FEVAC F5 VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

FELINE CALICIVIRUS - INACTIVATED; FELINE LEUKAEMIA VIRUS - INACTIVATED; FELINE CHLAMYDIA PSITTACI - INACTIVATED; FELINE PANLEUCOPENIA VIRUS - INACTIVATED; FELINE RHINOTRACHEITIS VIRUS - INACTIVATED

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

feline rhinotracheitis+feline calicivirus+feline parvovirus + others

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

FELINE CALICIVIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 U; FELINE LEUKAEMIA VIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 U; FELINE CHLAMYDIA PSITTACI - INACTIVATED VACCINE-VIRAL Active 0.0 U; FELINE PANLEUCOPENIA VIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 U; FELINE RHINOTRACHEITIS VIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 U

Units in package:

*25 x 1 mL; *Vials; 20 x 1mL; Vials

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

CAT - OVER 8 WEEKS OF AGE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: CAT - OVER 8 WEEKS OLD: [FELINE CALICIVIRUS, FELINE CHLAMYDIA PSITTACI, FELINE ENTERITIS, FELINE LEUKAEMIA VIRUS, FELINE RHINOTRACHEITIS]; For the active immunisation of healthy cats 8 weeks of age or older to aid in the reduction of clinical symptoms caused by infection with feline rhinotracheitis virus, panleucopenia virus, feline calicivirus, chlamydophila felis and feline leukaemia virus

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

AUSTRALIAN GOVERNMENT
Australian Pesticides and
Veterinary Medicines Authority
RLP
APPENDIX 2
Appre
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
1:1
New Product (include all applicable RLPs) OR
El Variation (highlight instructions that are being varied). Approval
no. of label being varied: 55303/1104.
Signal heading:
FOR ANIMAL TREATMENT ONLY
Product name:
Fevac® F5
vaccine
Active constituent/s:
Feline rhinotracheitis virus (FVR 605, RP
1.0), feline calicivirus (FCV 255, RP
1.0), panleucopenia virus (FPV CU-4, RP .?. 1.0),
Chlamydophila felis
(CELLO, RP
1.0) and feline leukaemia virus (1161E, RP
1.0).
Amphotericin
(0.32
pg/mL),
polymixin
B
(14
IU/nnL),
neomycin
(4
pg/mL) and
thionnersal (18 pg/mL) have been added as preservatives.
Statement of claims:
An inactivated vaccine for the active immunisation of healthy cats 8
weeks of age or
older to aid in the reduction of clinical symptoms caused by infection
with feline
rhinotracheitis virus, panleucopenia virus, feline calicivirus,
Chlamydophila felis
and
feline leukaemia virus. This vaccine does not prevent infection or
shedding.
Net contents:
20 x lnnL Dose Vials
25 x 1mL Dose Vials
Directions for Use
Heading:
DIRECTIONS FOR USE
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
To be used by, or under the direction of a registered veterinary
surgeon.
Restraints:
N/A
Contraindications:
N/A
Precautions:
Vaccinate only healthy cats or kittens with normal temperatures.
Animals under
treatment with immunosuppressive drugs should be vaccinated with
caution. Studies
to support the use of the product in pregnant queens have not been
conducted.
Side effects:
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 parenteral treatment with an antihistamine, a
corticosteroid or
adrenalin as appropriate. Local site r

Read the complete document

Summary of Product characteristics

PRODUCT NAME: FEVAC F5 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® F5 VACCINE
OTHER NAMES:
None.
APVMA APPROVAL NO:
55303
CHEMICAL FAMILY:
Inactivated Feline Calicivirus, Feline Panleucopenia virus Feline
Rhinotracheitis virus,
Feline Leukaemia virus and Feline Chlamydia psittaci in an aqueous
medium.
RECOMMENDED USE:
For the immunisation of cats against feline leukaemia, feline
enteritis
(panleucopenia), feline rhinotracheitis (feline herpes virus type 1),
feline calicivirus
and Chlamydiosis. 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: Pr

Read the complete document