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Date: Saturday, June 15, 2024 0:23

Release 3.74
Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs & Cats
 
Species: Cats, Cattle, Dogs, Horses and other equidae, Pigs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Injections: Steroids
Active ingredient: Dexamethasone
Product:Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs & Cats
Product index: Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs & Cats
Cattle - milk: 72 hours
Cattle - meat: 8 days
Pig - meat: 2 days
Withdrawal notes: Horses: 8 days
Incorporating:
Qualitative and quantitative composition
Per ml:
Active substance:
Dexamethasone 2 mg
(as dexamethasone sodium phosphate 2.63 mg)
Pharmaceutical form
Clear, colourless, aqueous solution for injection.
Clinical particulars
Target species:
Cattle, horses, pigs, dogs and cats.
Indications for use
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.
Contra-indications
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
None.
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.
Adverse reactions
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 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).
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 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 GI tract 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.
Corticosteroid use may increase the risk of acute pancreatitis. Other possible adverse reactions associated with corticosteroid use include laminitis and reduction in milk yield.
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.
Interactions
Concurrent use with non-steroidal anti-inflammatory drugs may exacerbate GI 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.
Administration of dexamethasone may induce hypokalaemia and hence increase the risk of toxicity from cardiac glycosides. 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.
Species
Dosage
Horse, cattle, pigs
0.06 mg/kg body weight corresponding to 1.5ml /50kg
Dogs, cats
0.1 mg/kg body weight corresponding to 0.5 ml/10kg
For the treatment of primary ketosis in cattle (acetonaemia) 0.02 to 0.04 mg/kg body weight corresponding to a dose of 5 -10 ml per 500kg BW 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.
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 500kg BW after day 260 of pregnancy.
Parturition will normally occur within 48-72 hours.
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.
Overdose
An overdose can induce drowsiness and lethargy in horses.
Withdrawal periods
Cattle:
Meat and offal:8 days
Milk: 72 hours
Pigs:
Meat and offal:2 days
Horses:
Meat and offal:8 days
Not permitted for use in horses producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Corticosteroids for systemic use, dexamethasone. ATC vet-code: QH02AB02.
Pharmacodynamic properties
This preparation contains the sodium phosphate ester of dexamethasone, a fluoro-methyl derivative of prednisolone, which is a potent glucocorticoid with minimal mineralocorticoid activity. Dexamethasone has ten to twenty times the anti-inflammatory activity of prednisolone.
Corticosteroids suppress the immune response by inhibition of dilatation of capillaries, migration and function of leucocytes and phagocytosis.
Glucocorticoids have an effect on metabolism by increasing gluconeogensis.
Pharmacokinetic properties
After extravascular (intramuscular, subcutaneous, intra-articular) administration, this soluble ester of dexamethsone is rapidly absorbed from the injection site following by immediate hydrolysation into the parent compound, dexamethasone.
Absorption of dexamethasone is rapid. The time to reach maximum plasma concentrations (Cmax) of dexamethasone in cattle, horse, pig and dog is within 20 min after intramuscular administration. Bioavailability following IM administration (compared to IV administration) is high in all species. Elimination half-life after intravenous administration in horses is 3.5 hours. After intramuscular administration, apparently elimination half-life has been shown to range between 1 and 20 hours according to the species.
Pharmaceutical particulars
List of Excipients
Benzyl alcohol
Sodium chloride
Sodium citrate
Citric acid, anhydrous (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injection
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
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.
Immediate packaging
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.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Dopharma Research B.V.
Zalmweg 24
4941 VX Raamsdonksveer
The Netherlands
Marketing Authorisation Number
UK: Vm 28365/4003
Northern Ireland: Vm 28365/3000
Significant changes
Date of the first authorisation or date of renewal
24 August 2012
Date of revision of the text
September 2023
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Dexa-ject 100ml
GTIN:8714377282595