ULTRAVAC 5 IN 1 VACCINE

País: Austrália

Língua: inglês

Origem: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes ativos:

CLOSTRIDIUM CHAUVOEI - FORMOL CULTURE; CLOSTRIDIUM NOVYI TYPE B; CLOSTRIDIUM PERFRINGENS TYPE D TOXOID; CLOSTRIDIUM SEPTICUM - TOXOID; TETANUS = CLOSTRIDIUM TETANI; THIOMERSAL

Disponível em:

ZOETIS AUSTRALIA PTY LTD

DCI (Denominação Comum Internacional):

Cl perfringens toxoid (D)+Cl tetani - toxoid+Cl novyi type B + others

Forma farmacêutica:

MISC. VACCINES OR ANTI SERA

Composição:

CLOSTRIDIUM CHAUVOEI - FORMOL CULTURE VACCINE-MICROBIAL Active 0.0 P; CLOSTRIDIUM NOVYI TYPE B VACCINE-MICROBIAL Active 0.0 P; CLOSTRIDIUM PERFRINGENS TYPE D TOXOID VACCINE-TOXOID Active 0.0 P; CLOSTRIDIUM SEPTICUM - TOXOID VACCINE-TOXOID Active 0.0 P; TETANUS = CLOSTRIDIUM TETANI VACCINE-TOXOID Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml

Unidades em pacote:

100mL; 250mL; 500mL; 50mL

Classe:

VM - Veterinary Medicine

Fabricado por:

ZOETIS AUSTRALIA

Grupo terapêutico:

CATTLE | SHEEP | SHEEP RAM (MALE) | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW

Área terapêutica:

IMMUNOTHERAPY

Indicações terapêuticas:

BLACK DISEASE | BLACKLEG | ENTEROTOXAEMIA (PULPY KIDNEY) | MALIGNANT OEDEMA | SWELLED HEAD | TETANUS | VACCINE | CLOSTRIDIUM PERFRINGENS TYPE D | EQUINE ROTAVIRUS | TETANUS VACCINATION

Resumo do produto:

Poison schedule: 0; Withholding period: Meat: Zero (0) days MILK: Zero (0) days Zero (0) days; Host/pest details: CATTLE: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP RAM (MALE): [SWELLED HEAD]; Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: CATTLE: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP RAM (MALE): [SWELLED HEAD]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP RAM (MALE): [SWELLED HEAD]; For the prevention of enterotoxaemia (pulpy kidney disease), tetanus, black disease, malignant oedema (blackleg like disease) and blackleg in cattle and sheep, including swelled head in rams.

Status de autorização:

Registered

Data de autorização:

2023-07-01

Folheto informativo - Bula

APPENDIX2
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary Products)
Select appropriate:
[]
New Product (include
all
applicable RLPs)
OR
0
Variation
(highlight instructions that
are
being varied).
Approval
no.
of label
being
varied:
51279/1 [2,3.4]10509
Signal heading:
Product name:
Active
constituent/s:
Statement of
claims:
Net contents:
Directions for Use
Heading:
Restraints:
Contraindications:
Precautions:
Side effects:
Dosage
&
administration:
FOR ANIMAL TREATMENT ONLY
Ultravac® 5
in
1 Vaccine
Ultravac 5in1 is a multicomponent adjuvanted product containing
Clostridium
perfringens
typeD<:
51U/mL
Cl.
tetani
<:
2.51U/mL,
Cl.
novyi
type B
<:3.51U/mL,
Cl.
septicum
<:2.51U/mL
(as
ultrafiltered toxoids)
and
Cl.
chauvoei
0.3mL/mL
(as formol culture). The adjuvant, which
is
an
aluminium salt, increases the
level and duration of the immunity conferred
by
the
vaccine. The type of
adjuvant
and
the purification procedures used ensure maximum protection of
stock with minimum risk of local reactions at the site of injection.
Thiomersal
0.1
mg/mL
is
added
as
a preservative.
For
the
prevention
of
enterotoxaemia
(pulpy
kidney disease),
tetanus,
black
disease,
malignant
oedema (blackleg-like disease) and
blackleg
in
cattle and sheep
including
swelled head in rams
50mL, 100mL, 250
mL
and
500
mL
DIRECTIONS FOR USE
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
RLl
Contents must
be
left
in
outer package until immediately before
use.
A,.,,.HV
Shake
well
before use and keep
thoroughly
mixed
during
use.
It
is important that the vaccine is kept properly mixed before and during
use.
Before vaccine
is
injected, the proposed site of inoculation
on
the animal's
skin may
be
cleaned
by
swabbing with cotton-wool soaked
in
an
antiseptic
solution, such
as
methylated spirits.
N/A
N/A
N/A
Localised swelling may develop at the site of injection
and
a firm nodular lump
may
persist for some weeks or even months.
The
route
of
inoculation
is
subcutaneous
Uust
u

Características técnicas

PRODUCT NAME: ULTRAVAC
® 5 IN 1 VACCINE
PAGE: 1 OF 5
THIS REVISION ISSUED: APRIL, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: [phone]
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
SUBSTANCE:
Water solution/suspension of bacterial toxoids.
TRADE NAME:
ULTRAVAC
® 5 IN 1 VACCINE
OTHER NAMES:
_Cl. perfringens_ Type D, _Cl. tetani, Cl. septicum, Cl. novyi_ Type
B, _Cl. chauvoei_
Vaccine
PFIZER MSDS CODE:
0711
PRODUCT USE:
For the prevention of clostridial diseases in sheep and cattle.
CREATION DATE:
DECEMBER, 2004
THIS VERSION ISSUED:
APRIL, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
None (Aust); S2 (NZ)
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Aqueous suspension.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
INACTIVATED CULTURES AND TOXOIDS ARE NOT REGARDED AS PATHOGENIC IN
HUMANS.
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely. The
spray mist may be
discomforting to the upper respiratory tract and lungs, and repeated
exposure may cause sensitisation and/or
allergic/asthma-like response.
LONG TERM EXPOSURE:
No data for h