FEVAC F4 VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

FELINE CALICIVIRUS - 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 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 1mL; *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:

FELINE CALICIVIRUS | FELINE CHLAMYDIA PSITTACI | 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 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 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 and chlamydophila felis.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

AUSTRALIAN GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
RLP
APPENDIX 2
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
1:1
New Product (include all applicable RLPs) OR
IZI Variation (highlight instructions that are being varied). Approval
no. of label being varied: 55302/1004.
Signal heading:
FOR ANIMAL TREATMENT ONLY
Product name:
FEVAC
® F4 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) and
Chlamydophila felis
(CELLO, RP
?.. 1.0).
Amphotericin
(1.36 pg/mL),
polymixin
B (20 IU/mL),
neomycin
(12 pg/mL) and
thiomersal (68 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 and
Chlamydophila felis.
This vaccine does not prevent infection or shedding.
Net contents:
20 x 1mL
Dose Vials
25 x lnnL 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 reactions after vaccination are
rare but transient

Summary of Product characteristics

PRODUCT NAME: FEVAC F4 VACCINE
PAGE: 1 OF 5
THIS REVISION ISSUED: APRIL, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: [phone]
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
SUBSTANCE:
Emulsion of an inactivated virus combination.
TRADE NAME:
FEVAC
® F4 VACCINE
PFIZER MSDS CODE:
0889
PRODUCT USE:
For the immunisation of cats against feline enteritis (panleucopenia),
feline
rhinotracheitis (feline herpes virus type 1), feline calicivirus and
Chlamydiosis.
Administer by Injection. (Inactivated).
CREATION DATE:
SEPTEMBER, 2004
THIS VERSION ISSUED:
APRIL, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Pale pink aqueous liquid .
ODOUR:
No data - expected to be mild odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that this
product is not harmful. In addition product is unlikely to cause any
discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT: