DRAXXIN INJECTABLE SOLUTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TULATHROMYCIN

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

tulathromycin(100mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TULATHROMYCIN ANTIBIOTIC Active 100.0 mg/ml

Units in package:

100mL; 250 mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

CATTLE | PIG - ADULT | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | S

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

BOVINE RESPIRATORY DISEASE | HAEMOPHILUS SPP. | HISTOPHILUS SOMNI | MANNHEIMIA HAEMOLYTICA | MYCOPLASMA BOVIS | MYCOPLASMA HYOPNEUMONIAE | PASTEURELLA MULTOCIDA | RESPIRATORY DISEASE | FOWL CHOLERA | HAEMOPHILUS AGNI | HAEMOPHILUS BOVIS | HAEMOPHILUS PARAINFLUENZAE | HAEMOPHILUS PARASUIS | HAEMOPHILUS PLEUROPNEUMONIAE | HAEMOPHILUS SOMNUS | HAEMOPHILUS SUIS | REDUCTION OF LUNG LESIONS | RESPIRATORY DISEASE | SHIPPING FEVER | SWINE ENZOOTIC PNEUMONIA

Product summary:

Poison schedule: 4; Withholding period: Cattle: Meat: DO NOT USE less than 35 da ys before slaughter for human consumptio n. Pigs: DO NOT USE less than 14 days b efore slaughter for human consumption. Sheep: Meat: DO NOT USE less than 28 d ays before slaughter for human consumpti on. Any variation by the prescribing veterinarian to the approved dose, frequ ency, duration, route, disease or target species may result in the need to exten d the approved withholding period. Ca ttle: DO NOT USE less than 35 days befor e slaughter for export. Pigs: DO NOT U SE less than 26 days before slaughter fo r export. Sheep: DO NOT USE less than 49 days before slaughter for export. Before using this product, confirm the current ESI from Zoetis on 1800 814 883 or the APVMA website (www.apvma.gov.au/r esidues); Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE CALVING): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]; SHEEP: [FOOTROT - DICHELOBACTER NODOSUS]; Poison schedule: 4; Withholding period: Cattle: Meat: DO NOT USE less than 35 da ys before slaughter for human consumptio n. Milk: DO NOT USE in dairy cows excep t replacement dairy heifers that are pro ducing milk or may in the future produce milk for human consumption or processin g. DO NOT USE in bobby calves. Pigs: D O NOT USE less than 14 days before slaug hter for human consumption. RE-TREATMEN T INTERVALS: Cattle: DO NOT RE-TREAT ca ttle for 12 weeks after last treatment o r dairy heifers. Pigs: DO NOT RE-TREAT pigs for 8 weeks after last treatment. Cattle: DO NOT USE less that 35 days b efore slaughter for export. Pigs: DO NO T USE less that 26 days before slaughter for export.; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE CALVING): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]; Poison schedule: 4; Withholding period: WHP: Cattle: Meat: DO NOT USE less tha n 35 days before slaughter for human c onsumption. Milk: DO NOT USE in dairy c ows except replacement dairy heifers t hat are producing milk or may in the f uture produce milk for human consumpt ion or processing. DO NOT USE in bobby calves. Pigs: DO NOT USE less than 14 d ays before slaughter for human consump tion. RE-TREATMENT INTERVALS: Cattle: DO NOT RE-TREAT cattle for 12 weeks aft er last treatment or dairy heifers. P igs: DO NOT RE-TREAT pigs for 8 weeks a fter last treatment. EXPORT SLAUGHTER I NTERVALS: Cattle: DO NOT USE less that 35 days before slaughter for export. Pigs: DO NOT USE less that 26 days bef ore slaughter for export.; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE CALVING): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]; For the treatment of respiratory infections in cattle and pigs.DO NOT use in dairy cows, except replacement dairy heifers, that are producing or may in the future produce milk or milk products for human consumption. DO NOT use in bobby calves. USE ONLY in respiratory infections. See RESTRAINTS on label

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Copy in the header and footer will not appear on the final printed
label
DRAXXIN INJECTABLE SOLUTION
Prepared: 27/09/2013
VIAL LABEL
LEFT SIDE
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Draxxin
®
Injectable Solution
100MG/ML TULATHROMYCIN
For the treatment of respiratory infections in cattle and pigs
[50][100] mL
Zoetis [logo]
VIAL LABEL
RIGHT SIDE – label element between {} applies to the 100mL only
READ LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
RESTRAINTS
DO NOT USE IN DAIRY COWS, EXCEPT REPLACEMENT DAIRY HEIFERS, THAT ARE
PRODUCING
MILK OR MAY IN THE FUTURE PRODUCE MILK FOR HUMAN CONSUMPTION OR
PROCESSING.
DO NOT USE IN BOBBY CALVES.
USE ONLY IN RESPIRATORY INFECTIONS.
DO NOT RE-TREAT BEFORE 12 WEEKS FOR CATTLE, 8 WEEKS FOR PIGS, DAIRY
HEIFERS.
DO NOT TREAT DAIRY HEIFERS FOLLOWING THE FIRST MATING.
DOSAGE {AND ADMINISTRATION
Use within 28 days of first broaching vial}
1 mL per 40kg. Single injection. Cattle S/C. Pigs I/M
WITHHOLDING PERIODS:
CATTLE MEAT: DO NOT USE LESS THAN 35 DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
CATTLE MILK: DO NOT USE IN DAIRY COWS, EXCEPT REPLACEMENT DAIRY
HEIFERS.
PIGS: DO NOT USE LESS THAN 14 DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
EXPORT SLAUGHTER INTERVAL (ESI): Cattle 35 days, Pigs 26 days.
{FIRST AID: If poisoning occurs, contact a doctor or Poisons
Information Centre.
Phone Australia131126.
DISPOSAL: Dispose of empty container by wrapping with paper and
putting in garbage.}
APVMA: 60018/52864
Page 1 of 9 RLP APPROVED
Copy in the header and footer will not appear on the final printed
label
DRAXXIN INJECTABLE SOLUTION
Prepared: 27/09/2013
Made in France
Zoetis Australia Pty Ltd
Wharf Road, West Ryde, NSW 2114
Discard date:
Store below 30°C (Room Temperature).
Batch:
Expiry:
Page 2 of 9
Copy in the header and footer will not appear on the final printed
label
DRAXXIN INJECTABLE SOLUTION
Prepared: 27/09/2013
LEAFLET/INSERT
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Draxxin
®
Inje

Summary of Product characteristics

PRODUCT NAME: DRAXXIN INJECTABLE SOLUTION
PAGE: 1 OF 7
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
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE 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]
PRODUCT IDENTIFIER:
DRAXXIN INJECTABLE SOLUTION
APVMA APPROVAL NO:
60018
OTHER NAMES:
None.
CHEMICAL FAMILY:
Tulathromycin injectable solution.
RECOMMENDED USE:
For the treatment of respiratory infections in cattle and pigs.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xi, Irritating. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R36, R43. Irritating to eyes. May cause sensitisation by skin contact.
SAFETY PHRASES:
S23, S25, S28, S36. Do not breathe vapours or mists. Avoid contact
with eyes. After contact with
skin, wash immediately with plenty of soap and water. Wear suitable
protective clothing.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
GHS LABEL ELEMENTS:
GHS SIGNAL WORD: WARNING
GHS CLASSIFICATION:
H317: May cause an allergic skin reaction.
H319: Causes serious eye irritation.
PREVENTION
P102: Keep out of reach of children.
P261: Avoid breathing fumes, mists, vapours or spray.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P281: Use personal protective equipment as required.
RESPONSE
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if
present and easy to do. Continue