GENTAM INJECTABLE GENTAMICIN SOLUTION

Land: Australië

Taal: Engels

Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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20-06-2017
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Werkstoffen:

GENTAMICIN AS GENTAMICIN SULFATE

Beschikbaar vanaf:

TROY LABORATORIES PTY LTD

INN (Algemene Internationale Benaming):

gentamicin as sulfate(50mg/mL)

farmaceutische vorm:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Samenstelling:

GENTAMICIN AS GENTAMICIN SULFATE ANTIBIOTIC Active 50.0 mg/ml

Eenheden in pakket:

100mL; 50mL

klasse:

VM - Veterinary Medicine

Geproduceerd door:

TROY LABORATORIES

Therapeutische categorie:

CAT - NOT PREGNANT | DOG - NOT PREGNANT | HORSE - NOT PREGNANT

Therapeutisch gebied:

ANTIBIOTIC & RELATED

therapeutische indicaties:

BACTERIAL INFECTION | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA

Product samenvatting:

Poison schedule: 4; Withholding period: WHP: MEAT:Not to be used in horses that may be slaughtered for human consumpti on; Host/pest details: CAT - NOT PREGNANT: [BACTERIAL INFECTION]; DOG - NOT PREGNANT: [BACTERIAL INFECTION]; HORSE - NOT PREGNANT: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT - NOT PREGNANT: [BACTERIAL INFECTION]; DOG - NOT PREGNANT: [BACTERIAL INFECTION]; HORSE - NOT PREGNANT: [BACTERIAL INFECTION]; For the control of gentamicin-susceptible bacterial infections in dogs, cats and horses.NOT to be used in animals producing food for human consumption. DO NOT use this product in pregnant animals. NOT to be used unless sensitivity testing indicates other antibiotics are ineffective.

Autorisatie-status:

Registered

Autorisatie datum:

2023-07-01

Bijsluiter

                                •
Main
'osnei-:
bottle label
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
GENTAM
INJECTABLE GENTAMICIN SOLUTION
50mg/mL
GENTAMICIN
(as GENTAMICIN SULPHATE)
For the control
of
Gentamicin-susceptible bacterial
infections in dogs, cats and horses
ILIUM
50mL
I
100mL
Ancillary panel
DIRECTIONS FOR USE:
NOT TO BE USED in
animals
producing
food
for
human
consumption.
DO NOT USE
this
product
in
pregnant
animals.
NOT TO BE USED
unless
sensitivity
testing
indicates
other
antibiotics
are
ineffective.
DOGS
&
CATS:
4.4
mg/kg
i.rn.
or
s.c.,
12 hourly on the first
day then once daily.
In life
threatening infections,
use this dose every 8 hours.
HORSES:
Parenteral:
2.0
mg/kg
kg bodyweight
three times
daily
by
intravenous or
intramuscular injection.
Intrauterine infusion:
40-50mL diluted with 200-300mL
of
sterile saline.
Use
aseptic technique.
Infuse daily for 3-5 days during oestrus.
MEAT WITHHOLDING PERIOD:
NOT TO BE USED in
horses
that
may
be
slaughtered
for
human
consumption.
fROY
LABORATORIES PTY. LIMITED
98 LONG ST. SMITHFIELD NSW 2164 AUSTRALIA
Dispose
of empty container by wrapping with paper and putting in the
garbage.
Store below 25°C (Air Conditioning)
Protect from light.
NRAApproval
No.
50436(fJ?rr
Batch:
Expiry:
N.R.A.
APPROVED
LABEL
(TEXT)
Label
No:
~D.~.~~/f?z?.9.
Date:
i!;;/if..
_!.'J.'1_
_._
Signature
..
Draft
/aba/-
1
June 1999
_1012_
Main
pane/-
carton
label
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
GENTAM
INJECTABLE GENTAMICIN SOLUTION
50mg/mL GENTAMICIN
(as GENTAMICIN SULPHATE)
For the control
of
Gentamicin-susceptible bacterial
infections in dogs, cats and horses
ILIUM
50mL /
100mL
Ancillary pane/1
DIRECTIONS FOR USE:
NOT TO BE USED in
animals
producing
food
for
human
consumption.
DO NOT USE
this
product
in
pregnant
animals.
Not
to
be
used
unless
sensitivity
testing
indicates
other
antibiotics
are
ineffective.
DOGS
&
CATS:
4.4 mg/kg i.m.
or
s.c.,
12 hourly on the first
day then once daily.
In life
threatening infections,
use th
                                
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Productkenmerken

                                MATERIAL SAFETY DATA SHEET
PRODUCT NAME: GENTAM INJECTABLE GENTAMICIN SOLUTION
PAGE: 1 OF 4
THIS REVISION ISSUED: OCTOBER, 2007
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
TROY LABORATORIES PTY. LIMITED ABN: 21 000 283 769
TEL:
(02)9604 6266
98 LONG STREET
FAX:
(02) 9725 1772
SMITHFIELD NSW 2164
SUBSTANCE:
Antibiotic solution.
TRADE NAME:
GENTAM INJECTABLE GENTAMICIN SOLUTION
APVMA CODE:
50436
PRODUCT USE:
Control of gentamicin susceptible bacteria in animals.
CREATION DATE:
OCTOBER, 2007
REVISION DATE:
OCTOBER, 2007
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of ASCC.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Clear, colourless liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
Gentamicin is an antibiotic. Any
person with a history of allergies to this class of substances should
avoid all contact with this product as it may cause
sensitisation.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health effects associated with long term skin exposure.
EYE CONTACT:
SHORT TERM EXPOSURE
: This product may be mildly irritating to eyes, bu
                                
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