FEL-O-VAX 5 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 LEUKAEMIA VIRUS - 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 LEUKAEMIA VIRUS - 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 0.32 ug/ml; NEOMYCIN ANTIBIOTIC Other 4.0 ug/ml; POLYMYXIN B ANTIBIOTIC Other 14.0 IU/ml; THIOMERSAL MERCURY Other 18.0 ug/ml

Units in package:

10 x 1mL vials; 25 x 1mL vials

Class:

VM - Veterinary Medicine

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, feline calicivirus, panleucopenia virus, Chlamydophila felis and feline leukaemia virusSee Precaution/ Side effects information on label. This vaccine does not prevent infection or shedding.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

READ
SAFETY
DIRECTIONS
FOR ANIMAL TREATMENT
ONLY
FEL-0-VAX® 5 VACCINE (INACTIVATED)
Contents:
1 dose
Vial label
Fei-0-Vax 5 Vaccine (Inactivated)
APVMA51366
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 51366/57811
Batch No.:
Expiry:
Boehringer
lngelheim
Tray
label-
10
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
FEL-0-VAX® 5 VACCINE (INACTIVATED)
ACTIVE CONSTITUENTS:
Fei-0-Vax 5 Vaccine (Inactivated)
APVMA51366
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),
Chlamydophifa fefis
(CELLO, RP
2!
1.0) and
feline leukaemia virus
(1161
E,
RP"
1.0), amphotericin, polymyxin
B,
neomycin and thiomersal
( <0.05% w/v) added as preservatives.
Contents:
1 0 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,
Chfamydophifa felis
and feline leukaemia virus.
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. 51366/57811
Batch No.:
Expiry:
Fei-0-Vax® 5 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® 5 VACCINE (INACTIVATED)
ACTIVE CONSTITUENTS:
Fei-0-Vax 5 Vaccine (Inactivated)
APVMA51366
Page 3 of 5
8 October 2013
Inactivated feline rhinotrachei

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Summary of Product characteristics

CS: 1.9.46
Page:
1
MATERIAL SAFETY DATA SHEET
4
of
Infosafe No™
LQ088
August 2011
ISSUED by BOEHRING
Issue Date :
FEL-O-VAX® 5 VACCINE (INACTIVATED)
Product Name :
Not classified as hazardous
1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER
FEL-O-VAX® 5 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, panleucopenia virus, feline
calicivirus,
feline leukaemia 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 1mL contains inactivated feline rhinotracheitis virus,
inactivated feline
calicivirus, inactivated feline panleucopenia virus, inactivated
feline
leukaemia virus and inactivated feline Chlamydophila felis (each at
relative
potency of > 1). Amphotericin, polymyxin B, neomycin and thiomersal
added as
preservatives.
INFORMATION ON
COMPOSITION
NAME
RISK PHRASE
CAS
PROPORTION
HAZARD SYMBOL
INGREDIENTS
Ingredients determined
not to be hazardous
-
Balance
Live virus vaccine
-
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
W

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