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Nelio tablets contain the drug benazapril, which has an effect on the kidneys and blood circulation. Nelio is helpful for dogs with heart failure and for cats with reduced kidney function. Both cats and dogs will often eat Nelio flavoured tablets spontaneously, but they can be given in food if it is easier. They are recommended to be given just once daily
All prices include VAT where applicable.
Each Nelio 2.5 mg tablet contains: Benazepril 2.5 mg)
Each Nelio 5 mg tablet contains: Benazepril hydrochloride 5 mg
Nelio 2.5 mg: oblong scored beige tablet, divisible into halves.
Nelio 5 mg: clover shaped scored beige tablet, divisible into halves or quarters.
Target species
Cats
Indications for use
Nelio 2.5 mg - Reduction of proteinuria associated with chronic kidney disease.
Nelio 5 mg - Cats weighing more than 2.5 kg: Reduction of proteinuria associated with chronic kidney disease.
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.
Special warnings for each target species
None
Special precautions for use
Efficacy and safety of benazepril have not been established in cats of weight less than 2.5 kg
No evidence of renal toxicity to the veterinary medicinal product has been observed in cats 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 product to animals
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately and show the label to the physician.
Pregnant women should take special care to avoid accidental oral exposure, because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans.
Adverse reactions
In cats with chronic kidney disease, the product may increase plasma creatinine concentrations at the start of therapy. A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and therefore is not necessarily a reason to stop therapy in the absence of other signs.
The product may increase food consumption and body weight.
Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions.
Use during pregnancy or lactation
Do not use during pregnancy or lactation. The safety of the product has not been established in breeding, pregnant or lactating cats. Benazepril reduced ovary / oviduct weights in cats when administered daily at 10 mg / kg for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Interactions
In humans, the combination of ACE inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of the product and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary..Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using the product in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Amounts to be administered and administration route
The product should be given orally once daily, with or without food. The duration of treatment is unlimited. The product tablets are flavoured and are taken voluntarily by most cats. The product should be administered orally at a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight once daily according to the following table:
In case of use of half tablets: Put the remaining half of the tablet back into the blister pocket and use for the next administration.
Overdose
The product reduced erythrocyte counts in normal cats when dosed at 10 mg/kg body weight once daily for 12 months but this effect was not observed at the recommended dose during clinical trials in cats.
Transient reversible hypotension may occur in cases of accidental overdose. Therapy should consist of intravenous infusion with warm isotonic saline.
Pharmacodynamic properties
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Benazeprilat is a highly potent and selective inhibitor of ACE, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone. Therefore, it blocks effects mediated by angiotensin II and aldosterone, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes).
The product causes long-lasting inhibition of plasma ACE activity in cats, with more than 95% inhibition at peak effect and significant activity (>90%) persisting 24 hours after dosing.
In cats with experimental renal insufficiency,the product normalized the elevated glomerular capillary pressure and reduced the systemic blood pressure.
Reduction in glomerular hypertension may retard the progression of kidney disease by inhibition of further damage to the kidneys. Placebo controlled clinical field studies in cats with chronic kidney disease (CKD) have demonstrated that the product significantly reduced levels of urine protein and urine protein to creatinine ratio (UPC); this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.
No effect of the product on survival in cats with CKD has been shown, but the product increased the appetite of the cats, particularly in more advanced cases
Pharmacokinetic properties
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 2 hours ) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat. The systemic bioavailability is incomplete due to incomplete absorption (<30% in cats) and first pass metabolism.
Peak benazeprilat concentrations (Cmax of 110.0 ng/ml after a dose of 0.65 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1 hour and half.
Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=2.4 hours) represents elimination of free drug, while the terminal phase (1/2=29 hours) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
Repeated administration of the product leads to slight bioaccumulation of benazeprilat (R=1.36 with 0.5 mg/kg), steady state being achieved within a few days.
Benazeprilat is excreted 85% via the biliary and 15% via the urinary route. The clearance of benazeprilat is not affected in cats with impaired renal function and therefore no adjustment of the product dose is required in cases of renal insufficiency.
Excipients
Pig liver flavour, Yeast, Lactose monohydrate, Croscarmellose sodium, Anhydrous colloidal silica, Hydrogenated castor oil, Microcrystalline cellulose.
Major incompatibilities
Not known.
Shelf life
Nelio 2.5 mg: 24 months.
Shelf-life of divisions of the tablets: 24 hours
Nelio 5 mg: 2 years.
Shelf-life of divisions of the tablets: 72 hours
Special precautions for storage
Nelio 2.5mg: Do not store above 25°C. Store in original package.
Nelio 5mg: Do not store above 30°C. Store in original package.
Nelio 2.5 mg Tablets: any part-used tablet should be returned to the opened blister and used within 24 hours
Nelio 5 mg Tablets: any part-used tablet should be returned to the opened blister and used within 3 days
Immediate packaging
Nelio 2.5 mg Tablets: Aluminium/Aluminium heat-sealed blister pack 10 tablets per strip.
Box with 1 strip of 10 tablets; Box with 2 strips of 10 tablets; Box with 5 strips of 10 tablets; Box with 10 strips of 10 tablets; Box with 14 strips of 10 tablets; Box with 18 strips of 10 tablets.
Nelio 5 mg Tablets: Blister complex: [PA-Al-PVC] / Aluminium heat sealed blisters with 10 tablets / blister.
Cardboard box with 1 blister of 10 tablets; Cardboard box with 2 blisters of 10 tablets; Cardboard box with 3 blisters of 10 tablets; Cardboard box with 5 blisters of 10 tablets; Cardboard box with 10 blisters of 10 tablets; Cardboard box with 20 blisters of 10 tablets; Cardboard box with 50 blisters of 10 tablets.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Nelio 2.5 mg Tablets for Cats: Vm 15052/4107
Nelio 5 mg Tablets for Cats: Vm 15052/4109
Nelio 2.5 mg Tablets for Cats: 16 February 2010
Nelio 5 mg Tablets for Cats: 27 February 2009
Nelio 2.5 mg Tablets for Cats: June 2016
Nelio 5 mg Tablets for Cats: June 2016
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 this label to the doctor.
Each Nelio 5 mg Tablet contains: benazepril hydrochloride 5 mg
Each Nelio 20 mg Tablet contains: benazepril hydrochloride 20 mg
Clover shaped scored beige tablets, divisible into halves or quarters.
Target species
Dogs
Indications for use
Treatment of congestive heart failure
Contra-indications
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
Special precautions for use in animals
No evidence of renal toxicity of the veterinary medicinal product has been observed 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.
The safety and efficacy of the product has not been examined in dogs weighing less than 2.5 kg
Special precautions to be taken by the person administering the product to animals
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician.
Pregnant women should take special care to avoid accidental oral exposure, because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans.
Adverse reactions
In double-blind clinical trials in dogs with congestive heart failure, the product was well tolerated with an incidence of adverse reactions lower than observed in placebo-treated dogs.
A small number of dogs may exhibit transient vomiting, incoordination or signs of fatigue.
In dogs with chronic kidney disease, the product may increase plasma creatinine concentrations at the start of therapy. A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs.
Use during pregnancy or lactation
Do not use during pregnancy or lactation. The safety of the product has not been established in breeding, pregnant or lactating dogs. In cats benazepril reduced the weight of the ovaries and the ovarian ducts when given at a daily dose of 10 mg/kg for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Interactions
In dogs with congestive heart failure, this product has been given in combination with digoxin, diuretics, pimobendan and anti-arrhythmic veterinary medicinal products without demonstrable adverse interactions.
In humans, the association of ACE inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of this product and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary.
Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using this product in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Amounts to be administered and administration route
The product should be given orally once daily, with or without food. The duration of treatment is unlimited.
Dogs: The product should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table:
The dose may be doubled, still administered once daily, to a minimum dose of 0.5 mg/kg (range 0.5-1.0), if judged clinically necessary and advised by the veterinary surgeon.
In case of use of quarters or half tablets: Put the remaining quantity of the tablet back into the blister pocket and use for the next administration.
The tablets are flavoured and may be taken spontaneously by dogs, but can also be administered directly into the dog’s mouth or be given with food if necessary.
Overdose
The product reduced erythrocyte counts in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in dogs.
Transient reversible hypotension may occur in case of accidental overdose. Therapy should consist of intravenous infusion with warm isotonic saline.
Withdrawal periods
Not Applicable
Pharmacodynamic properties
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Benazeprilat is a highly potent and selective inhibitor of ACE, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone. Therefore, it blocks effects mediated by angiotensin II and aldosterone, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes).
The product causes long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80%) persisting 24 hours after dosing.
The product reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.
Pharmacokinetic properties
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat. The systemic bioavailability is incomplete (~13%) due to incomplete absorption (38%) and first pass metabolism.
Peak benazeprilat concentrations (Cmax of 30 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1.5 hours.
Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=1.7 hours) represents elimination of free drug, while the terminal phase (t1/2=19 hours) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs. Repeated administration of the product leads to slight bioaccumulation of benazeprilat (R=1.47 with 0.5 mg/kg), steady state being achieved within a few days (4 days).
Benazeprilat is excreted 54% via the biliary and 46% via the urinary route. The clearance of benazeprilat is not affected in dogs with impaired renal function and therefore no adjustment of the product dose is required in cases of renal insufficiency.
Excipients
Pig liver flavour, Yeast, Lactose monohydrate, Croscarmellose sodium, Anhydrous colloidal silica, Hydrogenated castor oil, Microcrystalline cellulose.
Major incompatibilities
None known
Shelf life
Nelio 5 mg and Nelio 20 mg: 2 years.
Shelf-life of divisions of the tablets: 72 hours.
Special precautions for storage
Do not store above 30 °C. Store in original package in order to protect from moisture. Any part-used tablet should be returned to the opened blister and used within 3 days.
Immediate packaging
Nelio 5 mg Tablets: [PA-Al-PVC] / Aluminium heat sealed blister strip of 10 tablets
Cardboard box with 1 blister strip of 10 tablets; Cardboard box with 5 blister strips of 10 tablets; Cardboard box with 10 blister strips of 10 tablets; Cardboard box with 25 blister strips of 10 tablets.
Nelio 20 mg Tablets: [PA-Al-PVC] / Aluminium heat sealed blister strip of 10 tablets.
Cardboard box with 1 blister strip of 10 tablets; Cardboard box with 5 blister strips of 10 tablets; Cardboard box with 10 blister strips of 10 tablets; Cardboard box with 14 blister strips of 10 tablets; Cardboard box with 18 blister strips of 10 tablets.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Nelio 5 mg Tablets for Dogs: Vm 15052/4110
Nelio 20 mg Tablets for Dogs: Vm 15052/4108
Nelio 5 mg and 20 mg tablets for Dogs: 7 September 2009
Nelio 5 mg and 20 mg tablets for Dogs: June 2016
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 this label or the package leaflet to the doctor.
Each Nelio 5 mg Tablet contains: benazepril hydrochloride 5 mg
Each Nelio 20 mg Tablet contains: benazepril hydrochloride 20 mg
Clover shaped scored beige tablets, divisible into halves or quarters.
Target species
Dogs
Indications for use
Treatment of congestive heart failure
Contra-indications
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
Special precautions for use in animals
No evidence of renal toxicity of the veterinary medicinal product has been observed 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.
The safety and efficacy of the product has not been examined in dogs weighing less than 2.5 kg
Special precautions to be taken by the person administering the product to animals
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician.
Pregnant women should take special care to avoid accidental oral exposure, because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans.
Adverse reactions
In double-blind clinical trials in dogs with congestive heart failure, the product was well tolerated with an incidence of adverse reactions lower than observed in placebo-treated dogs.
A small number of dogs may exhibit transient vomiting, incoordination or signs of fatigue.
In dogs with chronic kidney disease, the product may increase plasma creatinine concentrations at the start of therapy. A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs.
Use during pregnancy or lactation
Do not use during pregnancy or lactation. The safety of the product has not been established in breeding, pregnant or lactating dogs. In cats benazepril reduced the weight of the ovaries and the ovarian ducts when given at a daily dose of 10 mg/kg for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Interactions
In dogs with congestive heart failure, this product has been given in combination with digoxin, diuretics, pimobendan and anti-arrhythmic veterinary medicinal products without demonstrable adverse interactions.
In humans, the association of ACE inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of this product and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary.
Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using this product in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Amounts to be administered and administration route
The product should be given orally once daily, with or without food. The duration of treatment is unlimited.
Dogs: The product should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table:
The dose may be doubled, still administered once daily, to a minimum dose of 0.5 mg/kg (range 0.5-1.0), if judged clinically necessary and advised by the veterinary surgeon.
In case of use of quarters or half tablets: Put the remaining quantity of the tablet back into the blister pocket and use for the next administration.
The tablets are flavoured and may be taken spontaneously by dogs, but can also be administered directly into the dog’s mouth or be given with food if necessary.
Overdose
The product reduced erythrocyte counts in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in dogs.
Transient reversible hypotension may occur in case of accidental overdose. Therapy should consist of intravenous infusion with warm isotonic saline.
Withdrawal periods
Not Applicable
Pharmacodynamic properties
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Benazeprilat is a highly potent and selective inhibitor of ACE, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone. Therefore, it blocks effects mediated by angiotensin II and aldosterone, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes).
