CALMANT INJECTION SEDATIVE / ANALGESIC FOR HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

DETOMIDINE HYDROCHLORIDE

Available from:

RANVET PTY. LIMITED

INN (International Name):

detomidine HCl(10mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

DETOMIDINE HYDROCHLORIDE IMIDAZOLE Active 10.0 mg/ml

Units in package:

5 mL

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:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

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

Product summary:

Poison schedule: 4; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): NOT T O BE USED IN HORSES INTENDED FOR HUMAN CONSUMPTION.; Host/pest details: HORSE: [ANALGESIC, SEDATIVE]; For mild to heavy sedation of horses; and for all analgesia, including colic. Rapidly renders a horse easy to handle prior to, minor surgery, medication, treatment, examination, travel, etc.Use in conjunction with potentiated sulfonamide solns. Not recommended for use in pregnant mares. NOT TO BE USED in food producing animals. See PRECAUTIONS & OTHER EFFECTS on leaflet also.

Authorization status:

Registered

Authorization date:

2022-07-01

Patient Information leaflet

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
B:
Exp:
_Sedative/Analgesic for horses_
Active constituent:
Detomidine Hydrochloride 10mg/mL
5 ML
FOR I.M. OR I.V. INJECTION
APVMA APPROVAL NO. 60223/5mL/(0109)
RANVET PTY LTD
10-12 Green Street, Botany
NSW 2019 Australia
TOLL FREE (AUS): 1800 727 217
Phone: [phone]
Fax: [phone]
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
RESTRAINTS: NOT TO BE USED IN FOOD
PRODUCING ANIMALS.
Rapidly renders a horse easy to
handle prior to:
MINOR SURGERY
MEDICATION
TREATMENT
EXAMINATION
TRAVEL etc.
For mild to heavy sedation of horses;
and for all analgesia including colic.
DOSAGE AND ADMINISTRATION:
DISCARD WITHIN 28 DAYS OF THE INITIAL
VIAL BROACHING.
0.1mL to 0.8mL per 100kg of
body weight I.M. or I.V..
For full directions, see enclosed leaflet.
MEAT WITHHOLDING PERIOD
(HORSES): NOT TO BE USED IN
HORSES INTENDED FOR HUMAN
CONSUMPTION.
FIRST AID: If poisoning occurs,
contact a doctor or Poisons
Information Centre.
Phone Australia 131126;
New Zealand 0800 764 766.
DISPOSAL:
Dispose of empty vial by wrapping
with paper and putting in garbage
STORAGE:
Store below 25ºC (Air Conditioning).
Do not freeze. Protect from light.
_Sedative/Analgesic for horses_
_CALMANT_
_INJECTION_
_CALMANT_
_INJECTION_
WHILE EVERY EFFORT HAS BEEN MADE TO ENSURE THAT THERE ARE NO ERRORS,
IT REMAINS THE CLIENTS RESPONSIBILITY TO PROVIDE THE FINAL INDEPENDANT
INSPECTION. PLEASE CHECK THE MATERIAL CAREFULLY.
• Please check all copy, legal standards and sign and date your
approval for print • Colours are representational only.
SIZE:
F: 138 x 143 mm
COLOURS:
VERSION:
DATE:
ALTERATIONS:
FILE NAME: 42424_60223_5ML_PRIMARY_MPL_VO1
ROLL DIRECTION:
ART MEMO:
ARTIST: ALFRED
CLIENT APPROVAL:
DATE:
PMS 2593
DIE LINE
PH [phone] FAX [phone]
1. Supplied art
07/01/09
25/02/09
2. Alt art
PMS 165
File Name: 42424_60223_5mL_primary_MPL_VO1.pdf Size: 138 x 143mm Scale
on A4: 100%
APPROVED
LABEL
Info
PEST


Verified
PRESCRIPTION AN

Summary of Product characteristics

RANVET CALMANT INJECTION 5 ML
CHEMWATCH MATERIAL SAFETY DATA SHEET
ISSUE DATE: 5-MAR-2008 CHEMWATCH 4677-55
NA317EC
CD 2006/2 PAGE 1 OF 8
SECTION 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
PRODUCT NAME
RANVET CALMANT INJECTION 5 ML
SYNONYMS
PRODUCT USE
Sedative / analgesic for horses.
SUPPLIER
Company: Ranvet Pty Ltd (ACN: 001 606 033)
Address:
10- 12 Green Street
East Botany
NSW, 2019
AUS
TRALIA
Telephone: [phone]
Emergency Tel: +61
4 1 8 4 9 3 5 3 3 A/H
Fax: [phone]
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
NON-HAZARDOUS SUBSTANCE. NON-DANGEROUS GOODS. According to the
Criteria of
NOHSC, and the ADG Code.
POISONS SCHEDULE
S4
RISK
SAFETY
None under normal operating conditions.
Avoid exposure - obtain special instructions
before use.
SECTION 3 - COMPOSITION / INFORMATION ON INGREDIENTS
NAME
CAS RN
%
detomidine hydrochloride
90038-01-0
1
performance additives nonhazardous
>60
water
7732-18-5
SECTION 4 - FIRST AID MEASURES
SWALLOWED
For advice, contact a Poisons Information Centre or a doctor.
CONTINUED...
RANVET CALMANT INJECTION 5 ML
CHEMWATCH MATERIAL SAFETY DATA SHEET
ISSUE DATE: 5 - MAR - 2008 CHEMWATCH 4677-55
NA317EC
CD 2006/2 PAGE 2 OF 8
SECTION 4 - FIRST AID MEASURES
EYE
If this product comes in contact with eyes:
- Wash out immediately with water.
- If irritation continues, seek medical attention.
- Removal of contact lenses after an eye injury should only be
undertaken by skilled
personnel.
SKIN
If skin or hair contact occurs:
- Flush skin and hair with running water (and soap if available).
- Seek medical attention in event of irritation.
INHALED
- If fumes or combustion products are inhaled remove from contaminated
area.
- Other measures are usually unnecessary.
NOTES TO PHYSICIAN
Following recent ingestion or overdose of anxiolytic sedatives,
hypnotics and
neuroleptics, the stomach may be emptied by gastric lavage and
aspiration. Patients
should be managed with intensive symptomatic and supportive therapy
with particular
attention being paid to the maintenan