ilium Tula Injection

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: APVMA (Australian Pesticides and Veterinary Medicines Authority)

সক্রিয় উপাদান:

TULATHROMYCIN

থেকে পাওয়া:

TROY LABORATORIES PTY LTD

ফার্মাসিউটিকাল ফর্ম:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

রচনা:

TULATHROMYCIN ANTIBIOTIC Active 100.0 mg/ml

প্যাকেজ ইউনিট:

100 mL; 50 mL

শ্রেণী:

VM - Veterinary Medicine

থেরাপিউটিক এলাকা:

ANTIBIOTIC & RELATED

পণ্য সারাংশ:

Poison schedule: 4; Withholding period: MEAT: Cattle - DO NOT USE less than 35 d ays before slaughter for human consumpti on. Pigs - DO NOT USE less than 14 da ys before slaughter for human consumptio n. Any variation by the prescribing v eterinarian to the approved use pattern, may require an extended withholding per iod. EXPORT SLAUGHTER INTERVAL (ESI): Cattle: DO NOT USE less than 35 days b efore slaughter for export. Pigs: DO NOT USE less than 26 days before slaught er for export. Before using this prod uct, confirm the current ESI from Troy L aboratories on ([phone] or the APVMA website (apvma.gov.au/residues).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE FIRST MATING) – BOVINE (DAIRY): [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: MEAT: Cattle: 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. MILK: DO NOT USE in dairy cows (except r eplacement dairy heifers) that are produ cing milk or may in the future produce m ilk for human consumption or processing. DO NOT USE in bobby calves. DO NOT US E in dairy heifers following the first m ating. Any variation by the prescribing veterinarian to the approved dose, freq uency, duration, route, disease or targe t species may result in the need to exte nd the approved withholding period. EXP ORT SLAUGHTER INTERVAL (ESI): Cattle: D O NOT USE less than 35 days before slaug hter for export. Pigs: DO NOT USE less than 26 days before slaughter for export . The ESIs on this label were correct a t the time of label approval. Before usi ng this product, confirm the current ESI from the manufacturer on [phone] or the APVMA website (www.apvma.gov.au/ residues/).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE FIRST MATING) – BOVINE (DAIRY): [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: MEAT: Cattle: 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. MILK: DO NOT USE in dairy cows (except r eplacement dairy heifers) that are produ cing milk or may in the future produce milk for human consumption or processing . DO NOT USE in bobby calves. DO NOT U SE in dairy heifers following the first mating. Any variation by the prescribin g veterinarian to the approved dose, fre quency, duration, route, disease or tar get species may result in the need to ex tend the approved withholding period. EXPORT SLAUGHTER INTERVAL (ESI): Cattle : DO NOT USE less than 35 days before sl aughter for export. Pigs: DO NOT USE le ss than 26 days before slaughter for exp ort. The ESIs on this label were correc t at the time of label approval. Before using this product, confirm the current ESI from the manufacturer on (02) 8808 3600 or the APVMA website (www.apvma.go v.au/residues/).; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; HEIFER (BEFORE FIRST MATING) – BOVINE (DAIRY): [BOVINE RESPIRATORY DISEASE, HISTOPHILUS SOMNI, MANNHEIMIA HAEMOLYTICA, MYCOPLASMA BOVIS, PASTEURELLA MULTOCIDA]; PIG - ADULT: [HAEMOPHILUS SPP., MYCOPLASMA HYOPNEUMONIAE, PASTEURELLA MULTOCIDA, RESPIRATORY DISEASE]

