Banacep Vet 5 mg Film-Coated Tablet for Dogs and Cats Benazepril Hydrochloride

Main information

  • Trade name:
  • Banacep Vet 5 mg Film-Coated Tablet for Dogs and Cats Benazepril Hydrochloride
  • Available from:
  • Laboratorios Calier, SA
  • Prescription type:
  • POM-V
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Banacep Vet 5 mg Film-Coated Tablet for Dogs and Cats Benazepril Hydrochloride
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • VMD
  • Authorization date:
  • 12-02-2008
  • Last update:
  • 09-08-2016

Patient Information leaflet


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Revised: January 2010

AN: 00175/2009

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,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:

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:

In dogs weighing more than 5 kg bw: Treatment of congestive heart failure.

In cats: Treatment of chronic renal insufficiency.

4.3 . Contraindications:

Do not use in case of hypersensitivity to angiotensin converting enzyme

inhibitors or to any other ingredients.

Do not use in dogs with cardiac failure resulting from aortic stenosis.

See Section 4.7.

4.4 Special warnings for each target species

None

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AN: 00175/2009

4.5 Special precautions for use

i. Special precautions for use in animals

No evidence of renal toxicity to benazepril has been observed in dogs

or cats. However, as is routine in cases of chronic renal insufficiency, it

is recommended to monitor plasma creatinine and urea during therapy.

The safety of benazepril has not been established in cats below 2.5 kg

body weight.

ii. Special precautions to be taken by the person administering the

veterinary medicinal product to animals

Pregnant women should take special care to avoid accidental oral

exposure, because ACE inhibitors have been found to affect the unborn

child during pregnancy in humans.

Wash hands after use.

In case of accidental ingestion by children seek medical advice

immediately and show the label to the doctor.

4.6 Adverse reactions (frequency and seriousness):

Some dogs may e xhibit transient signs of fatigue.

At the start of treatment a decrease of blood pressure may occur.

Benazepril hydrochloride may lead to increased plasma creatinine

concentrations.

In a small number of cats the benazepril hydrochloride can produce sporadic

and not severe diarrhoea.

In cats with chronic renal insufficiency, benazepril may increase plasma

creatinine concentrations at the start of therapy. This effect is related to the

therapeutic effect of the product in reducing blood pressure, and therefore is

not necessarily a reason to stop therapy in the absence of other signs. As is

routine in cases of chronic renal insufficiency, it is recommended to monitor

plasma creatinine during therapy.

Benazepril reduced erythrocyte counts in normal cats at high doses, but this

effect was not observed at the recommended dose during clinical trials in cats

with chronic renal insufficiency. As is routine in cases of chronic renal

insufficiency, it is recommended to monitor erythrocyte counts during therapy.

Emesis, anorexia, dehydration and lethargy have been reported on rare

occasions in this species.

4.7 Use during pregnancy and lactation

Laboratory studies in rats have shown embryotoxic effects of Benazepril at

non- maternotoxic doses (urinary system abnormalities in foetus). Benazepril

administered to cats at a daily dose of 10 mg / kg for 52 weeks resulted in the

reduction of ovary / oviduct weights.

Safety of this product has not been tested in pregnant or lactating queens and

bitches.

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Revised: January 2010

AN: 00175/2009

Do not use in pregnant or lactating females nor in animals intended for

breeding

4.8 Interaction with other medicaments and other forms of interaction:

Concomitant administration of potassium sparing diuretics may be considered.

It is then recommended to regularly monitor potassium plasma levels.

The combination of this product with other anti-hypertensive agents (e.g.

calcium channel blockers, b blockers or diuretics) anaesthetics or sedatives

may lead to additive hypotensive effects. In man, the combination of ACE

inhibitors and NSAIDs can lead to reduced anti-hypertensive efficacy or

impaired renal function. Therefore the concurrent use of NSAIDs or

medications with hypotensive effect should be considered with care.

4.9 Amounts to be administered and administration route:

In dogs:

The dose is 0.23 mg benazepril /kg bw per day, corresponding to 0.25 mg of

Benazepril hydrochloride / kg bw per day. It should be given orally once daily,

with or without food. It corresponds to 1 tablet per 20 kg given according to the

follo wing regime:

Weight of dog (kg) Number of tablets

>

5 - 10 1/2 tablet

>

10 - 20 1 tablet

In cats:

The dose is 0.46 mg benazepril /kg bw per day, corresponding to 0.50 mg of

Benazepril hydrochloride / kg bw per day. It should be given orally once daily,

with or without food. It corresponds to 1 tablet per 10 kg given according to the

following regime:

Weight of cat (kg) Number of tablets

2.5 – 5 1/2 tablet

5 - 10 1 tablet

Dosage may be doubled, still administered once daily, if judged clinically

necessary and advised by the veterinary surgeon

4.10 Overdose (symptoms, emergency procedures, antidotes):

Transient reversible signs of hypotension may occur in cases of accidental

overdose. Symptomatic treatment consists of intravenous infusion of warm

isotonic saline.

