Forzepril Tablets 20 mg

Country: Ireland

Language: English

Source: HMA (Heads of Medicines Agencies)

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Active ingredient:

benazepril 20 mg

Available from:

Chanelle Pharmaceutical Manufacturing Ltd

ATC code:

QC09AA07

Pharmaceutical form:

Film coated tablet

Therapeutic group:

benazepril

Therapeutic area:

Dogs Non Food

Authorization date:

2012-06-27

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Forzepril 20 mg film-coated tablet for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril 18.42 mg
(equivalent to Benazepril Hydrochloride 20 mg)
EXCIPIENT:
Titanium Dioxide (E171)
Iron Oxide Yellow (E172)
Iron Oxide Red (E172)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A round reddish orange 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 40 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/08/2012_
_CRN 7011152_
_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 advice and show the label or the package l
                                
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