Ah.novartis.com.au

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Tablets for Dogs and Cats (APVMA 56829)
Each tablet contains 2.5 mg benazepril hydrochloride Tablets for Dogs and Cats (APVMA 61193)
Each tablet contains 5 mg benazepril hydrochloride Tablets for Dogs (APVMA 61192)
Each tablet contains 20 mg benazepril hydrochloride Indications
Because of its biliary excretion route, there is little risk of FORTEKOR is indicated for the treatment of heart failure in bioaccumulation of benazeprilat in dogs or cats with dogs, and chronic renal insufficiency and hypertrophic impaired renal function. For this reason no dose adjustment of FORTEKOR is necessary in cases of renal insufficiency.
Contraindications
FORTEKOR is indicated for the treatment of left-sided heart Contraindicated in animals known to be hypersensitive to failure in dogs, most commonly resulting from Mitral Regurgitation (MR) (Endocardiosis) and Dilated Cardiomyopathy (DCM). FORTEKOR, by inhibiting the renin Precautions
angiotensin aldosterone (RAA) system, minimises the undesirable effects of vasoconstriction and sodium Use during Pregnancy and Lactation: The safety of retention mediated by this system. The end result is an FORTEKOR has not been tested in breeding dogs. improvement in the clinical status of the dog. FORTEKOR FORTEKOR is therefore not recommended for use in leads to an extension of the life span of dogs with heart pregnant or lactating bitches. No data are available in failure and also improves clinical signs, notably a reduction in coughing, and improvement to the quality of life. In double blind clinical trials, FORTEKOR was well toler ated FORTEKOR may be used in combination therapy with with an incidence of adverse effects statist ically lower than diuretics (for example frusemide), digoxin and observed in placebo treated dogs. A small number of dogs may exhibit transient signs of fatigue.
Clinical trials have shown FORTEKOR to have good renal toler ance. Plasma urea and creatinine concentrations did FORTEKOR is indicated for the treatment of chronic renal not change and no evidence of renal toxicity of FORTEKOR insufficiency in cats. In such cats, FORTEKOR reduces has been observed in dogs during clinical trials. The biliary protein loss in urine and lowers systemic and excretion of benazeprilat means that there is little risk of intraglomerular blood pressure. FORTEKOR increases bioaccumulation in dogs and cats with impaired renal quality of life, particularly in advanced cases. FORTEKOR function. However, as is routine in cases of renal has been shown to increase the survival time in cats with a insufficiency, it is recommended to monitor plasma urea urinary protein/creatinine ratio (UPC) equal to or exceeding 0.8 before treatment, and to improve the appetite in cats FORTEKOR is well tolerated by the target species. In normal with a UPC ratio exceeding 1.0. FORTEKOR has some dogs overdosage up to 200-fold was without incident. beneficial effects on clinical signs and cardiac remodelling Transient reversible hypotension may occur in cases of in cats with feline hypertrophic cardiomyopathy (HCM) and is accidental overdosage. Therapy should consist of well tolerated. Most cases of HCM in cats will require other intravenous infusion of warm isotonic saline solution.
medications in addition to FORTEKOR. The most commonly Signs of hypotension such as tiredness or dizziness may prescribed of these medications will be a calcium channel appear in rare cases. Reduce the dose of the diuretic if Interactions with potassium preserving drugs, like Pharmacological Properties
spironolactone, triamterene or amiloride cannot be ruled FORTEKOR contains benazepril hydrochloride, a prodrug out. It is recommended to monitor plasma potassium levels hydrolysed in vivo to benazeprilat, which inhibits the when using FORTEKOR in combination with a potassium angiotensin converting enzyme (ACE), thus preventing the sparing diuretic. As with other ACE inhibitors, the use of conversion of inactive angiotensin I into active angiotensin II. hypotensive medicinal products or anaesthetics with a FORTEKOR reduces all effects mediated by angiotensin II, hypotensive effect may add to the anti-hypertensive effect including vasoconstriction of both arteries and veins and of benazepril. In man, the combination of ACE inhibitors and retention of sodium and water by the kidney. FORTEKOR NSAIDs can lead to reduced anti-hypertensive efficacy of causes long-lasting inhibition of plasma ACE in dogs and the ACE inhibitor or impaired renal function. Therefore cats, with significant inhibition persisting for 24 hours after concurrent use of NSAIDs should be considered with Benazepril is rapidly but incompletely absorbed from the gastrointestinal tract following oral administration. Absorbed benazepril is partially hydrolysed by hepatic enzymes to the active substance, benazeprilat; unchanged concentrations at the start of therapy. This effect is related benazepril and hydrophilic metabolites account for the to the therapeutic effect of the product in reducing remainder. Peak plasma benazeprilat concentrations are glomerular capillary blood pressure and therefore it is not attained within about two hours both in fasting and fed necessarily a reason to stop therapy in the absence of other situations. Benazepril and benazeprilat are bound to plasma signs. FORTEKOR reduced erythrocyte counts in normal proteins, and in tissues are found mainly in the liver and cats at high doses, but this effect was not observed at the kidney. The major part of benazeprilat is rapidly eliminated, recommended dose during clinical trials in cats with chronic although there is in addition a slow terminal elimination renal insufficiency. Therefore, as is routine in cases of phase. Benazeprilat is excreted approximately equally via chronic renal insufficiency, it is recommended to monitor both biliary and urinary routes in dogs, and primarily via the plasma creatinine and erythrocyte counts during therapy.
