SEDIVET INJECTABLE SEDATIVE FOR HORSES
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Send request.
Active ingredient:
ROMIFIDINE HYDROCHLORIDE
Available from:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
INN (International Name):
romifidine HCl(10mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
ROMIFIDINE HYDROCHLORIDE UNGROUPED Active 10.0 mg/ml
Units in package:
20mL
Class:
VM - Veterinary Medicine
Therapeutic group:
HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL
Therapeutic area:
CENTRAL NERVOUS SYSTEM
Therapeutic indications:
PRE-ANAESTHETIC | TRANQUILLISER | ANAESTHETIC PREMEDICANT | CALMING AGENT | SEDATIVE
Product summary:
Poison schedule: 4; Withholding period: WHP: Do not administer later than 6 days before slaughter for human consumption.; Host/pest details: HORSE: [PRE-ANAESTHETIC, TRANQUILLISER]; Poison schedule: 4; Withholding period: WHP: Do not administer later than 6 day s before slaughter for human consumptio n.; Host/pest details: HORSE: [PRE-ANAESTHETIC, TRANQUILLISER]; Sedative to facilitate handling, examination and treatment, and as premedication agent prior to general anaesthesia.DO NOT USE IN PREGNANT MARES
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
Page 1
of
4
Sedivel
NRA359801
25.10.2000
BOTILE
LABEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
SEDIVEr®
Injectable sedative for horses
ACTIVE CONSTITUENT:
ROMIFIDINE HYDROCHLORIDE 10 MGTML
Sedative 10 facilitate handling,
examination and treatment, and as a premedication agent pnor
to general
anaesthesia.
20 mL
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
Pre~cription
Animal
Remedy (P.A.R) Class II.
For use only In the presence of a veterinarian.
DISPOSAL
Dispose ot empty container by wrappmg with paper and putting in
garbage.
STORAGE
Store below
30°C
(Room Temperature).
AUSTRALIA
Boehringer Ingelheim
Pty
Limited
Vetmedica Division
85
Waterloo Road
NORTH RYDE
NSW
2113
NRA
_35980/1100_
Batch No.:
Expiry Date:
NEW
ZEALAND
Boehringer Ingelheim(NZ) l-irrilted
Vetmedica Division
47
Druces Road, Wiri
1701
ARB No.
6097
N.R.A
.
..
~:~R~:~~~~~I.!.~~~.~
.
\\
.
Date:
_'Q_
_. ._
J....
.../.
......
Signature:
. .
"'0..--
Page 2 of 4
Sedivet
NRA
_359801_
25.10.2000
CARTON LABEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
SEDIVET"
Injectable sedative for horses
Active
Constituent:
Romifidine
hydrochloride
10
mglmL
Sedative to facilitate handling, examination and treatment, and as a
premedication agent prior
to general anaesthesia.
20mL
~O
'HE:
E.I'JC/..v~"'D
i--E:AF<'-£'r
BeFoRE
VSiNC,
THI5'
f>R.oP<.JGT
/ptJ~
DIRECTIONS FOR USE
(/
{/
DO NOT USE IN PREGNANT MARES
Injection to be given intravenously.
Lowering of the head is the first sign of sedation.
Light sedation:
0.04 mg active ingredient/kg bodyweight equals 0.4 mL injection
solution/100 kg bodyweight
Deep sedation:
0.08 mg active ingredient/kg bodyweight equals 0.8 mL injection
solution/100 kg bodyweiqht
Deep sedation with:
0.12 mg active ingredient/kg bodyweight equals 1.2 mL injection
prolonged duration
solution/100 kg bodyweight
WITHHOLDING PERIOD
Do
not
administer later
than
6 days before
slaughter
for
human
consumption.
,
,
Prescription Animal
Remedy (P.A.R) Class II.
For use on
Read the complete document
