Nchi: Australia
Lugha: Kiingereza
Chanzo: APVMA (Australian Pesticides and Veterinary Medicines Authority)
OCLACITINIB MALEATE
ZOETIS AUSTRALIA PTY LTD
oclacitinib maleate(16mg/Tb)
ORAL TABLET
OCLACITINIB MALEATE Active 16.0 mg/Tb
100tablets; 20 tablets
VM - Veterinary Medicine
ZOETIS AUSTRALIA
ANTIPRURITIC
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.
Registered
2023-07-01
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 Soma hati kamili
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 (02) 8876 0444 EMAIL australia.animalhealth@zoetis.com 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 Soma hati kamili