DUVAXYN R EQUINE ROTAVIRUS VACCINE (INACTIVATED)

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Δραστική ουσία:

EQUINE ROTAVIRUS (INACTIVATED); APRAMYCIN; AMPHOTERICIN B; NEOMYCIN; THIOMERSAL

Διαθέσιμο από:

ZOETIS AUSTRALIA PTY LTD

INN (Διεθνής Όνομα):

vaccine - rotavirus (killed)

Φαρμακοτεχνική μορφή:

MISC. VACCINES OR ANTI SERA

Σύνθεση:

EQUINE ROTAVIRUS (INACTIVATED) BIOLOGICAL Active 1.0 RP; APRAMYCIN ANTIBIOTIC Other 0.0 P; AMPHOTERICIN B ANTIBIOTIC Other 0.0 P; NEOMYCIN ANTIBIOTIC Other 0.0 P; THIOMERSAL MERCURY Other 0.1 %

Μονάδες σε πακέτο:

10ml; 10x10mL

Kατηγορία:

VM - Veterinary Medicine

Κατασκευάζεται από:

ZOETIS AUSTRALIA

Θεραπευτική ομάδα:

HORSE PREGNANT

Θεραπευτική περιοχή:

IMMUNOTHERAPY

Θεραπευτικές ενδείξεις:

ROTAVIRUS ENTERITIS | VACCINE | EQUINE ROTAVIRUS

Περίληψη προϊόντος:

Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: HORSE PREGNANT: [ROTAVIRUS ENTERITIS, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: HORSE PREGNANT: [ROTAVIRUS ENTERITIS, VACCINE]; For the vaccination of pregnant mares to stimulate production of antibodies against equine rotavirus in colostrum and milk as an aid in the management of rotavirus enteritis.See PRECAUTIONS and SIDE EFFECTS on label.

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2023-07-01

Φύλλο οδηγιών χρήσης

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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
0
Variation (highlight instructions that are being varied). Approval no.
of
label being varied: 56501/0607.
Signal
heading:
Product
name:
Active
constituenVs:
Statement of
claims:
Net
contents:
DIRECTIONS
FOR
USE
Heading:
Restraints:
CONTRA
INDICATIONS:
PRECAUTIONS:
Side
effects:
Dosage
&
ADMINISTRATION:
FOR ANIMAL TREATMENT ONLY
DUVAXYN® R EQUINE ROTAVIRUS VACCINE (INACTIVATED)
Contains equine rotavirus (RP
2:
1.0), grown in tissue culture, chemically inactivated
and added to an oil adjuvant.
Contains Polymyxin
B,
neomycin, Amphotericin
Band
thiomersal (0.01%) as
preservatives.
For the vaccination
of
pregnant mares to stimulate the production
of
antibodies
against equine rotavirus
in
colostrum and milk as an aid
in
the management
of
rotavirus enteritis.
A~
10mL vial
"'If
10 x 10mL vials
RLP
DIRECTIONS FOR USE
Approveu
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
READ INSTRUCTIONS
ON
BACK OF LABEL BEFORE USING THIS PRODUCT
N/A
N/A
For use
in
pregnant mares only.
Foals born from vaccinated mares may still show signs
of
diarrhoea. Thorough
diagnosis
of
the infectious agents, including rotavirus,
is
recommended to assist in the
control
of
infectious diarrhoea.
Allergic reactions such as anaphylaxis occur rarely and may require
parenteral
treatment with an antihistamine, a corticosteroid or adrenalin as
appropriate.
Use entire contents immediately upon opening. Administer 1
mL intramuscularly
in
the
8th,
gth
and
10
1
h
months
of
pregnancy using aseptic technique. A booster dose should
be
given one month prior to foaling for each subsequent pregnancy.
The presence
of
antibodies to rotavirus, even at high levels,
is
not always sufficient
to
prevent rotaviral disease
in
foals. Management practices should be implemented
in
conjunction with vaccination
to
assist
in
reducing the impa

Αρχείο Π.Χ.Π.

PRODUCT NAME: DUVAXYN® R EQUINE ROTAVIRUS VACCINE (INACTIVATED)
PAGE: 1 OF 6
THIS VERSION ISSUED: 6 JUNE 2014
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
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: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
DUVAXYN® R EQUINE ROTAVIRUS VACCINE (INACTIVATED)
APVMA APPROVAL NO:
56501
OTHER NAMES:
None.
CHEMICAL FAMILY:
Contains chemically inactivated equine rotavirus in an oily adjuvant.
Also contains
preservatives.
RECOMMENDED USE:
For the vaccination of pregnant mares to stimulate the production of
antibodies
against equine rotavirus in colostrum and milk as an aid in the
management of
rotavirus enteritis.
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 the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S36, S24/25. Wear suitable protective clothing. Avoid contact with
skin and eyes.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMSBC criteria.
GHS CLASSIFICATION:
GHS LABEL ELEMENTS: NONE. NOT HAZARDOUS.
SIGNAL WORD: NONE. NOT HAZARDOUS.
HAZARD STATEMENT: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P235: Keep cool, preferably between 2 and 8°C, but do not freeze.
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 burni