BEXEPRIL 5 MG FILM-COATED TABLET FOR DOGS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
13-10-2016
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Trimite cerere.
Trimite cerere.
Ingredient activ:
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
Disponibil de la:
Chanelle Pharmaceuticals Manufacturing Limited
Codul ATC:
QC09AA07
INN (nume internaţional):
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
Dozare:
5 mg/tablet
Forma farmaceutică:
Film Coated Tablet
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Canine
Zonă Terapeutică:
Benazepril
Indicații terapeutice:
Cardiovascular
Statutul autorizaţiei:
Authorised
Data de autorizare:
2010-06-04
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 5 mg Film-coated tablet for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril
4.6 mg
(equivalent to Benazepril Hydrochloride 5mg)
EXCIPIENT:
Titanium Dioxide (E171)
0.9348 mg
Iron Oxide Yellow (E172)
0.0476 mg
Quinoline Yellow Aluminum Lake (E104)
0.0176mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A round yellow biconvex tablet with break line on one side. 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
In dogs weighing more than 10 kg:
Treatment of congestive heart failure associated with, in particular, dilated cardiomyopathy and/or mitral insufficiency.
4.3 CONTRAINDICATIONS
Do not use in any dog that has evidence of cardiac output failure due, for example, to aortic stenosis.
Do not use in animals known to be hypersensitive to the active substance or to any of the excipient(s).
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 28/09/2016_
_CRN 7024622_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity to the product has been observed in dogs during clinical trials. However, as is routine in
cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash hands after use.
In case of accidental oral ingestion, seek medical adv
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