NV GENTAMAX 100 INJECTION

País: Austrália

Língua: inglês

Origem: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes ativos:

GENTAMICIN AS GENTAMICIN SULFATE

Disponível em:

CEVA ANIMAL HEALTH PTY LTD

DCI (Denominação Comum Internacional):

gentamicin as sulfate(100mg/mL)

Forma farmacêutica:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composição:

GENTAMICIN AS GENTAMICIN SULFATE ANTIBIOTIC Active 100.0 mg/ml

Unidades em pacote:

100mL; 50mL

Classe:

VM - Veterinary Medicine

Fabricado por:

CEVA ANIMAL HEALTH

Grupo terapêutico:

CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH

Área terapêutica:

ANTIBIOTIC & RELATED

Indicações terapêuticas:

ACTINOBACILLUS SPP. | BORDETELLA BRONCHISEPTICA | ENTEROBACTER SPP. | ESCHERICHIA COLI (E. COLI) | KLEBSIELLA SPP. | PSEUDOMONAS SPP. | CANINE COUGH SYNDROME | INCLUDING B-LACTAMASE PRODUCIN | INFECTIOUS TRACHEOBRONCHITIS

Resumo do produto:

Poison schedule: 4; Withholding period: WHP: Meat: Horses: NOT TO BE USED in h orses intended for human consumption.; Host/pest details: CAT: [ACTINOBACILLUS SPP., BORDETELLA BRONCHISEPTICA, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PSEUDOMONAS SPP.]; DOG: [ACTINOBACILLUS SPP., BORDETELLA BRONCHISEPTICA, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PSEUDOMONAS SPP.]; HORSE: [ACTINOBACILLUS SPP., BORDETELLA BRONCHISEPTICA, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PSEUDOMONAS SPP.]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ACTINOBACILLUS SPP., BORDETELLA BRONCHISEPTICA, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PSEUDOMONAS SPP.]; DOG: [ACTINOBACILLUS SPP., BORDETELLA BRONCHISEPTICA, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PSEUDOMONAS SPP.]; HORSE: [ACTINOBACILLUS SPP., BORDETELLA BRONCHISEPTICA, ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA SPP., PSEUDOMONAS SPP.]; For the treatment of infections due to gram-negative organisms in horses, cats and dogs.NOT FOR USE in food producing animals. Do not use for more than 5 days. Do not use in animals with impaired renal function. Use restricted to situations where sensitivity indicates no other alternative antibiotic.

Status de autorização:

Registered

Data de autorização:

2023-07-01

Folheto informativo - Bula

DRAFT CARTON: NV Gentamax 100 Injection
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NV
GENTAMAX 100
INJECTION
ACTIVE CONSTITUENT:
100 mg/mL GENTAMICIN (as Sulfate)
FOR THE TREATMENT OF INFECTIONS DUE TO
SUCH GRAM-NEGATIVE ORGANISMS AS
_ACTINOBACILLUS_ SP., _KLEBSIELLA _SP.,
_BORDETELLA BRONCHISEPTICA_, _ENTEROBACTER_
SP., _PSEUDOMONAS_ SP. AND_ E. COLI _IN
HORSES, CATS AND DOGS.
100 mL / 50 mL
READ
THE
ENCLOSED
LEAFLET
BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
RESTRAINTS:
NOT FOR USE IN FOOD PRODUCING
ANIMALS.
DO NOT USE FOR MORE THAN 5 DAYS.
DO NOT USE IN ANIMALS WITH IMPAIRED
RENAL FUNCTION.
USE RESTRICTED TO SITUATIONS WHERE
SENSITIVITY INDICATES NO OTHER ALTERNATIVE
ANTIBIOTIC.
Administer by subcutaneous, intramuscular
or intravenous injection.
HORSES: 1.5mg/kg every 8 hours.
CATS AND DOGS: 4.0mg/kg twice on the
first day then once daily.
MARES: Intrauterine infusion: 2.5 g diluted
in 400 mL sterile normal saline, once daily
for 3 - 5 days during oestrus.
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
NV
GENTAMAX 100
INJECTION
ACTIVE CONSTITUENT:
100 mg/mL GENTAMICIN (as Sulfate)
FOR THE TREATMENT OF INFECTIONS DUE TO
SUCH GRAM-NEGATIVE ORGANISMS AS
_ACTINOBACILLUS_ SP., _KLEBSIELLA _SP.,
_BORDETELLA BRONCHISEPTICA_, _ENTEROBACTER_
SP., _PSEUDOMONAS_ SP. AND_ E. COLI _IN
HORSES, CATS AND DOGS.
100 mL / 50 mL
MEAT WITHHOLDING PERIOD
(HORSES): NOT TO BE USED IN
HORSES INTENDED FOR HUMAN
CONSUMPTION.
DISPOSE
of
empty
container
by
wrapping
with
paper
and
putting
in
garbage.
STORE below 25ºC (Air Conditioning).
Protect from light.
Use the contents of the vial within 3
months of initial broaching, and discard
any unused portion.
Batch No.:
Expiry Date:
NRA : 55873/0103
NATURE VET PTY LIMITED
11 Moore's Rd.
Glenorie, NSW 2157
Tel: [phone]
Fax: [phone]
www.naturevet.com.au
Product: NV Gentamax 100 Injection
Date: 8/8/2002
50 mL & 100 mL Carton Label
Page 1 of 2
DRAFT CONTAINER: NV Gentamax 100 Injection
READ
THE
ENCLOSED

Características técnicas

PRODUCT NAME: NV GENTAMAX 100 INJECTION
PAGE: 1 OF 5
THIS VERSION ISSUED: JANUARY, 2015
SAFETY DATA SHEET
Issued by: Ceva 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
CEVA ANIMAL HEALTH PTY LTD
PHONE: [phone] (OFFICE HOURS)
11 MOORES RD
FAX: [phone]
GLENORIE, NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
Gentamicin in a water solution.
TRADE NAME:
NV GENTAMAX 100 INJECTION
PRODUCT USE:
For the treatment of infections due to gram-negative organisms
CREATION DATE:
JANUARY, 2015
THIS VERSION ISSUED:
JANUARY, 2015
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.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
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: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 25°C.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal service.
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR