JUROCLAV 250 BROAD SPECTRUM ANTIBIOTIC TABLETS

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Informasjon til brukeren (PIL)

20-06-2017

Preparatomtale (SPC)

20-06-2017

Sikkerhetsdatablad (SDS)

10-07-2008

Aktiv ingrediens:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Tilgjengelig fra:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

clavulanic acid as K salt(50mg/Tb) + others

Legemiddelform:

ORAL TABLET

Sammensetning:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 200.0 mg/Tb; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 50.0 mg/Tb

Enheter i pakken:

250 Tablets

Klasse:

VM - Veterinary Medicine

Terapeutisk gruppe:

Terapeutisk område:

ANTIBIOTIC & RELATED

Indikasjoner:

Produkt oppsummering:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, BACTERIAL INFECTION]; For the treatment of bacterial infections sensitive to clavulanic acid and amoxicillin in dogs and cats.Do not administer to small herbivores (e.g. guinea pigs) or animals with a history of allergic reaction to penicillins. For oral administration only.

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

NEW ZEALAND INFORMATION
WARNING
May cause damage to organs through prolonged or repeated exposure.
Read label and Safety Data Sheet before use.
Do not brethe dust/vapours.
Get medical advice/attention if you feel unwell.
APVMA Approval No. 61670/250 Tab /0408
NEW ZEALAND INFORMATION
WARNING
May cause damage to organs through prolonged or repeated exposure.
Read label and Safety Data Sheet before use.
Do not brethe dust/vapours.
Get medical advice/attention if you feel unwell.
Prescription Animal Remedy (P.A.R.) Class 1
For use only under the authority or prescription of a veterinarian.
Registered to Jurox New Zealand Limited
8 Kordel Place, East Takami, Auckland, Infoline 0800 857 696
Registered purusant to the ACVM Act 1997, No. A9854
See www.nzfsa.gov.nz/acvm for registeration condition.
PACKAGING DEVELOPMENT
ITEM CODE : XXXX
ARTIST : DATTARAM
PRODUCT NAME : JURACLAV 250 CARTON
CORDINATOR : SAMMER / RAJENDRA
GRAIN DIRECTION : PERPENDICULAR TO CREASE
FONTS : CONVERT TO CURVE
COLOURS : CYAN 70% + PANTONE 186 C + BLACK
LINKS : NA
SUPERSEDES /REFERENCE : NA
SCREEN :#
UNWINDING DIRECTION :
DESIGN : BSO
MATERIAL :
PHARMACODE / 2D COD NA
E :
VARNISH : U.V.
ACTUAL SIZE : 180 X 135 X 73 MM
SIZE AFTER FOLDING : NA
PRINT REPEAT LENGTH : NA
REFERENCE / INSTRUCTION / REMARK / BRAILLE TEXT EMBOSSING : NA
SOFTWARE : Illustrator-CS2
DATE : 4-6-2008
PATH : D:\JURACLAV 250 CARTON.AI
TUCK FLAP: NA
SIDE / COLLAR FLAP OVERLAP : YES/ NO.
FIRST AID: If poisoning occurs contact a doctor or Poisons Information
Centre. Phone Australia 13 11 26.
For the treatment of bacterial infections sensitive to clavulanic acid
and amoxicillin in dogs and cats.
ACTIVE CONSTITUENTS: EACH TABLET CONTAINS
_50 MG_ CLAVULANIC ACID as clavulanate potassium
_200 MG_ AMOXICILLIN as amoxicillin trihydrate
Dispose of empty container by wrapping with
paper and placing in garbage.
Store below 25°C (Air conditioning) in a dry place.
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
DO NOT ADMINISTER TO SMALL HERBIVORES (E.G. GUINEA PIGS) OR ANIM

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Preparatomtale

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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Sikkerhetsdatablad

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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