GLANVAC 3S B12 VACCINE
Država: Australija
Jezik: engleski
Izvor: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Uputa o lijeku
(PIL)
19-06-2017
Svojstava lijeka
(SPC)
19-06-2017
Aktivni sastojci:
SELENIUM; VITAMIN B12A = HYDROXOCOBALAMIN; CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS; CLOSTRIDIUM PERFRINGENS TYPE D TOXOID; TETANUS = CLOSTRIDIUM TETANI; THIOMERSAL
Dostupno od:
ZOETIS AUSTRALIA PTY LTD
INN (International ime):
Corynebacterium pseudotubercul(6cpu/mL) + others
Farmaceutski oblik:
MISC. VACCINES OR ANTI SERA
Sastav:
SELENIUM MINERAL-SELENIUM Active 1.0 mg/ml; VITAMIN B12A = HYDROXOCOBALAMIN VITAMIN-B12 Active 2.0 mg/ml; CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS VACCINE-MICROBIAL Active 0.0 P; CLOSTRIDIUM PERFRINGENS TYPE D TOXOID VACCINE-TOXOID Active 0.0 P; TETANUS = CLOSTRIDIUM TETANI VACCINE-TOXOID Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml
Jedinice u paketu:
250mL; 500mL
Razred:
VM - Veterinary Medicine
Proizveden od:
ZOETIS AUSTRALIA
Terapijska grupa:
LAMB | SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER
Područje terapije:
IMMUNOTHERAPY
Terapijske indikacije:
CHEESY GLAND | ENTEROTOXAEMIA (PULPY KIDNEY) | SELENIUM DEFICIENCY | TETANUS | VITAMIN | WHITE MUSCLE DISEASE | BIOTIN DEFICIENCIES | CLOSTRIDIUM PERFRINGENS TYPE D | DETOXIFYING AGENT | ERYTHROPOIETIC ACTIVITY | LYMPHADENITIS | LYMPHANGITIS | SELENIUM DEFICIENCY | STAMINA | STIFF LAMB DISEASE | SUBACUTE ENZOOTIC MUSCULAR DYS | TETANUS VACCINATION | VITAMIN A | VITAMIN B | VITAMIN C | VITAMIN D | VITAMIN DEFICIENCIES | VITAMIN E | VITAMIN K | WHITE MUSCLE DISEASE
Proizvod sažetak:
Poison schedule: 6; Withholding period: WHP: Meat Milk: Nil. EXPORT SLAUGHTER INTERVAL (ESI): ESI not required.; Host/pest details: LAMB: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), SELENIUM DEFICIENCY, TETANUS, WHITE MUSCLE DISEASE]; SHEEP: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS, VITAMIN]; Poison schedule: 6; Withholding period: ; Host/pest details: LAMB: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), SELENIUM DEFICIENCY, TETANUS, WHITE MUSCLE DISEASE]; SHEEP: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS, VITAMIN]; For the control of caseous lymphadenitis (CLA or cheesy gland) in sheep and lambs. For the prevention of enterotoxaemia (pulpy kidney disease) and tetanus in sheep and lambs. For prevention of white muscle disease. selenium deficiency.B12 deficiency.Use only in selenium deficient areas. If in doubt, consult a veterinarian.
Status autorizacije:
Registered
Datum autorizacije:
2023-07-01
Uputa o lijeku
Australian
Government
Australian Pesticides
and
Veterinary Medicines Authority
RLP
APPENDIX 2
Approved
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
[]
New
Product
(include
all
applicable
RLPs)
OR
K
Variation
(highlight
instructions
that
are
being
varied)
Approval
no
of
label
being
varied· 50139/62775
Signal
heading:
POISON
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
Product
name:
GLANVAC
3$
812
VACCINE
Active
constituenVs:
C.
pseudotuberculosis (ovis)
2:
6
cpu/ml,
Ct.
perfringens
type
D
~
5
IU/mL,
Ct.
tetani
~
2.5
IU/ml,
(as ultrafiltered
toxoids)
1
mgtml
selenium
and
2
mg/mL
hydroxocobalamin.
0.1
mg/ml
Thiomersal is added as a
preservative.
Statement
of
claims:
For
the
control
of
caseous
lymphadenitis
(CLA
or
cheesy gland)
in
sheep
and lambs.
For
the
prevention
of
enterotoxaemia (pulpy kidney disease)
and tetanus
in
sheep and lambs.
For
the
prevention
of
white
muscle
disease
in
lambs, in areas
of
known
or
suspected selenium deficiency,
after
they
have
been
vaccinated
at marking.
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
3S
812
Vaccine is to be used for the prevention
of
enterotoxaemia
(pulpy kidney disease)
and
tetanus, and the control of cheesy gland
in
sheep
and lambs. Also for the prevention of white muscle disease
in
lambs,
in
areas
of known or suspected selenium deficiency, after they have been
vaccinated
at marking, and
in
the treatment and prevention of Vitamin 812 deficiency
in
sheep
in
areas of known or suspected cobalt deficiency. The product is to be
used only
in
areas where selenium deficiency
is
known to
be
a problem;
in
all
other districts Glanvac® 3
812
Vaccine or Glanvac® 3 should be used.
Caseous lymphadenitis, is a chronic disease of sheep.
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
ps
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Svojstava lijeka
PRODUCT NAME: GLANVAC® 3S B12 VACCINE
PAGE: 1 OF 6
THIS VERSION ISSUED: 17 MARCH 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: 1800 814 883
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: 1800 814 883
Fax: (02) 8876 0444
Email: australia.animalhealth@zoetis.com
PRODUCT IDENTIFIER:
GLANVAC® 3S B12 VACCINE
OTHER NAMES:
None.
APVMA APPROVAL NO:
50139
CHEMICAL FAMILY:
Aqueous suspension of inactivated bacteria with added Selenium and
Vitamin B12.
RECOMMENDED USE:
For the control of CLA and the prevention of clostridial diseases and
selenium 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
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