Benamix 6.25 mg/g Premix for Medicated Feeding Stuff for Cats

Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Butylhydroxyanisole (E320)
0.2 mg
Silica colloidal anhydrousPolysorbate 80Triglycerides, medium chain
White to yellow suspension.
3. CLINICAL INFORMATION
In accordance with The Veterinary Medicinal Regulations 2013 Schedule 5, the
medicated feed label must include in a simple, clear and easily understandable
manner all the bolded clinical information listed in sections 3.1 to 3.12.
3.1 Target species
Cats.
3.2 Indications for use for each target species
Reduction of proteinuria associated with chronic kidney disease.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
AN: 03649/2023 & 03664/2023
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 (see section 3.7.).
3.4 Special warnings
The uptake of the medicated feed can be altered as a consequence of CKD or
other diseases and should be monitored. In case of insufficient feed intake, i.e
less than 50% of the prescribed feed intake for more than 7 consecutive days,
the efficacy of the treatment cannot be guaranteed and the animal should be
presented to a veterinarian in order to investigate the cause of this diminished
feed intake and apply the suitable treatment. Cats suffering from anorexia or
inappetence should not be treated via medicated feed.
To ensure a better acceptance of the new feed and to avoid digestive issues, a
feed transition may be implemented over some days at the discretion of the
veterinarian.
3.5 Special precautions for use
Special precautions for safe use in the target species:
If more than one cat is living in the household, ensure that only the cat for
which this treatment is prescribed has access to the medicated feed, and that
the cat being treated receives the appropriate dose (i.e., amount of medicated
feed).
No evidence of renal toxicity of benazepril 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 efficacy
and safety of the veterinary medicinal product has not been established in cats
below 2.5 kg body weight.
The use of a Renin-Angiotensin-Aldosterone System (RAAS) inhibitor is not
recommended in any cat that is clinically dehydrated or is showing signs of
hypovolemia. Check and correct dehydration before using these drugs, otherwise
glomerular filtration rate may drop precipitously if these drugs are introduced before
the patient is adequately hydrated.
Precautions to be taken by the person administering the medicated feed to animals:
The medicated feed may be harmful when ingested by children
Avoid accidental ingestion. The medicated feed and the feed bowl should be
placed out of the reach and sight of children. In case of accidental oral ingestion,
seek medical advice immediately and show the label of the medicated feed to
the physician.
AN: 03649/2023 & 03664/2023
Angiotensin converting enzyme (ACE) inhibitors have shown to affect the foetus
Pregnant women, and women of childbearing potential, should take special care
to avoid any skin exposure with the medicated feed, including oral exposure
due to hand-to-mouth contact.
In case of accidental skin exposure or accidental ingestion, wash or rinse
thoroughly and immediately with water, seek medical advice and show the label
of the medicated feed to the physician.
Angiotensin converting enzyme (ACE) may cause hypersensitivity reactions.
People with known hypersensitivity to benazepril should avoid contact.
In case of hypersensitivity reactions, seek medical advice and show the label of
the medicated feed to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable
3.6 Adverse events
Cats.
Rare
(1 to 10 animals / 10,000 animals
treated):
Diarrhoea, Emesis
Anorexia, Dehydration, Lethargy
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Elevated creatinine
Increased appetite, Weight gain
In cats with chronic kidney disease, the veterinary medicinal 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.
Reporting adverse events is important. It allows continuous safety monitoring
of a veterinary medicinal product.
veterinarian, to either the marketing authorisation holder or its local representative or
the national competent authority via the national reporting system. See the package
leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during
breeding, pregnancy and lactation.
Pregnancy and lactation:
Benazepril reduced ovary/oviduct weights in cats when administered daily at the
overdose of 10 mg/kg body weight for 52 weeks. Embryotoxic effects (foetal urinary
tract malformation) were seen in trials with laboratory animals (rats) at maternally
non toxic doses.
Do not use during pregnancy or lactation.
AN: 03649/2023 & 03664/2023
3.8 Interaction with other medicinal products and other forms of interaction
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 veterinary medicinal product and other anti-
hypertensive agents (e.g. calcium channel blockers, or diuretics),
anaesthetics or sedatives may lead to additive hypotensive effects. Therefore,
concurrent use of NSAIDs, telmisartan 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 veterinary medicinal product in combination with a potassium sparing
diuretic because of the risk of hyperkalaemia
3.9 Administration routes and dosage
In-feed use.
Only to be mixed into dry feed by a feed business operator.
The veterinary medicinal product is a premix intended for the manufacture of
medicated feeding stuff. Do not administer the veterinary medicinal product other than
mixed with feed by an authorized manufacturer of medicated feed.
Mixing instructions:
The barrel should be shaken about 20 seconds before use.
The incorporation process should consist in the incorporation of the whole barrel
through simple mixing steps performed under normal conditions of temperature. The
premix should be incorporated only by a coating process at the coating stage of the
kibbles. An appropriate amount of fat and a palatable agent for cats should be
incorporated in the external coating of the kibble. The premix should not be
incorporated in the feed during the extrusion of the kibbles or by another process than
coating
To ensure the shelf-life of 12 months after incorporation in the feed, it is recommended
that the medicated feed be filled into a bag with an aluminized layer and an internal
polyethylene PE layer, and stored at a temperature not above 25°C.
In order to obtain the correct dosage, the concentration of the premix in the
medicated feed may need to be adjusted accordingly by the feed business operator,
taking into account the metabolizable energy of the feed.
In case the veterinary medicinal product is mixed at an incorporation rate of 72mg of
benazepril per kg feed into a feed appropriate for renal patients, with a metabolizable
energy of 416 kcal/ 100g, the feeding recommendation table might read as follows:
AN: 03649/2023 & 03664/2023
Body Weight
(kg)
Range of daily ration (g/day) depending on
the body condition and the activity of the cat*
2.5 - 2.9 25 - 353.0 - 3.425 - 353.5 - 3.930 - 454.0 - 4.435 - 504.5 - 4.940 - 555.0 - 5.445 - 605.5 - 5.950 - 65