FEVAC 3 VACCINE
Land: Australië
Taal: Engels
Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Bijsluiter
(PIL)
20-06-2017
Productkenmerken
(SPC)
20-06-2017
Werkstoffen:
FELINE CALICIVIRUS - INACTIVATED; FELINE PANLEUCOPENIA VIRUS - INACTIVATED; FELINE RHINOTRACHEITIS VIRUS - INACTIVATED; THIOMERSAL
Beschikbaar vanaf:
ZOETIS AUSTRALIA PTY LTD
INN (Algemene Internationale Benaming):
feline parvovirus+feline rhinotracheitis+feline calicivirus
farmaceutische vorm:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Samenstelling:
FELINE CALICIVIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 P; FELINE PANLEUCOPENIA VIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 P; FELINE RHINOTRACHEITIS VIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml
Eenheden in pakket:
!20 x 1mL; !Vials; #50x1mL; #vials; %10mL vial; *50x1mL; *syringes; +20x1mL; +syringes; /25x1mL; /syringes; @25x1mL; @vial; 20 x
klasse:
VM - Veterinary Medicine
Geproduceerd door:
ZOETIS AUSTRALIA
Therapeutische categorie:
CAT | CAT - QUEEN | CAT - TOM | KITTEN
Therapeutisch gebied:
IMMUNOTHERAPY
therapeutische indicaties:
FELINE CALICIVIRUS | FELINE ENTERITIS | FELINE RHINOTRACHEITIS | CALICIVIRUS (FELINE) | ENTERITIS (FELINE) | FCV | FELINE HERPESVIRUS TYPE 1 | FELINE INFECTIOUS ENTERITIS | FELINE PANLEUCOPENIA (FP) | FHV-1 | FVR | HERPESVIRUS 1 (FELINE) | HERPESVIRUS TYPE 1 (FELINE) | PANLEUCOPENIA (FELINE) | RHINOTRACHEITIS (FELINE)
Product samenvatting:
Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: CAT: [FELINE CALICIVIRUS, FELINE ENTERITIS, FELINE RHINOTRACHEITIS]; For the immunisation of cats against feline panleucopaenia (feline enteritis) virus, feline rhinotracheitis virus (feline herpes virus type 1), and feline calicivirus.
Autorisatie-status:
Registered
Autorisatie datum:
2023-07-01
Bijsluiter
C-
APPENDIX 2
AUSTRALIAN GOVERNMENT
AUSTRALIAN.
PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
C
New Product (include all applicable RLPs)
OR
0
Variation (highlight instructions that are being varied). Approval
no.
of
label being varied: 52630/54868.
Signal
head·lng:
Product
name:
Active
constituenUs:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
PRECAUTIONS:
Side
effects:
Dosage
&
ADMINISTRATION:
FOR ANIMAL TREATMENT ONLY
FEVAC® 3 VACCINE
Fevac 3 Vaccine is
an
inactivated vaccine prepared from feline panleucopaenia
(feline enteritis) virus 10
76
TCID
5
o/L,
feline rhinotracheitis virus (feline herpesvirus type
1)
10m"TCID
5
ofL
and feline calicivirus
10
100
TCID
50
/L which have been grown
in
a
continuous feline cell line. FEVAC 3 Vaccine contains a water soluble
adjuvant
to
enhance immune response. Thiomersal
(0.1
mglmL)
is
added as a preservative. The
viruses and cell line have been fully tested for adventitious agents.
The cell line has
been tested for oncogenicity. Both viruses and cell line are used
on
approved seed lot
principles.
The vaccine has been fully tested and found
to
conform
to
accepted standards
of
potency, safety and sterility.
For the immunization
of
cats against feline panleucopaenia (feline enteritis) virus,
feline rhinotracheitis virus (feline herpesvirus type
1)
and feline calicivirus.
PRODUCT
IS
IN
1ML DOSE SYRINGE OR 1ML DOSE VIAL
IN
PACKS
OF
20,
25
AND 50.
PRODUCT
IS
IN
1
OML
DOSE VIAL.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
Contents must
be
left
in
outer package until immediately before use
'
Shake gently before use
N/A
~
N/A
RT:P
.
NIA
.
Some animals may show transient post-vaccination reactions including
pain, malaise,
lethargy, inappetence, transient fever, depression and/or stiffness.
These reactions
usually disappear within 24 -
48
hours.
Allergic reactions such as anaphylaxis occur
rarely and may require parenter
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Productkenmerken
PRODUCT NAME: FEVAC 3 VACCINE
PAGE: 1 OF 6
THIS VERSION ISSUED: 19 FEBRUARY 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:
FEVAC® 3 VACCINE
OTHER NAMES:
None.
APVMA APPROVAL NO:
52630
CHEMICAL FAMILY:
Inactivated Feline Calicivirus, Feline Panleucopenia virus and Feline
Rhinotracheitis
virus in an aqueous medium.
RECOMMENDED USE:
For the immunisation of cats against feline enteritis (panleucopenia),
feline
rhinotracheitis (feline herpes virus type 1) and feline calicivirus.
Administer by
injection.
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
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