In healthy cats, after the administration of 10 times the recommended dose for

one year no clinical signs of toxicity were observed.

4.11 Withdrawal period:

Not applicable

5. PHARMACOLOGICAL PROPERTIES

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Revised: January 2010

AN: 00175/2009

Pharmacotherapeutic group: ACE inhibitors, benazepril

ATCvet code: QC09AA07

5.1 Pharmacodynamic properties

Benazepril hydrochloride is a prodrug hydrolysed in vivo to benazeprilat. This

active metabolite inhibits angiotensin converting enzyme (ACE), thus

preventing the conversion of inactive angiotensin I into active angiotensin II.

Therefore, benazeprilate inhibits all effects induced by angiotensin II, in

particular, vasoconstriction of both arteries and veins and retention of sodium

and water by the kidney. Benazepril hydrochloride causes long-lasting

inhibition of plasma ACE in dogs, with significant inhibition persisting for 24

hours after a single dose.

In dogs with cardiac insufficiency, benazepril hydrochloride reduces the

peripheral resistance, blood pressure of left ventricle and volume load on the

heart

In cats with renal insufficiency, benazepril hydrochloride reduces systemic

blood and intraglomerular pressure. At the same time, it decreases glomerular

basal membrane permeability. In consequence, it reduces protein loss in the

urine and renal insufficiency progression.

5.2. Pharmacokinetic properties

After oral administration, benazepril is rapidly absorbed from the

gastrointestinal tract. One part of absorbed benazepril is hydrolyzed by hepatic

enzymes to the active substance, benazeprilat; unchanged benazepril and

hydrophilic metabolites account for the remainder. The absolute systemic

bioavailability, calculated for oral benazepril versus intravenous benazepril is

about 9%. Peak benazeprilat concentrations are achieved within about 2

hours, both in fasting and fed situations.

Benazepril and benazeprilat are extensively bound to plasma proteins.

Repeated administration leads to slight accumulation of benazeprilat in

plasma, steady state being achieved in less than 4 days.

In dogs, the major part of benazeprilat is rapidly eliminated, and it is excreted

equally via hepatic and urinary routes.

After the administration of a single dose of the product (0.23 mg benazepril/ kg

b.w.), peak benazeprilat concentrations (Cmax of 40.9 ng/ml) were achieved

within about 1.5 h (Tmax of 1.5h), with AUC of 320.5 ng/ml.h and a half-life

(t

1/2 ) of 12.4 h.

In cats, benazeprilat is excreted 85% via the biliary and 15% via the urinary

route. The clearance of benazeprilat is not affected in cats with decreased

glomerular filtration; therefore, no adjustment of the dose is required.

After the administration of a single dose of the product in cats (0.46 mg

benazepril/ kg b.w.), peak benazeprilat concentrations (Cmax of 198.7 ng/ml)

were achieved within about 1.0 h (Tmax of 1.03h), with AUC of 969.4 ng/ml.h

and a half-life (t

1/2 ) of 13.9 h.

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Revised: January 2010

AN: 00175/2009

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Iron oxide yellow (E-172)

Iron oxide red (E-172)

Iron oxide black (E-172

Titanium dioxide (E-171)

Cellulose microcrystalline

Lactose monohydrate

Povidone

Maize starch

Silica colloidal anhydrous

Magnesium stearate

Hypromellose

Macrogol 8000

6.2 Incompatibilities

Not applicable

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months

Return any halved tablet to the blister pack and use within 1 day. The blister

pack should be inserted back into the cardboard box.

6.4 Special precautions for storage:

Do not store above 25°C. Store in a dry place.

6.5 Nature and composition of immediate packaging:

Blister made of clear film of PVC/PE/PVDC and aluminium film containing 14

tablets.

Box with:

- 1 blister (14 tablets)

- 10 blisters (140 tablets)

Not all pack size may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

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Revised: January 2010

AN: 00175/2009

7. MARKETING AUTHORISATION HOLDER

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

Les Franqueses del Valles (Barcelona)

SPAIN

8. MARKETING AUTHORISATION NUMBER

Vm

20634/4002

9. DATE OF THE FIRST AUTHORISATION /RENEWAL OF THE

AUTHORISATION

12 th

February 2008

10. DATE OF REVISION OF THE TEXT

January 2010

PROHIBITION OF SALE, SUPPLY AND/OR USE

Under veterinary prescription

Summary of Product characteristics


Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised: January 2010

AN: 00175/2009

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,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:

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:

In dogs weighing more than 5 kg bw: Treatment of congestive heart failure.

