ilium Gentam 100 Injectable Gentamicin Solution

Land: Australië

Taal: Engels

Bron: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Werkstoffen:

GENTAMICIN AS GENTAMICIN SULFATE

Beschikbaar vanaf:

TROY LABORATORIES PTY LTD

INN (Algemene Internationale Benaming):

gentamicin as sulfate(100mg/mL)

farmaceutische vorm:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Samenstelling:

GENTAMICIN AS GENTAMICIN SULFATE ANTIBIOTIC Active 100.0 mg/ml

Eenheden in pakket:

100mL

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: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE in horses that may be used for huma n consumption; Host/pest details: CAT - NOT PREGNANT: [BACTERIAL INFECTION]; DOG - NOT PREGNANT: [BACTERIAL INFECTION]; FOALS < 14 DAYS OLD: [BACTERIAL INFECTION]; HORSE - NOT PREGNANT: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: WHP: MEAT (HORSES): Not to be used in horses intended for human consumption.; 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.DO NOT USE in food producing species of animals. DO NOT USE unless sensitivity testing indicates other antibiotics are ineffective. DO NOT USE this product in pregnant animals.

Autorisatie-status:

Registered

Autorisatie datum:

2022-07-01

Bijsluiter

ilium Gentam 100 Injectable Gentamicin Solution
46373/136746
Product Name:
APVMA Approval No:
Label Name:
ilium Gentam 100 Injectable Gentamicin Solution
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 mg/mL GENTAMICIN AS GENTAMICIN SULFATE
Claims:
For the control of gentamicin-susceptible bacterial infections in
dogs, cats and horses.
Indiscriminate use of ilium Gentam 100 may contribute to the
development of antibiotic
resistance.
Net Contents:
100 mL
Directions for Use:
Restraints:
DO NOT USE in food-producing species of animals.
DO NOT USE unless sensitivity testing indicates other antibiotics are
ineffective.
Contraindications:
Precautions:
Avoid use of this product in small cats and dogs since there is a risk
of overdosing due
to the very small injection volumes required. This product should not
be used in pregnant
animals.
Administration should not exceed 5 days without biochemical
confirmation that kidney
function is unaffected.
Use only in situations where sensitivity indicates that there is no
suitable alternative
antibiotic. RLP APPROVED
The safety of ilium Gentam 100 Injectable Gentamicin Solution has not
been established
in neonatal foals. The risk of nephrotoxicity following gentamicin
administration is
comparatively higher in neonates compared to adult horses.
Use in neonatal foals should be based on a risk: benefit assessment
undertaken by the
attending veterinarian. Given the higher total body water content, it
is recommended to
refer to scientific literature or seek expert advice regarding
appropriate dose rates and inter-
dosage intervals.
Additional Precautionary Advice:
In order to reduce the nephrotoxic risk, adequate hydration of animals
under treatment
should be ensured. Fluid therapy should be instituted, if required.
Close monitoring of
animals being treated with gentamicin is strongly advised. This
monitoring may include
assessing relevant kidney parameters in blood (e.g., creatinine and
urea) and urinalysis

Productkenmerken

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: GENTAM 100 INJECTABLE GENTAMICIN SOLUTION
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Troy Laboratories Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
TROY LABORATORIES AUSTRALIA PTY. LTD ABN: 21 000 283 769
TEL:
[phone]
31-35 GLENDENNING ROAD
FAX:
[phone]
GLENDENNING NSW 2761
CHEMICAL NATURE:
Active ingredient is an antibiotic
TRADE NAME:
GENTAM 100 INJECTABLE GENTAMICIN SOLUTION
PRODUCT CODE:
46373
PRODUCT USE:
Control of gentamicin susceptible bacteria in dogs, cats and horses.
CREATION DATE:
JULY, 2005
THIS VERSION ISSUED:
JULY, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S20, S24/25. When using, do not eat or drink. Avoid contact with skin
and eyes.
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:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that
this product is not harmful. In addition product is unlikely to cause
any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXP