ECOVACLE-E.COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
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:
ERYSIPELOTHRIX RHUSIOPATHIAE; WHOLE CELL E. COLI INCLUDING FIMBRIAL ANTIGENS K88, K99; LEPTOSPIRA INTERROGANS SEROVAR POMONA; FORMALDEHYDE; THIOMERSAL
Available from:
INTERVET AUSTRALIA PTY LIMITED
INN (International Name):
E.coli+L. pomona+E.rhusiopathiae
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
ERYSIPELOTHRIX RHUSIOPATHIAE VACCINE-GENERAL Active 0.0 U; WHOLE CELL E. COLI INCLUDING FIMBRIAL ANTIGENS K88, K99 VACCINE-MICROBIAL Active 0.0 U; LEPTOSPIRA INTERROGANS SEROVAR POMONA VACCINE-MICROBIAL Active 0.0 U; FORMALDEHYDE ALDEHYDE Other 0.3 mg/ml; THIOMERSAL MERCURY Other 0.1 mg/ml
Units in package:
100mL; 250mL; 500mL
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
PIG - PIGLET | PIGS | BOAR | GILT | NEONATAL PIGLET | NEW BORN PIG | PIGLET | SOW | SUCKER PIG | SWINE
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
ERYSIPELAS INFECTION | ESCHERICHIA COLI SCOURS | LEPTOSPIROSIS - LEPTOSPIRA POMONA | L. INTERROGANS SEROVAR POMONA | LEPTOSPIRA POMONA INFECTION | WHITE SCOURS
Product summary:
Poison schedule: 0; Withholding period: WHP:Nil. TRADE ADVICE ESI: ESI NOT RE QUIRED.; Host/pest details: PIG - PIGLET: [ESCHERICHIA COLI SCOURS]; PIGS: [ERYSIPELAS INFECTION, LEPTOSPIROSIS - LEPTOSPIRA POMONA]; For protection against E.coli scours in neonatal pigs and Erysipelas and Leptospira pomona infections in pigs.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
E. COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS.
ACTIVE CONSTITUENTS:
INACTIVATED ADJUVANTED VACCINE CONTAINING:
WHOLE CELL _E. COLI_ INCLUDING FIMBRIAL ANTIGENS K88, K99 AND
987P; WHOLE CELL _LEPTOSPIRA INTERROGANS _SEROVAR_ POMONA_
AND _ERYSIPELOTHRIX RHUSIOPATHIAE _ANTIGENS
Preservatives: 0.1 mg/mL Thiomersal; < 1.2 mg/mL Formaldehyde
For protection against E. coli scours in neonatal piglets and
Erysipelas
and Leptospira pomona infections in pigs.
E. COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS.
E. COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS.
E. COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS.
E. COLI/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS.
Batch No.:
Expiry Date:
250 ML
93228390 2053 2
FOR ANIMAL TREATMENT ONLY
FOR ANIMAL TREATMENT ONLY
250 ML
CA3632B/02
Client: Intervet/Schering-Plough Animal Health
Product Description: ECOvacLE 250mL Carton
Scale: 100%
Colour:
PMS warm grey 6
100% Black
Keyline:
(not to be printed)
Uncoated/unvarnished area
Dimensions: 100 x 80 x 136mm - overall size: 372 x 331mm
Clients Code: CA3632B/02
Agency Code & Version: IVT7033 V3
Last revised: 10/3/10
Intervet/Schering-Plough
Animal Health
91-105 Harpin Street
BENDIGO EAST VIC 3550
Phone: (03) 5440 9888
APVMA Approval No.: 46409/250M/0410
DISPOSAL:
Dispose of empty container by wrapping with paper and
putting in garbage.
STORAGE:
Store between 2
o
C and 8
o
C. (Refrigerate. Do not freeze).
Protect from light.
DISCARD IF PREVIOUSLY FROZEN.
WARRANTY:
Intervet Australia Pty Ltd (IAPL) warrants that this product
is of merchantable quality and fit for its intended
purpose. IAPL's liability for any loss, including
consequential losses or injury caused by act or omission,
including negligent acts or omissions, by IAPL or its
agent, is limited to replacing or repairing the product at
the option of IAPL. If possible, a sample of any product
causing concern should be retained or delivered to IAPL
within 30 days for a scientific examination.
READ ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
SHAKE WELL TO MIX BEFORE
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Summary of Product characteristics
PRODUCT NAME: ECOVACLE E. COLI/ERSIPELAS/LEPTOSPIROSIS
VACCINE FOR PIGS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
ECOvac LE – E.coli/Leptospirosis/Erysipelas Vaccine for Pigs.
TRADE NAME:
ECOVACLE _E. COLI_/ERSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
PRODUCT CODE:
3632A (500mL) and 3632B (250mL)
RECOMMENDED USE:
For protection against _E. coli _scours in neonatal pigs and
_Erysipelothrix rhusiopathiae_ and
_Leptospira interrogans_ _serovar pomona_ infections in pigs.
APVMA NO:
46409
CREATION DATE:
November, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R43. May cause sensitisation by skin contact.
SAFETY PHRASES:
S28. After contact with skin, wash immediately with plenty of soap and
water.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Opaque, beige coloured liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
possible skin sensitiser.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Classified as a potential sensitiser by skin contact. Exposure to a
skin sensitiser, once
sensitisation has occurred, may manifest itself as skin rash or
inflammation, and in some individuals this reaction can be
severe. In addition product may be mildly irritating, but is unlikely
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