The product causes long-lasting inhibition of plasma ACE activity in dogs, with more than 95% inhibition at peak effect and significant activity (>80%) persisting 24 hours after dosing.
The product reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.
Pharmacokinetic properties
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat. The systemic bioavailability is incomplete (~13%) due to incomplete absorption (38%) and first pass metabolism.
Peak benazeprilat concentrations (Cmax of 30 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1.5 hours.
Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=1.7 hours) represents elimination of free drug, while the terminal phase (t1/2=19 hours) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs. Repeated administration of the product leads to slight bioaccumulation of benazeprilat (R=1.47 with 0.5 mg/kg), steady state being achieved within a few days (4 days).
Benazeprilat is excreted 54% via the biliary and 46% via the urinary route. The clearance of benazeprilat is not affected in dogs with impaired renal function and therefore no adjustment of the product dose is required in cases of renal insufficiency.
Excipients
Pig liver flavour, Yeast, Lactose monohydrate, Croscarmellose sodium, Anhydrous colloidal silica, Hydrogenated castor oil, Microcrystalline cellulose.
Major incompatibilities
None known
Shelf life
Nelio 5 mg and Nelio 20 mg: 2 years.
Shelf-life of divisions of the tablets: 72 hours.
Special precautions for storage
Do not store above 30 °C. Store in original package in order to protect from moisture. Any part-used tablet should be returned to the opened blister and used within 3 days.
Immediate packaging
Nelio 5 mg Tablets: [PA-Al-PVC] / Aluminium heat sealed blister strip of 10 tablets
Cardboard box with 1 blister strip of 10 tablets; Cardboard box with 5 blister strips of 10 tablets; Cardboard box with 10 blister strips of 10 tablets; Cardboard box with 25 blister strips of 10 tablets.
Nelio 20 mg Tablets: [PA-Al-PVC] / Aluminium heat sealed blister strip of 10 tablets.
Cardboard box with 1 blister strip of 10 tablets; Cardboard box with 5 blister strips of 10 tablets; Cardboard box with 10 blister strips of 10 tablets; Cardboard box with 14 blister strips of 10 tablets; Cardboard box with 18 blister strips of 10 tablets.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Nelio 5 mg Tablets for Dogs: Vm 15052/4110
Nelio 20 mg Tablets for Dogs: Vm 15052/4108
Nelio 5 mg and 20 mg tablets for Dogs: 7 September 2009
Nelio 5 mg and 20 mg tablets for Dogs: June 2016
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 this label or the package leaflet to the doctor.
Each Nelio 2.5 mg tablet contains: Benazepril 2.5 mg)
Each Nelio 5 mg tablet contains: Benazepril hydrochloride 5 mg
Nelio 2.5 mg: oblong scored beige tablet, divisible into halves.
Nelio 5 mg: clover shaped scored beige tablet, divisible into halves or quarters.
Target species
Cats
Indications for use
Nelio 2.5 mg - Reduction of proteinuria associated with chronic kidney disease.
Nelio 5 mg - Cats weighing more than 2.5 kg: Reduction of proteinuria associated with chronic kidney disease.
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.
Special warnings for each target species
None
Special precautions for use
Efficacy and safety of benazepril have not been established in cats of weight less than 2.5 kg
No evidence of renal toxicity to the veterinary medicinal product has been observed in cats 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 product to animals
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately and show the label to the physician.
Pregnant women should take special care to avoid accidental oral exposure, because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans.
Adverse reactions
In cats with chronic kidney disease, the product may increase plasma creatinine concentrations at the start of therapy. A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and therefore is not necessarily a reason to stop therapy in the absence of other signs.
The product may increase food consumption and body weight.
Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions.
Use during pregnancy or lactation
Do not use during pregnancy or lactation. The safety of the product has not been established in breeding, pregnant or lactating cats. Benazepril reduced ovary / oviduct weights in cats when administered daily at 10 mg / kg for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally nontoxic doses.
Interactions
In humans, the combination of ACE inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of the product and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc) should be monitored closely and treated as necessary..Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using the product in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Amounts to be administered and administration route
The product should be given orally once daily, with or without food. The duration of treatment is unlimited. The product tablets are flavoured and are taken voluntarily by most cats. The product should be administered orally at a minimum dose of 0.5 mg (range 0.5-1.0) benazepril hydrochloride/kg body weight once daily according to the following table:
In case of use of half tablets: Put the remaining half of the tablet back into the blister pocket and use for the next administration.
