Bonqat

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

pregabalin

זמין מ:

Orion Corporation

קוד ATC:

QN03AX16

INN (שם בינלאומי):

pregabalin

קבוצה תרפויטית:

Cats

איזור תרפויטי:

Antiepileptics

סממני תרפויטית:

Alleviation of acute anxiety and fear associated with transportation and veterinary visits.

מצב אישור:

Authorised

תאריך אישור:

2021-07-13

עלון מידע

14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
BONQAT 50 MG/ML ORAL SOLUTION FOR CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer responsible for batch release:
Orion Corporation Orion Pharma
Tengströminkatu 8
FI-20360 Turku
Finland
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bonqat 50 mg/ml oral solution for cats
pregabalin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCE:
Pregabalin 50 mg
EXCIPIENT:
Sodium benzoate (E211) 2 mg
Clear, colourless solution.
4.
INDICATION(S)
Alleviation of acute anxiety and fear associated with transportation
and veterinary visits.
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
16
6.
ADVERSE REACTIONS
Signs of sedation (characterised by tiredness, difficulties in
perception of the position and movement
of the body, and problems with balance) and vomiting have been
observed commonly in clinical
studies. Muscle tremor, dilatated pupils, loss of appetite, weight
loss and reduced number of white
blood cells 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).
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform your veterin

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bonqat 50 mg/ml oral solution for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Pregabalin 50 mg
EXCIPIENT:
Sodium benzoate (E211) 2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless solution
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.
3
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