Rapidexon 2 mg/ml Solution for Injection

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Dexamethasone

Disponible des:

Eurovet Animal Health B.V.

Codi ATC:

QH02AB02

Designació comuna internacional (DCI):

Dexamethasone

formulario farmacéutico:

Solution for injection

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Cats, Cattle, Dogs, Horses, Pigs

Área terapéutica:

Anti Inflammatory corticosteroid

Estat d'Autorització:

Authorized

Data d'autorització:

2006-02-21

Fitxa tècnica

Revised: January 2014
AN: 01165/2013
Page 1 of 7
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 the 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.
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.
Revised: January 2014
AN: 01165/2013
Page 2 of 7
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
i) 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 hor