APOQUEL 16 MG TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OCLACITINIB MALEATE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

oclacitinib maleate(16mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

OCLACITINIB MALEATE Active 16.0 mg/Tb

Units in package:

100tablets; 20 tablets

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic area:

ANTIPRURITIC

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ALLERGIC DERMATITIS, ATOPIC DERMATITIS, PRURITIS]; For the treatment of pruritus associated with allergic dermatitis in dogs. For the treatment of the clinical manifestatios of atopic dermatitis in dogs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPENDIX2
AUSTRALIAN
GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
+
RLP
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
_(VETERINARY PRODUCTS) _
_Select appropriate: _
./New
Product (include all applicable RLPs)
OR
[]
Variation (highlight instructions that are being varied). Approval
no.
of label being varied: ...
v4
.. :
..........
.
Signal
heading:
Product
name:
Active
constituenUs:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
PRECAUTIONS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
APOQUEL 16
MG
TABLETS FOR DOGS
EACH TABLET CONTAINS 16 MG OCLACITINIB MALEATE
FOR THE TREATMENT OF PRURITUS ASSOCIATED WITH ALLERGIC DERMATITIS IN
DOGS.
FOR THE TREATMENT OF THE CLINICAL MANIFESTATIONS OF ATOPIC DERMATITIS
IN
DOGS.
20 OR 100 X 16
MG
TABLETS
DIRECTIONS FOR USE
READ THE PACKAGE LEAFLET BEFORE USE
Each tablet contains 3.6
mg,
5.4 mg or 16
mg
oclacitinib as oclacitinib maleate.
Each tablet
is
scored
and
marked with
AQ
and either
an
S,
M,
or L that correspond
to
the different tablet strengths
on
both sides.
PRESENTATION
APOQUEL
is
available
in
bottles containing
20
or 100 tablets of 3.6, 5.4 or 16 mg
oclacitinib.
OR
APOQUEL
is
available
in
blister packs containing
20
or 100 tablets of 3.6, 5.4 or 16
mg
oclacitinib.
NIL.
This product
is
contraindicated
in
animals with known hypersensitivity
to
oclacitinib.
This product
is
contraindicated
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.
APOQUEL (oclacitinib) modulates the immune system.
APOQUEL may increase the
susceptibility
to
infection and the development of papillomas, and may exacerbate
neoplastic conditions
including
subclinical
neoplastic
conditions.
Dogs
receiving
APOQUEL should
therefore
be
monitored
for the
development of infections and
neoplasia.
The safety of t

Summary of Product characteristics

Issue date: 03-November-2016
Version number: 01
SAFETY DATA SHEET
1. IDENTIFICATION
APOQUEL
PRODUCT IDENTIFIER
OTHER MEANS OF IDENTIFICATION
Oclacitinib Maleate Film Coated Tablets
SYNONYMS
RECOMMENDED USE OF THE CHEMICAL AND RESTRICTIONS ON USE
Veterinary product
RECOMMENDED USE
Not for human use
RESTRICTIONS ON USE
DETAILS OF MANUFACTURER OR IMPORTER
MANUFACTURER
COMPANY NAME (AU)
Zoetis Australia Pty Ltd
ABN 94 156 476 425
Level 6, 5 Rider Boulevard
Rhodes NSW 2138 AUSTRALIA
TEL
1800 814 883
FAX
[phone]
EMAIL
[e-mail]
EMERGENCY PHONE
1800 814 883 (all hours)
POLICE AND FIRE BRIGADE
Dial 000
IF INEFFECTIVE
Dial Poisons Information Centre (13 1126 from anywhere in Australia)
2. HAZARD(S) IDENTIFICATION
CLASSIFICATION OF THE HAZARDOUS CHEMICAL
Not classified.
PHYSICAL HAZARDS
Category 1
Serious eye damage/eye irritation
HEALTH HAZARDS
Category 3
Hazardous to the aquatic environment, acute
hazard
ENVIRONMENTAL HAZARDS
LABEL ELEMENTS, INCLUDING PRECAUTIONARY STATEMENTS
HAZARD SYMBOL(S)
Corrosion
SIGNAL WORD
Danger
HAZARD STATEMENT(S)
Causes serious eye damage. Harmful to aquatic life.
PRECAUTIONARY STATEMENT(S)
PREVENTION
Avoid release to the environment. Wear eye protection/face protection.
RESPONSE
IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present
and easy to do. Continue rinsing. Immediately call a POISON CENTRE or
doctor/physician.
STORAGE
Store away from incompatible materials.
DISPOSAL
Dispose of contents/container in accordance with
local/regional/national/international regulations.
OTHER HAZARDS WHICH DO NOT
RESULT IN CLASSIFICATION
None known.
SUPPLEMENTAL INFORMATION
May cause slight skin irritation.
3. COMPOSITION/INFORMATION ON INGREDIENTS
MIXTURE
1 / 9
Material name: APOQUEL
559
SDS AUSTRALIA
CONCENTRATION OF
INGREDIENTS
IDENTITY OF CHEMICAL INGREDIENTS
5
CAS NUMBER AND OTHER
UNIQUE IDENTIFIERS
1208319-27-0
Oclacitinib Maleate
*
557-04-0
Magnesium stearate
*
9004-34-6
Microcrystalline cellulose
*Designates that a specific chem