BILOSIN 200 TYLOSIN INJECTION

Maa: Australia

Kieli: englanti

Lähde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiivinen ainesosa:

TYLOSIN

Saatavilla:

BIMEDA (AUSTRALIA) PTY. LIMITED

INN (Kansainvälinen yleisnimi):

tylosin(200mg/mL)

Lääkemuoto:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Koostumus:

TYLOSIN ANTIBIOTIC Active 200.0 mg/ml

Kpl paketissa:

100mL

luokka:

VM - Veterinary Medicine

Valmistaja:

BIMEDA (AUSTRALIA)

Terapeuttinen ryhmä:

CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI

Terapeuttinen alue:

ANTIBIOTIC & RELATED

Käyttöaiheet:

AID IN COMBATING INFECTION | BACTERIAL INFECTION | CALF PNEUMOENTERITIS | CALF PNEUMONIA | DYSENTERY | ERYSIPELAS - SWINE | FOOT ROT | LEPTOSPIROSIS | MASTITIS | METRITIS | PNEUMONIA | SECONDARY INFECTION | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | BACTERIAL PNEUMONIA | CONTAGIOUS CALF PNEUMONIA | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | L. HARDJO | L. INTERROGANS | L. POMONA | L. TARASSOVI | POST PARTURIENT BACTERIAL INFE | POST-INJURY | POST-SURGERY | PRIMARY BACTERIAL INFECTION | SECONDARY BACTERIAL INFECTIONS | SECONDARY BACTERIAL INVADERS | SECONDARY INFECTION TO VIRUS | SUBCLINICAL MASTITIS | SULFADIAZINE SENSITIVE BACTERI | SWINE ERYSIPELAS | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA

Tuoteyhteenveto:

Poison schedule: 4; Withholding period: CATTLE MEAT: DO NOT USE less than 21 da ys before slaughter for human consumptio n. MILK: Milk collected from cows withi n 72 hours (6 milkings) following treatm ent MUST NOT BE USED or processed for h uman consumption, or fed to bobby calves . PIGS MEAT: DO NOT USE less than 3 da ys before slaughter for human consumptio n. EXPORT SLAUGHTER INTERVAL (ESI): An ESI has not been established for this pr oduct. Note – observing the meat withho lding period may not be sufficient to mi tigate potential risks to export trade. Trade advice should be sought from the distributor on 02 8090 7187 before usin g this product.; Host/pest details: CATTLE: [AID IN COMBATING INFECTION, BACTERIAL INFECTION, CALF PNEUMOENTERITIS, CALF PNEUMONIA, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, PNEUMONIA]; PIGS: [BACTERIAL INFECTION, DYSENTERY, ERYSIPELAS - SWINE, PNEUMONIA, SECONDARY INFECTION]; Poison schedule: 4; Withholding period: WHP: Meat: Cattle - do not use less than 21 days before slaughter for human consumption. Meat: Pigs - do not use less than 3 days before slaughter for h uman consumption. Milk: Milk collecte d from animals within 72 hours (6 milki ngs) following treatment must not be us ed for human consumption or processing. This milk should not be fed to bobby c alves. TRADE ADVICE EXPORT SLAUGHT ER INTERVAL (ESI): This product does no t have an ESI established. For advice on the ESI contact the distributor on 02 80907187 or the APVMA website (ht tp://www.apvma.gov.au/residues/).; Host/pest details: CATTLE: [AID IN COMBATING INFECTION, BACTERIAL INFECTION, CALF PNEUMOENTERITIS, CALF PNEUMONIA, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, PNEUMONIA]; PIGS: [BACTERIAL INFECTION, DYSENTERY, ERYSIPELAS - SWINE, PNEUMONIA, SECONDARY INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [AID IN COMBATING INFECTION, BACTERIAL INFECTION, CALF PNEUMOENTERITIS, CALF PNEUMONIA, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, PNEUMONIA]; PIGS: [BACTERIAL INFECTION, DYSENTERY, ERYSIPELAS - SWINE, PNEUMONIA, SECONDARY INFECTION]; For treatment of organisms sensitive to tylosin in cattle and pigs.

