PRILACTONE NEXT 10 MG CHEWABLE TABLETS FOR DOGS

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

SPIRONOLACTONE

Dostupné z:

Ceva Santé Animale

ATC kód:

QC03DA01

INN (Medzinárodný Name):

SPIRONOLACTONE

Dávkovanie:

10 mg/tablet

Forma lieku:

Tablets Chewable

Typ predpisu:

POM

Terapeutické skupiny:

Canine

Terapeutické oblasti:

Spironolactone

Terapeutické indikácie:

Neurological Preparations

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2016-04-22

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Prilactone Next 10 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
ACTIVE SUBSTANCE:
Spironolcatone ................................... 10 mg
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Oblong scored beige tablet. The tablets can be divided into equal
halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use in combination with standard therapy (including diuretic
support, where necessary) for the treatment of
congestive heart failure caused by degenerative mitral valve disease
in dogs.
4.3 CONTRAINDICATIONS
Do not use in animals used for or intended for use in breeding.
Do not use the product in dogs suffering from hypoadrenocorticism,
hyperkalaemia or hyponatraemia.
Do not administer spironolactone in conjunction with NSAIDs to dogs
with renal insufficiency.
Do not use in the case of hypersensitivity to spironolactone or any of
the excipients
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Kidney function and plasma
potassium levels
should be
evaluated before
initiating