Solensia

País: Unión Europea

Idioma: inglés

Fuente: EMA (European Medicines Agency)

Ingredientes activos:

frunevetmab

Disponible desde:

Zoetis Belgium SA

Designación común internacional (DCI):

frunevetmab

Grupo terapéutico:

Cats

Área terapéutica:

Analgesics

indicaciones terapéuticas:

For the alleviation of pain associated with osteoarthritis in cats.

Estado de Autorización:

Authorised

Fecha de autorización:

2021-02-17

Información para el usuario

14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
SOLENSIA 7 MG/ML SOLUTION FOR INJECTION 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:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
or
Zoetis Belgium SA
Unit 5, Sragh Technology Park
Tullamore
Co. Offaly
IRELAND
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SOLENSIA 7 mg/ml solution for injection for cats
frunevetmab
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
ACTIVE SUBSTANCE:
Each ml of solution contains:
Frunevetmab*
7 mg
* Frunevetmab is a felinised monoclonal antibody (mAb) expressed
through recombinant techniques
in Chinese hamster ovary (CHO) cells.
4.
INDICATION(S)
For the alleviation of pain associated with osteoarthritis in cats.
5.
CONTRAINDICATIONS
Do not use in animals under 12 months and/or under 2.5 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
16
Do not use in animals intended for breeding.
Do not use in pregnant and lactating animals.
6.
ADVERSE REACTIONS
Focal skin reactions (e.g. pruritus, dermatitis and alopecia) occurred
commonly in studies.
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 veterinary surgeon.
7.
TARGET SPECIES
Cats.
8.
DOSAGE FOR EAC

Ficha técnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SOLENSIA 7 mg/ml solution for injection for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each ml of solution contains:
Frunevetmab*
7 mg
* Frunevetmab is a felinised monoclonal antibody (mAb) expressed
through recombinant techniques
in Chinese hamster ovary (CHO) cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear to slightly opalescent solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the alleviation of pain associated with osteoarthritis in cats.
4.3
CONTRAINDICATIONS
Do not use in animals under 12 months and/or under 2.5 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals intended for breeding.
Do not use in pregnant and lactating animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Continuation of treatment should be based on the individual response
of each animal. If a positive
response is not observed, consider alternative treatments.
This veterinary medicinal product may induce transient or persistent
anti-drug antibodies. The
induction of such antibodies may reduce the efficacy of the product
although this was not observed
during the 84 days of the pivotal clinical trial. No information is
available for longer duration
treatment.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The safety and efficacy of this product has not been investigated in
cats with kidney disease IRIS
stages 3 and 4. Use of the product in such cases should be based on a
benefit-risk assessment
performed by the responsible veterinarian.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Hypersensitivity reactions, including anaphylaxis, could potentially
occur in the case of accidental
self-injection. Repeated accidental self-administration may i