JUROCLAV 500 BROAD SPECTRUM ANTIBIOTIC TABLETS

Country: Ավստրալիա

language: անգլերեն

source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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PIL (PIL)

15-11-2022

SPC (SPC)

20-06-2017

SDS (SDS)

10-07-2008

active_ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

MAH:

ZOETIS AUSTRALIA PTY LTD

INN:

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 Tablets

class:

VM - Veterinary Medicine

therapeutic_group:

therapeutic_area:

ANTIBIOTIC & RELATED

therapeutic_indication:

leaflet_short:

Poison schedule: 4; Withholding period: MEAT: CALVES - DO NOT USE less than 4 da ys before slaughter for human consumptio n. Any variation by the prescribing v eterinarian to the approved dose, freque ncy, duration, route, disease or target species may result in the need to extend the approved withholding period. ESI : EXPORT SLAUGHTER INTERVAL (ESI): An ES I has not been established for this prod uct. Note – observing the meat withhold ing period may not be sufficient to miti gate potential risks to export trade. Tr ade advice should be sought from Jurox P ty Limited on 1800 023 312 before using this product.; Host/pest details: CALF: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: WHP: CALVES: DO NOT USE LESS THAN 4 D AYS BEFORE SLAUGHTER FOR HUMAN CONSUMPT ION. DO NOT USE IN BOBBY CALVES. EXPOR T SLAUGHTER INTERVAL (ESI): This produc t does not have an ESI established. Fo r advice on the ESI, contact Jurox Pty Limited on 1800 023 312 before using th is product.; Host/pest details: CALF: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; For the treatment of bacterial infections sensitive to clavulanic acid and amoxicillin in calves and dogs.For oral administration only. DO NOT administer to small herbivores (e.g. guinea pig) or animals with a history of allergic reactions to penicillins. DO NOT USE in bobby calves. Not indicated for cases involving Pseudomonas spp.

authorization_status:

Registered

authorization_date:

2023-07-01

PIL

JUROCLAV 500 BROAD SPECTRUM ANTIBIOTIC TABLETS
61671/136334
Product Name:
APVMA Approval No:
Label Name:
JUROCLAV 500 BROAD SPECTRUM ANTIBIOTIC TABLETS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each tablet contains 400 mg AMOXYCILLIN as amoxycillin trihydrate and
100 mg
CLAVULANIC ACID as potassium clavulanate.
Claims:
For the treatment of bacterial infections sensitive to clavulanic acid
and amoxicyllin in
calves and dogs.
Juroclav 500 Broad Spectrum Antibiotic Tablets have a notably broad
spectrum of
bactericidal activity against bacteria commonly found in calves and
dogs and are indicated
for the oral treatment of bacterial infections caused by susceptible
organisms. These
include enteritis, respiratory tract infections, and skin infections
in dogs.
PRODUCT SUMMARY
• Dual action of clavulanic acid and amoxycillin.
• Extended spectrum of activity - clavulanate extends the spectrum
of amoxycillin by
making it active against resistant (B-lactamase producing) strains of
Staphylococcus spp.,
E. coli and Salmonella spp., as well as adding Klebsiella spp. to the
list of susceptible
organisms.
• Rapid bactericidal action - increases the likelihood of a rapid
clinical cure.
• Excellent absorption and penetration.
• Easy to administer.
• Convenient twice daily dosage.
• Absorption not significantly affected by food.
MODE OF ACTION
Resistance to many antibiotics is caused by B-lactamase enzymes which
destroy the
antibiotic before it can act on the bacteria. The clavulanate in
Juroclav counteracts this
defence mechanism by inactivating the B-lactamases, thus rendering the
organisms
sensitive to amoxycillin's rapid bactericidal effect at concentrations
readily attainable in the
body.
In vitro Juroclav is active against a wide range of clinically
important bacteria, including:
Gram - positive
Staphylococcus spp (including B-lactamase producing strains);
Corynebacterium spp.; Streptococcus spp. RLP APPROVED
Gram - negative
Escheri

