ENROBACTIN 50 ANTIBIOTIC TABLETS

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv ingrediens:

ENROFLOXACIN

Tilgjengelig fra:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN (International Name):

enrofloxacin(50mg/Tb)

Legemiddelform:

ORAL TABLET

Sammensetning:

ENROFLOXACIN ANTIBIOTIC Active 50.0 mg/Tb

Enheter i pakken:

100 tablets; 200 tablets

Klasse:

VM - Veterinary Medicine

Produsert av:

APEX LABORATORIES

Terapeutisk gruppe:

DOG | BITCH | CASTRATE | PUPPY

Terapeutisk område:

ANTIBIOTIC & RELATED

Indikasjoner:

ABSCESS | BACTERIAL INFECTION | INFECTION OF THE GENITOURINARY TRACT | INFECTIONS OF THE SKIN | INFECTIONS OF UPPER RESPIRATORY TRACT | INFECTIOUS SINUSITIS | WOUND INFECTIONS | ABSCESSES | AMOXYCILLIN SENSITIVE BACTERIA | ANAL SACCULITIS | ASSOCIATED WITH VIRAL DISEASE | DISCHARGING SINUSES | FUNGAL | GINGIVITIS | GRAM NEGATIVE BACTERIA | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE BACTERIA | GRAM POSITIVE ORGANISMS | POST PARTURIENT BACTERIAL INFE | POST-PARTURIENT INFECTIONS | PRIMARY BACTERIAL INFECTION | PYODERMA | SEPTICAEMIA | SULFADIAZINE SENSITIVE BACTERI | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA | YEAST

Produkt oppsummering:

Poison schedule: 4; Withholding period: WHP:N/A; Host/pest details: DOG: [ABSCESS, BACTERIAL INFECTION, INFECTION OF THE GENITOURINARY TRACT, INFECTIONS OF THE SKIN, INFECTIONS OF UPPER RESPIRATORY TRACT, INFECTIOUS SINUSITIS, WOUND INFECTIONS]; Treatment of bacterial infections caused by organisms sensitive to enrofloxacin in dogs. This includes treatment of infections of the skin, upper and lower respiratory tract, genitourinary tract, wounds, abscesses and discharging sinuses.DO NOT use in food producing species of animals. Should not be administered to dogs under a certain age (see label for details).

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

APEX ENROFLOXACIN 50 ANTIBIOTIC TABLETS
59484/120010
Product Name:
APVMA Approval No:
Label Name:
APEX ENROFLOXACIN 50 ANTIBIOTIC TABLETS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
50 mg ENROFLOXACIN
Claims:
Treatment of bacterial infections caused by organisms sensitive to
Enrofloxacin in
dogs. This includes treatment of infections of the skin, upper and
lower respiratory tract,
genitourinary tract, wounds abscesses and discharging sinuses.
Net Contents:
200 Tablets
100 Tablets
Directions for Use:
DO NOT USE in food producing species of animals.
Restraints:
Contraindications:
This product is contraindicated for use in dogs during the rapid
growth phase. This means
Enrofloxacin should not be used in dogs under one year of age, or
under 18 months of age
for giant breeds.
Precautions:
Side Effects:
Vomiting is an uncommon side effect of Enrofloxacin administration in
dogs.
Dosage and
Administration:
Dose Rate: RLP APPROVED
Dogs: 5mg/kg bodyweight to be administered once daily. Duration of
therapy should be for
2 to 3 days after clinical signs have subsided. If no improvement has
been noted within 5
days, the diagnosis should be re-evaluated.
Longer duration of therapy may be required for chronic or refractory
conditions, such as
pyodermas and discharging sinuses.
Underdosing patients with antibiotics can lead to selection of
resistant bacterial strains,
as can insufficient duration of therapy. It is therefore important
that dose regimens are
complied with. Ideally culture and sensitivity testing should be
performed to identify the
causal agent prior to selection of an antimicrobial agent. Similarly
culture should be
repeated at the conclusion of therapy to verify resolution.
Dosing guide:
(refer to attachment)
General Directions:
Actions: Enrofloxacin is a synthetic drug from the class of
fluoroquinolones. It has a
broad spectrum of bactericidal activity against Gram negative and Gram
positive bacteria
including Staphylococcus aureus,

Preparatomtale

Apex Enrofloxacin Tablets 

Page 1 of 5 
----------------------------------------------------------------------------------------------------------------------------------------------------------- 
MATERIAL SAFETY DATA SHEET 

ENROFLOXACIN 150MG AND 50MG TABLETS 
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC 

SECTION I   
IDENTIFICATION OF THE MATERIAL AND SUPPLIER 

Product Name   
Enrofloxacin Antibiotic Tablets 
Recommended Use 
Infections caused by organisms sensitive to enrofloxacin. 
Supplier details  
Apex Laboratories Pty Ltd 
   ACN 
000 
397 
240 
   61 
Chivers 
Road 
   Somersby 
NSW 
2250 

[phone] (Business hours – 8.30am – 5.30pm) 

[phone] (fax) 
   www.apexlabs.com.au 
Emergency contact 
As above or Poisons Information Centre 131126 (Australia) 

SECTION II   
HAZARD IDENTIFICATION 

Classification 

Not classified as hazardous according to the criteria of NOHSC  
Risk Phrases 

None allocated 
Safety Phrases   
None allocated 
ADG Class 

None allocated 
Hazchem Code  
None allocated 
Poisons Schedule 
S4 

SECTION III   
COMPOSITION 

Ingredients 

CAS No 
Proportion 
TWA 
mg/m
3

STEL 
mg/m
3

Enrofloxacin 
  93106-60-6 
30-60% 
 not 
set 
 not 
set 
Other non hazardous ingredients 

to 100% 

The TWA exposure value is the average airborne concentration of
a particular substance when calculated over a 
normal 8 hour working day for a 5 day working week over an
entire working lifetime.  The TWA exposure standard 
set by Worksafe Australia for dusts not otherwise specified is
10mg/m
3
.  The STEL (Short Term Exposure Limit) is an 
exposure value that should not be exceeded for more than 15 minutes
and should not be repeated for more than 4 
times per day. There should be at least 60 minutes between successive
exposures at the STEL. 

---------------------------------------------------