RELSURE PCV

국가: 오스트레일리아

언어: 영어

출처: APVMA (Australian Pesticides and Veterinary Medicines Authority)

유효 성분:

CPCV 1-2 INACTIVATED SUSPENSION

제공처:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

porcine circovirus type 2

약제 형태:

MISC. VACCINES OR ANTI SERA

구성:

CPCV 1-2 INACTIVATED SUSPENSION VACCINE-VIRUS Active 0.0 Undefined

패키지 단위:

#100mL; #50 doses; $125 doses; $250mL; %250 doses; %500mL; ^1L; ^500 doses

수업:

V - Veterinary

Manufactured by:

ZOETIS AUSTRALIA

치료 영역:

IMMUNOTHERAPY

제품 요약:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: PIG: [CONTROL OF PCV ASSOCIATED DISEASE- PCVAD, EARLY COLONISATION OF INTESTINAL TRACT, PREVENTION OF NASAL AND FAECAL SHEDDING, PREVENTION OF PORCINE CIRCOVIRUS TYPE 2, REDUCTION OF LYMPHOID DEPLETION ]; Poison schedule: 0; Withholding period: ; Host/pest details: PIG: [CONTROL OF PCV ASSOCIATED DISEASE- PCVAD, EARLY COLONISATION OF INTESTINAL TRACT, PREVENTION OF NASAL AND FAECAL SHEDDING, PREVENTION OF PORCINE CIRCOVIRUS TYPE 2, REDUCTION OF LYMPHOID DEPLETION ]; For the vaccination of healthy pigs 3 weeks of age or older as an aid in the prevention of Porcine Circovirus Type 2 (PCV2) viraemia, prevention of nasal and faecal shedding, reduction of colonisation, reduction of lymphoid depletion caused by PCVAD.

승인 상태:

Stopped

승인 날짜:

2022-07-01

환자 정보 전단

COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
ZOETIS AUSTRALIA PTY LTD
RELSURE PCV
64179/100662
LABEL NAME:
RELSURE PCV
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each dose contains inactivated Porcine Circovirus Type 1-Type 2
Chimera (RP>=1.0).
Contains thiomersal as a preservative.
CLAIMS:
For the vaccination of healthy pigs 3 weeks of age or older as an aid
in the prevention
of Porcine Circovirus Type 2 (PCV2) viraemia, as an aid in the
prevention of nasal and
faecal shedding, as an aid in the reduction of colonisation, and as an
aid in the reduction
of lymphoid depletion caused by PCV2 and in the control of PCV
associated disease
(PCVAD).
NET CONTENTS:
10 doses
50 doses
125 doses
250 doses
500 doses
DIRECTIONS FOR USE:
DIRECTIONS FOR USE
USE ALL PRODUCT WITHIN 12 HOURS OF OPENING
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
Safety studies to support the use of the product in breeding animals
have not been
conducted.
The benefit of the vaccination of pigs with very high levels of
maternally-derived antibodies,
e.g. due to vaccination of their mothers, has not been determined.
SIDE EFFECTS:
Local tissue reactions in the form of swelling and tissue hardness (by
palpation) at the
injection site may occur and could last for up to 28 days. The area of
local reaction is
generally less than 8 cm in diameter, but in some cases a larger
swelling may occur. RLP APPROVED
Vomiting may occur during the first hour after vaccination, but no
consequential negative
effects are observed. Anaphylactic reactions are uncommon. In case of
such reactions,
appropriate treatment is recommended. If left untreated, anaphylactic
reactions might be
lethal.
DOSAGE AND
ADMINISTRATION:
Shake well before use. Unused vaccine must be discarded within 12
hours of opening.
Inject intramuscularly into the side of the neck using aseptic
technique.
Inject 2 mL intramuscularly into pigs 3 weeks of age or older, or 2 x
1mL doses at a 3 week
interval.
Duration of immunity has been demonstrated for at least 23 weeks
following a s

제품 특성 요약

PRODUCT NAME: RELSURE PCV
PAGE: 1 OF 6
THIS VERSION ISSUED: 13 MAY 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
38-42 Wharf Road
West Ryde NSW 2114 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
RELSURE® PCV
APVMA APPROVAL NO:
64179
OTHER NAMES:
None.
CHEMICAL FAMILY:
Porcine Circovirus Vaccine, Type 1-Type 2 Chimera, Killed Virus
RECOMMENDED USE:
Animal vaccine for use in pigs as described on the product label.
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:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S36, S61, S24/25. Wear suitable protective clothing. Avoid release to
the environment. Refer to
special instructions/Safety Data Sheets. Avoid contact with skin and
eyes.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
GHS CLASSIFICATION: NONE. NOT HAZARDOUS.
GHS LABEL ELEMENTS: NONE. NOT HAZARDOUS.
SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P235: Keep cool.
P261: Avoid breathing mists, vapours or spray.
P262: Do not get in eyes, on skin, or on clothing.
P273: Avoid release to the environment.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P501: Dispose of small quantities and empty containe