Benakor 20 mg tablets for dogs

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Benazepril hydrochloride

から入手可能:

Le Vet BV

ATCコード:

QC09AA07

INN（国際名）:

Benazepril hydrochloride

投薬量:

20 mg/tablet

医薬品形態:

Tablet

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療群:

Dogs

治療領域:

benazepril

適応症:

Cardiovascular

認証ステータス:

Authorised

承認日:

2008-10-24

製品の特徴

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NL: Benazepril hydrochloride LeVet 20 mg tabletten voor honden
AT: Benakor 20 mg, Tabletten für Hunde
BE: Benakor 20 mg tabletten voor honden
CZ: Benakor 20 mg, tablety pro psy
EE: Benakor 20 mg tabletid koertele
ES: Benakor 20 mg comprimidos para perros
FI: Benakor vet 20 mg tabletti
FR: Benakor 20 comprimés pour chiens
IE: Benakor 20 mg tablets for dogs
IT: Benakor 20 mg compresse per cani
LU: Benakor 20 mg comprimés pour chiens
NO: Benakor vet. 20 mg tabletter til hund
PL: Benakor vet. 20 mg tabletki dla psów
PT: Benakor 20 mg comprimidos para cães
SK: Benakor 20 mg tablety pre psov
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Benazepril hydrochloride
20 mg
EXCIPIENT:
Colourant: Iron oxides (E172) 8 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Orange oblong divisible tablets, with a break mark on both sides.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of congestive heart failure.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or
acute renal failure.
Do not use in cases of cardiac output failure due to aortic or
pulmonary stenosis.
Do not use during pregnancy or lactation (section 4.7).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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 chronic kidney disease, it is recommended to
monitor plasma creatinine, urea
and erythrocyte counts 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 advice immediately
and s