Banacep vet 5 mg Filmtablette für Hunde
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
23-11-2012
Summary of Product characteristics
(SPC)
23-11-2012
Active ingredient:
benazepril hydrochloride 4.6 mg
Available from:
Laboratorios Calier
ATC code:
QC09AA07
Pharmaceutical form:
Tablet
Therapeutic group:
benazepril
Therapeutic area:
Cats, Dogs
Authorization date:
2012-12-02
Patient Information leaflet
PART I.B.2. PROPOSAL FOR INMEDIATE AND PACKAGE
LEAFLET
PACKAGE LEAFLET
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AND
OF
THE
MANUFACTURING
AUTHORISATION
HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer
Laboratorios Calier, S.A.
Barcelonès, 26 (Pla del Ramassà)
Les Franqueses del Vallès (Barcelona)
SPAIN
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
BANACEP
®
vet
5
mg
film-coated
tablet
for
dogs
and
cats
(BE,DK,DE,EL,ES,FI,IT,NL,PL,PT,SW,UK)
Benazepril hydrochloride
BANACEP
®
vet 5 film-coated tablet for dogs and cats [FR]
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER
INGREDIENT(S)
Each divisible tablet contains:
Benazepril ........................................ 4.6 mg
(equivalent to Benazepril Hydrochloride 5 mg)
Excipients :
Titanium dioxide (E171) .................. 1.929 mg
Iron oxide yellow (E172) ................. 0.117 mg
Iron oxide red (E172)...................... 0.014 mg
Iron oxide black (E172) .................. 0.004 mg
4. INDICATION(S)
Banacep vet 5 mg or 5 _ _belongs to a group of medicines called Angiotensin
Converting Enzyme (ACE) inhibitors. It is prescribed by the veterinary surgeon
for the treatment of congestive heart failure in dogs and for reduction of
proteinuria associated with chronic kidney disease in cats.
5. CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance benazepril
hydrochloride or to any ingredient of the tablets.
Do not use in cases of hypotension (low blood pr
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Summary of Product characteristics
12462 BANACEP 5 renewal D90 SPC D81
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT:
BANACEP vet 5 mg film-coated tablet for dogs and cats (BE,DK,DE,EL,ES,FI,IT,NL, PL,PT,SW,UK)
Benazepril hydrochloride
BANACEP vet 5 film-coated tablet for dogs and cats [FR]
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each divisible tablet contains:
Benazepril ............................................ 4.6 mg
(equivalent to Benazepril Hydrochloride 5 mg)
Excipients :
Titanium dioxide (E171) .......................... 1.929 mg
Iron oxide yellow (E172).......................... 0.117 mg
Iron oxide red (E172) .............................. 0.014 mg
Iron oxide black (E172) ........................... 0.004 mg
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Film-Coated tablet
Beige oblong biconvex film-coated divisible tablets
4. CLINICAL PARTICULARS:
4.1 TARGET SPECIES:
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES:
Dogs:
Treatment of congestive heart failure.
Cats:
Reduction of proteinuria associated with chronic kidney disease.
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.
12462 BANACEP 5 renewal D90 SPC D81
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Do not use in pregnancy or lactation (see section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 S
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