CCD AMOXYCILLIN TRIHYDRATE FOR POULTRY
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
Safety Data Sheet
(SDS)
06-07-2000
Active ingredient:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE
Available from:
CCD ANIMAL HEALTH PTY LTD
INN (International Name):
amoxycillin as trihydrate(870mg/g)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 870.0 mg/g
Units in package:
110g; 1kg; 25kg; 500g
Class:
VM - Veterinary Medicine
Manufactured by:
CCD ANIMAL HEALTH
Therapeutic group:
POULTRY | BREEDERS | BROILER | CHICKENS | CHICKS | CHOOKS | DAY OLD CHICKS | HATCHLINGS | LAYERS
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
ANTIBIOTIC - ANTI-INFECTIVE | ABRASIONS | ABSCESSES | AIRSACCULITIS | ANTISEPTIC | AVIAN MYCOPLASMAS | BLACKHEAD | BODY ODOURS | BOWED TENDONS | BROAD SPECTRUM | BURNS | COCCIDIOSIS | COLIFORM COMPLEX | CONJUNCTIVITIS | COWPOX | CRACKS | CRUSTS | DANDRUFF | DERMATOLOGICAL DISORDERS | DERMATOSIS | DRY SKIN | DYSENTERY | ECZEMA | ENDOMETRITIS | ENTERIC DISEASES | ENZOOTIC PNEUMONIA | FEED EFFICIENCY | FUNGAL INFECTIONS | GIRTH GALLS | INFECTIONS | INFLAMMED PADS | ITCHING | KERATOLYTIC | LACERATIONS | MASTITIS | MYCOPLASMAS | ODOURS | OPEN WOUNDS | OTITIS | PRURITIS | QUEENSLAND ITCH | RESPIRATORY DISEASE | SADDLE RASH | SALMONELLOSIS | SCABS | SCALY SKIN | SHEATH ROT | SKIN IRRITATIONS | SORES | SWINE DYSENTERY | TEAT CRACKING | TEAT INFECTIONS | TOPICAL INFECTIONS | UDDER SORES | WEIGHT GAIN | WIRE CUTS | WOUNDS
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT: Do not use less than 2 days before slaughter for human consumption. EGGS: DO NOT USE in laying hens (i ncluding chickens turkeys and other p oultry). DO NOT USE in replacement chi cken layers (pullets or breeders) withi n 8 days of laying onset where eggs a re to be used or processed for human c onsuption. Eggs laid during the withhol ding period MUST NOT BE USED or process ed for human consuption.; Host/pest details: POULTRY: [ANTIBIOTIC - ANTI-INFECTIVE]; PULLET - REPLACEMENT: [ANTIBIOTIC - ANTI-INFECTIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: POULTRY: [ANTIBIOTIC - ANTI-INFECTIVE]; PULLET - REPLACEMENT: [ANTIBIOTIC - ANTI-INFECTIVE]; Water soluble medication for the treatment of amoxycillin susceptible infections of the alimentary, urogenital, and respiratory tracts of poultry, including organisms associated with the chronic respiratory disease complex and diseases caused by E.coli.See restrictions relating to the use of eggs from treated birds under the WITHHOLDING PERIODS section on the label.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
CCD ANIMAL HEALTH PTY LTD
PRODUCT NAME:
CCD AMOXYCILLIN TRIHYDRATE FOR POULTRY
ELABEL APPLICATION NO:
DC12-26121573E63
APVMA APPROVAL NO:
36443/103093
PRODUCT NO:
36443
VERSION NO:
4.0
APPLICATION STARTED:
2015-Jun-23 15:18:12
VERSION CREATED:
2015-Sep-17 09:29:30
STARTED BY:
David Sherwood
PRINTED:
2015-Sep-17 09:47:10
LABEL NAME:
CCD AMOXYCILLIN TRIHYDRATE FOR POULTRY
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
870 mg/g AMOXYCILLIN as the trihydrate
CLAIMS:
Water soluble medication for the treatment of amoxycillin susceptible
infections of the
alimentary, urogenital, and respiratory tracts of poultry, including
organisms associated with
the Chronic Respiratory Disease (CRD) complex and diseases caused by
E. coli
NET CONTENTS:
110g
1kg
25kg
500g
DIRECTIONS FOR USE:
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
SIDE EFFECTS:
DOSAGE AND
ADMINISTRATION:
Dose for chickens, turkeys and other poultry: 8-20mg Amoxycillin per
kilogram liveweight
daily depending on the severity of the condition. This is achieved by
adding 110g CCD
Amoxycillin Trihydrate to 900-1000 litres of drinking water for 3 to 5
days. Medicated water RLP APPROVED
For Official Use Only
should be consumed within 12 hours and fresh solution prepared daily.
Remove other
sources of medicated water.
Any variation by the prescribing veterinarian to the approved dose,
frequency, duration,
route, disease or target species may result in the need to extend the
approved withholding
period.
GENERAL DIRECTIONS:
WITHHOLDING
PERIODS:
Withholding Periods:
Meat: DO NOT USE less than 2 days before slaughter for human
consumption.
