ORBAX 6.25 MG TABLETS FOR DOGS AND CATS

País: Austràlia

Idioma: anglès

Font: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compra'l ara

Descargar Fitxa tècnica (SPC)
20-06-2017

ingredients actius:

ORBIFLOXACIN

Disponible des:

INTERVET AUSTRALIA PTY LIMITED

Designació comuna internacional (DCI):

orbifloxacin(6.25mg/Tb)

formulario farmacéutico:

ORAL TABLET

Composición:

ORBIFLOXACIN ANTIBIOTIC Active 6.25 mg/Tb

Unidades en paquete:

100x6.25mg; Tablets

clase:

VM - Veterinary Medicine

Fabricat per:

INTERVET AUSTRALIA

Grupo terapéutico:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Área terapéutica:

ANTIBIOTIC & RELATED

indicaciones terapéuticas:

ACINETOBACTER SPP. | ENTEROBACTER SPP. | ENTEROCOCCUS FAECALIS | ESCHERICHIA COLI (E. COLI) | KLEBSIELLA PNEUMONIAE | PASTEURELLA MULTOCIDA | PROTEUS MIRABILIS | PSEUDOMONAS SPP. | STAPHYLOCOCCUS INTERMEDIUS | STREPTOCOCCUS - HEMOLYTIC GROUP G | DEEP PYODERMAS | FOWL CHOLERA | INCLUDING B-LACTAMASE PRODUCIN | INCLUDING SECONDARY INVADERS | SEBORRHOEIC DERMATITIS

Resumen del producto:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ACINETOBACTER SPP., ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA PNEUMONIAE, PASTEURELLA MULTOCIDA, PSEUDOMONAS SPP., STAPHYLOCOCCUS INTERMEDIUS, STREPTOCOCCUS - HEMOLYTIC GROUP G]; DOG: [ACINETOBACTER SPP., ENTEROBACTER SPP., ENTEROCOCCUS FAECALIS, ESCHERICHIA COLI (E. COLI), KLEBSIELLA PNEUMONIAE, PASTEURELLA MULTOCIDA, PROTEUS MIRABILIS, PSEUDOMONAS SPP., STAPHYLOCOCCUS INTERMEDIUS, STREPTOCOCCUS - HEMOLYTIC GROUP G]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ACINETOBACTER SPP., ENTEROBACTER SPP., ESCHERICHIA COLI (E. COLI), KLEBSIELLA PNEUMONIAE, PASTEURELLA MULTOCIDA, PSEUDOMONAS SPP., STAPHYLOCOCCUS INTERMEDIUS, STREPTOCOCCUS - HEMOLYTIC GROUP G]; DOG: [ACINETOBACTER SPP., ENTEROBACTER SPP., ENTEROCOCCUS FAECALIS, ESCHERICHIA COLI (E. COLI), KLEBSIELLA PNEUMONIAE, PASTEURELLA MULTOCIDA, PROTEUS MIRABILIS, PSEUDOMONAS SPP., STAPHYLOCOCCUS INTERMEDIUS, STREPTOCOCCUS - HEMOLYTIC GROUP G]; For the treatment of diseases caused by orbifloxacin- sensitive bacteria in dogs and cats.Not for use in food producing species. DO NOT use in pregnant or lactating animals. DO NOT use in juvenile dogs during the rapid growth phase.

Estat d'Autorització:

Registered

Data d'autorització:

2023-07-01

Informació per a l'usuari

                                _________________________________________________________________________
50764_1099c.doc
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ORBAX TABLETS 6.25MG – PRIMARY PACK
CARTON - FRONT PANEL
_________________________________________________________________________________
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ORBAX



6.25 MG TABLETS FOR DOGS AND CATS
ACTIVE CONSTITUENT:
ORBIFLOXACIN 6.25 mg
For the treatment of diseases caused by
orbifloxacin-sensitive bacteria in dogs and cats.
100 TABLETS
SCHERING-PLOUGH
ANIMAL HEALTH
Info
PEST
✔
Verified
_________________________________________________________________________
50764_1099c.doc
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2
of
8
ORBAX TABLETS 6.25MG – PRIMARY PACK
CARTON - OTHER PANELS
_________________________________________________________________________________
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
INDICATIONS
DOGS AND CATS
: For treatment of skin and associated soft tissue infections (wounds
and abscesses)
caused by susceptible strains of
_Staphylococcus intermedius, E. coli, Enterobacter _
spp
_., Pasteurella_
_multocida, Klebsiella pneumoniae, Pseudomonas _
spp
_., Acinetobacter _
spp
_., and Streptococcus_
-
hemolytic group G.
DOGS
: For treatment of urinary tract infections caused by susceptible
strains of
_E. coli, Proteus_
_mirabilis, Staphylococcus intermedius _
and
_Enterococcus faecalis_
.
DIRECTIONS FOR USE:
NOT FOR USE IN FOOD PRODUCING SPECIES.
CONTRA-INDICATIONS AND PRECAUTIONS
DO NOT USE IN PREGNANT OR LACTATING ANIMALS.
DO NOT USE IN JUVENILE DOGS DURING THE RAPID GROWTH PHASE.
ORBAX Tablets are contra-indicated in juvenile dogs during the rapid
growth phase (between 2 and 8
months of age in small and medium breeds, up to 12 months in large
breeds and up to 18 months in
giant breeds.
DOSAGE AND ADMINISTRATION
FOR ORAL USE ONLY.
The recommended dosage is 2.5 mg/kg bodyweight administered once
daily. See enclosed leaflet for
further information.
FOR FURTHER INFORMATION CONTACT SCHERING-PLOUGH CUSTOMER SERVICE ON 1
800 2
                                
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Fitxa tècnica

                                PRODUCT NAME: ORBAX TABLETS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: AUGUST, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Orbifloxacin is a fluoroquinolone antibiotic.
TRADE NAME:
ORBAX TABLETS
OTHER NAMES:
This MSDS is intended for three sizes of tablet for different sized
dogs and cats.
RECOMMENDED USE:
For the treatment of diseases caused by orbifloxacin-sensitive
bacteria in dogs and cats.
APVMA NO:
510632; 510649; 510656
CREATION DATE:
August, 2009
THIS VERSION ISSUED:
August, 2009
and is valid for 5 years from this date.
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 the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S2, S22, S24/25. Keep out of reach of children. Do not breathe dust.
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
PHYSICAL DESCRIPTION & COLOUR:
White tablets.
ODOUR:
Mild odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. This is
an antibiotic preparation.
Any person with a history of allergies to this class of substances
should avoid all contact with this product as it may cause
sensitisation. This is a physiologically active product and so contact
should be minimised, especially if the user is taking a
form of medication, as interactions can sometimes give unexpected and
undesired results.
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 C
                                
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