TILMICABS AC (TILMICOSIN PHOSPHATE) AQUEOUS CONCENTRATE

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv bestanddel:

TILMICOSIN PHOSPHATE

Tilgængelig fra:

ABBEY LABORATORIES PTY LTD

INN (International Name):

tilmicosin as phosphate(250mg/mL)

Lægemiddelform:

ORAL SOLUTION/SUSPENSION

Sammensætning:

TILMICOSIN PHOSPHATE ANTIBIOTIC Active 250.0 mg/ml

Enheder i pakken:

10L; 1L; 2.5L; 250mL; 5L

Klasse:

VM - Veterinary Medicine

Fremstillet af:

ABBEY LABORATORIES

Terapeutisk område:

ANTIBIOTIC & RELATED

Produkt oversigt:

Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT: DO NOT USE l ess than 7 days before slaughter for hu man consumption. REMOVE ALL MEDICATED WATER 7 days before slaughter for human consumption. Any variation by the pr escribing veterinarian to the approved u se pattern, may require an extended with holding period. An ESI has not been e stablished for this product. Note—observ ing the meat withholding period may not be sufficient to mitigate potential risk s to export trade. Trade advice should b e sought from Abbey Animal Health Pty Lt d on 02 8088 0720 before using this prod uct or APVMA website (apvma.gov.au/ resi dues); Host/pest details: PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES PYOGENES, MYCOPLASMA HYOPNEUMONIAE, ORGANISMS SENSITIVE TO TILMICOSIN, PASTEURELLA MULTOCIDA, PNEUMONIA]; Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT: DO NOT USE less than 7 days before slaughter for h uman consumption.; Host/pest details: PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES PYOGENES, MYCOPLASMA HYOPNEUMONIAE, ORGANISMS SENSITIVE TO TILMICOSIN, PASTEURELLA MULTOCIDA, PNEUMONIA]; Poison schedule: 4; Withholding period: ; Host/pest details: PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, ACTINOMYCES PYOGENES, MYCOPLASMA HYOPNEUMONIAE, ORGANISMS SENSITIVE TO TILMICOSIN, PASTEURELLA MULTOCIDA, PNEUMONIA]; Water medication for the treatment of pneumonia in pigs caused by Actinobacillus pleuropneumoniae, Actinomyces pyogenes, Mycoplasma hyopneumoniae, Pasteurella multocida, and other organisms sensitive to tilmicosin.Use only in swine. Use only orally. DO NOT USE this product as an injectable as it contains disodium edetate. Avoid allowing horses or other equines access to drinking water containing tilmicosin

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

APPENDIX2
RLP
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Approved
Select appropriate:
I2Sl
New
Product
(include
all
applicable
RLPs)
OR
D
Variation
(highlight
instructions
that
are
being
varied).
Approval
no.
of
label
being
varied:
................
.
Signal heading:
Product name:
Active
constituentls:
Statement
of
claims:
Net contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side effects:
Dosage &
administration:
General
directions:
PRESCRIPTION ANIMAL REMEDY
KEEP
OUT
OF REACH
OF
CHILDREN
READ
SAFETY
DIRECTIONS BEFORE OPENING
OR
USING
FOR ANIMAL
TREATMENT
ONLY
TILMICABS
AC
{TILMICOSIN PHOSPHATE) AQUEOUS
CONCENTRATE
250mg/mL Tilmlcosln (as Tilmicosin phosphate)
Water
medication
for
the treatment
of
pneumonia
In
pigs caused
by
Actinobacillus pleuropneumoniae, Actinomyces pyogenes, Mycoplasma
hyopneumoniae, Pasteurella mu/tocida,
and other organisms sensitive to
tilmicosin.
250mL, 1L, 2.5L, 5L, 10L
USE ONLY
IN
SWINE
USE
ONLY
ORALLY
DO NOT USE this product
as
an injectable as it contains disodium edetate.
Avoid allowing horses
or
other equines access to drinking water containing
tilmicosin.
The safety
of
tilmicosin has not been established
in
boars intended for
breeding purposes.
Tilmicosin has a bitter taste. Exceeding the registered dose rate
may
result
in
reduced water intake. Monitor water intake carefully whilst medicating
with
Tilmicabs AC.
Prepared medicated drinking water should be used within 24 hours
of
mixing.
To be included
in
the drinking water
at
a dose rate
of
200mg per litre
(80mL
Tilmicabs
AC
per 1
OOL
water) for five consecutive days, to provide a daily
dose
of
15-20mg tilmicosin per
kg
bodyweight.
Any variation
by
the prescribing veterinarian to the approved dose, frequency,
duration, route, disease
or
target species may require extending the approved
withholding period.
18 WORMALD STREET, SYMONSTON ACT
2609
PO
BOX 6182, KINGSTON ACT
2604
AUSTRALIA
Tel:
+61
2 6210 4700
Fax:
+61
2 6210 4874
www.apvma.gov.au
ABN
19 495 043 447
Withholding
MEAT

Produktets egenskaber

PRODUCT NAME: TILMICABS AC
PAGE: 1 OF 5
THIS VERSION ISSUED: SEP, 2016
SAFETY DATA SHEET
Issued by: Abbey Animal Health Pty Ltd
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
ABBEY ANIMAL HEALTH PTY LTD
PHONE: [phone] (OFFICE HOURS)
39 BUCKENDERRA ROAD
MIDDLINGBANK NSW 2630
CHEMICAL NATURE:
Tilmicosin is a macrolide antibiotic, presented here as a aqueous
solution.
TRADE NAME:
TILMICABS AC
APVMA APPROVAL NO.:
69566
PRODUCT USE:
Water medication for the treatment of pneumonia in pigs caused by
_Actinobacillus_
_pleuropneumoniae_, _Actinomyces_ _pyogenes_, _Mycoplasma_
_hyopneumoniae_,
_Pasteurella_ _multocida_, and other organisms sensitive to
Tilmicosin.
CREATION DATE:
SEPTEMBER, 2016
THIS VERSION ISSUED:
OCTOBER, 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:
Xi, Irritating. N, Dangerous to the environment. 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
Skin Sensitisation Category 1
Serious eye damage/eye irritation Category 2B
Hazardous to aquatic environment Short term/Chronic Category 1
HAZARD STATEMENT:
H317: May cause an allergic skin reaction.
H320: Causes eye irritation.
H410: Very toxic to aquatic life with long lasting effects.
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.
P272: Contaminated work clothing should not be allowed out of the