Država: Australija
Jezik: engleski
Izvor: APVMA (Australian Pesticides and Veterinary Medicines Authority)
CYCLOSPORIN
ELANCO AUSTRALASIA PTY LTD
cyclosporin(10mg/Cp)
ORAL CAPSULE
CYCLOSPORIN BIOLOGICAL-ORGANISM-FUNGUS Active 10.0 mg/Cp
10 Caps; 15 Caps; 30 Caps; 60 Caps
VM - Veterinary Medicine
ELANCO AUSTRALASIA
DOG - LARGE
MISCELLANEOUS VETERINARY
ATOPIC DERMATITIS | PERIANAL FISTULAE
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - LARGE: [ATOPIC DERMATITIS, PERIANAL FISTULAE]; For the treatment of atopic dermatitis in dogs. Aids in the treatment of perianal fistulae in dogs.NOT TO BE USE in food producing species of animals. See PRECAUTIONS etc. on label.
Registered
2023-07-01
ATOPICA 10 mg Soft Capsules for Dogs APVMA No.: 54354 ACVM: A008300 Date: 16 December 2013 TEXT ABOVE THIS LINE IS NOT INCLUDED BLISTER FOIL (INTERNATIONAL DESIGN - SAME BLISTER FOR ALL COUNTRIES) ATOPICA 10 MG Ciclosporin Atopica 10 mg soft capsules for dogs. For animal treatment only Page 1 of 7 _RLP _ Approved ATOPICA 10 mg Soft Capsules for Dogs APVMA No.: 54354 ACVM: A008300 Date: 16 December 2013 Text above this LINE is not included Carton front panel PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY ATOPICA® 10 MG SOFT CAPSULES FOR DOGS Active Constituent: Each Capsule contains 10 mg CYCLOSPORIN Page 2 of 7 For the treatment of atopic dermatitis in dogs. Aids in the treatment of perianal fistulae in dogs. [graphic of small breed dog] Contents: 15 Soft Capsules ATOPICA 10 mg Soft Capsules for Dogs APVMA No .: 54354 ACVM: A008300 Date: 16 December 2013 Text ab ove this line is not included CARTON ANCILLARY PANELS ATOPICA® 10 mg Soft Capsules for Dogs REFER TO ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. DIRECTIONS FOR USE RESTRAINT: NOT TO BE USED IN FOOD PRODUCING SPECIES OF ANIMALS. Give ATOPICA without food, at least 2 hours before or after feeding. Dosage Page 3 of 7 Atopic dermatitis: 5 mg cyclosporin per kg bodyweight daily using the appropriate combination of capsules 2 to< 3 kg: 10 mg 3 to < 4 kg: 20 mg [pictogram] FIRST AID: IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS INFORMATION CENTRE. PHONE AUSTRALIA 131126; NEW ZEALAND 0800 764 766. DISPOSAL: Dispose of empty containers by wrapping with paper and putting in garbage. STORAGE: Store below 25 °C (Air Conditioning). Capsules mu st be left in the blister until required for use. When a blister is opened, a characteristic smell is noticeable, which is normal. AUSTRALIA No va rtis Animal Health Australasia Pt y Limited ACN 64 076 745 198 54 Waterloo Road NORTH RYDE NSW 2113 APVMA No. 54354/59475 NOVARTIS CUSTOMER ASSISTANCE Australia ~ 1800 633 768 TOLL FREE from anywhere in Australia 8.30 am to 5. 30 pm E.S.T. Mo Pročitajte cijeli dokument
PRODUCT NAME: ATOPICA® SOFT CAPSULES FOR DOGS (10MG/25MG/50MG/100MG) PAGE: 1 OF 5 THIS REVISION ISSUED: NOVEMBER, 2013 SAFETY DATA SHEET Issued by: Novartis Animal Health Australasia Pty Ltd. Phone: 02 9805 3555 (office hours) POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800 764 766 IN NEW ZEALAND) SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LTD. ABN 64 076 745 198 TELEPHONE 02 9805 3555 (OFFICE HOURS) 54 WATERLOO RD FAX 02 9888 8387 NORTH RYDE, NSW 2113 CHEMICAL NATURE: Peptide derived from certain fungi, used as an immunosuppressant. TRADE NAME: ATOPICA® SOFT CAPSULES FOR DOGS (10MG/25MG/50MG/100MG) APVMA CODE: 54354 (10mg), 54355 (25mg), 54356 (50mg), 54357 (100mg) DIFFERENT SIZES ARE MEANT FOR VARIOUS SIZES OF DOGS AS INDICATED ON THE PRODUCT LABELS. PRODUCT USE: A soft gel capsule for the treatment of atopic dermatitis in dogs. CREATION DATE: NOVEMBER, 2013 THIS VERSION ISSUED: NOVEMBER, 2013 and is valid for 5 years from this date. SECTION 2 - HAZARDS IDENTIFICATION STATEMENT OF HAZARDOUS NATURE This product is classified as: Xn, Harmful. Hazardous according to the criteria of SWA. Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code. RISK PHRASES: R22, R68. Harmful if swallowed. Possible risk or irreversible effects. SAFETY PHRASES: S20, S22, S36, S24/25. When using, do not eat or drink. Do not breathe dust. Wear suitable protective clothing. Avoid contact with skin and eyes. SUSMP CLASSIFICATION: S4 ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the ADG Code. UN NUMBER: None allocated GHS SIGNAL WORD: WARNING HAZARD STATEMENT: H302: Harmful if swallowed. H371: May cause damage to organs. PREVENTION P102: Keep out of reach of children. P260: Do not breathe dusts. P264: Wash contacted areas thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P281: Use personal protective equipment as required. RESPONSE P301+P312: IF SWALLOWED: Call a POISON CENTRE or doctor if you Pročitajte cijeli dokument