FORTEKOR 5 MG TABLETS FOR DOGS AND CATS

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
BENAZEPRIL HYDROCHLORIDE
Available from:
Elanco Australasia Pty Ltd
INN (International Name):
benazepril HCl(5mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 5.0 mg/Tb
Units in package:
10x14 Tabs; 112 Tabs; 126 Tabs; 14 Tablets; 28 Tablets; 42 Tablets; 56 Tablets; 70 Tablets; 84 Tablets; 98 Tablets
Class:
VM - Veterinary Medicine
Manufactured by:
ELANCO AUSTRALASIA
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
CARDIOVASCULAR SYSTEM
Therapeutic indications:
CARDIAC REACTANT | CHRONIC RENAL INSUFFICIENCY | HYPERTROPHIC CARDIOMYOPATHY | CARDIAC REACTANT | CARDIAC STIMULANT | HEART FAILURE
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [CHRONIC RENAL INSUFFICIENCY, HYPERTROPHIC CARDIOMYOPATHY]; DOG: [CARDIAC REACTANT]; For the treatment of heart failure in dogs due to mitral regurgitation (endocardiosis) and dilated cardiomyopathy. For the treatment of hypertrophic cardiomyopathy in cats. For the treatment of chronic renal insufficiency in cats.See Precautions on leaflet
Authorization status:
Registered
Authorization number:
53093
Authorization date:
2020-07-01

Product name

: Fortekor 5 mg Tablets for Dogs and Cats

Date

: 9 April 2003

Page

: 1 of 7

Pack sizes

: 14 tablets, 1, 2, 3, …10 x 14 tablets

Type of label

: Carton, Blister, Leaflet

File

: 53093_0403c.doc

Version

: 6

Reason

: New pack sizes. (JB)

Text above this line is not included

Carton, main panel

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Fortekor



5 mg

Tablets for Dogs and Cats

Active Constituent:

Each Tablet contains 5 mg benazepril hydrochloride

For the treatment of Heart Failure in Dogs due to Mitral Regurgitation (Endocardiosis) and

Dilated Cardiomyopathy.

For the treatment of Hypertrophic Cardiomyopathy in Cats.

For the treatment of Chronic Renal Insufficiency in Cats.

Contents:14 Tablets [28 Tablets, 42 Tablets, 56 Tablets, 70 Tablets,

84 Tablets, 98 Tablets, 112 Tablets, 126 Tablets, 10 x 14 Tablets]

Info

pest

Verified

Product name

: Fortekor 5 mg Tablets for Dogs and Cats

Date

: 9 April 2003

Page

: 2 of 7

Pack sizes

: 14 tablets, 1, 2, 3, …10 x 14 tablets

Type of label

: Carton, Blister, Leaflet

File

: 53093_0403c.doc

Version

: 6

Reason

: New pack sizes. (JB)

Text above this line is not included

Carton, back panel

READ THE ATTACHED LEAFLET BEFORE USING THIS PRODUCT

Directions for Use:

Oral doses to be administered once daily, with or without food:

Dogs:

0.25-0.5 mg/kg bodyweight.

Cats:

0.5 mg/kg bodyweight.

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre

(Phone: Australia 131126; New Zealand 03-474-7000)

Disposal: Dispose of empty containers by wrapping with paper and putting in garbage.

Storage: Store below 30

C (Room Temperature). Protect from heat and moisture.

See side panel for batch and expiry information.

NRA 53093/0403

NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED

A.C.N. 076 745 198

54 Waterloo Road,

North Ryde NSW 2113

PRESCRIPTION ANIMAL REMEDY (P.A.R.) Class 1

For use only following a veterinary consultation.

Registered pursuant to the ACVM Act 1997, No. A07772.

www.nzfsa.govt.nz/acvm

for registration conditions.

Registered to Novartis New Zealand Limited, 43-45 Patiki Road, Avondale, Auckland.

Registered trademark of Novartis Inc., Basel, Switzerland

Carton - side panel 1

Fortekor

Lot:

Exp:

Carton - side panel 2

Fortekor

Dose:

[Dog pictogram] 5-10 kg dogs: ½ tablet/day 11-20 kg dogs: 1 tablet/day

[Cat pictogram] 2.5-5 kg cats: ½ tablet/day >5-10 kg cats: 1 tablet/day

Product name

: Fortekor 5 mg Tablets for Dogs and Cats

Date

: 9 April 2003

Page

: 3 of 7

Pack sizes

: 14 tablets, 1, 2, 3, …10 x 14 tablets

Type of label

: Carton, Blister, Leaflet

File

: 53093_0403c.doc

Version

: 6

Reason

: New pack sizes. (JB)

Text above this line is not included

Blister

Fortekor

vet. tabl.

benazepril hydrochloride 5 mg

Novartis Animal Health

For animal treatment only.

