CLAVULOX PALATABLE TABLETS BROAD SPECTRUM ANTIBIOTIC 500MG

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

clavulanic acid as K salt(100mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 400.0 mg/Tb; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 100.0 mg/Tb

Units in package:

!100 Tabs; !Blister; !Pouch; 10 Tablets

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: Calves:Do not use less than 4 days before slaughter for human consumption . NOT FOR USE IN BOBBY CALVES.; Host/pest details: CALF: [BORDETELLA BRONCHISEPTICA, CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA, STAPHYLOCOCCUS SPP., STREPTOCOCCUS SPP.]; DOG: [BORDETELLA BRONCHISEPTICA, CORYNEBACTERIUM SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PASTEURELLA SPP., PROTEUS MIRABILIS, SALMONELLA, STAPHYLOCOCCUS SPP., STREPTOCOCCUS SPP.]; For the treatment of bacterial infections sensitive to clavulanic acid and amoxycillin in calves and dogs.for oral administration only. Do not administer to small herbivores (e.g. guinea pigs) or animals with a history of allergic reactions to penicillins. NOT FOR USE in bobby calves

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Pfizer Italia S.r.l.
LATINA ARTWORK
MERCATO
AUSTRALIA / NZ
EDIZI. & CODICE
MUCL500X10
DESCRIZIONE
CLAVULOX 500 MG
COMPONENTE
BOX
DIMENSIONI
50 X 40 X 100 MM
VERSIONE
5 C1
DATA
19/11/2008
latina.artwork@pfizer.com
SDM
PAG. 1 DI 1
THIS ARTWORK HAS BEEN COMPLETELY RETYPED
CHECK IT CAREFULLY BEFORE APPROVAL
FUSTELLA
G1X10-500
RISERVA VERNICE
BLACK
PANTONE 116
P. 3275
Batch No:
Expiry Date:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CLAVULOX
®
BROAD SPECTRUM ANTIBIOTIC
_500 MG_
_Each tablet contains_
_100 MG CLAVULANIC ACID as potassium clavulanate_
_400 MG AMOXYCILLIN as amoxycillin trihydrate_
_For the treatment of bacterial infections sensitive to_
_Clavulanic Acid and Amoxycillin in calves and dogs._
_10 TABLETS_
_Palatable Tablets_
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
FOR ORAL ADMINISTRATION ONLY.
DO NOT ADMINISTER TO SMALL HERBIVORES (EG GUINEA PIGS) OR ANIMALS WITH
A HISTORY OF ALLERGIC REACTIONS TO
PENICILLINS.
CALVES
DOSAGE: 1 tablet per 40-80 kg bodyweight twice daily. Use the higher
dose rate for the initial dose and for
severely affected calves.
WITHHOLDING PERIOD- CALVES:
DO NOT USE LESS THAN 4 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION
NOT FOR USE IN BOBBY CALVES
DOGS
DOSAGE: 1 tablet per 40kg bodyweight twice daily.
Made in Italy
PFIZER ANIMAL HEALTH
A division of Pfizer Australia Pty Ltd
Wharf Rd, West Ryde
NSW 2114 Australia
Pfizer New Zealand Limited
Normanby Rd, Mt Eden,
Auckland, New Zealand
NZ Technical Services 0800 650 277
® CLAVULOX is a trademark owned
and used under licence from
GlaxoSmithKline
PRESCRIPTION ANIMAL REMEDY (P.A.R) CLASS I.
For use only under the authority or prescription of a veterinarian
Registered pursuant to the ACVM Act 1997, No A8141.
See www.nzfsa.govt.nz/acvm for registration conditions
APVMA Approval No: 53445/ 500mgx10/ 0808
Dispose of empty container by wrapping with paper and putting
in garbage.
FIRST AID:_ _If poisoning occurs, contact a doctor or Poisons
Information Centre. Phone Australia 131

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Summary of Product characteristics

PRODUCT NAME: CLAVULOX PALATABLE TABLETS 50MG, 250MG, 500MG
PAGE: 1 OF 6
THIS VERSION ISSUED: 30 APRIL 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: 1800 814 883
Fax: (02) 8876 0444
Email: australia.animalhealth@zoetis.com
PRODUCT IDENTIFIER:
CLAVULOX PALATABLE TABLETS 50MG, 250MG, 500MG
APVMA APPROVAL NUMBER:
53444 (50mg), 53445 (500mg), 53446 (250mg)
OTHER NAMES:
None.
CHEMICAL FAMILY:
Mixture of antibiotics, carriers and tabletting aids.
RECOMMENDED USE:
Veterinary antibiotic for the treatment of bacterial infections
sensitive to Clavulanic
acid and Amoxycillin.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as 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:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S22, S25, S36. Do not breathe dust. Avoid contact with eyes. Wear
suitable protective clothing.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
GHS LABEL ELEMENTS: NONE
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: In case of fire, use carbon dioxide, dry chemical, foam,
water fog.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
P411+P235: Store at temperatures not exceeding 30°C. Keep cool.
DISPOSAL
P501: Dispose of sm

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