ANTISEDAN SPECIFIC REVERSER OF MEDETOMIDINE AND DEXMEDETOMIDINE FOR DOGS AND CATS

Country: Ástralía

Tungumál: enska

Heimild: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Virkt innihaldsefni:

ATIPAMEZOLE HYDROCHLORIDE

Fáanlegur frá:

ZOETIS AUSTRALIA PTY LTD

INN (Alþjóðlegt nafn):

atipamezole HCl(5mg/mL)

Lyfjaform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Samsetning:

ATIPAMEZOLE HYDROCHLORIDE UNGROUPED Active 5.0 mg/ml

Einingar í pakka:

10mL

Tegund:

VM - Veterinary Medicine

Framleitt af:

ZOETIS AUSTRALIA

Meðferðarhópur:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Lækningarsvæði:

ANTIDOTES

Ábendingar:

DEXMEDETOMIDINE REVERSING AGENT & ANT | MEDETOMIDINE REVERSING AGENT&ANTAGONIST

Vörulýsing:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [DEXMEDETOMIDINE REVERSING AGENT & ANT, MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; DOG: [DEXMEDETOMIDINE REVERSING AGENT & ANT, MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; For parenteral use in reversing and abolishing the effects of medetomididne hydrochloride (DOMITOR) and dexmedetomidine (DEXDOMITOR) In dogs and cats.Skin contact with solution should be avoided - wipe off excess spillage on skin of animals.

Leyfisstaða:

Registered

Leyfisdagur:

2023-07-01

Upplýsingar fylgiseðill

APPENDIX
2
Australian Government
Australian Pesticides and
Veterinary Medicines Authority
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
Cl
New
Product
(include
all
applicable
RLPs)
OR
a
Variation (highlight instructions that
are
being
varied). Approval
no.
of
label
being
varied: 40612/57338
Signal
heading:
Product name:
Active
constituentls:
Statement
of
claims:
.
·
.
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contraindication
s:
. .
Precautions:
Side
effects:
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL TREATMENT
ONLY
ANTIS
ED
AN®
Specific
reverser
of
medetomidine
and
dexmedetomidine
for
dogs
and
cats
5
mg
/mL
ATIPAMEZOLE
HYDROCHLORIDE
For parenteral use
in
reversing and abolishing the effects of medetomidine
hydrochloride (DOMITOR®) and dexmedetomidine hydrochloride
(DEXDOMITOR®)
in
dogs and cats .
.
10
ml
Refer to sections below.
Not applicable.
Atipamezole has only been administered to a limited number
of
pregnant dogs so
cannot be recommended during pregnancy.
~--
-··-
-
.
----
-~
Due
to
the
potent
pharmacological
activity
of
atipamezole,
skin
contact
with
ANTI SEDAN
solution
should
be
avoided.
Wipe off excess
spillage
on
skin
of
animals.
In
dogs,
a
transient
hypotensive effect has been
observed
during the
first
10
minutes post-injection. Vomiting and panting after atipamezole
injection have been
reported,
but
these
effects
appear
to
be
rare.
Transient
over-alertness
tachycardia
may
be observed after a possible overdosage.
"
18
Wormald Street, Symonston ACT 2609
PO
Box 6182, Kingston ACT 2604 Australia
Tel:
+61
2 6210 4700
Fax:
+61
2 6210 4874
1AIW\IV.apvma.gov.au
ABN 19
495
043 447
+
RLP
Approved
and
"""
""~
"
",Dosage
&
ANTISEDAN
is
to
be
used by the intramuscular
(1M)
route of administration.
·administration:
The following dosage should
be
adhered
to
when administering ANTISEDAN to
counter the effects of DOMlTOR (medetomidine hydrochloride):
Animal
Dose
Quantity
5 times that
of
previous
The same volume
as
the
Dog
medetomid

Vara einkenni

PRODUCT NAME: ANTISEDAN® SPECIFIC REVERSER OF MEDETOMIDINE FOR DOGS
AND CATS
PAGE: 1 OF 4
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:
Active ingredient is an imidazole derivative
TRADE NAME:
ANTISEDAN
® SPECIFIC REVERSER OF MEDETOMIDINE FOR DOGS AND CATS
PRODUCT USE:
This product is an alpha2-adrenergic antagonist, applied by injection.
CREATION DATE:
JULY, 2007
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until December, 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:
S45, S24/25. In case of accident or if you feel unwell, contact a
doctor or Poisons Information
Centre immediately (show this MSDS where possible). Avoid contact with
skin and eyes.
SUSMP CLASSIFICATION:
S4
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
: Clear, colourless liquid.
ODOUR:
No 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
Administration of atipamezole causes transient changes in heart rate
and blood pressure. Clinical use of this drug has caused
nervousness, excitation, vomiting, and diarrhoea. High doses of
atipamezole ma