Trovex 1 mg/ml suspension for injection for cattle, horses, pigs, cats and dogs

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Dexamethasone isonicotinate

Fáanlegur frá:

Emdoka

ATC númer:

QH02AB02

INN (Alþjóðlegt nafn):

Dexamethasone isonicotinate

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

dexamethasone

Leyfisstaða:

Authorised

Leyfisdagur:

2021-11-12

Vara einkenni

Health Products Regulatory Authority
12 November 2021
CRN009Q98
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Trovex 1 mg/ml suspension for injection for cattle, horses, pigs, cats
and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains: ​
​
​
ACTIVE SUBSTANCE: ​
​
Dexamethasone isonicotinate
​1.00 mg
(equivalent to 0.79 mg dexamethasone)
​
EXCIPIENTS:
​
Methylparahydroxybenzoate (E218)
​
1.35mg
​
Propylparahydroxybenzoate
​
0.15mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection
White to yellowish white suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, horses, pigs, cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horses, cattle, pigs, dogs and cats:
Treatment of inflammatory skin conditions, diseases of the locomotor
system and diseases of the respiratory system.
Cattle:
Treatment of ketosis (acetonaemia).
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 use in animals with known cases of hypersensitivity to the
active substance, to corticosteroids and to any other
ingredient of the product.
See also section 4.7.
Do not use for the treatment of laminitis in horses, where there is
the possibility that such treatment could worsen the
condition.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
12 November 2021
CRN009Q98
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
During a course of treatment the situation should be reviewed
frequently by close veterinary supervision.
Care should be taken not to overdose Channel Island breeds of cattle.
Use of