For oral use.

Voie orale.

USAGE VETERINAIRE

RESPECTER LES DOSES PRESCRITES

Tierarzneimittel zur oralen Einnahme.

Diergeneesmiddel voor orale toediening.

Per uso veterinario. Uso orale.

Para uso veterinario. Via oral.

Til dyr. Til oral brug.

For djur. For oral bruk.

Elaimille. Suun kautis.

Lot:

Exp:

NRA 53093/0403

Product name

: Fortekor 5 mg Tablets for Dogs and Cats

Date

: 9 April 2003

Page

: 4 of 7

Pack sizes

: 14 tablets, 1, 2, 3, …10 x 14 tablets

Type of label

: Carton, Blister, Leaflet

File

: 53093_0403c.doc

Version

: 6

Reason

: New pack sizes. (JB)

Text above this line is not included

Leaflet

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

FORTEKOR

5 mg

Tablets for Dogs and Cats

(53093)

Active Constituent:

Each tablet contains 5 mg benazepril hydrochloride

FORTEKOR

20 mg

Tablets for Dogs

(47965)

Active Constituent:

Each tablet contains 20 mg benazepril hydrochloride

Indications

FORTEKOR

indicated

treatment

heart

failure

dogs,

chronic

renal

insufficiency and hypertrophic cardiomyopathy in cats.

Dogs

FORTEKOR is indicated for the treatment of left-sided heart failure in dogs, most commonly

resulting from Mitral Regurgitation (Endocardiosis) (MR) and Dilated Cardiomyopathy (DCM).

FORTEKOR, by inhibiting the renin angiotensin aldosterone (RAA) system, minimises the

undesirable effects of vasoconstriction and sodium retention mediated by this system. The

end result is an improvement in the clinical status of the dog. FORTEKOR leads to an

extension of the life span of dogs with heart failure and also improves clinical signs, notably

reduction in coughing, and improvement to the quality of life. FORTEKOR may be used in

combination therapy with diuretics, for example frusemide, digoxin and antiarrhythmic drugs

as necessary.

Cats

FORTEKOR is indicated for the treatment of chronic renal insufficiency in cats. In such cats,

FORTEKOR reduces protein loss in urine and lowers systemic and intraglomerular blood

pressure. FORTEKOR increases quality of life, particularly in advanced cases. FORTEKOR

has been shown to increase the survival time in cats with a urinary protein/creatinine ratio

(UPC) equal to or exceeding 0.8 before treatment, and to improve the appetite in cats with a

UPC ratio exceeding 1.0. FORTEKOR has some beneficial effects on clinical signs and

cardiac remodelling in cats with feline hypertrophic cardiomyopathy and is well tolerated. Most

cases of HCM in cats will require other medications in addition to FORTEKOR. The most

commonly prescribed of these medications will be a calcium channel blocker, for example

diltiazem.

Pharmacological properties

FORTEKOR contains benazepril hydrochloride, a prodrug hydrolysed in vivo to benazeprilat,

which inhibits the angiotensin converting enzyme (ACE), thus preventing the conversion of

Product name

: Fortekor 5 mg Tablets for Dogs and Cats

Date

: 9 April 2003

Page

: 5 of 7

Pack sizes

: 14 tablets, 1, 2, 3, …10 x 14 tablets

Type of label

: Carton, Blister, Leaflet

File

: 53093_0403c.doc

Version

: 6

Reason

: New pack sizes. (JB)

Text above this line is not included

inactive angiotensin I into active angiotensin II. FORTEKOR reduces all effects mediated by

angiotensin II, including vasoconstriction of both arteries and veins and retention of sodium

and water by the kidney. FORTEKOR causes long-lasting inhibition of plasma ACE in dogs

and cats, with significant inhibition persisting for 24 hours after a single dose.

