APOQUEL 5.4 MG VETERINARY

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

OCLACITINIB MALEATE

Disponible des:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

formulario farmacéutico:

FILM COATED TABLETS

Composición:

OCLACITINIB MALEATE 5.4 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

ZOETIS LLC (SUBSIDIARY OF ZOETIS INC), USA

indicaciones terapéuticas:

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Data d'autorització:

2020-10-25

Informació per a l'usuari

CONSUMER PACKAGE INSERT FOR
A VETERINARY PREPARATION
The format of this leaflet was determined by
the Ministry of Health and its content
was checked and approved
The medicine is dispensed with a
veterinarian’s prescription only
For animal use only
1. NAME, FORM AND STRENGTH OF THE
VETERINARY MEDICINE
Apoquel 3.6 mg film-coated veterinary tablets
Apoquel 5.4 mg film-coated veterinary tablets
Apoquel 16 mg film-coated veterinary tablets
2. ACTIVE INGREDIENT
Each film-coated tablet contains:
Apoquel 3.6 mg veterinary tablets
3.6 mg oclacitinib (as oclacitinib maleate)
Apoquel 5.4 mg veterinary tablets
5.4 mg oclacitinib (as oclacitinib maleate)
Apoquel 16 mg veterinary tablets
16 mg oclacitinib (as oclacitinib maleate)
The list of inactive ingredients is in section 13.
3. WHAT IS THE MEDICINE INTENDED
FOR?
Control of pruritus associated with allergic
dermatitis and control of atopic dermatitis in
dogs at least 12 months of age.
4. CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the
active ingredient or to any of the ingredients of
the preparation.
Do not use in dogs under 12 months of age or
that weigh less than 3 kg.
Do
not
use
in
dogs
that
present
i m m u n o s u p p r e s s i o n ,
s u c h
a s
hyperadrenocorticism, or if there is evidence
of advanced malignant neoplasia, since the
active ingredient has not been evaluated in
these cases.
5. SIDE EFFECTS
The common side effects observed up to day 16
in field studies are listed in the table.
Side effects
observed in atopic
dermatitis study
up to day 16
Side effects
observed in
pruritus study
up to day 7
APOQUEL
(n=152)
Placebo
(n=147)
APOQUEL
(n=216)
Placebo
(n=220)
Diarrhea
4.6%
3.4%
2.3%
0.9%
Vomiting
3.9%
4.1%
2.3%
1.8%
Loss of
appetite
(anorexia)
2.6%
0%
1.4%
0%
New
cutaneous or
subcutaneous
lumps
2.6%
2.7%
1.0%
0%
Lethargy
2.0%
1.4%
1.8%
1.4%
Polydipsia
0.7%
1.4%
1.4%
0%
After day 16, the following side effects have
been observed: pustular dermatitis (pyoderma)
and non-specified dermal lumps are very
common effects. Otitis, vomiting, diarrhea,
be