Cytopoint
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
16-07-2021
Svojstava lijeka
(SPC)
16-07-2021
Izvješće o ocjeni javnog
(PAR)
15-09-2021
Aktivni sastojci:
lokivetmab
Dostupno od:
Zoetis Belgium SA
ATC koda:
QD11AH91
INN (International ime):
lokivetmab
Terapijska grupa:
Dogs
Područje terapije:
Other dermatological preparations, Agents for dermatitis, excluding corticosteroids
Terapijske indikacije:
Treatment of clinical manifestations of atopic dermatitis in dogs.
Proizvod sažetak:
Revision: 6
Status autorizacije:
Authorised
Datum autorizacije:
2017-04-25
Uputa o lijeku
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
CYTOPOINT 10 MG SOLUTION FOR INJECTION FOR DOGS
CYTOPOINT 20 MG SOLUTION FOR INJECTION FOR DOGS
CYTOPOINT 30 MG SOLUTION FOR INJECTION FOR DOGS
CYTOPOINT 40 MG SOLUTION FOR INJECTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and Manufacturer responsible for batch
release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CYTOPOINT 10 mg solution for injection for dogs
CYTOPOINT 20 mg solution for injection for dogs
CYTOPOINT 30 mg solution for injection for dogs
CYTOPOINT 40 mg solution for injection for dogs
lokivetmab
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCE:
Each vial of 1 ml contains:
CYTOPOINT 10 mg:
Lokivetmab*
10 mg
CYTOPOINT 20 mg:
Lokivetmab*
20 mg
CYTOPOINT 30 mg:
Lokivetmab*
30 mg
CYTOPOINT 40 mg:
Lokivetmab*
40 mg
*Lokivetmab is a caninised monoclonal antibody expressed through
recombinant techniques in
Chinese hamster ovary (CHO) cells
4.
INDICATION(S)
Treatment of pruritus associated with allergic dermatitis in dogs.
Treatment of clinical manifestations of atopic dermatitis in dogs.
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs less than 3 kg bodyweight.
18
6.
ADVERSE REACTIONS
Hypersensitivity reactions (anaphylaxis, facial oedema, urticaria)
have been reported to
occur in rare
cases from spontaneous reports. In such cases appropriate treatment
should be administered
immediately.
Vomiting and/or diarrhoea have been reported to occur
in rare cases from spontaneous reports and
may occur in connection with hypersensitivity reactions. Treatment
should be administered as needed.
Neurological signs (seizure, convulsion or ataxia) have been rarely
observed in spontaneous reports
following use of the veterinary medicinal product.
Applicat
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CYTOPOINT 10 mg solution for injection for dogs
CYTOPOINT 20 mg solution for injection for dogs
CYTOPOINT 30 mg solution for injection for dogs
CYTOPOINT 40 mg solution for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each vial of 1 ml contains:
CYTOPOINT 10 mg:
Lokivetmab*
10 mg
CYTOPOINT 20 mg:
Lokivetmab*
20 mg
CYTOPOINT 30 mg:
Lokivetmab*
30 mg
CYTOPOINT 40 mg:
Lokivetmab*
40 mg
*Lokivetmab is a caninised monoclonal antibody expressed through
recombinant techniques in
Chinese hamster ovary (CHO) cells
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The product should appear clear to opalescent without any visible
particle.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of pruritus associated with allergic dermatitis in dogs.
Treatment of clinical manifestations of atopic dermatitis in dogs.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs less than 3 kg bodyweight.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Lokivetmab may induce transient or persistent anti-drug antibodies.
The induction of such antibodies
is uncommon and may have no effect (transient anti-drug antibodies) or
may result in a noticeable
3
decrease in efficacy (persistent anti-drug antibodies) in animals that
responded to treatment
previously.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Avoidance or elimination of the allergen is an important consideration
in the successful treatment of
allergic dermatitis. When treating pruritus associated with allergic
dermatitis with lokivetmab,
investigate and treat any underlying causes (e.g. flea allergic
dermatitis, contact dermatitis, food
hypersensitivity); this product is not intended to be used as a
long-term maintenance therapy if the
off
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