Eluracat 20 mg/ml Oral Solution 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
Sodium methyl parahydroxybenzoate
(E 219)
1.5 mgSodium propyl parahydroxybenzoate
(E 217)
0.25 mgSodium chlorideCitric acidSucraloseVanillinPovidone (K-90)GlycerolMaltitol, liquidMagnasweet 110 (glycyrrhizic acid,
monoammonium glycyrrhizinate)
Purified water
Clear, colourless to yellowish or orange solution.
3. CLINICAL INFORMATION
3.1 Target species
Cats

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3.2 Indications for use for each target species
For body weight gain in cats experiencing poor appetite or unintended weight loss
resulting from chronic medical conditions (see section 4.2).
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in patients with severe haemodynamic instability such as hypovolaemic
shock. See also section 3.5 Special precautions for safe use in the target species.
Do not use in patients with hypersomatotropism (acromegaly).
3.4 Special warnings
This veterinary medicinal product does not treat the underlying chronic medical
conditions but is intended to provide supportive therapy.
The efficacy in cats less than 6 years old or with less than 2 kg body weight has not been
evaluated.
The efficacy of the veterinary medicinal product has not been established for more than
90 days. Therefore, the product should only be used for a period of greater than 90 days
following a benefit-risk assessment by the responsible veterinary surgeon.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The veterinary medicinal product has been shown to increase serum glucose levels in
cats, with highly variable effects on individual cats. However, in non-diabetic cats
homeostatic mechanisms adapt to maintain blood glucose levels within normal ranges
after a few days. Use in cats with diabetes mellitus has not been evaluated. In cases of
diabetes mellitus, use only according to the benefit-risk assessment by the responsible
veterinary surgeon.
The veterinary medicinal product causes transient reductions in blood pressure and heart
rate. In a target animal safety study conducted in eight healthy male cats, reductions in
blood pressure and heart rate of up to 30% below baseline were observed for
approximately four hours following administration of the recommended treatment dose of
2 mg/kg bodyweight. These effects were partially mitigated by human interaction
followed by feeding of the cat, without the need for additional treatment. Therefore, the
product should only be used according to a benefit-risk assessment by the responsible
veterinary surgeon, in patients with congestive heart failure, cardiac arrythmias,
dehydration, anaemia or other conditions that may impair tissue perfusion or
oxygenation. The product must not be used in cases of severe haemodynamic instability
such as hypovolaemic shock. See also section 3.3 Contraindications.
Use with caution in cats with hepatic dysfunction as capromorelin is metabolised in the
liver.
The safety in cats less than 10 months old or with less than 2 kg body weight has not
been evaluated.
The safety of the veterinary medicinal product for a treatment period of more than 90
days in cats with chronic medical conditions has not been evaluated. Therefore, the
product should only be used for a period of greater than 90 days following a benefit-
risk assessment by the responsible veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Ingestion by children may cause mild and reversible signs of abdominal pain,
lethargy, lightheadedness, palpitation, low back pain, feeling warm and increased
perspiration. Children should not have access to filled syringes. Do not leave a filled
syringe unattended. In case of accidental ingestion, seek medical advice immediately
and show the package leaflet or the label to the physician.
This veterinary medicinal product contains parabens and povidone, which may cause
allergic reactions. People with known hypersensitivity to these substances should
administer the veterinary medicinal product with caution.
This veterinary medicinal product may cause eye and skin irritation. Contact with the
eyes, skin and mucous membranes should be avoided. Wash hands after use. In
case of accidental eye or skin contact, rinse the affected area immediately with plenty
of fresh water. If irritation persists, seek medical advice and show the package leaflet
or the label to the physician.
Special precautions for the protection of the environment:
Not applicable
3.6 Adverse events
Cats:
Very common
(>1 animal / 10 animals treated):
Hypersalivation
1Common
(1 to 10 animals / 100 animals treated):
Diarrhoea, Vomiting Anaemia
Skin lesions (on the mouth and chin)
Dehydration, Lethargy, Inappetence
Rare
(1 to 10 animals / 10 000 animals treated):
Anorexia
Behavioural disorder
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Bradycardia, Hypotension
Dyspnoea
Loss of consciousness, Sedation
Recumbency
Muscle weakness
Hiding
At the time of dosing and resolved within a few minutes.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder 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
reproduction, pregnancy and lactation in the target species. However, laboratory
studies in rats have shown evidence of teratogenic effects.
Pregnancy and lactation:
Do not use during pregnancy and lactation.
Fertility:
Do not use in breeding animals.
3.8 Interaction with other medicinal products and other forms of interaction
The veterinary medicinal product causes transient decreases in blood pressure and
heart rate for up to several hours after dosing. Therefore, concurrent use of other
drugs that cause reductions in blood pressure and/or heart rate (e.g. sedatives,
anaesthetic agents, prazosin, ACE inhibitors) should only be according to a benefit-
risk evaluation by the responsible veterinary surgeon.
The veterinary medicinal product causes transient elevations in serum glucose levels
and insulin resistance in cats. Therefore, concurrent use of other drugs that cause
such effects (e.g. steroids) should only be according to a benefit-risk evaluation by the
responsible veterinary surgeon.
3.9 Administration routes and dosage
Oral use.
The recommended dose is 2 mg/kg body weight which is equivalent to 0.1 ml/kg body
weight. The veterinary medicinal product is to be administered once daily directly into
the mouth.
To administer the veterinary medicinal product:
- Remove the cap, insert the dosing syringe, invert the bottle, withdraw the
appropriate amount of solution using a ml scale syringe.
- Return the bottle to the upright position, remove the syringe, replace the cap tightly.
- Administer the solution into the cat’s mouth.
- Rinse the syringe and the plunger with water and leave apart to dry.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
After administration of the veterinary medicinal product up to 5 times the
recommended dose for 6 months to young healthy cats the following adverse
reactions were observed: Non-progressive increases in triglyceride levels were noted
in male cats. Increase in liver to brain weight ratio was observed and liver vacuolation
was noted in two animals (one in the 3x and one in the 5x group). One male cat in the
5x group was diagnosed with diabetic ketoacidosis and had elevated serum liver
parameters (bilirubin, ALT and AST) on day 50 of dosing. Other adverse reactions
observed were consistent with those mentioned in section 3.