BAYTRIL 50 ANTIBACTERIAL INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Safety Data Sheet (SDS)

16-11-2004

Active ingredient:

ENROFLOXACIN

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

enrofloxacin(50mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

ENROFLOXACIN ANTIBIOTIC Active 50.0 mg/ml

Units in package:

50mL

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 one 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

A18096/07/AUS

BAYTRIL 50 ANTIBACTERIAL INJECTION

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 50 ANTIBACTERIAL INJECTION

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

Other Names
Enrofloxacin, potassium hydroxide

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
HAZARDOUS SUBSTANCE
NON-DANGEROUS GOODS
Risk Phrases
Irritating to eyes and skin.
Safety Phrases
In case of contact with eyes rinse
immediately with plenty of water and
seek medical advice.
RISK

&

SAFETY

PHRASES

ARE

NOT

REQUIRED

ON

PACKAGES

INTENDED

FOR

END

USERS.

APPROPRIATE

SAFETY

DIRECTIONS

AND

FIRST

AID

STATEMENTS

ARE

SHOWN

ON

THE

PRODUCT

LABEL.

A18096/07/AUS BAYTRIL 50 ANTIBACTERIAL INJECTION
PAGE 2 OF 6

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Enrofloxacin*
93106-60-6
5%
Potassium hydroxide
1310-58-3
0.8%
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.

SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
None
General
In case
of accident, or if you feel unwell, seek medical adv

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Safety Data Sheet

typographica
Gesellschaft für Kommunikation, Werbung und Fotosatz mbH
Schwarz
Kontur
BEI RÜCKFRAGEN / FOR QUESTIONS CALL:
TEL.: 0049 - 2173 38 +
Technik
BHC-AH-OP-TO/PT
Herr Fromm……………………..
4702
Herr Habig……………………….
5519
Herr Müller………………………
4614
Herr Wilinski…………………….. 4701
TEXT UND LAYOUT
Frau Kunze……………………...
4082
Frau Müller ...…………………...
4128
Frau Steinacker …………...…… 3046
Frau Reich ………………...…… 4098
Frau
Petzgen …………………... 7539
YPM:
01499977
Antrag-Nr.:
001225
Format:
45x45x85 mm
Schriftgröße:
6,5 pt
VERWENDETE FARBEN
Z.-NR.:
-
OPERATOR-ID
PD
VERSION-NR.
1
KORR.-DATUM
21.11.05
VERS.-DATUM
-
THIS PROOF IS
NOT A TRUE REPRESENTATION OF THE FINAL COLOURS THAT WILL BE PRINTED.
LAETUS:
0082
Bayer HealthCare AG – Animal Health
FREIGEGEBEN DURCH AH-OP-TO/TP
TECHNIK
am
…………………….………………...……….……….
von
…………………….………………...……….………
AUFMACHUNG
am
…………………….….…….…..…………….………
von
…………………….………………...……….………
SIMA.-NR.:
0077
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 SENSITIVITY TESTING INDI-
CATE NO SUITABLE ALTER
NATIVE.
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 is 5 mg/kg per day by
subcutaneous injection equivalent to: 1 ML
BAYTRIL 50 INJECTION PER 10 KG BODYWEIGHT.
Baytril
Tablets or Baytril Oral Solution may be
used for follow-up treatment after an initial
dose of Baytril Injection.
FIRST AID
If
poisoning
occurs
contact
a
doctor
or
Poisons Information Centre.
Phone Australia 131126.
BAYER AUSTRALIA LTD
ACN 000 138 714
875 Pacific Highway
Pymble NSW 2073
DISPOSAL: Dispose
of empty packaging by

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