Eggs: DO NOT USE in laying hens (including chickens, turkeys and other
poultry). DO
NOT USE in replacement chicken layers (pullets or breeders) within 8
days of laying onset,
where eggs are to be used or processed for human consumption. Eggs
laid during the
withholding period MUST NOT BE USED or process
Read the complete document
Summary of Product characteristics
PRODUCT NAME: CCD AMOXYCILLIN TRIHYDRATE
SUBSTANCE KEY: CCD000201
ISSUED: 29 AUGUST 2012
VERSION: 6.0
PAGE: 1 OF 6
Material Safety Data Sheet
NON-HAZARDOUS SUBSTANCE, NON-DANGEROUS GOODS
1. MATERIAL AND SUPPLY COMPANY IDENTIFICATION
PRODUCT NAME:
CCD AMOXYCILLIN TRIHYDRATE
RECOMMENDED USE: Added to drinking water for poultry to treat
Amoxycillin sensitive organisms
SUPPLIER:
CCD Animal Health
ACN:
151 737 950
STREET ADDRESS:
Unit 2, 84-92 Barnes Street
Tamworth NSW 2340
TELEPHONE:
1300 791 009
CUSTOMER SERVICE CENTRE
TELEPHONE:
1300 791 009
FACSIMILE:
1300 798 005
EMAIL:
ccdsales@ccdanimalhealth.com.au
WEBSITE:
http://www.ccdanimalhealth.com.au/home.asp
EMERGENCY TELEPHONE NUMBER:
1300 791 009 (Monday to Friday: 8.30am – 5.00pm, EST)
0487 777 089 (All Hours)
2. HAZARDS IDENTIFICATION
AUSTRALIA CLASSIFICATION
Based on available information, this material is not classified as
hazardous according to criteria of Safe
Work Australia.
POISONS SCHEDULE (AUST): S4
NEW ZEALAND CLASSIFICATION
Based on available information, this material is not classified as
hazardous according to criteria of ERMA
New Zealand.
DANGEROUS GOODS CLASSIFICATION
Not classified as Dangerous Goods by the criteria of the “Australian
Code for the Transport of Dangerous
Goods by Road & Rail” and the “New Zealand NZS5433: Transport of
Dangerous Goods on Land”.
3. COMPOSITION INFORMATION
CHEMICAL ENTITY
CAS NO.
PROPORTION
Amoxycillin trihydrate
61336-70-7
100%
________
100%
PRODUCT NAME: CCD AMOXYCILLIN TRIHYDRATE
SUBSTANCE KEY: CCD000201
ISSUED: 29 AUGUST 2012
VERSION: 6.0
PAGE: 2 OF 6
Material Safety Data Sheet
4. FIRST AID MEASURES
If poisoning occurs, contact a doctor or Poisons Information Centre
(Phone Australia 131 126, New Zealand
0800 764 766).
INHALATION: Remove victim from exposure - avoid becoming a casualty.
Remove contaminated clothing and
loosen remaining clothing. Allow patient to assume most comfortable
position and keep warm. Keep at rest
until fully recovered. Seek medical advice if effects persist.
SKIN CONTACT: If skin o
Read the complete document
Safety Data Sheet
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CCD AMOXYCILLIN TRIHYDRATE FOR POULTRY
ACTIVE CONSTITUENT: 870MG/G AMOXYCILLIN AS THE TRIHYDRATE.
WATER SOLUBLE MEDICATION FOR THE TREATMENT OF AMOXYCILLIN SUSCEPTIBLE
INFECTIONS OF THE ALIMENTARY, UROGENITAL, AND
RESPIRATORY TRACTS OF POULTRY, INCLUDING ORGANISMS ASSOCIATED WITH THE
CHRONIC RESPIRATORY DISEASE (CRD) COMPLEX AND
DISEASES CAUSED BY _E.COLI_
110G, 500G, 1KG, 25KG
DIRECTIONS FOR USE:
DOSE FOR CHICKENS, TURKEYS AND OTHER POULTRY: 8 – 20MG AMOXYCILLIN
PER KILOGRAM LIVEWEIGHT DAILY DEPENDING ON THE
SEVERITY OF THE CONDITION. THIS IS ACHIEVED BY ADDING 110G CCD
AMOXYCILLIN TRIHYDRATE TO 900 – 1000 LITRES OF DRINKING
WATER FOR 3 - 5 DAYS. MEDICATED WATER SHOULD BE CONSUMED WITHIN 12
HOURS AND FRESH SOLUTION PREPARED DAILY. REMOVE
OTHER SOURCES OF MEDICATED WATER.
ANY VARIATION BY THE PRESCRIBING VETERINARIAN TO THE APPROVED DOSE,
FREQUENCY, DURATION, ROUTE, DISEASE OR
TARGET SPECIES MAY RESULT IN THE NEED TO EXTEND THE APPROVED
WITHHOLDING PERIOD.
WITHHOLDING PERIODS:
MEAT:
DO NOT USE LESS THAN 2 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION.
EGGS: C
HICKEN EGGS: ZERO (0) DAYS. DO NOT ALLOW EGGS TREATED WITH CCD
AMOXYCILLIN TRIHYDRATE FOR POULTRY WITHIN THE
LAST 14 DAYS TO BE SOLD FOR EXPORT.
FIRST AID:
IF POISONING OCCURS CONTACT A DOCTOR OR POISONS INFORMATION CENTRE.
PHONE 131 126
DISPOSAL:
DISPOSE OF EMPTY CONTAINER BY WRAPPING WITH PAPER AND PUTTING IN
GARBAGE.
STORAGE:
STORE IN A DRY PLACE BELOW 25°C (AIR CONDITIONING). PROTECT FROM
LIGHT. KEEP CONTAINER TIGHTLY CLOSED.
BATCH NUMBER:
EXPIRY:
APVMA APPROVAL NO. 36443/119710
CONDITIONS OF SALE
“The Company makes no representation as to the suitability of this
product for any
purpose and to the extent permitted by law all warranties and
conditions whether
expressed or implied are excluded.”
Read the complete document