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2022-07-01

তথ্য লিফলেট

Product Name:
APVMA Approval No:
Ilium Tulathromycin Injection
88512/121563
Label Name:
Ilium Tulathromycin Injection
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 mg/mL TULATHROMYCIN
Claims:
For the treatment of respiratory infections in cattle and pigs.
For subcutaneous injection in cattle, including dairy heifers up to
the point of first mating,
and intramuscular injection in pigs.
Cattle
Ilium Tulathromycin Injection is indicated for the treatment of bovine
respiratory disease
(BRD) associated with Mannheimia haemolytica, Pasteurella multocida,
Histophilus somni
and Mycoplasma bovis sensitive to tulathromycin.
Pigs
Ilium Tulathromycin Injection is indicated for the treatment of swine
respiratory disease
(SRD) associated with Pasteurella multocida, Mycoplasma hyopneumoniae,
and
Haemophilus parasuis sensitive to tulathromycin.
Net Contents:
50 mL
100 mL
Directions for Use:
Restraints:
USE ONLY in respiratory infections of cattle and swine.
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.
DO NOT TREAT dairy heifers following the first mating.
RE-TREATMENT INTERVALS:
Cattle: DO NOT RE-TREAT cattle for 12 weeks after last treatment.
Dairy heifers: DO NOT RE-TREAT dairy heifers RLP APPROVED
Pigs: DO NOT RE-TREAT pigs for 8 weeks after last treatment.
Contraindications:
Precautions:
Avoid using the product simultaneously with other macrolides or
lincosamides. Laboratory
studies in rats and rabbit have not produced any evidence of
teratogenic, foetotoxic or
maternotoxic effects. However, the effects of Ilium Tulathromycin
Injection on bovine and
porcine reproductive performance, pregnancy and lactation have not
been determined
Side Effects:
Subcutaneous administration of Ilium Tulathromycin Injection to cattle
frequently causes
transient pain reactions, and local swellings at the injection site
that can p

পণ্য বৈশিষ্ট্য

TROY LABORATORIES PTY LTD
Chemwatch Hazard Alert Code: 3
ILIUM TULA INJECTION
Chemwatch: 5436-74
Version No: 2.1.1.1
Safety Data Sheet according to WHS and ADG requirements
Issue Date: 18/11/2020
Print Date: 23/11/2020
S.GHS.AUS.EN
SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY
/ UNDERTAKING
PRODUCT IDENTIFIER
PRODUCT NAME
Ilium Tula Injection
SYNONYMS
Ilium Tulathromycin Injection; APVMA number 88512
OTHER MEANS OF IDENTIFICATION
Not Available
RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES ADVISED
AGAINST
RELEVANT IDENTIFIED USES
To be used as directed on product label.
Use according to manufacturer's directions.
DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET
REGISTERED COMPANY NAME
TROY LABORATORIES PTY LTD
ADDRESS
37 Glendenning Road Glendenning NSW 2761 Australia
TELEPHONE
02 8808 3600
FAX
02 9677 9300
WEBSITE
EMAIL
[e-mail]
EMERGENCY TELEPHONE NUMBER
ASSOCIATION / ORGANISATION
TROY LABORATORIES PTY LTD
EMERGENCY TELEPHONE
NUMBERS
02 8808 3600 (Office hours (8am – 4pm, Monday to Friday))
OTHER EMERGENCY TELEPHONE
NUMBERS
Not Available
SECTION 2 HAZARDS IDENTIFICATION
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
POISONS SCHEDULE
S4
CLASSIFICATION
[1]
Skin Corrosion/Irritation Category 2, Serious Eye Damage Category 1,
Skin Sensitizer Category 1
_LEGEND:_
_1. Classified by Chemwatch; 2. Classification drawn from HCIS; 3.
Classification drawn from Regulation (EU) No 1272/2008 - Annex VI_
LABEL ELEMENTS
HAZARD PICTOGRAM(S)
SIGNAL WORD
DANGER
HAZARD STATEMENT(S)
H315
Causes skin irritation.
H318
Causes serious eye damage.
H317
May cause an allergic skin reaction.
PRECAUTIONARY STATEMENT(S) PREVENTION
P280
Wear protective gloves/protective clothing/eye protection/face
protection.
P261
Avoid breathing mist/vapours/spray.
P272
Contaminated work clothing should not be allowed out of the workplace.
PRECAUTIONARY STATEMENT(S) RESPONSE
P305+P351+P338
IF IN EYES: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue