Država: Avstralija
Jezik: angleščina
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
AMOXYCILLIN (AS THE TRIHYDRATE); CLAVULANIC ACID AS POTASSIUM CLAVULANATE
LE VET BEHEER B. V.
amoxycillin as trihydrate(250mg/Tb) + others
ORAL TABLET
AMOXYCILLIN (AS THE TRIHYDRATE) ANTIBIOTIC Active 250.0 mg/Tb; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 62.5 mg/Tb
10 tabs; 100 tabs; 200 tabs; 250 tabs; 4 tabs
VM - Veterinary Medicine
LE VET BEHEER
DOG - MEDIUM | CASTRATE
ANTIBIOTIC & RELATED
BACTERIAL INFECTION | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - MEDIUM: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - MEDIUM: [BACTERIAL INFECTION]; For treatment of bacterial infections sensitive to clavulanic acid and amoxycillin in medium sized dogs.Contraindicated in small herbivores (e.g. Guinea pigs, rabbits, hamsters or gerbils) or animals with a history of allergic reactions to penicillins. NOT indicated for cases involving Pseudomonas spp.
Registered
2023-07-01
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs) (Veterinary Products) Select appropriate: Cl New Product (include all applicable RLPs) OR IRl Variation (highlight instructions that are being varied). Approval no. of label being varied: 5983910806 Signal heading: Product name: Active constituent/s: Statement of claims: Net contents: Directions for Use Heading: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY CLAVUBACTIN M 312.5 mg Broad Spectrum Antibiotic Tablets [Common Leaflet for Clavubactin products 59957, 59956 and 59839] CLAVUBACTIN® S 62.5 mg Broad Spectrum Antibiotic Tablets CLAVUBACTIN® L 625 mg Broad Spectrum Antibiotic Tablets Each tablet contains: 250mg AMOXYCILLIN (as the trihydrate) 62.5mg CLAVULANIC ACID (as Potassium Clavulanate) {Common Leaflet for Clavubactin products 59957, 59956 and 59839] Each Clavubactin S 62.5mg Broad Spectrum Antibiotic Tablet contains 50mg of AMOXYCILLIN as amoxycillin trihydrate and 12.5mg of CLAVULANIC ACID as potassium clavulanate. Each Clavubactin M 312.5mg Broad Spectrum Antibiotic Tablet contains 250mg of AMOXYCILLIN as amoxycillin trihydrate and 62.5mg of CLAVULANIC ACID as potassium clavulanate. Each Clavubactin L 625mg Broad Spectrum Antibiotic Tablet contains 500mg of AMOXYCILLIN as amoxycillin trihydrate and 125mg of CLAVULANIC ACID as potassium clavulanate. For treatment of bacterial infections sensitive to Clavulanic Acid and Amoxycillin in medium sized dogs. [Common Leaflet for Clavubactin products 59957, 59956 and 59839] For treatment of bacterial infections sensitive to Clavulanic Acid and Amoxycillin in small, medium, 1!, large dogs, and cats. 4 [1 0, 100, 200, 250] Tablets DIRECTIONS FOR USE: FOR ORAL ADMINISTRATION TO MEDIUM SIZED DOGS ONLY. [Common Leaflet f or Clavubactin products 59957, 59956 and 59839] FOR ORAL ADMINISTRATION TO DOGS AND CATS ONLY. Restr ai nt s: Contraindications: Contraindications THIS PRODUCT IS CONTRAINDICATED IN SMALL HERBIVORES (E .G. GUINEA PIGS, RABBITS, HAMSTERS OR GERBILS) OR ANIMALS WITH Preberite celoten dokument
Page 1 of 7 SAFETY DATA SHEET A18264/02/AUS CLAVUBACTIN M 312.5MG BROAD SPECTRUM ANTIBIOTIC TABLETS SECTION 1 – IDENTIFICATION, CONTACTS, HAZARDOUS NATURE Bayer Australia Ltd 875 Pacific Highway Pymble NSW 2073 EMERGENCY TELEPHONE NUMBER 1800 033 111 24 hour Emergency Service Australia Wide, Toll Free CONTACT POINT (FOR NON-EMERGENCY CALLS) Animal Health Division (02) 9391 6000 Full Product Name CLAVUBACTIN M 312.5MG BROAD SPECTRUM ANTIBIOTIC TABLETS Other Names Clavubactin Medium Product Use FOR ANIMAL TREATMENT ONLY Oral antibiotic tablet for organisms sensitive to Amoxycillin and Clavulanic Acid in medium dogs. Creation Date 12 th April 2011 Revision Date 19 June 2013 (SDS is current for 5 years from this date) SECTION 2 – HAZARDS IDENTIFICATION Hazard Classification CLASSIFIED AS A NON HAZARDOUS SUBSTANCE CLASSIFIED AS A NON DANGEROUS GOOD according to criteria of NOHSC Australia and ADG Code. Poison Schedule 4 Risk Phrases None allocated Safety Phrases None allocated SECTION 3 – COMPOSITION INGREDIENTS CAS NO PROPORTION Amoxycillin trihydrate equivalent to Amoxycillin 61336-70-7 250mg/tablet Potassium Clavulanate equivalent to Clavulanic acid 61177-45-5 62.5mg/tablet This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non hazardous ingredients are also present. A18264/02/AUS CLAVUBACTIN M 312.5MG BROAD SPECTRUM ANTIBIOTIC TABLETS Page 2 of 7 SECTION 4 – FIRST AID MEASURES Label Regulated First Aid Statement Nil. Scheduled Poisons Poison Schedule 4. Poisons Information Centres in each State capital city can provide additional assistance for scheduled poisons. Phone 131126. Inhalation Avoid inhaling Preberite celoten dokument
CLAVUBACTIN ® M PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY 312.5mg Broad Spectrum Antibiotic Tablets ACTIVE CONSTITUENTS: Each tablet contains: 250mg AMOXYCILLIN (as the trihydrate) 62.5mg CLAVULANIC ACID (as Potassium Clavulanate) For treatment of bacterial infections sensitive to Clavulanic Acid and Amoxycillin in medium sized dogs. 100 TABLETS READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: For oral administration to medium sized dogs only. Contraindications This product is contraindicated in small herbivores (e.g. Guinea pigs, rabbits, hamsters or gerbils) or animals with a history of allergic reactions to penicillins. DOSAGE AND ADMINISTRATION The standard dosage rate is 12.5mg/kg of combined active substance per kg bodyweight (1 tablet per 25kg/bw) twice daily. In persistent infections (i.e. respiratory infections) it is recommended to double the dosage (25mg/kg bodyweight twice daily). Treatment should be carried out for at least 5-10 days for the majority of infections at discretion of the Veterinarian. In chronic cases, a longer course of therapy is recommended as follows: *Chronic skin infections 10-30 days or longer in clinical refractory cases or in deep bacterial pyodermas (up to 6-8 weeks) depending on clinical response. *Chronic cystitis 10-28 days Dog weight Dosage 10.0 to 12.5 kg ½ Tablet Clavubactin M 12.5 to 25.0 kg 1 Tablet Clavubactin M 25.0 to 37.5 kg 1 ½ Tablets Clavubactin M 37.5 to 50.0 kg 2 Tablets Clavubactin M Clavubactin is not indicated for cases involving _Pseudomonas _spp_._ FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126. DISPOSAL: Dispose of empty container by wrapping with paper and putting in the garbage. STORAGE: Store below 25°C (air conditioning). Protect from light. Airtight. APVMA Approval No: 59839/61030 CLAVUBACTIN ® is a registered trademark of Le Vet Beheer B.V., The Netherlands. ABBEY LABORATORIES PTY LTD Distributed by: Abbey Animal Health Pty Ltd Preberite celoten dokument