国家: 澳大利亚
语言: 英文
来源: APVMA (Australian Pesticides and Veterinary Medicines Authority)
PASTEURELLA MULTOCIDA STRAIN PMP-1
BIOPROPERTIES PTY. LTD.
Pasteurella multocida
MISC. VACCINES OR ANTI SERA
PASTEURELLA MULTOCIDA STRAIN PMP-1 VACCINE-GENERAL Active 0.0 U
1000 dose; 2000 dose; 500 dose
VM - Veterinary Medicine
FOWL
IMMUNOTHERAPY
PASTEURELLA MULTOCIDA | FOWL CHOLERA
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.
Registered
2022-07-01
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 阅读完整的文件
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 阅读完整的文件
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 阅读完整的文件