DORMOSEDAN GEL

Страна: Австралия

Език: английски

Източник: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Активна съставка:

DETOMIDINE HYDROCHLORIDE

Предлага се от:

JUROX PTY LIMITED

INN (Международно Name):

detomidine HCl(7.6mg/mL)

Лекарствена форма:

ORAL GEL

Композиция:

DETOMIDINE HYDROCHLORIDE IMIDAZOLE Active 7.6 mg/ml

Броя в опаковка:

3mL

Клас:

VM - Veterinary Medicine

Произведено от:

JUROX

Терапевтична група:

HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL

Терапевтична област:

ANAESTHETICS/ANALGESICS

Терапевтични показания:

RESTRAINT | SEDATIVE | SEDATIVE

Каталог на резюме:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: HORSE: [RESTRAINT, SEDATIVE]; Oromucosal gel for sublingual use. For sedation and restraint in horses.NOT TO BE USED in food producing animals. See label.

Статус Оторизация:

Registered

Дата Оторизация:

2023-07-01

Листовка

REGISTRANT:
Pfizer Animal Health
TRADE NAME:
DORMOSEDAN
®
Gel
APVMA
NO.:
65579
PREPARATION DATE:
06 December 2012
PAGE:
1 of 9
COMMENTS:
Various changes to content as per APVMA requirements letter dated
30 November 2012.
Text in the header box will not appear on the final label
LABEL
RIGHT PANEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
[Horse graphic]
DORMOSEDAN
® GEL 3.0 ML
7.6 MG/ML DETOMIDINE HYDROCHLORIDE
Oromucosal gel for sublingual use.
For sedation and restraint in horses
[Pfizer Logo]
LABEL
CENTER PANEL
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
RESTRAINT: NOT TO BE USED IN FOOD PRODUCING ANIMALS
Dose: Refer to enclosed leaflet
MEAT WITHHOLDING PERIOD (HORSES): NOT TO BE USED IN HORSES INTENDED
FOR
HUMAN CONSUMPTION.
APVMA No. 65579/51349
Developed and Manufactured by
[Orion Pharma logo]
Orion Corporation
Espoo, Finland
Store below 25°C (Air Conditioning) in original packaging.
Protect from light.
[Label identifier]
LABEL
LEFT PANEL
Batch No
Exp:.: RLP APPROVED
REGISTRANT:
Pfizer Animal Health
TRADE NAME:
DORMOSEDAN
®
Gel
APVMA
NO.:
65579
PREPARATION DATE:
06 December 2012
PAGE:
2 of 9
COMMENTS:
Various changes to content as per APVMA requirements letter dated
30 November 2012.
Text in the header box will not appear on the final label
CARTON
MAIN PANEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
[Horse graphic]
DORMOSEDAN
® GEL
7.6 MG/ML DETOMIDINE HYDROCHLORIDE
For sedation and restraint in horses
3.0 ML Oromucosal gel for sublingual use.
[Pfizer Logo]
CARTON
REAR PANEL
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
RESTRAINT: NOT TO BE USED IN FOOD PRODUCING ANIMALS
DOSAGE:
This is a single-use product. Discard any remaining product after
administration.
APPROXIMATE
BODY WEIGHT
(KG)
DOSE VOLUME
(ML)
RANGE OF DOSES
(MG/KG)
150 – 199
1.00
0.051 – 0.038
200 – 249
1.25
0.047 – 0.038
250 – 2

Данни за продукта

PRODUCT NAME: DORMOSEDAN GEL
PAGE: 1 OF 5
THIS VERSION ISSUED: NOVEMBER, 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:
Detomidine is an imidazole derivative; an alpha-2-adrenergic receptor
agonist.
TRADE NAME:
DORMOSEDAN GEL
APVMA CODE:
65579
PRODUCT USE:
Veterinary product used as analgesic, sedative. For veterinary use
only as described
on the product label.
CREATION DATE:
JUNE, 2013
THIS VERSION ISSUED:
NOVEMBER, 2015
and is valid until June, 2018.
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:
S23, S36, S24/25. Do not breathe vapours. 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.
HAZARD STATEMENT:
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.
P403+P235: Store in a well-ventilated place. Keep cool.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if re

Информационен лист за безопасност

WWW.JUROX.COM.AU
Customer Service 1800 023 312
Dormosedan is a registered trademark of Orion Corporation
TECHNICAL NOTES
REGISTERED NAME
Dormosedan® Gel
ACTIVE CONSTITUENTS
7.6 mg/mL detomidine hydrochloride
DESCRIPTION
DORMOSEDAN Gel is an even, translucent blue gel containing 7.6 mg/mL
detomidine hydrochloride.
INDICATIONS
DORMOSEDAN Gel is indicated for sedation and restraint in horses,
appropriate for procedures such as grooming, hoof care, rasping of
teeth, passage of nasogastric tube, endoscopy of the upper airway,
oesophagus or stomach, or radiography.
PHARMACOKINETICS
Detomidine is an alpha-2 adrenoceptor agonist with a central effect
inhibiting the transmission of noradrenalin-mediated nervous
impulses. In the animal, the level of consciousness is lowered and the
pain threshold is increased. The duration and level of sedation are
dose dependent. In the studies conducted with the recommended 40
μg/kg dose of the gel, the time to onset of sedation has been
approximately 30-40 minutes and the duration of sedation 1.5 to 3
hours. With detomidine administration, heart rate is decreased. A
transient
change in the conductivity of the cardiac muscle may occur, as
evidenced by partial atrioventricular (AV) and sinoauricular (SA)
blocks.
Respiratory rate is slightly decreased. In some horses, sweating,
salivation and slight muscle tremors may be seen. Partial, transient
penis
prolapse may occur in stallions and geldings. Blood glucose
concentration may be temporally increased.
DORMOSEDAN
®
Gel
WWW.JUROX.COM.AU
Customer Service 1800 023 312
Dormosedan is a registered trademark of Orion Corporation
TECHNICAL NOTES
PHARMACODYNAMICS
At a dose of 40 μg/kg, the mean C
max
for the sublingual product was 4.3 ng/mL. Although the t
max
was 1.83 hours for the sublingual
product, clinical signs of sedation were evident at approximately half
an hour after dosing. The bioavailability of sublingually
administered detomidine gel in the horse is about 27%. If the product
is swallowed the bioavailability is significantly decrea