TYLOPHARM 200 INJECTION

מדינה: אוסטרליה

שפה: אנגלית

מקור: APVMA (Australian Pesticides and Veterinary Medicines Authority)

קנה את זה

עלון מידע (PIL)

20-06-2017

מאפייני מוצר (SPC)

20-06-2017

מרכיב פעיל:

TYLOSIN

זמין מ:

BIMEDA (AUSTRALIA) PTY. LIMITED

INN (שם בינלאומי):

tylosin(200mg/mL)

טופס פרצבטיות:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

הרכב:

TYLOSIN ANTIBIOTIC Active 200.0 mg/ml

יחידות באריזה:

100mL

סיווג:

VM - Veterinary Medicine

תוצרת:

BIMEDA (AUSTRALIA)

קבוצה תרפויטית:

איזור תרפויטי:

ANTIBIOTIC & RELATED

סממני תרפויטית:

leaflet_short:

Poison schedule: 4; Withholding period: WHP: Meat: Cattle-DO NOT USE less than 21 days before slaughter for human co nsumption. Meat: Pigs-DO NOT USE less t han 3 days before slaughter for human consumption. Milk:Milk collected from a nimals within 72 hours (6 milkings) fol lowing treatment. MUST NOT BE USED for human consumption or processing or fed to bobby calves.; Host/pest details: CATTLE: [BACTERIAL INFECTION, CALF PNEUMONIA, ENTERITIS, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, PNEUMONIA]; PIGS: [BACTERIAL INFECTION, DYSENTERY, ERYSIPELAS - SWINE, PNEUMONIA]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [BACTERIAL INFECTION, CALF PNEUMONIA, ENTERITIS, FOOT ROT, LEPTOSPIROSIS, MASTITIS, METRITIS, PNEUMONIA]; PIGS: [BACTERIAL INFECTION, DYSENTERY, ERYSIPELAS - SWINE, PNEUMONIA]; For the treatment of organisms sensitive to tylosin in cattle and pigs.Do not mix with other parenteral solutions

מצב אישור:

Registered

תאריך אישור:

2023-07-01

עלון מידע

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
RLP
Approved
Select appropriate:
IJ
New Product (include all applicable RLPs) OR
[g)
Variation
(highlight
instructions
that
are
being
varied).
Approval
no.
of
label
being
varied:
55331/51669
Signal heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Product name:
TYLOPHARM 200 INJECTION
Active
Active Constituent: 200
mg/ml
TYLOSIN
constituent/s:
Statement of
For
treatment
of
organisms
sensitive
to
tylosin in cattle
and
pigs.
claims:
Net
contents:
100
ML
Directions
for
Use
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Heading:
DIRECTIONS FOR USE
Restraints:
Contraindications:
Contraindications:
There are
no
known contra-indications
to
TYLOPHARM
200
Injection at this
time.
PRECAUTIONS:
Precautions:
If there
is
no
response
to
therapy
in
three days, diagnosis
and
treatment should
be
reassessed.
Do
not mix TYLOPHARM 200 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 TYLOPHARM 200
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 &
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 intramuscularly
or
by
slow
intravenous
injection
(which
is
equivalent to
0.5
mL
to
1
ml
Page 1 of 3
Last
updated: 3 July 2015
TYLOPHARM
200
Injection
per
20
kg
bodyweight).
Treatment
should
be
contin

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מאפייני מוצר

MATERIAL SAFETY DATA SHEET
MSDS
TYLOPHARM 200
TYLOSIN 200mg/mL Injection
DOCUMENT LAST EDITED ON 1/29/2004 1:32:00 PM AND REPLACES ANY EARLIER
VERSIONS
STATEMENT OF HAZARDOUS NATURE:
"HAZARDOUS ACCORDING TO CRITERIA OF WORKSAFE AUSTRALIA"
Harmful; R42/43 May cause sensitisation by inhalation and skin
contact.
Irritant; R36 Irritating to eyes.
COMPANY NAME AND ADDRESS:
Pharm Tech Pty Limited
A.B.N. 77 084 248 206
8 Apollo Ave
WEST PYMBLE NSW 2073
CONTACT NUMBERS AUSTRALIA WIDE:
Tel: 0500 886 668
Fax: 0500 886 669
EMERGENCY TELEPHONE NUMBERS:
As Above
OR
Poisons Information Centre:
131126 (Australia-wide)
_SECTION 1 - IDENTIFICATION _
PRODUCT NAME: TYLOPHARM 200
OTHER NAMES: Tylosin 200 Injection
UN NUMBER: None allocated
DANGEROUS GOODS CLASS/SUBSIDIARY RISK: None allocated
HAZCHEM CODE: None allocated
POISONS SCHEDULE NUMBER: S4
PACK SIZE AND CONTAINER TYPE: 100mL amber glass vials.
USE:
Major Recommended Uses: For use as an aid in controlling enteric
diseases susceptible
to Tylosin
Major Recommended Method(s) of Application: IM Injection
_SECTION 2 -COMPOSITION I INFORMATION ON INGREDIENTS _
INGREDIENT
CAS.
Tylosin 200mg/mL
1405-54-5
Excipients
EXPOSURE GUIDELINES: PEL and TLV not established.
_SECTION 3 -HAZARDS IDENTIFICATION _
APPEARANCE: yellow clear viscous liquid.
PHYSICAL STATE: Sterile Injectable Solution
ODOR: none.
EMERGENCY OVERVIEW
PRIMARY PHYSICAL AND HEALTH HAZARDS: Irritant (eyes). Severe Allergen.
CAUTION STATEMENT: Tylopharm 200 Injection may be irritating to the
eyes and is
classified as a severe allergen because repeated unprotected exposures
are likely to
cause allergic reactions.
ROUTES OF ENTRY: Inhalation and skin contact.
POTENTIAL SIGNS AND SYMPTOMS OF OCCUPATIONAL EXPOSURE: Allergic
reactions to
Tylosin in a manufacturing setting have been reported. Allergy
symptoms may include skin
rash, watery eyes, shortness of breath, nasal congestion, coughing,
and wheezing. Based
on animal data, may be irritating to the eyes.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Hypersensitivity to
Tylosin.

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