REVERSAMED INJECTION FOR DOGS AND CATS

Country: Awstralja

Lingwa: Ingliż

Sors: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredjent attiv:

ATIPAMEZOLE HYDROCHLORIDE

Disponibbli minn:

CEVA ANIMAL HEALTH PTY LTD

INN (Isem Internazzjonali):

atipamezole HCl(5mg/mL)

Għamla farmaċewtika:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Kompożizzjoni:

ATIPAMEZOLE HYDROCHLORIDE UNGROUPED Active 5.0 mg/ml

Unitajiet fil-pakkett:

10mL

Klassi:

VM - Veterinary Medicine

Manifatturat minn:

CEVA ANIMAL HEALTH

Żona terapewtika:

ANTIDOTES

Sommarju tal-prodott:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; DOG: [MEDETOMIDINE REVERSING AGENT&ANTAGONIST]; For reversing the sedative and analgesic effects of medetomidine HCl in dogs and cats.NOT recommended for pregnant dogs or cats. See label also for PRECAUTIONS and SIDE-EFFECTS.

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2023-07-01

Fuljett ta 'informazzjoni

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'
RELEVANT
LABEL
PARTICULARS: REVERSAMED INJECTION
FOR
DOGS AND
CATS
63507/45823
_Primary _
_Pack _
_(Carton): _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
REVERSAMED
INJECTION FOR DOGS AND CATS
Active constituent: 5 mg/mL ATIPAMEZOLE HYDROCHLORIDE
For reversing the sedative and analgesic effects of medetomidine HCI
in dogs and cats
10
ml
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
After withdrawal
of
the
first
dose,
use
remaining
product
within
28
days
after
opening.
RESTRAINT: NOT TO
BE
USED
IN
FOOD PRODUCING ANIMALS.
D
1/M
..
OSE RATE
InJectiOn
ANIMAL
DOSE
L!GLK!:L
QUANTITY
_MU _
1
0
KG
+
RLP
Approved
Dog
5 times that
of
the previous medetomidine
Same volume as the medetomidine HCI• dose
dose
(50-
400
UQ/kQ)
Cat
2.5 times that of the previous
Half the volume
of
the medetomidine HCI•
medetomidine dose
(125-
375
uq/kq)
dose
•when formulated at 1
mg/ml
metetomidine HCI
FIRST AID: IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS
INFORMATION CENTRE. PHONE AUSTRALIA 131126.
Registered to:
CEVA ANIMAL HEALTH PTY LTD
11
Moores
Rd
Glenorie
NSW
2157
Australia
Tel:
(61) 2
9652
7000
Fax:
(61) 2
9652
7001
WWW.CEVA.COM.AU
DISPOSE
of empty container by wrapping with paper and putting in garbage.
STORE
below 25"C (Air Conditioning).
Do
not freeze. Protect from light.
APVMA No.: 63507/45823
B:
Exp:
DOM:
PRODUCT OF AUSTRALIA
Ceva Animal Health
Page
1
OF
4
RELEVANT LABEL PARTICULARS: REVERSAMED INJECTION FOR DOGS AND CATS
63507/45823
_Immediate Container: _
PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT ONLY
Reversamed
Injection
for
Dogs and Cats
Active constituent:
5
mg/mL ATIPAMEZOLE HYDROCHLORIDE
For reversing the sedative and analgesic effects
of
medetomidine HCI
in
dogs and cats
10 mL
READ ENCLOSED LEAFLET BEFORE USING PRODUCT.
DIRECTIONS FOR USE: Refer Ia leaflet.
Registered
to:
CEVA Animal Health Pty Ltd
APVMA
No.
63507/45823
STORE below 25"C (Air Conditioning).
Do
not freeze. Protect from li

Karatteristiċi tal-prodott

PRODUCT NAME: REVERSAMED INJECTION FOR DOGS AND CATS
PAGE: 1 OF 5
THIS VERSION ISSUED: AUGUST, 2016
SAFETY DATA SHEET
Issued by: Ceva Animal Health Pty Ltd
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
CEVA ANIMAL HEALTH PTY LTD
PHONE: [phone] (OFFICE HOURS)
11 MOORES RD
FAX: [phone]
GLENORIE NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
Atipamezole injection.
TRADE NAME:
REVERSAMED INJECTION FOR DOGS AND CATS
APVMA CODE:
63507
PRODUCT USE:
Injection for Dogs and Cats – reversing Agent for Medetomidine.
CREATION DATE:
FEBRUARY, 2015
THIS VERSION ISSUED:
AUGUST, 2016
and is valid for 5 years from this date.
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 Australian Dangerous Goods (ADG)
Code, IATA and IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S23, S36, S24/25. Do not breathe vapours or mists. Wear suitable
protective clothing. 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
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P332+P313: If skin irritation occurs: Get medical advice.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal service.
EMERGENCY OVERVIEW
PHYSIC