Dexa-ject

1 x 100 ml

Liquid for injection, solution

Active substance

Dexamethasone (Dexamethasone sodium phosphate) : 2 mg/ml

ATC code

QH02AB02 Dexamethasone (Corticosteroids - moderately potent (group II))

QH02AB Glucocorticoids

QH02A Corticosteroids for systemic use, plain

QH02 Corticosteroids for systemic use

QH Systemic hormonal preparations, excl. sex hormones and insulins

Species

Cattle, horses, pigs, dogs and cats.

Indications

Horses, cattle, pigs, dogs and cats:

Treatment of inflammatory or allergic conditions.

Cattle:

Induction of parturition.

Treatment of primary ketosis (acetonaemia).

Horses:

Treatment of arthritis, bursitis or tenosynovitis.

Dose to be administered and administration route

Cattle, pigs, dogs and cats: intramuscular use.

Horses: intravenous, intramuscular or intraarticular use.

Treatment of inflammatory or allergic conditions:

Horses, cattle, pigs: 0.06 mg dexamethasone/kg body weight corresponding to 1.5 ml/50 kg

Dogs, cats: 0.1 mg dexamethasone/kg body weight corresponding to 0.5 ml/10 kg

The actual dose used should be determined by the severity of the signs and the length of time for which they have been present.

Treatment of primary ketosis in cattle (acetonaemia):

0.02 to 0.04 mg dexamethasone/kg body weight corresponding to a dose of 5-10 ml per 500 kg BW 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.

Induction of parturition - to avoid foetal oversize and mammary oedema in cattle:

0.04 mg dexamethasone/kg body weight corresponding to 10 ml per 500 kg BW after day 260 of pregnancy.

Parturition will normally occur within 48-72 hours.

Treatment of arthritis, bursitis or tenosynovitis in horses:

1 - 5 ml of the veterinary medicinal product by intra-articular injection.

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 ensure a correct dosage, body weight should be determined as accurately as possible.

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

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.

Adverse reactions

Cattle, horses, pigs, dogs and cats:

Undetermined frequency (cannot be estimated from the available data):

Iatrogenic hyperadrenocorticism (Cushing’s disease)¹ Polyuria², polydipsia², polyphagia²

Sodium retention³, water retention³, hypokalaemia³

Cutaneous calcinosis

Delayed wound healing, weakened resistance to or

exacerbation of existing infections⁴

Gastro-intestinal ulceration⁵, hepatomegaly⁶ Changes in blood biochemical and haematological parameters Hyperglycaemia⁷

Retained placenta⁸

Reduced viability of the calf⁹

Pancreatitis¹⁰

Milk production decrease

Laminitis

¹ Involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g., redistribution of body fat, muscle weakness and wastage and osteoporosis may result.

² After systemic administration and particularly during early stages of therapy.

³ Upon long-term use.

⁴ 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.

⁵ May be exacerbated in patients given non-steroidal anti-inflammatory drugs and in animals with spinal cord trauma.

⁶ With increased serum hepatic enzymes.

⁷ Transient.

⁸ When used for induction of parturition in cattle, with possible subsequent metritis and/or subfertility.

⁹ When used for induction of parturition in cattle particularly at early time points.

¹⁰ Increased risk of acute pancreatitis.

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 upon long-term use and when esters possessing a long duration of action are administered. During medium to long-term use, the dose should therefore generally be kept to the minimum necessary to control symptoms.

During therapy effective doses suppress the hypothalamic-pituitary-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).

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product.

Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.