CYLAP RCD VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

INACTIVATED RABBIT CALICIVIRUS DISEASE VIRUS; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

RHDV (calicivirus)(2560U/mL)

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

INACTIVATED RABBIT CALICIVIRUS DISEASE VIRUS VACCINE-VIRAL Active 2560.0 HAu/mL; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

10mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

RABBIT - EUROPEAN

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

RABBIT CALICIVIRUS DISEASE

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil; Host/pest details: RABBIT - EUROPEAN: [RABBIT CALICIVIRUS DISEASE]; Poison schedule: 0; Withholding period: ; Host/pest details: RABBIT - EUROPEAN: [RABBIT CALICIVIRUS DISEASE]; For the control of rabbit calicivirus disease in European rabbits.See RESTRAINTS etc. on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

----------------------------------------------
APPENDIX 2
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary Products)
Select appropriate:
D
New
Product
(include
all
applicable
RLPs)
OR
liD
Variation (highlight instructions that
are
being
varied).
Approval
no.
of
label
being
varied:49682/1 0/0610
Signal
heading:
Product
name:
Active
constituent/s:
Statement
of
claims:
Net
contents:
Directions for Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
+
RLP
Approved
Dosage
&
administration:
FOR
ANIMAL TREATMENT ONLY
CYLAP®
RCD
Vaccine
Each
1
ml
dose
contains
inactivated rabbit calicivirus
(2560
haemagglutination units)
and
not
more
than
0.1
mg/ml thiomersal
added
as
a preservative
For the control
of
Rabbit Calicivirus Disease in European Rabbits
1
Oml
(1
0
Doses)
DIRECTIONS FOR USE
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
READ USER SAFETY AND FIRST AID INFORMATION BEFORE USE
To
be
used
by,
or
under
the
direction
of
a
registered
veterinary
surgeon
Rabbits
in
good health should be immunised when they are least likely to be
environmentally stressed
by extremes of temperature
or
humidity. A small
number of animals
in
any population may fall to respond
to
vaccination
as
a
result of immunological incompetence or for some other reason. Some
breeds
of European rabbits,
particularly dwarf rabbits,
may respond
differently to
vaccination due to their specific genetic profile.
N/A
Side
Effects:
In
a small number of vaccinated animals a localised injection site
reaction
may occur. This may
be
seen as a swelling and/or alopecia (loss
of
hair).
Some rabbits may show a transient general malaise. As with all
immunobiologicals and chemotherapeutics, occasional hypersensitivity
reactions such as anaphylaxis may occur.
In
such an event these rabbits
should
be
treated without delay by the parenteral administration
of
antihistamines, corticosteroids
or
adrenalin
as
is appropriate.
Dosage and
Administration:
Use the entire cont

Summary of Product characteristics

Product Name: Cylap® RCD Vaccine
Page: 1 of 5
This revision issued: October, 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
CHEMICAL NATURE:
Suspension of haemorrhagic viral disease (HVD) of rabbits virus
(inactivated).
TRADE NAME:
CYLAP
® RCD VACCINE
OTHER NAMES:
Cylap
APVMA CODE:
49682
PRODUCT USE:
Prevention of rabbit calicivirus disease (RCD) by vaccination in
European rabbits.
CREATION DATE:
JULY, 2012
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until November, 2017.
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 the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
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
: Fluid vaccine oil/water emulsion (50% water).
ODOUR:
No data.
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
INACTIVATED CULTURES AND TOXOIDS ARE NOT REGARDED AS PATHOGENIC IN
HUMANS.
SELF INJECTION: IN ALL INSTANCES OF ACCIDENTAL SELF INJECTION CONTACT
A DOCTOR AS SOON AS POSSIBLE. FURTHER
INFORMATION ON TREATMENT IS AVAILABLE FROM POISONS INFORMATION CENTRE.
PHONE 131 126.
INHALATION
SHORT TERM EXPOSURE:
The spray mist may be d