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 benazepril and hydrophilic metabolites account for the

remainder. Peak plasma benazeprilat concentrations are attained within about two hours both

in fasting and fed situations. Benazepril and benazeprilat are bound to plasma proteins, and in

tissues are found mainly in the liver and kidney. The major part of benazeprilat is rapidly

eliminated, although there is in addition a slow terminal elimination phase. Benazeprilat is

excreted approximately equally via both biliary and urinary routes in dogs, and primarily via the

biliary route in cats. Repeated administration of FORTEKOR leads to slight accumulation of

benazeprilat in plasma; steady state is attained within four days.

Because of its biliary excretion route, there is little risk of bioaccumulation of benazeprilat in

dogs or cats with impaired renal function. For this reason no dose adjustment of FORTEKOR

is necessary in cases of renal insufficiency.

Directions for Use

FORTEKOR should be given orally, once daily, with or without food.

Heart failure in dogs

The minimum recommended oral daily dose is 0.25 mg/kg body weight, given according to the

following regime.

Fortekor 5

Fortekor 20

Weight of

dog (kg)

Standard Dose

Standard Dose

5-10

0.5 tablet

11-20

1 tablet

21-40

0.5 tablet

41-80

1 tablet

The above dose may be doubled, still administered once daily, if judged clinically necessary

and advised by the veterinary surgeon.

Chronic renal insufficiency and hypertrophic cardiomyopathy in cats

The minimum recommended oral daily dose is 0.5mg/kg body weight, given according to the

following regime.

Weight of cat

(kg)

Fortekor 5

2.5-5

0.5 tablet

>5-10

1 tablet

Precautions

Dogs

Use during Pregnancy and Lactation: The safety of FORTEKOR has not been tested in

breeding dogs. FORTEKOR is therefore not recommended for use in pregnant or lactating

bitches. No data are available in lactating bitches.

In double blind clinical trials, FORTEKOR was well tolerated with an incidence of adverse

effects statistically lower than 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 tolerance. Plasma urea and

creatinine concentrations did not change and no evidence of renal toxicity of FORTEKOR has

Product name

: Fortekor 5 mg Tablets for Dogs and Cats

Date

: 9 April 2003

Page

: 6 of 7

Pack sizes

: 14 tablets, 1, 2, 3, …10 x 14 tablets

Type of label

: Carton, Blister, Leaflet

File

: 53093_0403c.doc

Version

: 6

Reason

: New pack sizes. (JB)

Text above this line is not included

been observed in dogs during clinical trials. The biliary excretion of benazeprilat means that

there is little risk of bioaccumulation in dogs and cats with impaired renal function. However,

as is routine in cases of renal insufficiency, it is recommended to monitor plasma urea and

creatinine levels.

FORTEKOR is well tolerated by the target species. In normal dogs overdosage up to 200 fold

was without incident. Transient reversible hypotension may occur in cases of accidental

overdosage. Therapy should consist of intravenous infusion of warm isotonic saline solution.

Signs of hypotension such as tiredness or dizziness may appear in rare cases. Reduce the

dose of the diuretic if necessary.

Interactions with potassium preserving drugs, like spironolactone, triamterene or amiloride

cannot be ruled out. It is recommended to monitor plasma potassium levels when using

FORTEKOR in combination with a potassium sparing diuretic. As with other ACE inhibitors,

the use of hypotensive medicinal products or anaesthetics with a hypotensive effect may add

to the anti-hypertensive effect of benazepril.

Cats

FORTEKOR may increase plasma creatinine concentrations at the start of therapy. This effect

is related to the therapeutic effect of the product in reducing glomerular capillary blood

pressure and therefore it is not necessarily a reason to stop therapy in the absence of other

signs. FORTEKOR 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.

Therefore,

routine

cases

chronic

renal

insufficiency,

recommended to monitor plasma creatinine and erythrocyte counts during therapy.

The efficacy and safety of FORTEKOR have not been established in cats below 2.5 kg body

weight.

The safety of FORTEKOR has not been tested in breeding cats, or pregnant or lactating

queens. FORTEKOR should therefore be used only if justified clinically, considering the

risk/benefit ratio. FORTEKOR reduced ovary/oviduct weights when administered daily at 10

mg/kg for 52 weeks. ACE inhibitors have been found to be teratogenic in the second and third

trimesters in other species.

There are no known interactions between FORTEKOR and other medicaments in cats. The

combination of ACE inhibitors and other antihypertensive agents (e.g. calcium channel

blockers, beta-blockers or diuretics) may lead to additive hypotensive effects. In man, the

combination of ACE inhibitors and NSAIDS can lead to reduced anti-hypertensive efficacy of

the ACE inhibitor or impaired renal function.

