产品特点
VETERINARY MEDICINAL PRODUCT
TEMPORA 100 MG CHEWABLE TABLETS FOR DOGS
PART I B
SUMMARY OF THE PRODUCT CHARACTERISTICS
Pharmaceutical Form
Chewable Tablet
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TEMPORA 100 MG CHEWABLE TABLETS FOR DOGS
TEMPORA VET (NO)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
ACTIVE SUBSTANCE:
Spironolactone ............................................................ 100 mg
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Clover-shaped scored beige tablet. The tablet can be divided into four equal parts
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.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Kidney function and plasma potassium levels should be evaluated before initiating combined
treatment with spironolactone and ACE inhibitors. Unlike in humans, an increased incidence
of hyperk
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