BAYTRIL 25 ANTIBACTERIAL ORAL SOLUTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Safety Data Sheet (SDS)

05-11-2004

Active ingredient:

ENROFLOXACIN

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

enrofloxacin(25mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

ENROFLOXACIN ANTIBIOTIC Active 25.0 mg/ml

Units in package:

100mL

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: ANIMAL - EXOTIC: [ANTIBIOTICS - ORAL, PARENTERAL, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, STAPHYLOCOCCUS INTERMEDIUS, WOUND INFECTIONS]; CAT: [ANTIBIOTICS - ORAL, PARENTERAL, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, STAPHYLOCOCCUS INTERMEDIUS, WOUND INFECTIONS]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, STAPHYLOCOCCUS INTERMEDIUS, WOUND INFECTIONS]; Poison schedule: 4; Withholding period: ; Host/pest details: ANIMAL - EXOTIC: [ANTIBIOTICS - ORAL, PARENTERAL, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, STAPHYLOCOCCUS INTERMEDIUS, WOUND INFECTIONS]; CAT: [ANTIBIOTICS - ORAL, PARENTERAL, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, STAPHYLOCOCCUS INTERMEDIUS, WOUND INFECTIONS]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE URINARY TRACTS, STAPHYLOCOCCUS INTERMEDIUS, WOUND INFECTIONS]; For the treatment of diseases caused by susceptible bacterial pathogens in dogs and cats.DO NOT use in food producing species of animals. FOR USE ONLY in companion animals where culture and sensitivity testing indicate no suitable alternative. Not for use in dogs less than 1 year of age, or cats less than 12 weeks of age

Authorization status:

Registered

Authorization date:

2023-07-01

Summary of Product characteristics

PAGE 1 OF  6

SAFETY DATA SHEET

A18097/08/AUS

BAYTRIL 25 ANTIBACTERIAL ORAL SOLUTION

SECTION 1 – IDENTIFICATION, CONTACTS

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073

EMERGENCY TELEPHONE NUMBER
1800 033 111
24 hour Emergency Service Australia Wide, Toll Free

CONTACT POINT (FOR NON-EMERGENCY CALLS)
Animal Health Division
TELEPHONE NUMBER: (02) 9391-6000

Product Name
BAYTRIL 25 ANTIBACTERIAL ORAL SOLUTION

Product Use
Antibacterial treatment for dogs and cats.
PRESCRIPTION ANIMAL REMEDY

Other Names
Enrofloxacin

Creation Date
25
th
June 2003

Revision Date
29 April 2013  (SDS is current for 5 years from this date)

SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
NON-HAZARDOUS SUBSTANCE
NON-DANGEROUS GOODS
Risk Phrases
None
Safety Phrases
None

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Enrofloxacin*
93106-60-6
2.5%
Other ingredients, predominantly water, determined not to
be hazardous
-
>60%
*Enrofloxacin
is a fluoroquinolone antibiotic: 1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-
fluoro-1,4-dihydro4-oxoquinoline-3-carboxylic acid.

A18097/08/AUS BAYTRIL 25 ANTIBACTERIAL ORAL SOLUTION
PAGE 2 OF  6

SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
None
General
Remove victim from contaminated area. If there is a risk of
unconsciousness, position and transport in
a stable lateral position.
Remove soiled or soaked clothing immediately.
Scheduled Poisons
Poisons Information Centres in each State capital city can
provide
additional assistance for scheduled poisons. Phone 131126.
Inhalation
Inhalation of this product will not occur except as aspiration
into

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Safety Data Sheet

100 ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
01499942
48 x 48 x 135
BAYTRIL
®
25
ANTIBACTERIAL ORAL SOLUTION
Active Constituent:
25 MG/ML ENROFLOXACIN
For the treatment of diseases
caused by susceptible bacterial
pathogens in dogs and cats
100 ML
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ THE ENCLOSED
LEAFLET BEFORE USING
THIS PRODUCT.
DIRECTIONS FOR USE.
RESTRAINTS
DO NOT USE IN FOOD PRODUCING
SPECIES OF ANIMALS.
FOR USE ONLY IN COMPANION
ANIMALS WHERE CULTURE AND SENSI-
TIVITY TESTING INDICATE NO SUITABLE
ALTERNATIVE.
CONTRAINDICATIONS
NOT FOR USE IN DOGS LESS THAN ONE
YEAR OF AGE, OR CATS LESS THAN 12
WEEKS OF AGE (SEE LEAFLET).
The dose of Baytril in dogs and
cats is 5 mg/kg per day equivalent
to: 1 ML BAYTRIL 25 ORAL SOLUTION
PER 5 KG BODYWEIGHT.
FIRST AID
If poisoning occurs contact a doc-
tor or Poisons Information Centre.
Phone Australia 131126.
BAYTRIL
®
25
BAYTRIL
®
25
BAYER AUSTRALIA LTD
ACN 000 138 714
875 Pacific Highway
Pymble NSW 2073
DISPOSAL:
Dispose of empty packaging by
wrapping with paper and putting
in garbage.
Store below 30°C
(Room Temperature).
APVMA 46027/1/0705
For Batch and Expiry see top of
pack.
BAYTRIL
®
is a trademark of
Bayer AG, Leverkusen, Germany
Batch:
Expiry:
BAYTRIL
®
25
ANTIBACTERIAL ORAL SOLUTION
CUSTOMER
INFORMATION LINE
☎
1 800 678 368
TOLL FREE
from anywhere in Australia
9.00 am to 4.00 pm
(Eastern Time) Monday to Friday
BAYTRIL
®
25
ANTIBACTERIAL ORAL SOLUTION
Active Constituent:
25 MG/ML ENROFLOXACIN
For the treatment of diseases
caused by susceptible bacterial
pathogens in dogs and cats
DESCRIPTION:
Enrofloxacin is a synthetic drug from the class of the quinolone
carboxylic acid derivatives, also known as fluoroquinolones. It has
antibacterial activity against a broad spectrum of gram negative
and gram positive bacteria, including Mycoplasma. (See Table 1).
It is rapidly absorbed from the digestive tract, penetrating into all
measured body tissues and fluids (See Table 2

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