Overdose
The product reduced erythrocyte counts in normal cats when dosed at 10 mg/kg body weight once daily for 12 months but this effect was not observed at the recommended dose during clinical trials in cats.
Transient reversible hypotension may occur in cases of accidental overdose. Therapy should consist of intravenous infusion with warm isotonic saline.
Pharmacodynamic properties
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Benazeprilat is a highly potent and selective inhibitor of ACE, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone. Therefore, it blocks effects mediated by angiotensin II and aldosterone, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes).
The product causes long-lasting inhibition of plasma ACE activity in cats, with more than 95% inhibition at peak effect and significant activity (>90%) persisting 24 hours after dosing.
In cats with experimental renal insufficiency,the product normalized the elevated glomerular capillary pressure and reduced the systemic blood pressure.
Reduction in glomerular hypertension may retard the progression of kidney disease by inhibition of further damage to the kidneys. Placebo controlled clinical field studies in cats with chronic kidney disease (CKD) have demonstrated that the product significantly reduced levels of urine protein and urine protein to creatinine ratio (UPC); this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.
No effect of the product on survival in cats with CKD has been shown, but the product increased the appetite of the cats, particularly in more advanced cases
Pharmacokinetic properties
After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 2 hours ) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat. The systemic bioavailability is incomplete due to incomplete absorption (<30% in cats) and first pass metabolism.
Peak benazeprilat concentrations (Cmax of 110.0 ng/ml after a dose of 0.65 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1 hour and half.
Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=2.4 hours) represents elimination of free drug, while the terminal phase (1/2=29 hours) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues.
Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.
Repeated administration of the product leads to slight bioaccumulation of benazeprilat (R=1.36 with 0.5 mg/kg), steady state being achieved within a few days.
Benazeprilat is excreted 85% via the biliary and 15% via the urinary route. The clearance of benazeprilat is not affected in cats with impaired renal function and therefore no adjustment of the product dose is required in cases of renal insufficiency.
Excipients
Pig liver flavour, Yeast, Lactose monohydrate, Croscarmellose sodium, Anhydrous colloidal silica, Hydrogenated castor oil, Microcrystalline cellulose.
Major incompatibilities
Not known.
Shelf life
Nelio 2.5 mg: 24 months.
Shelf-life of divisions of the tablets: 24 hours
Nelio 5 mg: 2 years.
Shelf-life of divisions of the tablets: 72 hours
Special precautions for storage
Nelio 2.5mg: Do not store above 25°C. Store in original package.
Nelio 5mg: Do not store above 30°C. Store in original package.
Nelio 2.5 mg Tablets: any part-used tablet should be returned to the opened blister and used within 24 hours
Nelio 5 mg Tablets: any part-used tablet should be returned to the opened blister and used within 3 days
Immediate packaging
Nelio 2.5 mg Tablets: Aluminium/Aluminium heat-sealed blister pack 10 tablets per strip.
Box with 1 strip of 10 tablets; Box with 2 strips of 10 tablets; Box with 5 strips of 10 tablets; Box with 10 strips of 10 tablets; Box with 14 strips of 10 tablets; Box with 18 strips of 10 tablets.
Nelio 5 mg Tablets: Blister complex: [PA-Al-PVC] / Aluminium heat sealed blisters with 10 tablets / blister.
Cardboard box with 1 blister of 10 tablets; Cardboard box with 2 blisters of 10 tablets; Cardboard box with 3 blisters of 10 tablets; Cardboard box with 5 blisters of 10 tablets; Cardboard box with 10 blisters of 10 tablets; Cardboard box with 20 blisters of 10 tablets; Cardboard box with 50 blisters of 10 tablets.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Nelio 2.5 mg Tablets for Cats: Vm 15052/4107
Nelio 5 mg Tablets for Cats: Vm 15052/4109
Nelio 2.5 mg Tablets for Cats: 16 February 2010
Nelio 5 mg Tablets for Cats: 27 February 2009
Nelio 2.5 mg Tablets for Cats: June 2016
Nelio 5 mg Tablets for Cats: June 2016
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 this label to the doctor.
Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.
For UK delivery, we charge the following:
| Order Total | Weight | Delivery |
| £0-£28.99 | Under 2kg | £2.99 |
| 2kg+ | £4.99 | |
| £29-£38.99 | Under 2kg | Free |
| 2kg+ | £4.99 | |
| £39+ | Under 2kg | Free |
| 2kg+ | Free |
Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.
For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.
We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.
Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.
Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.
Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.
To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.
*For full details on returns, see our terms and conditions page.
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