SILIRUM VACCINE

国: オーストラリア

言語: 英語

ソース: APVMA (Australian Pesticides and Veterinary Medicines Authority)

有効成分:

MYCOBACTERIUM PARATUBERCULOSIS

から入手可能:

ZOETIS AUSTRALIA PTY LTD

INN（国際名）:

M. paratuberculosis

医薬品形態:

MISC. VACCINES OR ANTI SERA

構図:

MYCOBACTERIUM PARATUBERCULOSIS VACCINE Active 2.5 mg/ml

パッケージ内のユニット:

20mL; 50mL; 5mL

クラス:

VM - Veterinary Medicine

製:

ZOETIS AUSTRALIA

治療領域:

IMMUNOTHERAPY

製品概要:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: CATTLE: [MYCOBACTERIUM PARATUBERCULOSIS SHEDDING]; For the active immunisation of cattle against Mycobacterium avium subsp. paratuberculosis, as an aid in the control of Bovine Johne's Disease (BJD or paratuberculosis).See RESTRAINTS, PRECAUTIONS, SAFETY DIRECTIONS etc. on label.

認証ステータス:

Registered

承認日:

2023-07-01

情報リーフレット

Product Name:
APVMA Approval No:
SILIRUM VACCINE
59642/137719
Label Name:
SILIRUM VACCINE
Signal Headings:
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
This vaccine contains a suspension of the microorganism Mycobacterium
avium subsp.
paratuberculosis, strain 316F, inactivated by heat and adjuvanted with
mineral oil in a
multiple emulsion. It contains 2.5 mg of dried microorganisms per mL.
Thiomersal at 0.1
mg/mL is used as preservative.
Claims:
For the active immunisation of cattle against Mycobacterium avium
subsp.
paratuberculosis, as an aid in the control of Bovine Johne’s Disease
(BJD or
Paratuberculosis).
Net Contents:
5 mL, 20 mL, 50 mL
Directions for Use:
Restraints:
DO NOT vaccinate cattle intended for live export to countries
requiring tuberculosis testing.
Cattle administered with this killed vaccine are likely to test
positive when screened for
tuberculosis (caudal fold test) due to cross reactivity between the
vaccine and the test.
DO NOT vaccinate cattle intended for live export to countries
requiring JD negative
antibody testing and/or certified JD-freedom property status. Cattle
administered with this
killed vaccine may test positive when screened for Johne’s Disease
(JD-ELISA - blood
antibody test) due to immunity developed to the vaccine.
All animals vaccinated with Silirum Vaccine MUST be positively
identified as Silirum
vaccinated animals by application of a 3 hole punch preferably
administered in the outer
third of the right ear. The person administering the vaccine MUST
ensure animals which
have been vaccinated are reported to the NLIS database.
Vaccinated cattle MUST be excluded from export markets that are
sensitive to bovine
Johne’s disease or bovine tuberculosis unless there is an agreement
on the eligibility for
export of vaccinated animals with the importing country. Seek
professional advice if you
require guidance. RLP APPROVED
Contraindications:
Studies on the effects of vaccination on reproduction in male cattle
have not been
conducted.
Precautions:

製品の特徴

PRODUCT NAME: SILIRUM® VACCINE
PAGE: 1 OF 7
THIS VERSION ISSUED: 18 AUGUST 2014
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
SILIRUM® VACCINE
APVMA APPROVAL NO:
59642
OTHER NAMES:
None.
CHEMICAL FAMILY:
This vaccine contains a suspension of the microorganism _Mycobacterium
avium_
subsp._ paratuberculosis_, strain 316F, inactivated by heat and
adjuvanted with mineral
oil in a multiple emulsion. It contains 2.5 mg of dried microorganisms
per mL.
Thiomersal at 0.1 mg/mL is used as preservative.
RECOMMENDED USE:
Animal vaccine for use as described on the product label for the
control of Johne’s
Disease in cattle.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R36/38. Irritating to eyes and skin.
SAFETY PHRASES:
S23, S36, S24/25. Do not breathe mists. Wear suitable protective
clothing. Avoid contact with skin
and eyes.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMSBC criteria.
GHS LABEL ELEMENTS:
GHS SIGNAL WORD: WARNING
HAZARD STATEMENT:
H315: Causes skin irritation.
H320: Causes eye irritation.
PREVENTION
P262: Do not get in eyes, on skin, or on clothing.
P102: Keep out of reach of children.
P235: Keep cool. Refrigerate, preferably between 2 and 8°C, but do
not freeze.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P352: Wash with plenty of soap and