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SPC

JUROCLAV TABLETS
Page 1 of 6
continued
ISSUED:
19 NOVEMBER 2012
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
JUROCLAV BROAD SPECTRUM ANTIBIOTIC TABLETS
PRODUCT CODE:
503585 (50 mg x 100’s); 503590 (250 mg x 250’s); 503595 (500 mg x
100’s)
RECOMMENDED USE:
For the treatment of bacterial infections sensitive to clavulanic acid
and
amoxicillin in dogs, cats and calves.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9a.m. – 5p.m.)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS:
EYE IRRITATION CATEGORY 2A
RESPIRATORY SENSITIZER CATEGORY 1
SKIN CORROSION/IRRITATION CATEGORY 2
SKIN SENSITISER CATEGORY 1
STOT-SE CATEGORY 3
GHS PICTOGRAMS*:
EXCLAMATION MARK
HEALTH HAZARD
SIGNAL WORD*:
DANGER
HAZARD STATEMENTS*:
Causes skin irritation.
Many cause an allergic skin reaction.
Causes serious eye irritation.
May cause allergy or asthma symptoms or breathing difficulties if
inhaled.
May cause respiratory irritation.
PRECAUTIONARY STATEMENTS*:
PREVENTION
Avoid breathing dust.
Wash hands thoroughly after handling.
Use only outdoors or in a well-ventilated area.
Contaminated work clothing should not be allowed out of the workplace.
Wear protective gloves.
Use personal protective equipment as required.
In case of inadequate ventilation wear respiratory protection.
RESPONSE
IF ON SKIN: Wash with plenty of soap and water.
IF INHALED: Remove victim to fresh air and keep at rest in a position
comfortable for
breathing.
IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
Call a POISON CENTRE or doctor if you feel unwell.
If skin irritation or rash occurs: Get medical advice.
If eye irritation persists: Get medical advice.
JUROCLAV TABLETS
Page 2 of 6
continued
If experiencing respiratory symptoms: Call a POISON CE

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SDS

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Each tablet of Juroclav 50, Juroclav 250 or Juroclav 500 contains both
clavulanic acid (as clavulanate potassium) 10 mg, 50 mg or
100 mg; and amoxicillin (as amoxicillin trihydrate) 40 mg, 200 mg or
400 mg.
ACTIONS
Resistance to many antibiotics is caused by β-lactamase enzymes which
destroy the antibiotic before it can act on the bacteria. The
clavulanate in Juroclav counteracts this defence mechanism by
inactivating the β-lactamases, thus rendering the organisms sensitive
to amoxicillin’s rapid bactericidal effect at concentrations readily
attainable in the body.
MICROBIOLOGY
In vitro, Juroclav is active against a wide range of clinically
important bacteria, including:-
•
GRAM-POSITIVE BACTERIA: _Staphylococcus _spp. (including β-lactamase
producing strains), _Corynebacterium_ spp. and _Streptococcus_ spp.;
•
GRAM-NEGATIVE BACTERIA: _Escherichia coli _(including β-lactamase
producing strains), _Salmonella_ spp. (including β-lactamase
producing
strains), _Bordetella bronchiseptica_, _Pasteurella _spp_., Proteus
mirabilis_ and other sensitive strains and _Klebsiella _spp.
Juroclav is not indicated for cases involving _Pseudomonas_ spp.
INDICATIONS
JUROCLAV 50 AND 250 TABLETS: Clinically, Juroclav has been shown to be
effective in treating a wide range of diseases of cats and
dogs, including skin disease (deep and superficial pyodermas), urinary
tract infection, respiratory disease (involving upper and lower
respiratory tract) and enteritis. They have a notably broad spectrum
of bactericidal activity against bacteria commonly found in cats
and dogs, and are indicated for the oral treatment of bacterial
infections caused by susceptible organisms.
JUROCLAV 500 TABLETS: Have a notably broad spectrum of bactericidal
activity against bacteria commonly found in calves and dogs
and are indicated for the oral treatment of bacterial infections
caused by susceptible organisms. These incl

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