APOQUEL 16 MG VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

OCLACITINIB MALEATE

متاح من:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

OCLACITINIB MALEATE 16 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ZOETIS BELGIUM S.A.

الخصائص العلاجية:

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

تاريخ الترخيص:

2021-11-30

نشرة المعلومات

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

خصائص المنتج

1
Apoquel LPD 08.07.2021
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Apoquel 3.6 mg Veterinary film-coated tablets
Apoquel 5.4 mg Veterinary film-coated tablets
Apoquel 16 mg Veterinary film-coated tablets
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
Control of pruritus associated with allergic dermatitis and control of
atopic dermatitis in dogs at least 12
months of age.
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.
2
Apoquel LPD 08.07.2021
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
underlying