Rapidexon 2 mg/ml solution for injection

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Dexamethasone
Available from:
Eurovet Animal Health B.V.
ATC code:
QH02AB02
INN (International Name):
Dexamethasone
Dosage:
2 milligram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cats, Cattle, Dogs, Horses, Pigs
Therapeutic area:
dexamethasone
Therapeutic indications:
Corticosteroid
Authorization status:
Authorised
Authorization number:
VPA10989/056/001
Authorization date:
2008-04-04

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Rapidexon 2 mg/ml solution for injection.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each millilitre contains:

Active substance:

Dexamethasone (as Dexamethasone Sodium Phosphate) 2.0 mg

Excipient:

Benzyl alcohol (E1519), 15.0 mg

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Solution for injection.

A clear colourless solution practically free from particles.

4 CLINICAL PARTICULARS

4.1 Target Species

Horses, cattle, pigs, cats and dogs.

4.2 Indications for use, specifying the target species

In horses, cattle, pigs, dogs and cats:

Treatment of inflammatory or allergic conditions.

In cattle:

Treatment of primary ketosis (acetonaemia).

Induction of parturition

In horses:

Treatment of arthritis, bursitis or tenosynovitis.

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4.3 Contraindications

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.

Refer to section 4.7.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

If the veterinary medicinal 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. 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 the parturition, corticoid 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.

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.

Only the 25 ml vial should be used to treat cats, dogs and small piglets to prevent excessive puncturing of the closure.

See section 4.6.

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

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

People with known hypersensitivity to the active substance or any of the excipients should avoid contact with the

veterinary medicinal product.

Pregnant women should not handle this veterinary medicinal product.

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4.6 Adverse reactions (frequency and seriousness)

Corticosteroids are known to exert a wide range of side-effects. Whilst single high doses are generally well tolerated,

they may induce severe adverse reactions with 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 clinical signs.

Steroids themselves, during treatment, may cause iatrogenic hyperadrenocorticism (Cushings disease) involving

significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, increase in

body weight, muscle weakness and wastage and osteoporosis may result.

During therapy effective doses suppress the hypothalamo-pituitreal adrenal axis. Following cessation of treatment, signs

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 information see standard texts).

Systemically 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).

Corticosteroid use may delay wound healing and the immunosuppressant actions may weaken resistance to or

exacerbate existing infections. In the presence of bacterial infection, concurrent antibacterial therapy is usually

required. In the presence of viral infections, corticosteroids 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.

Corticosteroid use may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes and may

increase the risk of acute pancreatitis. Other possible adverse reactions associated with corticosteroid use include

retained placenta, metritis, subfertility, laminitis, reduction in milk yield, changes in blood biochemical and

haematological parameters.

Transient hyperglycaemia can occur.

4.7 Use during pregnancy, lactation or lay

Do not administer the product in pregnant females, except where the intention is to induce parturition. Administration

in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late

pregnancy is likely to cause abortion or early parturition in ruminants and may have a similar effect in other species.

Use of the veterinary medicinal product in lactating cows may cause a reduction in milk yield.

Refer to section 4.5.

4.8 Interaction with other medicinal products and other forms of interaction

Concurrent use with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration.

Because corticosteroids can reduce the immunoresponse 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 anticholinestaerase 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 dexamethason.

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4.9 Amounts to be administered and administration route

Horses: for intravenous, intramuscular, intra-articular, intrabursal or local administration.

Cattle, pigs, dogs and cats:

For intramuscular injection.

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.

For the treatment of primary ketosis in cattle (acetonaemia)

0.02 to 0.04 mg/kg body weight corresponding to 5-10 ml per cow 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 -

0.04 mg/kg body weight corresponding to 10 ml per cow as a single intramuscular injection after day 270 of pregnancy.

Parturition will normally occur within 48-72 hours.

For the treatment of arthritis, bursitis or tenosynovitis by single intra-articular, intrabursal or local injection in the

horse.

Dosage

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.

To measure small volumes of less than 1 ml a suitably graduated syringe should be used to ensure accurate

administration of the correct dose.

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

An overdose can induce drowsiness and lethargy in horses. Refer to section 4.6.

4.11 Withdrawal Period(s)

Cattle

meat and offal: 8 days

milk: 72 hours

meat and offal: 2 days

Horse

meat and offal: 8 days

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

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: corticosteroid for systemic use, glucocorticoid.

ATCvet code: QH02AB02

Species

Dosage

Horses, cattle, pigs

0.06 mg/kg body weight corresponding to 1.5 ml/50 kg

Dog, cat

0.1 mg/kg body weight corresponding to 0.5 ml/10 kg

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5.1 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 immunologic response by inhibition of

dilatation of capillaries, migration and function of leucocytes and phagocytosis. Glucocorticoids have an effect on

metabolism by increasing gluconeogenesis.

5.2 Pharmacokinetic properties

Following intramuscular injection this soluble ester of dexamethasone is readily absorbed and hydrolysed to the parent

alcohol giving a prompt response which is maintained for approximately 48 hours. T

in cattle, horses, pigs and dogs

is reached within 20 minutes following intramuscular administration. T

varies per species between 5 and 20 hours.

Bioavailability after intramuscular administration is almost 100%. Dexamethasone has a medium duration of activity.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride,

sodium citrate dihydrate

benzyl alcohol (E1519),

citric acid monohydrate,

sodium hydroxide,

water for injections

6.2 Incompatibilities

In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary

medicinal products.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale in 50 ml and 100 ml vials: 2 years.

Shelf-life of the veterinary medicinal product as packaged for sale in 25 ml vials: 18 months.

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

6.4 Special precautions for storage

Do not store above 25°C.

Do not freeze.

Keep vial in the outer carton.

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6.5 Nature and composition of immediate packaging

- Vial

* volume 25 ml (filled in 30 ml vial), 50 ml and 100 ml;

* glass type I; quality Ph.Eur.

* uncoloured;

- Stopper

* bromobutyl rubber stopper type I

* secured with aluminium cap

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be

disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

8 MARKETING AUTHORISATION NUMBER(S)

VPA: 10989/056/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 4th April 2008

Date of last renewal: 21st April 2011

10 DATE OF REVISION OF THE TEXT

January 2014

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