Apoquel
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
21-01-2022
Valmisteyhteenveto
(SPC)
21-01-2022
Julkisesta arviointikertomuksesta
(PAR)
21-01-2022
Aktiivinen ainesosa:
oclacitinib maleate
Saatavilla:
Zoetis Belgium SA
ATC-koodi:
QD11AH90
INN (Kansainvälinen yleisnimi):
oclacitinib maleate
Terapeuttinen ryhmä:
Dogs
Terapeuttinen alue:
Agents for dermatitis, excluding corticosteroids
Käyttöaiheet:
- Treatment of pruritus associated with allergic dermatitis in dogs.- Treatment of clinical manifestations of atopic dermatitis in dogs.
Tuoteyhteenveto:
Revision: 8
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-09-12
Pakkausseloste
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET:
APOQUEL 3.6 MG FILM-COATED TABLETS FOR DOGS
APOQUEL
5.4 MG FILM-COATED TABLETS FOR DOGS
APOQUEL 16 MG FILM-COATED TABLETS 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:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Pfizer Italia S.R.L.
Via del Commercio 25/27
63100 Marino Del Tronto (AP)
ITALY
or
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apoquel 3.6 mg film-coated tablets for dogs
Apoquel 5.4 mg film-coated tablets for dogs
Apoquel 16 mg film-coated tablets for dogs
oclacitinib
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib
(as oclacitinib maleate).
White to off-white, oblong shaped film-coated tablets with a
score-line on both sides and marked with
the letters "AQ" and "S", "M" or "L" on both sides. The letters "S",
"M" and "L" refer to the different
strengths of tablets: "S" is on the 3.6 mg tablets, "M" on the 5.4 mg
tablets, and "L" on the 16 mg
tablets.
The tablets can be divided into equal halves.
4.
INDICATION(S)
Treatment of pruritus associated with allergic dermatitis in dogs.
Treatment of clinical manifestations of atopic dermatitis in dogs.
30
5.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to oclacitinib or to any of
the excipients.
Do not use in dogs less than 12 months of age or less than 3 kg
bodyweight.
Do not use in dogs with evidence of immune suppression such as
hyperadrenocorticisim or with
evidence of progressive malignant neoplasia as the active substance
has not been evaluated in these
cases.
6.
ADVERSE REACTIONS
The common adverse reactions seen up to day 16 of the field trials are
listed in the following table:
Adverse reactions observed in
atopic dermatitis study up to day 16
Ad
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apoquel 3.6 mg film-coated tablets for dogs
Apoquel
5.4 mg film-coated tablets for dogs
Apoquel 16 mg film-coated tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each film-coated tablet contains:
Apoquel 3.6 mg:
3.6 mg oclacitinib (as oclacitinib maleate)
Apoquel 5.4 mg:
5.4 mg oclacitinib (as oclacitinib maleate)
Apoquel 16 mg:
16 mg oclacitinib (as oclacitinib maleate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White to off-white, oblong shaped film-coated tablets with a
score-line on both sides and marked with
the letters "AQ" and "S", "M" or "L" on both sides. The letters "S",
"M" and "L" refer to the different
strengths of tablets: "S" is on the 3.6 mg tablets, "M" on the 5.4 mg
tablets, and "L" on the 16 mg
tablets.
The tablets can be divided into equal halves.
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 12 months of age or less than 3 kg
bodyweight.
Do not use in dogs with evidence of immune suppression, such as
hyperadrenocorticism, or with
evidence of progressive malignant neoplasia as the active substance
has not been evaluated in these
cases.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
Oclacitinib modulates the immune system and may increase
susceptibility to infection and exacerbate
neoplastic conditions. Dogs receiving Apoquel tablets should therefore
be monitored for the
development of infections and neoplasia.
When treating pruritus associated with allergic dermatitis with
oclacitinib, investigate and treat any
underly
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