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2023-07-01

Pakkausseloste

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
+
RLP
_Approved _
Select appropriate:
[]New
Product (include all applicable RLPs) OR
l8J
Variation
(highlight
instructions
that
are
being
varied).
Approval
no.
of
label
being
varied:
52228/59526
Signal
heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Product
name:
BILOSIN 200 TYLOSIN INJECTION
ACTIVE
Active Constituent: 200
mg/ml
TYLOSIN
CONSTITUENTLS:
Statement
of
For treatment
of
organisms sensitive
to
tylosin
in
cattle and pigs
CLAIMS:
Net
contents:
100
mL
Directions
for
Use
Heading:
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
Restraints:
CONTRAINDICATIONS:
CONTRAINDICATIONS:
There are no known contra-indications
to
BILOSIN 200 Tylosin Injection at this
time.
PRECAUTIONS:
PRECAUTION:
If
there
is
no response
to
therapy
in
three days, diagnosis and
treatment should
be
reassessed.
Do not mix BILOSIN 200 Tylosin Injection with other parenteral
solutions as this
may cause precipitation of the active ingredient.
Side
effects:
SIDE EFFECTS:
Occasionally pigs have been observed with a reaction
to
BILOSIN 200 Tylosin
Injection. This consists of
an
oedema of the rectal mucosa, mild anal protrusion,
diarrhoea, erythema and pruritis.
Discontinuation of treatment has affected
an
uneventful recovery from these symptoms. As with the injection of any
foreign
substance,
an
injection site reaction may very occasionally occur
in
some pigs.
If
the reaction is of concern to the producer, allowing a period of at
least three weeks
to elapse before slaughter will minimise the need for excessive trim
at the injection
site.
Dosage
&
DOSAGE AND ADMINISTRATION:
ADMINISTRATION:
Use the contents within
28
days of first broaching
of
the vial. Discard the unused
portion.
Cattle:
Inject 5
to
10 mg tylosin per kilogram of bodyweight daily intra-muscularly
or
by
slow intravenous injection (which
is
equivalent
to
0.5 mL
to
1
ml
BILOSIN
200 Tylosin Injection per 20
kg
bodyweight). Treatment should
be
continue

Valmisteyhteenveto

First Effective Date: 1
st
of Nov. 2013
Page 1 of 5
_ _
ABBEY ANIMAL HEALTH PTY LTD
MATERIAL SAFETY DATA SHEET
SUPPLIER COMPANY DETAILS: Abbey Animal Health Pty Ltd
ADDRESS: 165 Sharp ST, Cooma NSW 2630
TELEPHONE NUMBER: 02 8090 7187
FACSIMILE NUMBER: 02 9475 0775
EMERGENCY NUMBER: Australian Poisons Information Centre: 13 11 26 (24
Hour service).
PRODUCT NAME: BILOSIN 200 TYLOSIN INJECTION
OTHER NAMES: None allocated
APPEARANCE: A clear yellow aqueous solution
USE: For Animal Treatment Only. Veterinary antibiotic preparation, for
the treatment of
organisms sensitive to Tylosin in pigs and cattle. Administer by
intramuscular injection only.
STATEMENT OF HAZARDOUS NATURE: Non-hazardous substance, non-dangerous
goods according to criteria of NOHSC* Australia and ADG** Code.
POISON SCHEDULE: S4.
CAUTION STATEMENT: Tylosin tartrate may be irritating to the eyes, and
is classified as a
severe allergen because repeated unprotected exposures are likely to
cause allergic
reactions.
*NOHSC = National Occupational Health and Safety Commission.
**ADG= Australian Dangerous Goods code.
INGREDIENT:
Chemical Name CAS No. Content
Tylosin Base
1401-69-0 200mg/mL
_BILOSIN 200 _
_TYLOSIN INJECTION _
SECTION 1- IDENTIFICATION OF PRODUCT AND SUPPLIER
SECTION 2- HAZARDS IDENTIFICATION
SECTION 3- COMPOSITION / INFORMATION ON INGREDIENTS
First Effective Date: 1
st
of Nov. 2013
Page 2 of 5
EYES: Holding eyelids apart, wash immediately with plenty of eyewash
solution or clean water for
at least 15 minutes. Seek medical advice.
SKIN: Remove contaminated clothing. Wash off skin immediately with
soap and clean warm
water. Rinse and dry hands. If irritation develops seek medical
advice.
INGESTION: Wash out mouth with water. Seek medical advice
INHALATION: Not applicable
OTHER: May cause hypersensitivity reaction in susceptible individuals.
If you develop symptoms following exposure such as a skin rash, you
should seek medical advice
and show the doctor this Material Safety Data Sheet. Swelling of the
face, lips, eyes or difficulty
breathing a