Dexa-ject 2 mg/ml,100 ml, Dexamethasone, Cattle, horses, pigs, dogs and cats

Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats.

COMPOSITION:
Each ml contains:
Active substance:
Dexamethasone…… 2 mg
as dexamethasone sodium phosphate …… 2.63 mg
Excipients:
Benzyl alcohol (EI 519) …… 15 mg
Aqueous, clear, colourless solution for injection.

INDICATIONS:
Horses, cattle, pigs, dogs and cats:
Treatment of inflammatory or allergic conditions.
Cattle:
Induction of parturition.
Treatment of primary ketosis (acetonemia).
Horses:
Treatment of arthritis, bursitis or tenosynovitis.

CONTRAINDICATIONS:
Except in emergency situations, do not use in animals suffering from diabetes, renal failure, heart failure, hyperadrenocorticism or osteoporosis.
Do not use in viral infections during the viraemic phase or in cases of systemic fungal infections.
Do not use in animals suffering from gastrointestinal or corneal ulcers or demodicosis.
Do not administer intra–articular in situations where there are signs of fractures, bacterial infections of the joints and aseptic bone necrosis.
Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.

SIDE EFFECTS:
Cattle, horses, pigs, dogs and cats
Frequency not known (cannot be estimated based on available data): iatrogenic hyperadrenocorticism (Cushing‘s disease)1, polyuria2, polydipsia2, polyphagia2, sodium retention3, water retention3, hypokalaemia3, skin calcinosis, delayed wound healing, weakened resistance or exacerbation of existing infections4, gastrointestinal ulceration5, hepatomegaly6, changes in biochemical and hematological parameters in the blood, hyperglycemia7, placental retention8, reduced calf viability9, pancreatitis10, decreased milk production, laminitis.

1 It involves a significant change in the metabolism of fats, carbohydrates, proteins and minerals, for example, redistribution of body fat, muscle weakness and loss of energy and osteoporosis.
2 After systemic administration and especially in the early stages of therapy.
3 For long-term use.
4 In the presence of bacterial infection, taking antibacterial drugs is usually necessary when using steroids. In the presence of viral infections, steroids can worsen or speed up the progress of the disease.

5 There may be exacerbations in patients receiving nonsteroidal anti–inflammatory drugs and in animals with spinal cord trauma.
6 With elevated serum liver enzymes.
7 Transitional.
8 When used to induce parturition in cattle with possible metritis and/or subsequent subfertility.
9 When used to induce parturition in cattle, especially in the early stages.
10 Increased risk of acute pancreatitis.

TARGET SPECIES:
Cattle, horses, pigs, dogs and cats.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION:
Cattle, pigs, dogs and cats: intramuscular use.
Horses: intravenous, imtamuscular, or intra-articular use.
Treatment of inflammatory or allergic conditions:
Horses, cattle, pigs: 0.06 mg dexamethasone/kg body weight equivalent to 1.5 ml/50 kg.
Dogs, cats: 0.1 mg dexamethasone/kg body weight equivalent to 0.5 ml/10 kg.
The current dose used should be determined by the severity of the signs and the length of time they have been present.
Treatment of primary ketosis in cattle (acetonemia):

0.02 to 0.04 mg dexamethasone/kg body weight equivalent to a dose of 5–10 ml/500 kg body weight, depending on cow size and duration of signs. Caution should be exercised not to overdose cattle breeds in the Channel Islands. Higher doses will be required if signs have been present for a longer time or if animals with relapses are treated.
Induction of parturition: – to avoid excessive fetal size and mammary edema in cattle:
0.04 mg dexamethasone/kg body weight equivalent to 10 ml/500 kg body weight after day 260 of gestation. Parturition will normally occur within 48–72 hours.
Treatment of arthritis, bursitis or tenosynovitis by intra–articular injection in horses.
1–5 ml veterinary medicinal product by intra–articular injection.

These quantities are not specific and are mentioned for guidance only. Injections into the joint spaces or bursae should be preceded by the extraction of an equivalent volume of synovial fluid. Strict asepsis is essential. To ensure a correct dose, body weight should be determined as accurately as possible. For the measurement of small volumes, less than 1 ml, a properly graduated syringe should be used to ensure accurate administration of the correct dose. When treating groups of animals, use a pulling needle to avoid excessive perforation of the stopper. The maximum number of perforations must be limited to 50.

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
See above.

WAITING PERIODS:
Cattle: Meat and offal: 8 days.
Milk: 72 hours.

Pigs: Meat and offal: 2 days.
Horses: Meat and offal: 8 days.
It is not permitted for use in horses producing milk for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE:
Keep out of sight and reach of children.
Do not store at a temperature higher than 25C.
Store the bottle in the outer carton to protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle. The expiration date refers to the last day of that month.
Shelf life after the first opening of the bottle: 28 days.

Pregnancy and lactation:
Apart from the use of the product to induce parturition in cattle, corticosteroids are not recommended during gestation. It is known that administration in the early stages of gestation has caused fetal abnormalities in laboratory animals. Late pregnancy can cause premature parturition or miscarriage. The use of the product in lactating cows can cause a reduction in milk production.
Interaction with other medicinal products and other forms of interaction:
Concomitant use with nonsteroidal anti–inflammatory drugs may exacerbate ulcerations of the gastrointestinal tract. As corticosteroids may reduce the immune response to vaccination, dexamethasone should not be used in combination with vaccines or within two weeks of vaccination.

Administration of dexamethasone may induce hypokalaemia and therefore increase the risk of toxicity as a result of cardiac glycosides. The risk of hypokalaemia may be increased if dexamethasone is administered in combination with potassium depletion diuretics. Concomitant use with anticholinesterase may result in increased muscle weakness in patients with myasthenia gravis. Glucocorticoids antagonize the effects of insulin. Concomitant use with phenobarbital, phenytoin, and rifampicin may reduce the effects of dexamethasone.
Overdose:
An overdose can induce drowsiness and lethargy in horses.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

DIMENSION:
Bottle x 100 ml.