ULTRAVAC 5 IN 1 S WITH SELENIUM FOR LAMBS VACCINE

Pays: Australie

Langue: anglais

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Achète-le

Notice patient (PIL)

19-06-2017

Résumé des caractéristiques du produit (SPC)

19-06-2017

Ingrédients actifs:

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

Disponible depuis:

ZOETIS AUSTRALIA PTY LTD

DCI (Dénomination commune internationale):

Cl perfringens toxoid (D)(5IU/mL)+Cl tetani - toxoid(2.5IU/mL) + others

forme pharmaceutique:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

THIOMERSAL MERCURY Active 0.1 mg/ml; SELENIUM MINERAL-SELENIUM Active 1.0 mg/ml; CLOSTRIDIUM CHAUVOEI - TOXOID VACCINE-TOXOID Active 0.0 P; CLOSTRIDIUM NOVYI TYPE B - TOXOID VACCINE-TOXOID 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

Unités en paquet:

250mL

classe:

VM - Veterinary Medicine

Fabriqué par:

ZOETIS AUSTRALIA

Groupe thérapeutique:

Domaine thérapeutique:

IMMUNOTHERAPY

indications thérapeutiques:

Descriptif du produit:

Poison schedule: 6; Withholding period: WHP: Nil TRADE ADVICE: EXPORT SLAUGHT ER INTERVAL (ESI): ESI not applicable.; Host/pest details: LAMB: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, WHITE MUSCLE DISEASE]; SHEEP: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS]; Poison schedule: 6; Withholding period: ; Host/pest details: LAMB: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, WHITE MUSCLE DISEASE]; SHEEP: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS]; For the prevention of enterotoxaemia (pulpy kidney), tetanus, black disease, malignant oedema (blackleg like disease) and blackleg in sheep and lambs and the prevention of white muscle disease in lambs after they have been vaccinated at marking.See CAUTION - AVOID CARCASE DAMAGE on label.

Statut de autorisation:

Registered

Date de l'autorisation:

2023-07-01

Notice patient

APPENDIX2
Australian
Government
Australian Pesticides and
Veterinary Medicines Authority
+
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary Prodlltetg)
Select appropriate:
RLP
Approved
[J
New Product (include all applicable RLPs)
OR
00
Variation
(highlight instructions that are being
48866/0509
varied).
Approval
no.
of label being
varied:
Signal heading:
Product name:
Active
constituent/s:
Statement of
claims:
Net contents:
Directions for Use
Heading:
Restraints:
Contraindications:
Precautions:
Side effects:
Dosage
&
administration:
POISON
KEEP PUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
Ultravac®
5
in
1 S with Selenium for Lambs Vaccine
Ultravacqi)S in 1 S
with
Selenium
for
Lambs Vaccine
is
a multicomponent
adjuvant vaccine containing ultrafiltered antigens of
~
5 IU/mL
Clostridium
perfringens
type
D,
~
2.5 IU/mL
Cl.
tetani,
~
3.5 IU/mL
Cl.
novyi
type
B,
~
2.5
IU/mL
Cl.
septicum
and
formol culture of
~
0.33 mL!mL
Cl.
chauvoei.
It
also
contains
2.4
mg/mL
sodium
selenate
(equivalent
to
1
mg
of
elemental
selenium
per
1
mL
dose).
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
sheep and
lambs and the prevention of white muscle disease
in
lambs after they have
been
vaccinated at marking
250
mL
DIRECTIONS FOR USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Contents must be left
in
outer package until immediately before
use.
Shake well before use and keep thoroughly mixed
during
use.
It
is
important that the vaccine is kept properly mixed before and during
use.
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
e

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Résumé des caractéristiques du produit

ULTRAVAC™ 5 IN 1 VACCINE 5MG SELENIUM
(New Zealand Only)
Material Safety Data Sheet
0011
Date of Issue: Tue 24 September 2002
------------------------------------------------------------------------------------------------------------------------------------------------
IDENTIFICATION
------------------------------------------------------------------------------------------------------------------------------------------------
STATEMENT OF HAZARDOUS NATURE
_Classified as hazardous according to Worksafe Australia criteria_
SUPPLIER
Company:
CSL Limited (Animal Health Division)
(ABN 99 051 588 348)
Address:
45 Poplar Road
Parkville, Victoria 3052 Australia
Telephone:
1800 333 011
Emergency Tel:
(03) 9389 1984
Fax:
(03) 9389 1646
Product Name:
Ultravac™ 5 in 1 with Selenium
Other Names:
Cl. perfringens Type D, Cl. tetani, Cl. septicum, Cl. novyi Type B,
Cl.
chauvoei Vaccine with Selenium
Product Code:
0011
CAS RN No(s):
None
UN Number:
None
Dangerous Goods Class:
None
Subsidiary Risk:
None
Hazchem Code:
None
Poisons Schedule Number:
NZS2
USE
_For the prevention of clostridial diseases in sheep_
_in areas of selenium deficiency_
Administer by Injection
PHYSICAL DESCRIPTION/PROPERTIES
Appearance:
Aqueous liquid suspension
Boiling Point (deg C):
100
Melting Point (deg C):
0
Vapour Pressure (kPa):
3.19 @25C
Specific Gravity:
1.01
Flash Point (deg C):
Not applicable
Lower Explosive Limit (%):
Not applicable
Upper Explosive Limit (%):
Not applicable
Solubility in Water (g/L):
Miscible
INGREDIENTS
Name
CAS RN
%
Saline suspension
>90
Containing ultrafiltered,
Cl. perfringens Type D Toxoid
Cl. tetani Toxoid
Cl. novyi Type B Toxoid
Cl. septicum Toxoid
Page 1/4
And formol culture of Cl. chauvoei
(in amounts sufficient in balanced proportion to satisfy potency
requirements of BP(Vet) 1993)
Sodium selenate, decahydrate
10102-23-5
0.60
Adjuvant
<0.4
Preservative
54-64-8
0.01
------------------------------------------------------------------------------------------------------------------------------------------------
HEALTH H

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