GUDAIR VACCINE

País: Austràlia

Idioma: anglès

Font: APVMA (Australian Pesticides and Veterinary Medicines Authority)

ingredients actius:

MYCOBACTERIUM PARATUBERCULOSIS; THIOMERSAL

Disponible des:

ZOETIS AUSTRALIA PTY LTD

Designació comuna internacional (DCI):

M. paratuberculosis(2.5mg/mL)

formulario farmacéutico:

MISC. VACCINES OR ANTI SERA

Composición:

MYCOBACTERIUM PARATUBERCULOSIS VACCINE Active 2.5 mg/ml; THIOMERSAL MERCURY Other 0.1 mg/ml

Unidades en paquete:

100mL; 250mL

clase:

VM - Veterinary Medicine

Fabricat per:

ZOETIS AUSTRALIA

Grupo terapéutico:

GOAT | SHEEP | BILLY | BUCK | CAPRA HIRCUS | DOE | EWE | HOGGET | KID | LAMB | OVINE | RAM | WEANER | WETHER

Área terapéutica:

IMMUNOTHERAPY

indicaciones terapéuticas:

JOHNE'S DISEASE | MYCOBACTERIUM PARATUBERCULOSIS SHEDDING

Resumen del producto:

Poison schedule: 0; Withholding period: WHP:(Meat Milk):Nil; Host/pest details: GOAT: [JOHNE'S DISEASE]; SHEEP: [JOHNE'S DISEASE, MYCOBACTERIUM PARATUBERCULOSIS SHEDDING]; Poison schedule: 0; Withholding period: ; Host/pest details: GOAT: [JOHNE'S DISEASE]; SHEEP: [JOHNE'S DISEASE, MYCOBACTERIUM PARATUBERCULOSIS SHEDDING]; Active immunisation for the control of Johne's disease and reduction in faecal Mycobacterium paratuberculosis shedding in sheep. Active immunisation as an aid in the control of Johne's disease in goats.Do not vaccinate sheep or goats younger than 1 month. NOTE: VACCINATED ANIMALS ARE LIKELY TO GIVE POSITIVE RESULTS WHEN TESTED FOR TUBERCULOSIS OR JOHNE'S DISEASE.

Estat d'Autorització:

Registered

Data d'autorització:

2023-07-01

Informació per a l'usuari

AUSTRALFAN GOVERNMENT
AUSTRALIAN PESTICIDES
AND
VETERINARY
MEDICINES
AUTHORITY
RLP
APPENDIX 2
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
[J
New Product (include all applicable RLPs) OR
X
Variation (highlight instructions that are being varied). Approval no.
of
label being varied:
53839/0808
Signal heading:
Product name:
Active constituent/s:
Statement
of
claims:
Net contents:
Directions for Use
Heading:
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
Gudair® Vaccine
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
Additional Constituent: Thiomersal
0.1
mg/ml
as
preservative
Active immunisation for the control
of
Johne's disease and reduction
in
faecal
Mycobacterium avium
subsp.
paratuberculosis
shedding
in
sheep. Active
immunisation as
an
aid
in
the control
of
Johne's disease
in
goats.
INDICATIONS FOR USE
GUDAIR® VACCINE
is
indicated for the control of Johne's disease
in
sheep, and
as
an
aid
in
the control
of
Johne's disease
in
goats.
Transmission
of
Mycobacterium avium
subsp.
paratuberculosis
in
sheep and goats
is
primarily by the faecal-oral route. The bacteria enter through the
Peyer's patches
of
the small
intestine and
infect the terminal
ileum,
caecum,
colon
and
associated
mesenteric lymph nodes and vessels. Johne's disease has a prolonged
incubation
period
with
clinical
disease,
characterised
by weight
loss
and
emaciation,
most
commonly seen
in
sheep older than two years
of
age. About 1
0%
of
clinical cases
show diarrhoea
in
the end stage
of
the disease. Some animals become carriers of the
infection, intermittently shedding the bacteria into their
environment. These subclinical
carriers can develop into active clinical cases which usually die from
malabsorption.
Milk production
in
infected sheep and goats
is
reduced and wool break and poor
fleece condition have

Fitxa tècnica

PRODUCT NAME: GUDAIR® VACCINE
PAGE: 1 OF 6
This revision issued: 24
th
September, 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:
GUDAIR
® VACCINE
OTHER NAMES:
None.
CHEMICAL FAMILY:
Oil-water emulsion with vaccine and other minor ingredients.
APVMA APPROVAL NUMBER:
53839
PRODUCT USE:
Animal vaccine for use as described on the product label for the
control of Johne’s
Disease in sheep and goats.
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S23, S36, S24/25. Do not breathe vapours or 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 IMDG/IMSBC criteria.
GHS CLASSIFICATION: NOT HAZARDOUS.
GHS LABEL ELEMENTS: NONE. NOT HAZARDOUS.
SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
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 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.
P411: Store between 2°C and 8°C (refrigerate, do not freeze).
DISPOSAL
P501: Dispose of small quantities and empty containers