FORTEKOR has been shown to be effective and safe when used in combination with diets

containing low amounts of protein and salt.

inhibitors

increase

blood

potassium

levels,

which

beneficial

where

hypokalaemia occurs associated with chronic renal insufficiency. It is recommended to

monitor plasma potassium levels when using FORTEKOR in combinations with diuretics that

may have additive potassium sparing effects.

Overdose: FORTEKOR is well tolerated in the target species. 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.

Product name

: Fortekor 5 mg Tablets for Dogs and Cats

Date

: 9 April 2003

Page

: 7 of 7

Pack sizes

: 14 tablets, 1, 2, 3, …10 x 14 tablets

Type of label

: Carton, Blister, Leaflet

File

: 53093_0403c.doc

Version

: 6

Reason

: New pack sizes. (JB)

Text above this line is not included

Additional information

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre

(Phone: Australia 131126; New Zealand 03-474-7000).

Disposal: Dispose of empty containers by wrapping in paper and putting in garbage.

Storage: Store below 30ºC (room temperature). Protect from moisture and heat.

Unused half tablets should be returned to the open blister space and inserted back into the

carton.

CONDITIONS OF SALE

The manufacturer of this animal remedy extends/grants to the purchaser a warranty that this

animal remedy is reasonably fit for the purposes for which its use is recommended, provided

that the purchaser uses the remedy only for the purposes for which it is recommended him

and strictly in accordance with the directions on this container.

NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED

ACN 076 745 198

54 Waterloo Road,

North Ryde NSW 2113

Registered pursuant to the ACVM Act 1997, Nos. 7772, 7773.

www.nzfsa.govt.nz/acvm

for registration conditions.

Registered to Novartis New Zealand Limited, 43-45 Patiki Road, Avondale, Auckland.

Registered trademark of Novartis Inc., Basel, Switzerland

PRESCRIPTION ANIMAL REMEDY (P.A.R.) Class 1

For use only following a veterinary consultation.

NRA 53093/0403

Product Name: FORTEKOR ® Flavour 5mgTablets for Dogs and Cats

PageNo: 1of3

Dateof issue: August2008

MATERIALSAFETY DATA SHEET

Novartis Animal HealthAustralasia Pty Ltd

Section 1 - IdentificationofChemical Product and Company

COMPANY DETAILS:

Novartis Animal Health Australasia Pty Limited Phone: (02) 9805 3555

A.C.N. 076 745 198 Fax: (02) 9888 8387

54 Waterloo Road

North Ryde NSW 2113

Product Name: FORTEKOR ® Flavour 5mg Tablets for Dogs and Cats

Active Ingredients: Benazepril hydrochloride

NAH Substance Code : A-20051 B

Product Use: For the treatment of HeartFailure in Dogs due to Mitral Regurgitation

(Endocardiosis) and Dilated Cardiomyopathy. Forthetreatment of

HypertrophicCardiomyopathyin Cats. For the treatment of Chronic

Renal Insufficiencyin Cats.

Creation Date: August 2008

Section 2 Hazards Identification

Hazard classification: Non Hazardous Substance (NOHSCcriteria)

Non-Dangerous Goods

Risk Phrases: None

Safety Phrases: None

SUSDP Classification: 4

UN Number: None Allocated

Section 3 Composition / Information on Ingredients

Ingredients CAS No. Content

(mg/tablet)

Benazepril hydrochloride [86541-74-4] 5

Other ingredientsdeterminednot tobe

hazardous - up to 192

This is a commercial product whose exactratio of componentsmay varyslightly.

Section 4 First Aid Measures

Label regulated First

Aid Statement: If poisoningoccurs contact a doctororPoisons Information Centre

(Phone 131126).

Scheduled poisons : Product is anS

scheduledpoison. Poisons Information Centres in each

State capitalcitycan provide additionalassistance forscheduled poisons

(Phone 131126).

Skin Contact: Wash affected areas thoroughly with soap and water.

Eye contact: Flush eye with large quantities of clean tap water for atleast 15minutes.

Swallowed: Lie victimdown in the recoveryposition, cover andkeep warm. Seek

medical assistance

Advice to doctor: Hypotensionmayresult frompoisoning. Induce vomiting after ingestion

(if victimisconscious). Administer physiological (normal) saline

Product Name: FORTEKOR ® Flavour 5mgTablets for Dogs and Cats

PageNo: 2of3

Dateof issue: August2008

MATERIALSAFETY DATA SHEET

Novartis Animal HealthAustralasia Pty Ltd

Section 5 Fire Fighting Measures

Extinguishing Media: This product is not flammable and non-explosive. Use extinguishing

media suitedto the materials that are burning.

