VAXSAFE PM VACCINE (LIVING)

国家: 澳大利亚

语言: 英文

来源: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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30-11-2021
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01-07-2013
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30-11-2021

有效成分:

PASTEURELLA MULTOCIDA STRAIN PMP-1

可用日期:

BIOPROPERTIES PTY. LTD.

INN(国际名称):

Pasteurella multocida

药物剂型:

MISC. VACCINES OR ANTI SERA

组成:

PASTEURELLA MULTOCIDA STRAIN PMP-1 VACCINE-GENERAL Active 0.0 U

每包单位数:

1000 dose; 2000 dose; 500 dose

类:

VM - Veterinary Medicine

治疗组:

FOWL

治疗领域:

IMMUNOTHERAPY

疗效迹象:

PASTEURELLA MULTOCIDA | FOWL CHOLERA

產品總結:

Poison schedule: 0; Withholding period: WHP: Nil ESI: Export Slaughte Interva l - Not required; Host/pest details: FOWL: [PASTEURELLA MULTOCIDA]; Poison schedule: 0; Withholding period: WHP: Nil ESI: Export Slaughte Interval - Not required; Host/pest details: FOWL: [PASTEURELLA MULTOCIDA]; An aid in the control of fowl cholera due to infection with virulent homologous or heterologous strains of Pasteurella multocida.DO NOT administer to turkeys. This product is contraindicated for vaccinating unhealthy chickens.

授权状态:

Registered

授权日期:

2022-07-01

资料单张

                                Product Name:
APVMA Approval No:
VAXSAFE PM VACCINE (LIVING)
64191/129283
Label Name:
VAXSAFE PM VACCINE (LIVING)
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
PASTEURELLA MULTOCIDA STRAIN PMP-1 ≥ 10^7.2 cfu/dose
Claims:
The vaccine is recommended as an aid in the control of fowl cholera
due to infection with
virulent homologous or heterologous strains of Pasteurella multocida.
Net Contents:
2000 dose, 3mL or 10 ml vial
1000 dose, 3mL or 10 ml vial
500 dose, 3mL or 10 ml vial
Directions for Use:
Restraints:
Contraindications:
•
This product is contraindicated for vaccinating unhealthy chickens.
•
Do not administer to turkeys.
Precautions:
•
Exposure to disease must be minimised as much as possible especially
during the first
two weeks after vaccination.
•
Avoid stressful conditions during and following vaccination.
Side Effects:
•
Mild transient clinical signs such as inactivity or hunched posture
may be noted in some
birds following vaccination.
•
This vaccine may cause swelling at the site of injection. This
generally resolves within
28 days of the date of first vaccination, and does not require
specific treatment.
Dosage and
Administration:
Vaccine must be held between 4°C and 30°C prior to use.
Vaccine must be used within 4 hours of reconstitution. Discard unused
vaccine after this
period. RLP APPROVED
Reconstituted vaccine must not be frozen.
Administer 0.2 mL reconstituted vaccine by intramuscular injection to
healthy birds over
8 weeks of age.
Method of Vaccination
Preparation of Vaccine for intramuscular injection
Calculate the total number of vaccine doses required based on the
total bird number
rounded up to the nearest whole vial.
Two 500 dose vials can be reconstituted using a single 200 mL pack of
sterile diluent.
If only a single 500 dose vial is to be reconstituted, using a syringe
and needle accurately
remove 100 mL of diluent prior to reconstitution and discard. This
leaves 100 mL diluent in
the pack for reconstitution of the vaccine.
Each 1000 dose vial will 
                                
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产品特点

                                 
 
MSDS
 - 
MATERIAL SAFETY DATA SHEET
 
VAXSAFE
® 
PM VACCINE (LIVING) 
 
BIOPROPERTIES Pty Ltd 
Page 1 of 5 
Date of Issue:  August 2011
 
 
 MSDS-PM 
V11
 
BIOPROPERTIES PTY. LTD. 
 
