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Benefortin for Dogs & Cats

Benefortin for Dogs & Cats

Benefortin tablets contains benazapril which is one of the best drugs for treating heart failure in dogs or kidney failure in cats. It has the advantage over other formulations of being exceptionally palatable, so the tablets are much easier to give. This means that dogs and cats are more likely to receive the full benefit of the medication bought for them. Benazapril is known to be bitter tasting, but these tablets remain palatable even when crushed into food. Other tablets with the same ingredient are not swallowed as readily by animal patients and can be "spat out" without owners being aware. Benefortin can be given alone, or combined with other medications and special diets to best control the effects of the illness being treated.

Description

Presentation

Brownish, oval tablet scored on both sides to be divisable.

Uses

Treatment of congestive heart failure in dogs. Treatment of chronic renal insufficiency in cats. Quantitative composition: 2.5mg tablet contains 2.5mg benazepril hydrochloride (equivalent to benazepril 2.30mg), 5.0mg tablet contains 5.0mg benazepril hydrochloride (equivalent to 4.60mg benazepril) and 20.0mg tablet contains 20.0mg benazepril hydrochloride (equivalent to 18.4mg benazepril).

Dosage and administration

Oral use once daily, with or without food. Cats: The dose is 0.46 mg benazepril/kg bw per day, corresponding to 0.50 mg of benazepril hydrochloride/kg bw per day according to the dosing table below:

Benefortin Flavour 2.5mg tablets for cats

Weight of cat (kg)

Number of tablets

2.5-5

1 tablet

>5-10

2 tablets

Dogs: The dose is 0.23 mg benazepril/kg bw per day, corresponding to 0.25 mg of benazepril hydrochloride/kg bw per day which may be doubled if judged clinically necessary and advised by the veterinary surgeon, according to the dosing tables below:

Benefortin Flavour 2.5mg tablets for dogs corresponding to 1 x 2.5mg tablet per 10kg

Weight of dog (kg)

Number of tablets

2.5-5

0.5 tablet

>5-10

1 tablet

Benefortin Flavour 5.0mg tablets for dogs, corresponding to 1 x 5.0mg tablet per 20 kg

Weight of dog (kg)

Number of tablets

5-10

0.5 tablets

>10-20

1 tablet

Benefortin Flavour 20.0 mg tablets for dogs, corresponding to 1 x 20 mg tablet per 80 kg

Weight of dog (kg)

Number of tablets

20-40

0.5 tablet

>40-80

1 tablet

Contra-indications, warnings, etc

Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis. Do not use in animals known to be hypersensitive to the active substance or to any of the excipients. No evidence of renal toxicity to benazepril has been observed in dogs or cats. However, as is routine in cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy. The efficacy and safety of benazepril has not been established in cats below 2.5 kg body weight. Benazepril hydrochloride is well tolerated in the target species. Transient reversible hypotension may occur in cases of accidental overdosage. Therapy should consist of intravenous infusion of warm, isotonic saline. In normal cats, a 10-fold overdosage daily for one year was asymptomatic. Laboratory studies in rats have shown evidence of embryotoxic effects (malformation of urinary tract) of benazepril at non maternotoxic doses. Laboratory studies in rats as well as human observations have shown evidence of teratogenicity. The safety of benazepril hydrochloride has not been tested in breeding, pregnant or lactating dogs and cats. Do not use in breeding or lactating animals or in females intended for reproduction. Benazepril reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg for 52 weeks. Some dogs may exhibit transient signs of fatigue or dizziness. At the start of treatment, a decrease of blood pressure may occur. Benazepril may lead to increased plasma creatinine concentrations. Benazepril may increase food consumption and body weight in cats. Emesis, anorexia, diarrhoea and lethargy have been reported very rarely in this species. In dogs with heart failure, benazepril has been given in combination with digoxin, diuretics and anti-arrhythmic drugs without demonstrable adverse interactions. In man, the combination of ACE inhibitors and NSAIDs can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of benazepril 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 benazepril in combination with a potassium-sparing diuretic as life threatening reactions are a possibility.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the cardboard box and kept in a safe place out of the reach of children. Tablet halves should be used within 2 days.

User Advice: Wash hands after use. Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child after oral exposure during pregnancy in humans. In case of accidental ingestion, especially in children, seek medical advice immediately and show the doctor this warning. For animal treatment only. Keep out of reach and sight of children.

Disposal Advice: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

2.5 mg presentation PVC/Aluminium/Polyamide blister-forming laminate with aluminium lidding foil with 14 tablets/blister. Cardboard box with 1 blister strip of 14 tablets (14 tablets) Cardboard box with 2 blister strips of 14 tablets (28 tablets) Cardboard box with 4 blister strips of 14 tablets (56 tablets) Cardboard box with 10 blister strips of 14 tablets (140 tablets) 5.0 mg presentation: PVC/Aluminium/Polyamide blister-forming laminate with aluminium lidding foil with 14 tablets/blister. Cardboard box with 1 blister strip of 14 tablets (14 tablets) Cardboard box with 2 blister strips of 14 tablets (28 tablets) Cardboard box with 4 blister strips of 14 tablets (56 tablets) Cardboard box with 10 blister strips of 14 tablets (140 tablets) 20.0 mg presentation PVC/Aluminium/Polyamide blister-forming laminate with aluminium lidding foil with 7 tablets/blister. Cardboard box with 1 blister strip of 7 tablets (7 tablets) Cardboard box with 2 blister strips of 7 tablets (14 tablets) Cardboard box with 4 blister strips of 7 tablets (28 tablets) Cardboard box with 10 blister strips of 7 tablets (70 tablets) Not all pack sizes may be marketed.

Further information

Nil

Marketing Authorisation Holder (if different from distributor)

Lavet Pharmaceuticals Ltd, Ottó u. 14, 1161 Budapest, Hungary

Marketing authorisation number

Vm 32823/4006 (2.5 mg), Vm 32823/4007 (5 mg), Vm 32823/4008 (20.0 mg).

GTIN (Global Trade Item No)

Benefortin Flavour 2.5 mg tablets for cats and dogs - 2x14 tablets

5012917030105

Benefortin Flavour 5.0mg tablets for dogs - 2x14 tablets

5012917030112

Benefortin Flavour 20.0mg tablets for dogs - 4x7 tablets

5012917030129

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