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Prescription Products

KELAPRIL 5 mg

Oral tablet for Dogs and Cats

One tablet contains, 5 mg
benazepril hydrochloride

Advantages

Inhibitors of the angiotensin converting enzyme (ACE) are of great benefit for the management of congestive heart failure in dogs, improving symptoms and tolerance to exercise as well as extending the life span of the animal. In cats with chronic renal insufficiency they decrease proteinuria and systemic arterial pressure, and delay the progression of the disease.

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE
KELAPRIL 5 mg, film-coated tablets for dogs and cats
Benazepril hydrochloride

ACTIVE INGREDIENT AND QUANTITIES:
KELAPRIL 5 mg: Each tablet contains 5 mg Benazepril hydrochloride.
USE CLAIMS:

KELAPRIL 5 mg: For the treatment of heart failure due to mitral regurgitation and dilated cardiomyopathy in dogs, hypertrophic cardiomyopathy in cats, and chronic renal insufficiency in dogs and cats.

DIRECTIONS FOR USE:

For oral use only. KELAPRIL should be given once daily, with or without food. The duration of treatment is unlimited.

DOGS:
In dogs, the recommended oral dose is 0.25-0.5mg benazepril hydrochloride/kg body weight, given according to the following regime:

KELAPRIL 5 mg

Weight of dog (kg)

Standard dose

Double dose

2.5 - < 5

5 - 10

0.5 tablet

1 tablet

11 - 20

1 tablet

2 tablets

The dose may be doubled, still administered once daily, if judged clinically necessary and advised by the veterinary surgeon.

CATS:

In cats, KELAPRIL should be administered orally at a dose of 0.5-1.0 mg benazepril hydrochloride/kg body weight once daily according to the following table:

Weight of cat (kg)

KELAPRIL 5 mg

2.5 - 5

0.5 tablet

> 5 - 10

1 tablet

EXPIRY DATE:

Tablet halves should be used within 2 days.

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

NET CONTENTS:

28 tablets.

STORAGE INSTRUCTIONS:

KELAPRIL 5 mg: Store below 30°C in original blister.
Keep out of the reach and sight of children.

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.

ADVERSE EFFECTS, CAUTIONS AND CONTRAINDICATIONS:

Adverse effects:

On rare occasions transient signs of hypotension, such as lethargy and ataxia may occur.
In cats with chronic renal insufficiency, KELAPRIL may increase plasma creatinin 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.
KELAPRIL may increase food consumption and body weight in cats. Emesis, anorexia, dehydration and lethargy have been reported in rare occasions in this species. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Special warnings for each target species:

The efficacy and safety of the product has not been established in dogs and cats below 2.5 kg body weight.

Special precautions for use in animals:

No evidence of renal toxicity to the product has been observed in dogs or cats during clinical trials. As is routine in cases of renal insufficiency, it is recommended to monitor plasma creatinin and urea during therapy.

User warnings:

Wash hand after use.
Pregnant women should take special care to avoid accidental oral exposure.
People sensitive to benazepril hydrochloride or some of the excipients should not handle this product.
In case of accidental ingestion, seek medical advice immediately and show this label to the doctor.

Use during pregnancy and lactation:

The safety of KELAPRIL has not been tested in breeding, pregnant or lactating dogs or cats. The product should therefore be used only if justified clinically, considering the risk/benefit ratio.
ACE inhibitors have been found to be teratogenic in the second and third trimesters in other species.
 

Interaction with other medicinal products and other forms of interaction:

None known in dogs or cats.
In dogs with heart failure, benazepril has been given in combination with digoxin, diuretics and anti-arrhythmic
drugs without demonstrable adverse interactions.
The combination of KELAPRIL and other anti-hypertensive agents, anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of 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 when 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 possible.

Overdose (symptoms, emergency procedures, antidotes):

KELAPRIL is well tolerated in the target species. In normal dogs, overdosage up to 200-fold was asymptomatic. In normal cats, a 10-fold overdosage daily for one year was asymptomatic. Transient reversible hypotension may occur in cases of accidental overdosage. Therapy should consist of intravenous infusion of warm isotonic saline.

Special precautions for the disposal of unused product or waste materials:

Any unused product or waste material should be disposed of in accordance with local requirements.

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 in pregnant or lactating dogs or cats because the safety of benazepril hydrochloride has not been established during pregnancy or lactation in these species.

Registration
KELAPRIL 5 mg: ACVM Registration No. A10943

See www.foodsafety.govt.nz for registration conditions.

Registered to:
 

KELA N.V.,
St.Lenaartseweg 48, 2320 Hoogstraten, Belgium,
info@kela.be, + 32 3 340 04 11, manufactured in Belgium.

NZ Agent & Distributor:
 

Phoenix Pharm Distributors Ltd
PO Box 31363, Mairangi Bay, Auckland

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