BEXEPRIL 5 MG FILM-COATED TABLET FOR DOGS

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.

Prieinama:

Chanelle Pharmaceuticals Manufacturing Limited

ATC kodas:

QC09AA07

INN (Tarptautinis Pavadinimas):

BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.

Dozė:

5 mg/tablet

Vaisto forma:

Film Coated Tablet

Recepto tipas:

POM

Farmakoterapinė grupė:

Canine

Gydymo sritis:

Benazepril

Terapinės indikacijos:

Cardiovascular

Autorizacija statusas:

Authorised

Leidimo data:

2010-06-04

Prekės savybės

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
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_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