AMOXYCLAV 500 BROADSPECTRUM 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

Aktiv ingrediens:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID (AS POTASSIUM SALT)

Tilgjengelig fra:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN (International Name):

amoxycillin as trihydrate(400mg/Tb) + others

Legemiddelform:

ORAL TABLET

Sammensetning:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 400.0 mg/Tb; CLAVULANIC ACID (AS POTASSIUM SALT) ANTIBIOTIC Active 100.0 mg/Tb

Enheter i pakken:

104 Tabs; 120 Tablet; 144 Tablet; 16 Tablets; 160 Tablet; 168 Tablet; 192 Tablet; 200 Tablet; 216 Tablet; 240 Tablet; 264 Tablet

Klasse:

VM - Veterinary Medicine

Produsert av:

APEX LABORATORIES

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 caused by organisms sensitive to amoxycillin and clavulanic acid in dogs and cats.Contraindicated in animals with a history of allergic reactions to penicillins. Contraindicated in small herbivores (e.g. rabbits, guinea pigs).

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
APEX LABORATORIES PTY LTD
PRODUCT NAME:
AMOXYCLAV 500 BROADSPECTRUM ANTIBIOTIC TABLETS
ELABEL APPLICATION NO:
DC12-10478857E36
APVMA APPROVAL NO:
52694/101245
VERSION NO:
4.0
APPLICATION STARTED:
2014-Dec-17 16:34:05
VERSION CREATED:
2015-Apr-10 12:37:50
STARTED BY:
Rebecca Skinner
PRINTED:
2015-Apr-10 12:38:06
LABEL NAME:
AMOXYCLAV 500 BROADSPECTRUM ANTIBIOTIC TABLETS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each tablet contains:
400mg AMOXYCILLIN (as trihydrate)
100mg CLAVULANIC ACID (as potassium salt)
CLAIMS:
Treatment of bacterial infections caused by organisms sensitive to
Amoxycillin and
Clavulanic Acid in dogs and cats
NET CONTENTS:
50 tablets
100 tablets
104 tablets
16 tablets
DIRECTIONS FOR USE:
For oral administration only.
CONTRAINDICATIONS:
This product is contraindicated for use in animals with a history of
allergic reactions to
penicillins.
This product is contraindicated for use in small herbivores (eg
rabbits, guinea pigs).
DOSAGE AND
ADMINISTRATION:
DOGS AND CATS
12.5mg/kg bodyweight twice daily
Dose rates of up to 25mg/kg bodyweight have shown to be effective in
refractory cases.
Duration of therapy is typically 5-7 days or for 48 hours after
clinical signs have subsided
Longer duration of therapy (up to 28 days) is recommended for chronic
cystitis and
dermatitis conditions.
FIRST AID
INSTRUCTIONS:
If poisoning occurs contact a doctor or Poisons Information Centre.
Phone Australia131 126. RLP APPROVED
For Official Use Only
FIRST AID WARNINGS:
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage.
STORAGE:
Store below 25°C (air conditioning).
Protect from light.

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Preparatomtale

MATERIAL SAFETY DATA SHEET
AMOXYCLAV 50, 200, 250 AND 500 BROADSPECTRUM ANTIBIOTIC TABLETS
CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Amoxyclav 50, 200, 250 and 500 Broadspectrum Antibiotic Tablets
Recommended Use
Treatment of bacterial infections sensitive to amoxycillin and
clavulanic
acid.
Supplier Details
Apex Laboratories Pty. Ltd.
ACN Number
000 397 240
Street
61 Chivers Road
Suburb
Somersby
State
NSW
Country
Australia
Post Code
2250
Phone
+61 2 4372 1661 (Business hours – 8.30am – 5.00pm)
Fax
+61 2 4372 1668 (fax)
Website
http://www.apexlabs.com.au
Emergency contact
As above or Poisons Information Centre 131126 (Australia)
Classification
Classified as hazardous according to the criteria of NOHSC
Risk Phrases
R42/43 May cause sensitisation by inhalation and skin contact
Safety Phrases
None allocated
ADG Class
None allocated
Hazchem Code
None allocated
Poisons Schedule
S4
INGREDIENTS
CAS NO
PROPORTION
TWA MG/M3
STEL MG/M3
Amoxycillin
61336-70-7
30-60%
not set
not set
Clavulanic Acid
61177-45-5
<10%
not set
not set
Other non hazardous ingredients
NA
to 100%
NA
NA
The TWA exposure value is the average airborne concentration of a
particular substance when calculated over a normal 8 hour working day
for a 5 day
working week over an entire working lifetime. The TWA exposure
standard set by Worksafe Australia for dusts not otherwise specified
is 10mg/m3. The
STEL (Short Term Exposure Limit) is an exposure value that should not
be exceeded for more than 15 minutes and should not be repeated for
more than 4
times per day. There should be at least 60 minutes between successive
exposures at the STEL.
Ingestion
Generally not required. If concerned rinse mouth with water, give
water to
drink and seek medical advice.
Eye
Immediately flush eye(s) with lukewarm water for 20 minutes holding
eyelids open.Seek medical advice.
Skin
Generally not required. If concerned wash well with soap and water and
seek medical advice.
Inhalation
Generally not required. If concerned move to fresh air and see

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