NITROMEC INJECTION ENDECTOCIDE AND FLUKICIDE FOR CATTLE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

CLORSULON; IVERMECTIN; NITROXYNIL AS EGLUMINE

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

nitroxynil as eglumine(340g/L)+ivermectin(6.7g/L)+clorsulon(67g/L)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

CLORSULON UNGROUPED Active 67.0 g/L; IVERMECTIN ANTHELMINTIC Active 6.7 g/L; NITROXYNIL AS EGLUMINE PHENOL Active 340.0 g/L

Units in package:

1 L; 1 L X 3; 2.5 L; 500 mL

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 6; Withholding period: WHP: MEAT:DO NOT USE LESS than 56 days before slaughter for human consumption . Calves born to cows that have been tr eated with Virbac Nitromec Injection E ndectocide and Flukicide for Cattle dur ing pregnancy must not be slaughtered for human consumption for 56 days after treatment of the dam. MILK: DO NOT USE in cattle which are producing or may i n the future produce milk where the mil k or milk products may be used for huma n consumption. TRADE ADVICE: ESI: DO N OT USE less than 120 days before slaugh ter for export. Calves born to cows tha t have been treated with Virbac Nitrome c Injection Endectocide and Flukicide f or Cattle during pregnancy must not be slaughtered for export for 120 days a fter treatment of the dam. The ESI on t his label was correct at the time of la bel approval. Before using this product confirm the current ESI from either Vi rbac on 1800 009 847 or the APVMA websi te www.apvma.gov.au/residues/ ESI.shtml; Host/pest details: CATTLE: [EXTERNAL PARASITE, INTERNAL PARASITE, LIVER FLUKE - MATURE AND IMMATURE]; For the treatment & control of sensitive strains of internal & external parasites of cattle and triclabendazole resistant strains of early immature (incl. 2-week old stages), immature & adult liver fluke.NOT to be used intravenously or intramuscularly. DO NOT Re-TREAT CATTLE for 120 days after the last treatment. See WITTHOLDING PERIOD & Precautions sections on label also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

VIRBAC NITROMEC INJECTION ENDECTOCIDE & FLUKICIDE FOR CATTLE
Final
Label
- Carton
19th November 2008
____________________________________________________________________________________
Page
1 of 8
MAIN PANEL
POISON
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
VIRBAC NITROMEC INJECTION
ENDECTOCIDE & FLUKICIDE FOR CATTLE
ACTIVE CONSTITUENTS:
340g/L NITROXYNIL (as eglumine)
6.7 g/L IVERMECTIN
67g/L CLORSULON
FOR THE TREATMENT AND CONTROL OF NITROXYNIL, IVERMECTIN AND
CLORSULON SENSITIVE STRAINS OF INTERNAL AND EXTERNAL PARASITES OF
CATTLE AND TRICLABENDAZOLE RESISTANT STRAINS OF EARLY IMMATURE
(INCLUDING 2-WEEK OLD STAGES), IMMATURE AND ADULT LIVER FLUKE.
500ML
ROUNDWORMS
LICE
2-WEEK OLD LIVER FLUKE
APPROVED
LABEL
Info
PEST

Verified
VIRBAC NITROMEC INJECTION ENDECTOCIDE & FLUKICIDE FOR CATTLE
Final
Label
- Carton
19th November 2008
____________________________________________________________________________________
Page
2 of 8
Back Panel:
DIRECTIONS FOR USE:
RESTRAINTS:
DO NOT USE IN CATTLE WHICH ARE PRODUCING OR MAY IN THE FUTURE PRODUCE
MILK WHERE
THE MILK OR MILK PRODUCTS MAY BE USED FOR HUMAN CONSUMPTION.
PRECAUTIONS:
AVOID OVERDOSING OF CATTLE.
Care should be taken when administering NITROMEC or other medications
to sick debilitated
animals in poor condition. In these cases, a veterinarian should be
contacted.
If product leaks from the injection site staining of the coat of light
coloured cattle may occur for
a period of several weeks. Inject in a downward motion to avoid loss
of product and staining
at the injection site. Exercise care where staining may be a
disadvantage (eg. show cattle).
Gloves are recommended during usage.
DOSAGE AND ADMINISTRATION:
The recommended
dose is 1.5mL NITROMEC
per 50kg liveweight (equivalent to 200
µ
g
ivermectin, 2mg clorsulon per kg and nitroxynil 10.2mg per kg
liveweight) by subcutaneous
injection. This product is NOT to be used intravenously or
intramuscularly.
Cattle Treated
Liveweight
_Kg_
Dose
Volume_ mL_
_500

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Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
NITROMEC
INJECTION.DOC
REVISION D
SAFETY DATA SHEET
Product Name:
Nitromec Injection Endectocide and Flukicide for Cattle
PAGE: 1 OF 5
DATE OF ISSUE
8 APRIL, 2013
EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS ONLY)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
361 Horsley Rd, Milperra, NSW 2214, Australia
Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia
TELEPHONE:
(02) 9772 9772 or 1800 242 100
FAX:
(02) 9772 9773
EMERGENCY PHONE
As above during business hours; answering machine after hours
CHEMICAL NATURE:
Water solution of ingredients.
TRADE NAME:
NITROMEC INJECTION ENDECTOCIDE AND FLUKICIDE FOR CATTLE
PRODUCT USE:
Veterinary parasitic drench for use as described on the product label.
CREATION DATE:
AUGUST, 2003
THIS VERSION ISSUED:
APRIL, 2013
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Hazardous according to the criteria of SWA Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R20/21/22. Harmful by inhalation, in contact with skin, and if
swallowed.
SAFETY PHRASES:
S20, S24, S38. When using, do not eat or drink. Avoid contact with
skin. In case of insufficient
ventilation, wear suitable respiratory equipment.
SUSMP CLASSIFICATION:
S6
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING.
HAZARD STATEMENT:
H302: Harmful if swallowed.
H332: Harmful if inhaled.
PREVENTION
P261: Avoid breathing fumes, mists, vapours or spray.
P264: Wash contacted areas thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well ventilated area.
P280: Wear protective gloves, protective clothing and eye or face
protection.
RESPONSE
P312:

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