Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
MARBOFLOXACIN; CLOTRIMAZOLE; DEXAMETHASONE ACETATE
VETOQUINOL AUSTRALIA PTY LTD
marbofloxacin(3mg/mL)+clotrimazole(10mg/mL) + others
MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL
MARBOFLOXACIN ANTIBIOTIC Active 3.0 mg/ml; CLOTRIMAZOLE IMIDAZOLE Active 10.0 mg/ml; DEXAMETHASONE ACETATE STEROID-GLUCOCORTICOID Active 1.0 mg/ml
10ml; 20ml
VM - Veterinary Medicine
DOG | BITCH | CASTRATE | PUPPY
EAR,NOSE,THROAT PREPS.
OTITIS EXTERNA | ACUTE CANINE OTITIS | ASSOCIATED WITH YEAST &/OR BAC | CHRONIC CANINE OTITIS | MALASSEZIA PACHYDERMATIS | OTITIS (CANINE)
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [OTITIS EXTERNA]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [OTITIS EXTERNA]; For the treatment of Otitis externa in dogs of both bacterial & fungal origin respectively due to bacteria sensitive to marbofloxacin & fungi, especially Malassezia pachydermetis, sensitive to clotrimazole.DO NOT USE in food producing animals. USE ONLY in situations where sensitivity testing indicates no alternative antibiotic. See other contraindications in DFU on label.
Registered
2023-07-01
Product Name: APVMA Approval No: AURIZON EAR DROPS 67225/137718 Label Name: AURIZON EAR DROPS Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY READ SAFETY DIRECTIONS Constituent Statements: Each mL contains 10 mg CLOTRIMAZOLE 3 mg MARBOFLOXACIN 1 mg DEXAMETHASONE ACETATE Claims: For use by or under direction of a registered veterinarian. AURIZON is indicated for the treatment of otitis externa in dogs of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin and fungi, especially Malassezia pachydermatis, sensitive to clotrimazole. Resistance can develop to any antimicrobial. The product should be used based on susceptibility testing. Net Contents: 10 mL 20 mL Directions for Use: Use as directed by prescribing veterinarian. Restraints: DO NOT USE in food-producing animals. USE ONLY in situations where sensitivity testing indicates no alternative antibiotic. Contraindications: This product is contraindicated for use in dogs with known perforation of the eardrum (tympanic membrane). Marbofloxacin is contraindicated in immature dogs as it has been shown to cause arthropathy. RLP APPROVED Marbofloxacin is contraindicated in dogs known to be hypersensitive. Precautions: Do not use on pregnant or lactating bitches and dogs intended for breeding purposes. Do not use in dogs with known hypersensitivity to any of the active constituents. Corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, foetal death, retained placenta and metritis. Side Effec Read the complete document
PRODUCT NAME: AURIZON® EAR DROPS SUSPENSION PAGE: 1 OF 5 THIS VERSION ISSUED: OCTOBER, 2015 SAFETY DATA SHEET Issued by: Vetoquinol Australia Pty Ltd Phone: 1800 032 355 (BUSINESS HOURS) POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800 764 766 IN NEW ZEALAND) SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER VETOQUINOL AUSTRALIA PTY LTD PHONE: 1800 032 355 (BUSINESS HOURS) UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK, FAX: 1800 648 460 BRISBANE AIRPORT, QLD 4008 CHEMICAL NATURE: Antibiotic and antifungal ingredients in a suitable medium. TRADE NAME: AURIZON® EAR DROPS SUSPENSION APVMA CODE: 67225 PRODUCT USE: Antibacterial and antifungal ear drops suspension for dogs. CREATION DATE: OCTOBER, 2015 THIS VERSION ISSUED: OCTOBER, 2015 and is valid for 5 years from this date. POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA SECTION 2 - HAZARDS IDENTIFICATION STATEMENT OF HAZARDOUS NATURE This product is classified as: Xn, Harmful. Xi, Irritating. N, Dangerous to the environment. Hazardous according to the criteria of SWA. Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria. RISK PHRASES: R22, R43, R52. Harmful if swallowed. May cause sensitisation by skin contact. Harmful to aquatic organisms. SAFETY PHRASES: S20, S28, S36, S24/25. When using, do not eat or drink. After contact with skin, wash immediately with plenty of soap and water. Wear suitable protective clothing. Avoid contact with skin and eyes. SUSMP CLASSIFICATION: S4 ADG CLASSIFICATION: None allocated. Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria. UN NUMBER: None allocated GHS SIGNAL WORD: WARNING HAZARD STATEMENT: H302: Harmful if swallowed. H317: May cause an allergic skin reaction. H402: Harmful to aquatic life. PREVENTION P102: Keep out of reach of children. P261: Avoid breathing fumes, mists, vapours or spray. P262: Do not get in eyes, on skin, or on clothing. P264: Wash contacted areas thoro Read the complete document
2 0 M L READ THE ENCLOSED LEAFLET BEFORE OPENING OR USING DIRECTIONS FOR USE: RESTRAINT: DO NOT USE IN FOOD PRODUCING ANIMALS. USE ONLY IN SITUATIONS WHERE SENSITIVITY TESTING INDICATES NO ALTERNATIVE ANTIBIOTIC. This product is contraindicated for use in dogs with known perforation of the tympanic membrane. Marbofloxacin is contraindicated in immature dogs as it has been shown to cause arthropathy. Marbofloxacin is contraindicated in dogs known to be hypersensitive. Do not use on pregnant or lactating bitches and dogs intended for breeding purposes. Do not use in dogs with known hypersensitivity to any of the active constituents. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126. DISPOSE of empty container by wrapping with paper and putting in garbage. STORE below 25°C (Air conditioning). Protect from light. Do not freeze. Manufactured by: VETOQUINOL S.A., MAGNY VERNOIS, 70200 Lure (France) Distributed by: VETOQUINOL AUSTRALIA PTY LTD Unit 302/2, 6-12 Boronia Road, DaVinci Business Park, Brisbane Airport, Qld, 4008 Phone: 1800 032 355 sales.australia@vetoquinol.com APVMA Approval No.: 67225/55519 PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY _AURIZON ®_ _EAR DROPS SUSPENSION_ ACTIVE CONSTITUENTS: Each mL contains 3 mg marbofloxacin, 10 mg clotrimazole and 1 mg dexamethasone acetate. For the treatment of otitis externa in dogs of both bacterial and fungal origin respectively due to bacteria sensitive to marbofloxacin and fungi, especially _Malassezia _ _pachydermatis_, sensitive to clotrimazole. 20ML DOSAGE AND ADMINISTRATION SHAKE WELL BEFORE USE. Discard unused contents within 2 months of initial opening. When the product is intended for use in several dogs, use a single cannula for each dog. The external ear canal should be meticulously cleaned and dried before treatment. Apply ten drops into the ear once daily for 7 to 14 days. After 7 days of treatment, the veterinary su Read the complete document