentae may be experienced and possible subsequent metritis and/or subfertility.

Use of the product in lactating cows may cause a reduction in milk yield.

Interaction with other medicinal products and other forms of interaction

Gastrointestinal tract ulceration may be exacerbated by corticosteroids in patients given non-steroidal anti-inflammatory drugs.

Because corticosteroids can reduce the immunoresponse to vaccination, dexamethasone should not be used in combination with vaccines.

Withdrawal periods

Cattle meat: 7 days

Milk: 60 hours

Pig meat: 2 days

Not for use in horses intended for human consumption.

Pharmaceutical precautions

Do not store above 25°C. Keep container in the outer carton.

Legal category

POM-V

Packaging Quantities

Uncoloured glass vials in the following volumes:

25, 30, 50 and 100 ml

Not all pack sizes may be marketed.

Further information

Nil

Marketing authorisation number

Vm 16849/4007.

Significant Changes