4. CLINICAL PARTICULARS
4.1 Target species
Cats
4.2 Indications for use, specifying the target species
Alleviation of acute anxiety and fear associated with transportation and veterinary
visits.
4.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
4.4 Special warnings for each target species
None
4.5 Special precautions for use
Special precautions for use in animals
The safety of the veterinary medicinal product has not been established in cats
weighing less than 2 kg, younger than 5 months and older than 15 years. Use only
according to the benefit-risk assessment by the responsible veterinarian.
The safety of the veterinary medicinal product has only been established in healthy
cats or those with mild systemic illness. It has not been established in animals with
moderate or severe systemic disease e.g. moderate to severe renal, liver, or
cardiovascular disease. Use only according to the benefit-risk assessment by the
responsible veterinarian.
Always assess the cat’s health status before prescribing the veterinary medicinal
product.
The veterinary medicinal product may cause slight reduction in heart rate, respiratory
rate and body temperature. As a reduction of body temperature can occur after the
administration, the treated animal should be kept at a suitable ambient temperature.
Monitor the cat carefully for any symptoms of respiratory depression and sedation
when a CNS depressant is used concomitantly with pregabalin.
The prescribing veterinarian should advise the owner to always inform the attending
veterinarian if the veterinary medicinal product has been administered to the cat prior
to the veterinary visit.
If the cat spits part of the dose, vomits after treatment, or in case of hypersalivation,
do not give another dose.
The effect of the veterinary medicinal product can last approximately 7 hours. In case
the cat seems drowsy or shows other signs of exaggerated effects after treatment
administration, keep the cat indoors and do not offer water or feed until the cat has
fully recovered.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Exposure to pregabalin may cause adverse effects such as dizziness, tiredness,
ataxia, blurred vision and headache.
Avoid skin, eye or mucosal contact. Thoroughly wash hands immediately after
administration of the veterinary medicinal product.
In case of accidental eye or mucosal contact, flush with water. Seek medical advice if
symptoms (dizziness, tiredness, ataxia or blurred vision) occur.
In case of skin contact, wash with soap and water. Remove contaminated clothing.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician. Do not drive as tiredness may occur.
4.6 Adverse reactions (frequency and seriousness)
Signs of sedation (characterised by lethargy, proprioception abnormality and ataxia)
and emesis have been observed commonly in clinical studies. Muscle tremor,
mydriasis, anorexia, weight loss and leucopenia have been reported uncommonly in
clinical studies. Salivation has been reported rarely in clinical studies. Typically,
clinical signs are mild and transient.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1 000 animals treated)
- rare (more than 1 but less than 10 animals in 10 000 animals treated)
- very rare (less than 1 animal in 10 000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have shown evidence of embryofoetotoxic and
maternotoxic effects when pregabalin is administered repeatedly at high doses
(≥ 1 250 mg/kg/day). The safety of the veterinary medicinal product has not been
established in breeding animals or during pregnancy and lactation in the target
species. Use only according to the benefit-risk assessment by the responsible
veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
The use of other central nervous system depressants is expected to potentiate the
effects of pregabalin and therefore an appropriate dose adjustment should be made.
4.9 Amounts to be administered and administration route
Oral use.
The veterinary medicinal product is administered orally as a single dose of 5 mg/kg
bodyweight (0.1 ml/kg bw) approximately 1.5 hours before the start of the
transportation/planned veterinary visit.
The veterinary medicinal product can be administered either directly into the mouth
or mixed with a small amount of food. Large amounts of food may delay the onset of
effect.
Use the oral syringe provided in the package for administration of the veterinarymedicinal product.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Safety following repeated administration for 6 consecutive days and at up to 5 times
the recommended treatment dose was investigated in an overdose study.
Signs related to motor coordination (abnormal gait, limited usage of hind limbs/paws,
uncoordinated behaviour, ataxia), somnolence (decreased activity, closed eyes, lying on side, dilated pupils, decreased body temperature and depression), vomiting and
salivation were observed at greater frequency, severity and duration of the signs with
doses of 15 mg/kg and 25 mg/kg than that observed at the recommended dose rate
of 5 mg/kg bodyweight. Loss of consciousness was noted in one out of eight cats at
25 mg/kg.
If decrease in body temperature occurs, the cat should be kept warm.
4.11 Withdrawal period
Not applicable.