GLANVAC 6 B12 VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLOSTRIDIUM CHAUVOEI - FORMOL CULTURE; ENTEROTOXAEMIA = PULPY KIDNEY = C PERFRINGENS; CLOSTRIDIUM NOVYI TYPE B; MALIGNANT OEDEMA = CLOSTRIDIUM SEPTICUM; CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS; TETANUS = CLOSTRIDIUM TETANI; THIOMERSAL; VITAMIN B12A = HYDROXOCOBALAMIN

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

Corynebacterium pseudotubercul(6cpu/mL) + others

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

CLOSTRIDIUM CHAUVOEI - FORMOL CULTURE VACCINE-MICROBIAL Active 0.0 U; ENTEROTOXAEMIA = PULPY KIDNEY = C PERFRINGENS VACCINE-MICROBIAL Active 0.0 U; CLOSTRIDIUM NOVYI TYPE B VACCINE-MICROBIAL Active 0.0 U; MALIGNANT OEDEMA = CLOSTRIDIUM SEPTICUM VACCINE-MICROBIAL Active 0.0 U; CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS VACCINE-MICROBIAL Active 0.0 U; TETANUS = CLOSTRIDIUM TETANI VACCINE-TOXOID Active 0.0 U; THIOMERSAL MERCURY Other 0.1 mg/ml; VITAMIN B12A = HYDROXOCOBALAMIN VITAMIN-B12 Other 2.0 mg/ml

Units in package:

250mL; 500mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

GOAT | GOAT KID | LAMB | SHEEP | SHEEP RAM (MALE) | BILLY | BUCK | CAPRA HIRCUS | DOE | EWE | HOGGET | KID | LAMB | OVINE | RAM

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

BLACK DISEASE | BLACKLEG | CASEOUS LYMPHADENITIS (CHEESY GLAND) | ENTEROTOXAEMIA (PULPY KIDNEY) | MALIGNANT OEDEMA | SWELLED HEAD | TETANUS | VITAMIN B12 DEFICIENCY | ANAEMIA | CLOSTRIDIUM PERFRINGENS TYPE D | COBALT DEFICIENCY | TETANUS VACCINATION

Product summary:

Poison schedule: 0; Withholding period: WITHOLDING PERIODS: MEAT: Nil MILK: N il EXPORT SLUAGHTER INTERVAL (ESI): ES I Not applicable.; Host/pest details: GOAT: [BLACK DISEASE, BLACKLEG, CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS]; GOAT KID: [BLACK DISEASE, BLACKLEG, CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS]; LAMB: [BLACK DISEASE, BLACKLEG, CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VITAMIN B12 DEFICIENCY]; SHEEP: [BLACK DISEASE, BLACKLEG, CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VITAMIN B12 DEFICIENCY]; SHEEP RAM (MALE): [SWELLED HEAD]; Control of caseous lymphadenitis (CLA or cheesy gland) and the prevention of enterotoxaemia (pulpy kidney disease), tetanus, black disease, malignant oedema (blackleg-like disease) and blackleg in sheep, lambs, goats and kids, and swelled head in rams...CAUTION: AVOID CARCASS DAMAGE. See SIDE EFFECTS, etc. on leaflet.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPENDIX2
Australian
Government
Australian Pesticides
and
Veterinary Medicines Authority
RLP
Approved
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
[J
New
Product
(include
all
applicable
RLPs)
OR
)(Variation
(highlight
instructions
that
are
being
varied)
Approval
no
of
label
being
varied· 50381/62771
Signal
heading:
FOR
ANIMAL
TREATMENT
ONLY
Product
name:
GLANVAC
6 812
VACCINE
Active
constituenVs:
C.
pseudotuberculosis
(ovis)
;;,:6
cpulml,
Cl.
perfringens
type D
;;,:5
IU/ml,
Cl.
tetani
;;,:2.5
IUiml,
Cl.
novyi
type 8
;;,:3.5
IUiml,
Cl.
septicum
;;,:2.5
IU/ml
(as
ultrafiltered toxoids),
Cl.
chauvoei
(meets Ph.Eur.)
as
formol
culture, 2
mglml
hydroxocobalamin.
0.1
mglml
Thiomersal is added
as
a preservative.
Statement
of
claims:
For
the
control
of
caseous
lymphadenitis
(CLA
or
cheesy gland)
and
the
prevention
of
enterotoxaemia
(pulpy
kidney
disease),
tetanus,
black
disease,
malignant
oedema
(blackleg-like
disease)
and
blackleg
in
sheep,
lambs,
goats
and
kids,
and
swelled
head
in
rams.
For
the
treatment
and
prevention
of
Vitamin
812
deficiency
in
sheep
in
areas
of
known
or
suspected
cobalt
deficiency.
Indications
for
use
INDICATIONS FOR USE
Glanvac 6 812 Vaccine
is
effective
in
the control
of
caseous lymphadenitis
and
in
the prevention
of
enterotoxaemia (pulpy kidney disease), tetanus, black
disease,
malignant oedema (blackleg-like disease) and
blackleg
in
sheep,
lambs, goats and kids, and swelled head
in
rams; and
in
the
treatment and
prevention
of
Vitamin B12 deficiency
in
sheep
in
areas
of
known or suspected
cobalt deficiency.
Caseous
lymphadenitis,
is
a
chronic
disease of sheep
and
goats.
It
is
characterised
by
abscesses,
containing
a
cheese-like
green
pus,
in
the
superficial
and
internal
lymph nodes (glands) and
lungs.
The disease is
caused
by
Corynebacterium
pseudotuberculosis
(avis)
which
gains
entry
through breaks or abrasions of the skin or mucous membranes.
Transmission of the disease occurs primarily during husbandry
practices such
as shearing, crutching and dip

Summary of Product characteristics

PRODUCT NAME: GLANVAC® 6 B12 VACCINE
PAGE: 1 OF 6
THIS VERSION ISSUED: 17 MARCH 2015
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:
GLANVAC® 6 B12 VACCINE
OTHER NAMES:
None.
APVMA APPROVAL NO:
50381
CHEMICAL FAMILY:
Aqueous suspension of inactivated bacteria with added Vitamin B12.
RECOMMENDED USE:
For the control of CLA and the prevention of clostridial diseases and
cobalt deficiency
in sheep.
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, S25, S36. Do not breathe mists. Avoid contact with eyes. Wear
suitable protective clothing.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
GHS LABEL ELEMENTS: NONE
SIGNAL WORD: NONE – NOT HAZARDOUS.
GHS CLASSIFICATION: 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
P353: Rinse skin or shower with 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 at temperatures preferably between 2 and 8°C, but do not
freeze.
P403+P233: Store in a well-ventilated place. Keep container tightly
closed.
DISPOSAL
P501: Disp