In cats: Treatment of chronic renal insufficiency.

4.3 . Contraindications:

Do not use in case of hypersensitivity to angiotensin converting enzyme

inhibitors or to any other ingredients.

Do not use in dogs with cardiac failure resulting from aortic stenosis.

See Section 4.7.

4.4 Special warnings for each target species

None

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Revised: January 2010

AN: 00175/2009

4.5 Special precautions for use

i. Special precautions for use in animals

No evidence of renal toxicity to benazepril has been observed in dogs

or cats. However, as is routine in cases of chronic renal insufficiency, it

is recommended to monitor plasma creatinine and urea during therapy.

The safety of benazepril has not been established in cats below 2.5 kg

body weight.

ii. Special precautions to be taken by the person administering the

veterinary medicinal product to animals

Pregnant women should take special care to avoid accidental oral

exposure, because ACE inhibitors have been found to affect the unborn

child during pregnancy in humans.

Wash hands after use.

In case of accidental ingestion by children seek medical advice

immediately and show the label to the doctor.

4.6 Adverse reactions (frequency and seriousness):

Some dogs may e xhibit transient signs of fatigue.

At the start of treatment a decrease of blood pressure may occur.

Benazepril hydrochloride may lead to increased plasma creatinine

concentrations.

In a small number of cats the benazepril hydrochloride can produce sporadic

and not severe diarrhoea.

In cats with chronic renal insufficiency, benazepril may increase plasma

creatinine concentrations at the start of therapy. This effect is related to the

therapeutic effect of the product in reducing blood pressure, and therefore is

not necessarily a reason to stop therapy in the absence of other signs. As is

routine in cases of chronic renal insufficiency, it is recommended to monitor

plasma creatinine during therapy.

Benazepril reduced erythrocyte counts in normal cats at high doses, but this

effect was not observed at the recommended dose during clinical trials in cats

with chronic renal insufficiency. As is routine in cases of chronic renal

insufficiency, it is recommended to monitor erythrocyte counts during therapy.

Emesis, anorexia, dehydration and lethargy have been reported on rare

occasions in this species.

4.7 Use during pregnancy and lactation

Laboratory studies in rats have shown embryotoxic effects of Benazepril at

non- maternotoxic doses (urinary system abnormalities in foetus). Benazepril

administered to cats at a daily dose of 10 mg / kg for 52 weeks resulted in the

reduction of ovary / oviduct weights.

Safety of this product has not been tested in pregnant or lactating queens and

bitches.

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised: January 2010

AN: 00175/2009

Do not use in pregnant or lactating females nor in animals intended for

breeding

4.8 Interaction with other medicaments and other forms of interaction:

Concomitant administration of potassium sparing diuretics may be considered.

It is then recommended to regularly monitor potassium plasma levels.

The combination of this product with other anti-hypertensive agents (e.g.

calcium channel blockers, b blockers or diuretics) anaesthetics or sedatives

may lead to additive hypotensive effects. In man, the combination of ACE

inhibitors and NSAIDs can lead to reduced anti-hypertensive efficacy or

impaired renal function. Therefore the concurrent use of NSAIDs or

medications with hypotensive effect should be considered with care.

4.9 Amounts to be administered and administration route:

In dogs:

The dose is 0.23 mg benazepril /kg bw per day, corresponding to 0.25 mg of

Benazepril hydrochloride / kg bw per day. It should be given orally once daily,

with or without food. It corresponds to 1 tablet per 20 kg given according to the

follo wing regime:

Weight of dog (kg) Number of tablets

>

5 - 10 1/2 tablet

>

10 - 20 1 tablet

In cats:

The dose is 0.46 mg benazepril /kg bw per day, corresponding to 0.50 mg of

Benazepril hydrochloride / kg bw per day. It should be given orally once daily,

with or without food. It corresponds to 1 tablet per 10 kg given according to the

following regime:

Weight of cat (kg) Number of tablets

2.5 – 5 1/2 tablet

5 - 10 1 tablet

Dosage may be doubled, still administered once daily, if judged clinically

necessary and advised by the veterinary surgeon

4.10 Overdose (symptoms, emergency procedures, antidotes):

Transient reversible signs of hypotension may occur in cases of accidental

overdose. Symptomatic treatment consists of intravenous infusion of warm

isotonic saline.