ACN  007  303  728 
 
36 CHARTER STREET 
TELEPHONE: 
03 9876 0567
RINGWOOD  VIC   3134 
FACSIMILE: 
03 9876 0556
AUSTRALIA 
EMERGENCY: 
0417 548 879
 
 
WORK HAZARD ASSESSMENT 
 
NOT CLASSIFIED AS HAZARDOUS TO HEALTH ACCORDING TO CRITERIA OF
WORKSAFE AUSTRALIA 
 
PRODUCT IDENTIFICATION 
 
 
PRODUCT NAME:  VAXSAFE
® 
PM VACCINE (LIVING) 
OTHER NAMES: 
STRAIN PMP-1, PMP VACCINE, _PASTEURELLA MULTOCIDA_ (LIVING) 
VACCINE, FOWL CHOLERA VACCINE, CHOLERA VACCINE. 
PRODUCT CODE:  9202 PMP 
APVMA NO:  64191 
UN NUMBER:  None allocated 
DANGEROUS GOODS 
CLASS/SUBSIDIARY RISK:  None allocated 
HAZCHEM CODE:  None allocated 
POISONS SCHEDULE 
NUMBER:   Not scheduled 
PRODUCT TYPE:  Poultry vaccine 
CHEMICAL FAMILY:  The active ingredient consists of
viable _Pasteurella multocida_ (strain 
PMP-1) bacteria that have been freeze-dried in a protective
buffer. 
_Pasteurella multocida,_ strain PMP-1
is an attenuated vaccine strain. 
These organisms are unable to persist or continue replicating
without 
access to specific nutrients typically provided by specially
formulated 
culture media. 
No adjuvants are included in the formulation of this vaccine. 
USE:  A vaccine to aid in the control of Fowl Cholera in poultry. 
METHOD OF USE:  The freeze-dried vaccine cake is reconstituted
and diluted using the 
sterile diluent supplied. The vaccine is then administered by
intra-
muscular injection into the breast muscle of the bird. 
 
PHYSICAL DESCRIPTION AND PROPERTIES 
 
 
APPEARANCE:  A pale cream-coloured cake of freeze-dried vaccine
in a 3mL or 10 mL 
glass vial. The vial closure consists of a rubber stopper and
silver tear-
off seal. Each vial has a label which is white with a mauve strip
and 
black print. Each vial 
                                
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安全数据表

                                VAXSAFE
® PM VACCINE (LIVING)
VIAL SIZE:
3 ML
LABEL VERSION:
V2 D1
CHANGES FROM PREVIOUS VERSION: 2 – 8°C storage option removed.
APVMA number updated to
64191/59578.
20mm x 50mm
XX in label code: 1 for 1000 doses, 2 for 2000 doses, 5
for 5000 doses.
Note: Consider having the APVMA number printed on by BPL with Datamax
rather than
having it on the label from Insignia, so that it can be changed as
necessary without
needing a new label from Insignia.
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® PM
_P. multocida_ Strain PMP-1: ≥ 10
7.2
cfu/dose
READ ACCOMPANYING LEAFLET
BIOPROPERTIES PTY LTD
APVMA 64191/59578
Store at or below -18
o
C (deep
freeze) .
Batch:
Exp:
LBL PM/XX V2
ANIMAL TREATMENT ONLY
VAXSAFE
® PM VACCINE (LIVING)
_ _
ACTIVE CONSTITUENT:
Each dose contains ≥ 10
7.2
cfu of live
_Pasteurella multocida_ strain PMP-1, (Heddleston serotype 1,
_aroA _deleted)
STATEMENT OF CLAIMS:
The vaccine is recommended as an aid
in
the
control
of
fowl
cholera
due
to
infection
with
virulent
homologous or heterologous strains of _Pasteurella multocida_.
500, 1000 OR 2000 DOSES
CONTENTS
:
The
product
consists
of
a
freeze
dried
plug
of
vaccine within a 3 mL glass vial. Each vial contains 500, 1000 or
2000 doses.
Sterile
diluent
for
vaccine
preparation
and
administration
is
available separately in packs of 200 mL or 400 mL.
READ DIRECTIONS CAREFULLY
DIRECTIONS FOR USE:
CONTRAINDICATIONS_: _
•
This product is contraindicated for vaccinating unhealthy
chickens.
•
Do not administer to turkeys.
PRECAUTIONS:
•
The use of sterile equipment and proper sterile technique is
critical to avoiding contamination of Vaxsafe
®
PM.
•
Vaccine must be held between 4 and 30°C prior to use.
•
Reconstituted vaccine must not be frozen.
•
Vaccine must be used within 4 hours of reconstitution.
Discard unused vaccine after this period.
•
Administer only as directed.
•
Vaccinate all birds in a flock at one time.
•
Administer a full dose to each bird.
•
Use entire contents of vial when first opened.
•
Good
husbandry
practice
and

                                
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