SEDAMED MEDETOMIDINE INJECTION

Country: Ավստրալիա

language: անգլերեն

source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

active_ingredient:

MEDETOMIDINE HYDROCHLORIDE

MAH:

CEVA ANIMAL HEALTH PTY LTD

INN:

medetomidine HCl(1mg/mL)

pharmaceutical_form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

composition:

MEDETOMIDINE HYDROCHLORIDE IMIDAZOLE Active 1.0 mg/ml

units_in_package:

10mL

class:

VM - Veterinary Medicine

manufactured_by:

CEVA ANIMAL HEALTH

therapeutic_group:

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

therapeutic_area:

ANAESTHETICS/ANALGESICS

therapeutic_indication:

ANALGESIC | RESTRAINT | SEDATIVE | ANTIPYRETIC | COLIC | MUSCLE RELAXANT | SEDATIVE | SPASMOLYTIC

leaflet_short:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANALGESIC, RESTRAINT, SEDATIVE]; DOG: [ANALGESIC, RESTRAINT, SEDATIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANALGESIC, RESTRAINT, SEDATIVE]; DOG: [ANALGESIC, RESTRAINT, SEDATIVE]; Sedative and analgesic for use in the restraint of dogs and cats.NOT TO BE USED in food producing animals. Use of this product in pregnancy has not been monitored in sufficient animals, and is, therefore, not recommended. Not to be used in conjunction with sympathomimetic amines. Other precautions, etc See Label.

authorization_status:

Registered

authorization_date:

2023-07-01

PIL

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
SEDAMED
MEDETOMIDINE INJECTION
Active constituent: Medetomidine
Hydrochloride1
mg/ml
Sedative and analgesic for use
in
the restraint of
dogs and cats
10
ml
•
RLP
APPROVED
Product: SEDAMED Medetomidine Injection
Date:
21
January 2013
READ THE ENCLOSED LEAFLET BEFORE
FIRST
AID:
If
poisoning
occurs,
USING THIS PRODUCT.
contact
a
doctor
or
Poisons
Information Centre.
Phone Australia
DIRECTIONS FOR USE:
131126;
NZ
0800 764766.
After withdrawal of the first dose, use remaining
product within 3 months after opening.
RESTRAINT: NOT TO
BE
USED
IN
FOOD
PRODUCING ANIMALS.
DOSE RATE (DOGS)
1/M
or
1/V
injection
EFFECT
DOSE
QUANTITY
F.LG/KG
ML/10
KG
Mild
10-30
0.1
- 0.3
sedation
Moderate-
30-80
0.3-0.8
deep
sedation+
analgesia
Pre-
10-20
0.1
-0.2
anaesthesia
DOSE RATE (CATS)
1/M
injection
EFFECT
DOSE
QUANTITY
F.LG/KG
ML/5
KG
Moderate
50-
100
0.25-0.5
sedation
Deep
100-
150
0.5-0.75
sedation
Carton Label
Registered to:
CEVA ANIMAL HEALTH PTY LTD
11
Moores
Rd
Glenorie NSW 2157 Australia
Tel: [phone]
Fax: [phone]
7001
www.ceva.com.au
DISPOSE
of
empty
container
by
wrapping with
paper and putting
in
garbage.
STORE below 25oc (Air
Conditioning).
Do
not freeze .
APVMA No.:60918/58318
B:
Exp:
DOM:
Stock:
Carton-
White 315gsm bleach board crash bottom.
Dimensions: 138 X 143 mm
Colours:
Barcode: 9 322387 001946
Page 1
of4
Sedative and analgesic for use
in
the restraint of dogs and
cats
READ ENCLOSED LEAFLET BEFORE USING PRODUCT.
Ceva Animal Health Pty Ltd
APVMA No.
60918/58318
STORE
below 25°C (Air Conditioning).
Do
not freeze.
Product
SEDAMED Medetor:nidirie Injection
'
..
:~.
Date:
21
January 2013
PRESCRIPTION ANIMAL REMEDY
KEEP
OUT
OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
SEDAMED
MEDETOMIDINE INJECTION
Medetomidine Hydrochloride
1
mg/ml
10
ml
Vial Label
B:
Exp:
DOM:
Stock: High gloss white ET9 permanent 85 gsm, 75 mm core, roll
direction (4)
Dimensions: 25 X 75 mm
Colour:
Page 2
of4
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF

SPC

Sedamed Injection 

Creation Date: April 2006 
Revision Date: May 2011 
Version: 1   
Next revision due: May 2016 

MATERIAL SAFETY DATA SHEET 
_SEDAMED INJECTION_

Page 1 of 8 

COMPANY DETAILS

COMPANY:

ADDRESS: 
Ceva Animal Health Pty Ltd 

11 Moores Road 
ABN 54 002 692 426    

Glenorie   NSW   2157  Australia 

TELEPHONE NUMBER:

FACSIMILE NUMBER:

[phone] 

[phone] 

EMERGENCY TELEPHONE NUMBER:

[phone] (Business Hours) 
Poisons Information Centre: 131126 

SUBSTANCE IDENTIFICATION 

PRODUCT NAME: 
NV Sedamed Injection 

OTHER NAMES: 

 Sedamed 

 Medetomidine 
injection 

Medetomidine chemical name (CAS name):     
IH-Imidazole, 4(1-(2,3-dimethylphenyl)ethyl)- 

MANUFACTURER’S PRODUCT CODE: 
1MED 

UN NUMBER: 
None allocated 

DANGEROUS GOODS CLASS AND SUBSIDIARY RISK: 
None allocated 

HAZCHEM CODE: 
None allocated 

SUSDP POISONS SCHEDULE NUMBER: 
S4 

USE: 
Dose-dependent injectable sedative/analgesic for dogs and cats. 
SECTION 1 – IDENTIFICATION OF MATERIAL AND SUPPLIER 
Sedamed Injection 

Creation Date: April 2006 
Revision Date: May 2011 
Version: 1   
Next revision due: May 2016 

MATERIAL SAFETY DATA SHEET 
_SEDAMED INJECTION_

Page 2 of 8 

STATEMENT OF HAZARDOUS NATURE:

Hazardous according to criteria of NOHSC Australia. 

RISK PHRASES: 
None.  

SAFETY PHRASES: 
S46  
If swallowed, contact a doctor or Poisons Information
Centre immediately and show this 
container or label.” 

The substance is a complex mixture, including the following
ingredients.  

INGREDIENTS: 
 CHEMICAL 
NAME   CAS 
NUMBER 
  PROPORTION 
 *medetomidine 
hydrochloride 
 86347-15-1 
  1.0 
g/L 

other ingredients determined not to