In healthy cats, after the administration of 10 times the recommended dose for

one year no clinical signs of toxicity were observed.

4.11 Withdrawal period:

Not applicable

5. PHARMACOLOGICAL PROPERTIES

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Revised: January 2010

AN: 00175/2009

Pharmacotherapeutic group: ACE inhibitors, benazepril

ATCvet code: QC09AA07

5.1 Pharmacodynamic properties

Benazepril hydrochloride is a prodrug hydrolysed in vivo to benazeprilat. This

active metabolite inhibits angiotensin converting enzyme (ACE), thus

preventing the conversion of inactive angiotensin I into active angiotensin II.

Therefore, benazeprilate inhibits all effects induced by angiotensin II, in

particular, vasoconstriction of both arteries and veins and retention of sodium

and water by the kidney. Benazepril hydrochloride causes long-lasting

inhibition of plasma ACE in dogs, with significant inhibition persisting for 24

hours after a single dose.

In dogs with cardiac insufficiency, benazepril hydrochloride reduces the

peripheral resistance, blood pressure of left ventricle and volume load on the

heart

In cats with renal insufficiency, benazepril hydrochloride reduces systemic

blood and intraglomerular pressure. At the same time, it decreases glomerular

basal membrane permeability. In consequence, it reduces protein loss in the

urine and renal insufficiency progression.

5.2. Pharmacokinetic properties

After oral administration, benazepril is rapidly absorbed from the

gastrointestinal tract. One part of absorbed benazepril is hydrolyzed by hepatic

enzymes to the active substance, benazeprilat; unchanged benazepril and

hydrophilic metabolites account for the remainder. The absolute systemic

bioavailability, calculated for oral benazepril versus intravenous benazepril is

about 9%. Peak benazeprilat concentrations are achieved within about 2

hours, both in fasting and fed situations.

Benazepril and benazeprilat are extensively bound to plasma proteins.

Repeated administration leads to slight accumulation of benazeprilat in

plasma, steady state being achieved in less than 4 days.

In dogs, the major part of benazeprilat is rapidly eliminated, and it is excreted

equally via hepatic and urinary routes.

After the administration of a single dose of the product (0.23 mg benazepril/ kg

b.w.), peak benazeprilat concentrations (Cmax of 40.9 ng/ml) were achieved

within about 1.5 h (Tmax of 1.5h), with AUC of 320.5 ng/ml.h and a half-life

(t

1/2 ) of 12.4 h.

In cats, benazeprilat is excreted 85% via the biliary and 15% via the urinary

route. The clearance of benazeprilat is not affected in cats with decreased

glomerular filtration; therefore, no adjustment of the dose is required.

After the administration of a single dose of the product in cats (0.46 mg

benazepril/ kg b.w.), peak benazeprilat concentrations (Cmax of 198.7 ng/ml)

were achieved within about 1.0 h (Tmax of 1.03h), with AUC of 969.4 ng/ml.h

and a half-life (t

1/2 ) of 13.9 h.

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised: January 2010

AN: 00175/2009

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Iron oxide yellow (E-172)

Iron oxide red (E-172)

Iron oxide black (E-172

Titanium dioxide (E-171)

Cellulose microcrystalline

Lactose monohydrate

Povidone

Maize starch

Silica colloidal anhydrous

Magnesium stearate

Hypromellose

Macrogol 8000

6.2 Incompatibilities

Not applicable

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months

Return any halved tablet to the blister pack and use within 1 day. The blister

pack should be inserted back into the cardboard box.

6.4 Special precautions for storage:

Do not store above 25°C. Store in a dry place.

6.5 Nature and composition of immediate packaging:

Blister made of clear film of PVC/PE/PVDC and aluminium film containing 14

tablets.

Box with:

- 1 blister (14 tablets)

- 10 blisters (140 tablets)

Not all pack size may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!

Revised: January 2010

AN: 00175/2009

7. MARKETING AUTHORISATION HOLDER

Laboratorios Calier, S.A.

Barcelonès, 26 (Pla del Ramassà)

Les Franqueses del Valles (Barcelona)

SPAIN

8. MARKETING AUTHORISATION NUMBER

Vm

20634/4002

9. DATE OF THE FIRST AUTHORISATION /RENEWAL OF THE

AUTHORISATION

12 th

February 2008

10. DATE OF REVISION OF THE TEXT

January 2010

PROHIBITION OF SALE, SUPPLY AND/OR USE

Under veterinary prescription

There are no safety alerts related to this product.

There are no news related to this product.