Dexashot 2 mg/ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

DEXASHOT 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Dexamethasone 2 mg

As dexamethasone sodium phosphate 2.63 mg

Excipients:

Benzyl alcohol (E 1519) 15.6 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless aqueous solution

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, horse, pig, dog and cat

4.2 Indications for use, specifying the target species

Horses
Treatment of inflammation and allergic reactions.
Treatment of arthritis, bursitis or tenosynovitis.

Cattle
Treatment of inflammation and allergic reactions.
Induction of parturition.
Treatment of primary ketosis (acetonaemia).

Pigs
Treatment of inflammation and allergic reactions.

Dogs and cats
Treatment of inflammation and allergic reactions

4.3 Contraindications

Except in emergency situations the product should not be used in animals suffering from diabetes, chronic nephritis, renal disease, congestive heart failure and osteoporosis.

For infectious diseases it is necessary that application of corticosteroids is associated with effective antibiotic or chemotherapeutic treatment. Do not use in animals affected by gastrointestinal or corneal ulcers, or demodecosis.
Do not use in animals affected with Cushing’s syndrome.

4.4 Special warnings for each target species

If the product is used for induction of parturition in cattle, then reduced viability of calves and 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.

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.

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, e.g. dosing to coincide with the time of the endogenous cortisol peak (i.e. in the morning with regard to dogs and the evening regarding cats) and a gradual reduction of dosage (for further discussion see standard texts).

Its use in younger or older individuals may be associated with an increased risk of side effects. Therefore, it is necessary to decrease the dose and clinical monitoring during treatment. During a course of treatment the situation should be reviewed frequently by close veterinary supervision.

4.5 Special precautions for use

Special precautions for use in animals

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.
With the exception of ketosis and induction of labor, corticosteroids rather improve than treated the condition, for which are used. It is therefore recommended accurate diagnosis of the underlying cause.

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

Care should be taken to avoid accidental self-injection.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

People with known hypersensitivity to the active substance or to any of the excipients should avoid contact with the veterinary medicinal product.

Avoid contact with skin and eyes. In the event of accidental eye or skin contact, wash/irrigate the area with clean running water. Seek medical attention if irritation persists. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

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 Cushingoid 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.

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.

Gastro-intestinal 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.

Hypersensitivity reactions are possible, though rare.

4.7 Use during pregnancy, lactation or lay

Apart from the use of DEXASHOT to induce parturition in cattle, corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused fetal abnormalities in laboratory animals. Administration in late pregnancy may cause early parturition or abortion. 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.

4.8 Interaction with other medicinal products and other forms of interaction

Because corticosteroids can reduce the immuno response to vaccination, the product should not be used in combination with vaccines.

Dexamethasone should not be administered in conjunction with other anti-inflammatory substances.
DEXASHOT administration may cause hypokalaemia thus increasing the risk of toxicity of cardiac glycosides.

The risk of hypokalemia can increase when dexamethasone is administered together with diuretics which influence on excretion of potassium.
Co-administration with cholinesterase inhibitors can lead to muscle weakness in patients suffering from myasthenia gravis.

Glucocorticoids antagonize insulin.

Co-administration of phenobarbital, phenytoin and rifampicin can suppress the effect of dexamethasone.

4.9 Amounts to be administered and administration route

The cap should not be punctured more than 100 times. When treating groups of animals in one run, it is recommended to use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper.

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

(i.m.)

Horses, cattle, pigs 1.5 ml of product/50 kg bw (0.06 mg of dexamethasone/kg bw)

Dog, cat 0.5 ml of product/10 kg bw (0.1 mg of dexamethasone/ kg bw)

For the treatment of primary ketosis in cattle a dose of 0.02-0.04 mg of dexamethasone/kg bw (5-10 ml of product pro toto) 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 10 ml of product 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 of product pro toto

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

High doses of corticosteroids can cause the horses apathy and lethargy. At high doses may cause thrombosis due to a higher tendency to blood clotting. See 4.6 above.

4.11 Withdrawal period(s)

Cattle:

Meat and offal: 8 days

Milk: 72 hours

Pigs:

Meat: 2 days

Horses:

Meat and offal: 8 days

Not authorized for use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Corticosteroids for systemic use, dexamethasone.

ATC vet code: QH02AB02

5.1 Pharmacodynamic properties

This preparation contains the sodium phosphate ester of dexamethasone, a fluoro-methyl derivative of prednisolone, with anti-inflammatory, anti-allergic and immunosuppressive effect. Dexamethasone stimulatesgluconeogenesis, which leads to an increase in blood sugar levels. Relative potency expressed by anti-inflammatory effect of dexamethasone is about 25 times higher than hydrocortisone, while its mineralocorticoid effect isminimal.

5.2 Pharmacokinetic particulars

DEXASHOT is a short acting dexamethasone preparation with a rapid onset of activity. It contains the disodium phosphate ester of dexamethasone. After extravascular (intramuscular, intra-articular) administration, the ester is rapidly resorbed from the injection site followed by immediate hydrolysation into the parent compound, dexamethasone, giving a prompt response which is maintained for approximately 48 hours. 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 i.m. administration (compared to i.v. administration) is high in all species. The half-life after intravenous and intramuscular administration is similar, 5-20 hours depending on the species.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol (E1519)

Sodium chloride

Sodium citrate

Citric acid monohydrate (for pH adjustment)

Sodium hydroxide (for pH adjustment)

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 33 months.

Shelf life after first opening the immediate packaging: 28 days.

6.4. Special precautions for storage

Keep the vial in the outer carton in order to protect from light.

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