Fire Fighting: Extinguish warehouse and factoryfires using fine water sprayor foam

(do not use direct jet of water). Do not allow fire-water to enter drains or

seep into theground.

Section 6 Accidental Release Measures

Accidental Release: Minor spillsdo not normally need anyspecial cleanup measures and are

unlikelytooccur due to the nature of theproduct.

Section 7 Handling and Storage

Safe Handling: Keep out of reach of children.

Storage:

Store below 25°C (Air Conditioning). Protect frommoisture and heat.

Unused half tablets shouldbe returnedto the openblister space, inserted

back into thecarton, and used within 2days.

Section 8 Exposure Controls / Personal Protection

Exposure Limits:

No occupational exposurelimits TWA or STEL have been set for the

ingredients ofthis product.

Eye Protection: No special protective equipment required.

Skin protection: No special protective equipment required.

Respirator: No special protective equipment required.

Protective material types: No special protective equipment required.

Section 9 - Physical and Chemical Properties

Physical State: Solid oval tablet

Colour: Beige-light brown

Odour: Beef Flavour

Section 10 - Stability and Reactivity

Chemical Stability: Product is stable under normal conditions.

Section 11 - Toxicological Information

Acute Toxicity:

Oral: Not harmful.

Tests on rats indicate Benazepril hydrochloride is notharmful following

a single dose of this material. Rat oral LD

> 5,000mg/kg.

Dermal: No data is available, but this is an unlikely route ofpoisoning since

Fortekor is in tablet form.

Inhaled: No data is available, but this is an unlikely route ofpoisoning since

Fortekor is in tablet form.

Chronic Toxicity: Toxicological studies on the active ingredient have not shown any

mutagenic, reproductive, teratogenic or carcinogenic effects. No risks are

anticipated to humans during routine handling, including breakageof

divisible tablets.

Product Name: FORTEKOR ® Flavour 5mgTablets for Dogs and Cats

PageNo: 3of3

Dateof issue: August2008

MATERIALSAFETY DATA SHEET

Novartis Animal HealthAustralasia Pty Ltd

Section 12 -Ecological Information

Ecological data for Benazepril hydrochloride.

Bioaccumulation in water organisms is not likelybased on the n-octanol/water partition coefficient

(log pO/W <3.0)

Section 13 - Disposal Considerations

After intended use: Dispose of empty,used containers bywrapping inpaper and puttingin

garbage.

Section 14 - Transport Information

UN Number: None allocated

UN proper shipping name: None allocated

Class & Subsidiary Risk: None allocated

Packaging Group: None allocated

HAZCHEM Code: None allocated

Section 15 - Regulatory Information

Australia: Product is registered for use with the Australian Pesticides and

Veterinarymedicines Authority

Section 16 - Other Information

This MSDScontains only safety-related information. For other data see product literature.

Acronyms

CAS Number: Chemical Abstracts Service RegistryNumber

Hazchem Number:

NOHSC: Emergencyaction code ofnumbersand letters that provide

information to emergencyservicesespeciallyfire-fighters

National Occupational Healthand SafetyCommission

STEL: Short-termExposure Limit

SUSDP: Standard for the UniformSchedulingofDrugs & Poisons

TWA: TimeWeighted Average

UN Number: United Nations Number

This productis a registered veterinarychemicalandmustthereforebe used inaccordance with the container

labeldirections.Acomprehensive package of toxicological andenvironmentaldata fortheactive ingredientsof

thisproduct has beensubmitted tothe Federalhealthand environmentauthoritiesand has been evaluated by

experttoxicologistsandenvironmental scientists.

This MaterialSafety DataSheet summarises our bestknowledge ofthe healthand safetyhazard informationof

the productand how to safely handleand usetheproductin theworkplace.Each user should read this MSDS

and considerthe information in the contextofhowthe product will be handled and used inthe workplace

including in conjunction with other products. If clarification or further information is needed to ensure that an

appropriaterisk assessmentcanbe made,the user shouldcontact thiscompany.

Species LC

50 mg/L

ZebraFish(96hrs) >100

Micro-organisms (sewerage sludge-3hrs) >100

Daphinamagna > 1000

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