FEL-O-VAX 4 VACCINE (INACTIVATED)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

FELINE CALICIVIRUS - INACTIVATED; CHLAMYDOPHILIA FELIS INACTIVATED; FELINE PANLEUCOPENIA VIRUS - INACTIVATED; FELINE RHINOTRACHEITIS VIRUS - INACTIVATED; AMPHOTERICIN; NEOMYCIN; POLYMYXIN B; THIOMERSAL

Available from:

Boehringer Ingelheim Animal Health 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 P; CHLAMYDOPHILIA FELIS 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; AMPHOTERICIN ANTIBIOTIC Other 1.36 ug/ml; NEOMYCIN ANTIBIOTIC Other 12.0 ug/ml; POLYMYXIN B ANTIBIOTIC Other 20.0 IU/ml; THIOMERSAL MERCURY Other 68.0 ug/ml

Units in package:

10 x 1mL; 25 x 1mL

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT - OVER 8 WEEKS OF AGE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

Product summary:

Poison schedule: 0; Withholding period: ; Host/pest details: CAT - OVER 8 WEEKS OLD: [FELINE CALICIVIRUS, FELINE CHLAMYDIA PSITTACI, FELINE ENTERITIS, FELINE RHINOTRACHEITIS, VACCINE]; 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, VACCINE]; For the active immunisation of healthy cats 8 weeks of age or older to aid in the reductions of clinical symptoms caused by infection with feline rhinotracheitis virus, feline calicivirus, panleucopenia virus, and Chlamydia psittaci.To be used by, or under the direction of a registered veterinary surgeon. This vaccine does not prevent infection or shedding. See Precaution/Side effects on product leaflet.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
FEL-0-VAJ<"'
4
VACCINE (INACTIVATED)
Contents:
1 dose
Vial label
Fei-0-Vax 4 Vaccine (Inactivated)
APVMA50559
Page 1 of 5
8 October 2013
RLP
Approved
To
be
used by,
or
under
the
direction
of
a registered veterinary surgeon.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
Store between 2-8°C.
Do not freeze.
Protect from light.
APVMA 50559/57810
Batch No.:
Expiry:
Boehringer
lngelheim
\
\
Tray
label-10
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
FEL-0-VAX"' 4 VACCINE (INACTIVATED)
Active
Constituents:
Fei-0-Vax 4 Vaccine (Inactivated)
APVMA50559
Page 2 of 5
8 October 2013
Inactivated 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, polymyxin
B,
neomycin and thiomersal (<0.05% w/v) added as preservatives.
Contents:
10 single dose vials
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, feline
calicivirus, panleucopenia virus and
Chlamydophila felis.
This vaccine does not prevent infection or shedding.
To be
used
by,
or
under
the
direction
of
a registered
veterinary
surgeon.
READ ENCLOSED
LEAFLET
BEFORE USING THIS PRODUCT
Dose: Withdraw the contents of a single dose vial
(1
mL) aseptically into a sterile syringe and
inject subcutaneously.
Store between 2-8°C.
Do
not freeze.
Protect from light.
APVMA No. 50559/57810
Batch No.:
Expiry:
Fei-0-Vax® 4 is a registered trademark of Boehringer lngelheim
Vetmedica
Inc.
-used
under
license.
·
Please
recycle
leaflet,
label
and
tray
only.
Boehringer
lngelheim
Tray
label-
25
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
FEL-0-VAX® 4 VACCINE (INACTIVATED)
ACTIVE CONSTITUENTS:
Fei-0-Vax 4 Vaccine (Inactivated)
APVMA50559
Page 3 of 5
8 October 2013
Inactivated feline rhinotracheitis virus (FVR 605,
RP<:
1.0}, feline calicivirus (FCV 255, R

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Summary of Product characteristics

CS: 1.9.46
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ08D
August 2011
ISSUED by BOEHRING
Issue Date :
FEL-O-VAX® 4 VACCINE (INACTIVATED)
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
FEL-O-VAX® 4 VACCINE (INACTIVATED)
PRODUCT NAME
Boehringer Ingelheim Pty. Limited
COMPANY NAME
78 Waterloo Rd North Ryde
NSW 2113 Australia
ADDRESS
1800 038 037
EMERGENCY TEL.
Tel: 1800 038 037
Fax: +61 2 8875 8715
TELEPHONE/FAX
NUMBER
animalhealth.au@boehringer-ingelheim.com
EMAIL
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, feline calicivirus, panleucopenia
virus and
Chlamydophila felis.
RECOMMENDED USE
2. HAZARDS IDENTIFICATION
Not classified as hazardous
NON-HAZARDOUS SUBSTANCE.
NON-DANGEROUS GOODS.
Not Classified as Hazardous according to criteria of National
Occupational
Health & Safety Commission, Australia (NOHSC).
Not Classified as Dangerous Goods according to the Australian Code for
the
Transport of Dangerous Goods by Road and Rail. (7th edition)
HAZARD
CLASSIFICATION
3. COMPOSITION/INFORMATION ON INGREDIENTS
Each 1 mL contains inactivated feline rhinotracheitis virus, feline
calicivirus, panleucopenia virus and Chlamydophila felis (each at
relative
potency of > 1). Amphotericin, polymyxin B, neomycin and thiomersal
added as
preservatives.
COMPOSITION,
INFORMATION ON
INGREDIENTS
NAME
RISK PHRASE
CAS
PROPORTION
HAZARD SYMBOL
INGREDIENTS
Ingredients determined
not to be hazardous
-
Balance
May contain thimerosal,
neomycin, formalin,
polymixin B, and/or
amphotericin B as a
preservative
<0.01%
Killed virus
-
4. FIRST AID MEASURES
No special precautions required. However, if inhaled, remove affected
person
from contaminated area. Keep at rest until recovered. If symptoms
persist seek
medical attention.
INHALATION
Do not induce vomiting. Wash out mouth thoroughly with water. If
symptoms
develop seek medical attention.
INGESTION

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