Equisolon

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Prednisolone

MAH:

LE VET B.V.

ATC_code:

QH02AB06

INN:

Prednisolone

therapeutic_group:

Horses

therapeutic_area:

Corticosteroids for systemic use, plain, prednisolone, Systemic hormonal preparations, excl. sex hormones and insulin

therapeutic_indication:

Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.

leaflet_short:

Revision: 9

authorization_status:

Authorised

authorization_date:

2014-03-12

PIL

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET
EQUISOLON 100 MG ORAL POWDER FOR HORSES
EQUISOLON 300 MG ORAL POWDER FOR HORSES
EQUISOLON 600 MG ORAL POWDER FOR HORSES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Le Vet B.V.
Wilgenweg 7
3421 TV Oudewater
THE NETHERLANDS
Manufacturer responsible for batch release:
LelyPharma B.V.
Zuiveringweg 42
8243 PZ Lelystad
THE NETHERLANDS
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equisolon 100 mg oral powder for horses
Equisolon 300 mg oral powder for horses
Equisolon 600 mg oral powder for horses
prednisolone
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
White to off-white powder containing 33.3 mg/g of prednisolone.
ACTIVE SUBSTANCE:
100 mg prednisolone per 3 g sachet.
300 mg prednisolone per 9 g sachet.
600 mg prednisolone per 18 g sachet.
4.
INDICATION(S)
Alleviation of inflammatory and clinical parameters associated with
recurrent airway obstruction
(RAO) in horses, in combination with environmental control.
5.
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
to corticosteroids and to any
other ingredient of the product.
Do not use in viral infections in which the virus particles circulate
in the bloodstream or in cases of
systemic fungal infections.
Do not use in animals suffering from gastrointestinal ulcers.
Do not use in animals suffering from corneal ulcers.
Do not use during pregnancy.
25
6.
ADVERSE REACTIONS
Very rarely, laminitis has been observed after use of the product.
Therefore horses should be
monitored frequently during the treatment period.
Very rarely, neurological signs such as ataxia, recumbency, head
tilting, restlessness or incoordination
have been observed after use of the product.
Whilst single high doses of corticosteroids are generally well
tolerated, they may induce severe side-
effects in long term use. Dosage in medium to long term use should
therefore gener

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equisolon 100 mg oral powder for horses
Equisolon 300 mg oral powder for horses
Equisolon 600 mg oral powder for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
100 mg prednisolone per 3 g sachet.
300 mg prednisolone per 9 g sachet
600 mg prednisolone per 18 g sachet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder.
White to off-white powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammatory and clinical parameters associated with
recurrent airway obstruction
(RAO) in horses, in combination with environmental control.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
to corticosteroids or to any of
the excipients.
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 ulcers.
Do not use in animals suffering from corneal ulcers.
Do not use during pregnancy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Corticoid administration is to induce an improvement in clinical signs
rather than a cure. The treatment
should be combined with environmental control.
Each case should be assessed individually by the veterinarian and an
appropriate treatment program
determined. Treatment with prednisolone should only be initiated when
satisfactory alleviation of
clinical symptoms have not been obtained or are unlikely to be
obtained by environmental control
alone.
Treatment with prednisolone may not sufficiently restore respiratory
function in all cases, and in each
individual case the use of medicinal products with more rapid onset of
action may need to be
considered.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use in animals suffering from diabetes mellitus, renal
insufficiency, cardiac insufficiency,
hyperadrenocorticism, or os