Dexa-ject 2 mg/ml Solution for Injection 100ml.
Qualitative and quantitative composition
Dexamethasone 2 mg
as dexamethasone sodium phosphate 2.63 mg
Solution for injection.
Clear, colourless, aqueous solution.
Cattle, horses, pigs, dogs and cats.
Indications for use
Horses, cattle, pigs, dogs and cats:
Treatment of inflammatory or allergic conditions.
Induction of parturition.
Treatment of primary ketosis (acetonaemia).
Treatment of arthritis, bursitis or tenosynovitis.
Except in emergency situations, do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism or osteoporosis.
Do not use in viral infections during the viraemic stage or in cases of systemic mycotic infections.
Do not use in animals suffering from gastrointestinal or corneal ulcers, or demodicosis.
Do not administer intra-articularly where there is evidence of fractures, bacterial joint infections and aseptic bone necrosis.
Do not use in known cases of hypersensitivity to the active substance, to corticosteroids and to any other ingredient of the product.
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
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.
Because of the pharmacological properties of the active ingredient, special care should be taken when the product is used in animals with a weakened immune system.
Except in cases of acetonaemia and induction of parturition, corticosteroid administration is to induce an improvement in clinical signs rather than a cure. The underlying disease should be further investigated. When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper. The maximum number of broachings should be limited to 50.
Following intra-articular administration, use of the joint should be minimized for one month and surgery on the joint should not be performed within eight weeks of use of this route of administration.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to the active substance or any of the excipients should avoid contact with the product.
Wash hands after handling the product.
In case of accidental self-injection, seek medical advice and show the package leaflet or the label to the physician.
Pregnant women should not handle this veterinary medicinal product.
Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range of side effects. Whilst single high doses are generally well tolerated, they may induce severe side effects in 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 symptoms.
Steroids themselves, during treatment, may cause iatrogenic hyperadrenocorticism (Cushing’s disease) 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, symptoms 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 (for further discussion see standard texts).
Systematically 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).
Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections. In the presence of bacterial infection, antibacterial drug cover is usually required when steroids are used. In the presence of viral infections, steroids may worsen or hasten the progress of the disease.
Gastrointestinal ulceration has been reported in animals treated with corticosteroids and g.i.t. ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.
Corticosteroid use may induce changes in blood biochemical and haematological parameters. Transient hyperglycaemia can occur.
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. Such use of dexamethasone, particularly at early time points, may be associated with reduced viability of the calf.
Use during pregnancy, lactation or lay
Apart from the use of the product 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 may cause early parturition or abortion.
Use of the product in lactating cows may cause a reduction in milk yield.
Concurrent use with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration.
Because corticosteroids can reduce the immune response to vaccination, dexamethasone should not be used in combination with vaccines or within two weeks after vaccination.
The risk of hypokalaemia may be increased if dexamethasone is administered together with potassium depleting diuretics.
Concurrent use with anticholinesterase may lead to increased muscle weakness in patients with myasthenia gravis.
Glucocorticoids antagonise the effects of insulin.
Concurrent use with phenobarbital, phenytoin and rifampicin can reduce the effects of dexamethasone.
Amounts to be administered and administration route
The product 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. To measure small volumes of less than 1 ml a suitably graduated syringe should be used to ensure accurate administration of the correct dose.
For the treatment of inflammatory or allergic conditions the following average doses are advised. However the actual dose used should be determined by the severity of the signs and the length of time for which they have been present.
Horse, cattle, pigs
0.06 mg/kg body weight corresponding to 1.5m./50kg
0.1 mg/kg body weight corresponding to 0.5 ml/10kg
Doses may be repeated repeated once at 24-48 hours intervals if required. Injection sites should be alternated.
For the induction of parturition - to avoid foetal oversize and mammary oedema in cattle. A single intramuscular injection of 0.04 mg/kg body weight corresponding to 10 ml per cow after day 260 of pregnancy.
Parturition will normally occur within 48-72 hours. If calving does not occur within these periods the dose may be repeated.
For the treatment of arthritis, bursitis or tenosynovitis by intra-articular injection in the horse.
Dose 1 - 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.
An overdose can induce drowsiness and lethargy in horses.
Meat and offal:8 days
Milk: 72 hours
Meat and offal:2 days
Meat and offal:12 days
Not permitted for use in horses producing milk for human consumption.
Pharmacotherapeutic group: Corticosteroids for systemic use, dexamethasone. ATC vet-code: QH02AB02.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.
Cardboard box with 1 colourless, type I glass vial of 50 or 100 ml, which is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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