biliary route in cats. Repeated administration of FORTEKOR The efficacy and safety of FORTEKOR have not been leads to slight accumulation of benazeprilat in plasma; established in cats below 2.5 kg bodyweight.
steady state is attained within four days.
The safety of FORTEKOR has not been tested in breeding Fortekor Flavour Pack Size
o.G. SINR 910010 Mat-Nr 606277
163 x 297 mm Element
PP Country
schwarz Doc-Size 100% Print-Size 100%
Nick Gesù Agency
Inhouse Program
Adobe InDesign CS3
ARTWORK SPECIFICATION
2 Date 23.02.2010
cats, or pregnant or lactating queens. FORTEKOR should Additional Information
therefore be used only if justified clinically, considering the risk/benefit ratio. FORTEKOR reduced ovary/oviduct FIRST AID: If poisoning occurs, contact a doctor or
weights when administered daily at 10 mg/kg for 52 weeks. Poisons Information Centre (Phone: Australia
ACE inhibitors have been found to be teratogenic in the 13 1126; New Zealand 0800 764 766).
second and third trimesters in other species.
There are no known interactions between FORTEKOR and Disposal: Dispose of empty containers by wrapping in
other medicaments in cats. The combination of ACE inhibitors and other antihypertensive agents (e.g. calcium channel blockers, beta-blockers or diuretics) may lead Storage: Store below 25°C (Air Conditioning). Protect
to additive hypotensive effects. Concurrent use of ACE from moisture and heat. Unused half tablets should be inhibitors and NSAIDs shoud be considered with caution returned to the open blis ter space, inserted back into the as reduced efficacy of the ACE inhibitors or impaired renal function have been reported with their concurrent use in WARRANTY
FORTEKOR has been shown to be effective and safe when The manufacturer of this animal remedy extends /grants to used in combination with diets containing low amounts of the purchaser a warranty that this animal remedy is reasonably fit for the purposes for which its use is ACE inhibitors may increase blood potassium levels, which recommended, provided that the purchaser uses the may be beneficial where hypokalaemia occurs associated remedy only for the purposes for which it is recommended with chronic renal insufficiency. It is recommended to him and strictly in accordance with the directions on this monitor plasma potassium levels when using FORTEKOR in combinations with diuretics that may have additive NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED Overdose: FORTEKOR is well tolerated in the target species. ACN 076 745 198 In normal cats, overdosage of 10 times 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.
% 1800 633 768 TOLL FREE from anywhere in Australia DIRECTIONS FOR USE
8.30 am to 5.30 pm E.S.T. Monday to Friday FORTEKOR should be given orally, once daily, with or with- Unused half tablets should be returned to the open blister % 0800 588 001 TOLL FREE from anywhere in New Zealand space, inserted back into the carton and used within two APVMA Approval Nos. 56829/0907, 61193/0907, Heart failure in dogs
The minimum recommended o ral daily dose is 0.25 mg/kg bodyweight, given according to the following regime: PRESCRIPTION ANIMAL REMEDY (P.A.R.) Class 1.
Standard Dose
For use only under the authority or prescription of a
Weight of
veterinarian.
Fortekor
Registered pursuant to the ACVM Act 1997 Nos. A9195, Fortekor 2.5 Fortekor
Flavour 5
Flavour 20
See www.nzfsa.govt.nz/acvm for registration conditions.
Registered to Novartis New Zealand Limited, Building G, 5 Orbit Drive, Rosedale, AUCKLAND 0632 ® Registered trademark of Novartis AG, Basel, Switzerland The above doses may be doubled, still administered once daily, if judged clinically necessary and advised by the Chronic renal insufficiency and hypertrophic
cardio myopathy in cats
The minimum recommended oral daily dose is 0.5 mg/kg
bodyweight, given according to the following regime: Weight of cat (kg)
Fortekor 2.5
Fortekor Flavour
Fortekor Flavour Pack Size
o.G. SINR 910010 Mat-Nr 606277
163 x 297 mm Element
PP Country
schwarz Doc-Size 100% Print-Size 100%
Nick Gesù Agency
Inhouse Program
Adobe InDesign CS3
ARTWORK SPECIFICATION
2 Date 23.02.2010

Source: http://ah.novartis.com.au/verve/_resources/Fortekor_Flavour_5mg__20mg_LEAFLET.pdf