ROMAZINE 100 INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

XYLAZINE AS THE HYDROCHLORIDE

Available from:

AUSRICHTER PTY LTD

INN (International Name):

xylazine as HCl(100mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

XYLAZINE AS THE HYDROCHLORIDE THIAZOLE Active 100.0 mg/ml

Units in package:

50mL

Class:

VM - Veterinary Medicine

Manufactured by:

AUSRICHTER

Therapeutic group:

DEER | HORSE | COLT | DOE | DONKEY | ENDURANCE HORSE | FALLOW DEER | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES A

Therapeutic area:

CENTRAL NERVOUS SYSTEM

Therapeutic indications:

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

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT (HORSES DEER): DO NOT USE l ess than 28 days before slaughter for h uman consumption.; Host/pest details: DEER: [ANALGESIC]; HORSE: [ANALGESIC]; Poison schedule: 4; Withholding period: ; Host/pest details: DEER: [ANALGESIC]; HORSE: [ANALGESIC]; Sedative, analgesic and muscle relaxant for horses and deer.DO NOT treat during last month of pregnancy or where cardiovascular/cardiac disease/hypertension may already exist. DO NOT treat in conditions where respiratory depression already exists. DO NOT use in conj. with tranquillisers.

Authorization status:

Registered

Authorization date:

2023-07-01

Summary of Product characteristics

IN THE HORSE
SURGICAL PROCEDURES
GENERAL
DIAGNOSTIC
Cauterization
Bandaging
Radiography
Caslick’s procedure
Dental procedures
Endoscopy
Debridement
To calm and facilitate handling of
fractious horses
Abdominal/rectal palpation
Surgical procedures of
short duration
Cast application/removal
Catheterisations
Lancing of abscesses
Pain relief following surgery
Ultrasound
Suturing of lacerations
Administration of medications
Colic evaluation
Sedation before general
anaesthetic
Hair clipping
With local anaesthetics for pain
management
IN _CERVIDAE_ (DEER): Romazine 100 is registered for administration to
the
deer species (see pack insert). The use of Xyalzine is indicated:

To calm and facilitate handling fractious animals;

For management and identification procedures: ear tagging, ear
marking, ear tattooing;

Diagnostic procedures;

Minor surgical procedures including removal of antlers, hoof
treatment;

To facilitate medication for sedation, pain management and relief
following injury or surgery;

For pain management with local anaesthetics (such as procaine or
lidocaine).
www.drugs.com/vet/xylazine
XYLAZINE FOR COLIC IN HORSES
Xylazine also has potent effects on intestinal motility. The jejunum
and large
intestine have less activity for up to 2 hours after a 1.1 mg/kg dose.
This is a
profound effect giving relief from both somatic and visceral pain
caused by
distention or strangulation.
Xylazine may be indicated to help relax contracting intestine or to
help
restrain a horse in order to prepare for surgery. The short period of
ileus is
not detrimental and is followed by resumption of intestinal transit.
Analgesia may only last 10-30 minutes or have minimal effect in horses
with
strangulating lesions such as large colon torsion. In horses with
large or
small colon impactions Xylazine appears beneficial in relieving the
spasm of
the intestine around the obstructing mass, thereby allowing passage of
gas
and rehydration of ingesta.
This can often be accomplished with doses of 0.1 to 0.3 mg/kg
intrave

Safety Data Sheet

PRODUCT NAME: ROMAZINE 100 INJECTION
PAGE: 1 OF 5
THIS VERSION ISSUED: APRIL, 2016
SAFETY DATA SHEET
ISSUED BY: AUSRICHTER 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
AUSRICHTER PTY LTD
PHONE: [phone]
2/21 CHESTER ST
FAX: [phone]
CAMPERDOWN NSW 2050
[e-mail]
CHEMICAL NATURE:
Xylazine and other minor ingredients in water solution.
TRADE NAME:
ROMAZINE 100 INJECTION
APVMA CODE:
47523
PRODUCT USE:
Injectable anaesthetic preparation for cattle, horses and deer.
CREATION DATE:
APRIL, 2016
THIS VERSION ISSUED:
APRIL, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xn, Harmful. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING
Acute Toxicity Oral Category 4
HAZARD STATEMENT:
H302: Harmful if swallowed.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P312: IF SWALLOWED: Call a POISON CENTRE or doctor if you feel
unwell.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 30°C.
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P501: Dispose of sm