Tempora 50 mg chewable tablets for dogs
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
13-06-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
spironolactone
थमां उपलब्ध:
Sogeval
ए.टी.सी कोड:
QC03DA01
डोज़:
50 mg/tablet
फार्मास्यूटिकल फॉर्म:
Tablets Chewable
चिकित्सीय समूह:
Canine
चिकित्सीय क्षेत्र:
Neurological Preparations
प्राधिकरण का दर्जा:
Authorised
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tempora 50 mg chewable tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
ACTIVE SUBSTANCE:
Spironolactone............................................................ 50 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/09/2012_
_CRN 7010451_
_page number: 1_
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 hyperkalaemia was not observed in
clinical trials performed in dogs with this combination. However, in dogs with renal impairment, regular monitoring of
renal function and plasma potassium levels is
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