APEX AMOXYCILLIN - 400 BROAD-SPECTRUM ANTIBIOTIC TABLETS
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE
Available from:
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
INN (International Name):
amoxycillin as trihydrate(400mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 400.0 mg/Tb
Units in package:
500 Tabs
Class:
VM - Veterinary Medicine
Manufactured by:
APEX LABORATORIES
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
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
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [BACTERIAL INFECTION]; DOG: [BACTERIAL INFECTION]; For the treatment of infections caused by amoxycillin susceptible organisms in dogs and cats.Do not administer to small herbivores or animals with a history of allergic reactions to penicillins
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
PRODUCT NAME:
ELABEL APPLICATION NO:
APVMA APPROVAL NO:
APEX LABORATORIES PTY LTD
APEX AMOXYCILLIN - 400 BROAD-SPECTRUM ANTIBIOTIC TABLETS
DCNV-39255059E39
35697/102578
PRODUCT NO:
35697
VERSION NO:
5.0
APPLICATION STARTED:
2015-May-13 13:41:40
VERSION CREATED:
2015-Jun-05 11:32:40
STARTED BY:
Rebecca Skinner
PRINTED:
2015-Jun-05 13:53:48
LABEL NAME:
APEX AMOXYCILLIN - 400 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)
CLAIMS:
For the treatment of infections caused by Amoxycillin susceptible
organisms in dogs and
cats.
NET CONTENTS:
500 Tabs
DIRECTIONS FOR USE:
CONTRAINDICATIONS:
DO NOT ADMINISTER to small herbivores or animals with a history of
allergic reactions to
penicillins.
DOSAGE AND
ADMINISTRATION:
Dose: 4-11mg/kg body weight twice daily until 48 hours after clinical
signs have subsided.
FIRST AID
INSTRUCTIONS:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia
131126.
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. Close firmly
after use. RLP APPROVED
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Summary of Product characteristics
MATERIAL SAFETY DATA SHEET
AMOXYCILLIN 200, 400 BROAD SPECTRUM ANTIBIOTIC TABLETS
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Amoxycillin 200, 400 Broad Spectrum Antibiotic Tablets
Recommended Use
Treatment of bacterial infections sensitive to amoxycillin.
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
Not classified as hazardous according to the criteria of NOHSC
Risk Phrases
None allocated
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
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
Generally not required. If irritation does occur irrigate with copies
quantities of luke warm water for 10 minutes and 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 seek
medical
advice.
Extinguishing Media
Foam, dry chemical powder, carbon dioxide, water
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