BAYTRIL OTIC ANTIBACTERIAL DROPS
Country: Ավստրալիա
language: անգլերեն
source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
PIL active_ingredient:
ENROFLOXACIN; SILVER SULFADIAZINE
MAH:
ELANCO AUSTRALASIA PTY LTD
INN:
enrofloxacin(5mg/mL)+silver sulfadiazine(10mg/mL)
pharmaceutical_form:
TOPICAL SOLUTION/SUSPENSION
composition:
ENROFLOXACIN ANTIBIOTIC Active 5.0 mg/ml; SILVER SULFADIAZINE SULFANYL Active 10.0 mg/ml
units_in_package:
12 x 15mL; 6 x 30mL
class:
VM - Veterinary Medicine
manufactured_by:
BAYER AUSTRALIA
therapeutic_group:
DOG | BITCH | CASTRATE | PUPPY
therapeutic_area:
EAR,NOSE,THROAT PREPS.
therapeutic_indication:
OTITIS EXTERNA | ACUTE CANINE OTITIS | ASSOCIATED WITH YEAST &/OR BAC | CHRONIC CANINE OTITIS | MALASSEZIA PACHYDERMATIS | OTITIS (CANINE)
leaflet_short:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [OTITIS EXTERNA]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [OTITIS EXTERNA]; For the treatment of acute and chronic canine otitis externa caused by susceptible organisms.FOR USE ONLY in dogs where culture and sensitivity testing indicate no suitable alternative.
authorization_status:
Registered
authorization_date:
2023-07-01
PIL
BOTTLE LABEL MAIN PANEL
Issue Date: 8-3-11
Page: 1 of 1111
_The information in this header block is not included in the label _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
BAYTRIL
OTIC
ANTIBACTERIAL DROPS
Active Constituents:
Each mL contains 5 MG ENROFLOXACIN
10 MG SILVER SULFADIAZINE
15 ML
BOTTLE LABEL SIDE PANEL
Issue Date: 8-3-11
_The information in this header block is not included in the label _
DIRECTIONS FOR USE
Shake well before use.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
SAFETY DIRECTIONS
May irritate the eyes. Avoid contact with eyes. Wash hands after use.
Store below 25
°
C (air conditioning)
APVMA Approval No 51924/51473
Bayer Australia Ltd, 875 Pacific Highway, Pymble, NSW 2073
Batch
Expiry RLP APPROVED
Info
PEST
Verified
SHIPPER LABEL FRONT PANEL
Issue Date: 8-3-11
Page: 2 of 1111
_The information in this header block is not included in the label _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
BAYTRIL
OTIC
ANTIBACTERIAL DROPS
Active Constituents:
Each mL contains 5 MG ENROFLOXACIN 10 MG SILVER SULFADIAZINE
_(dog pictogram) _
For treatment of acute and chronic canine otitis externa
caused by susceptible organisms.
12 X 15 ML
SHIPPER LABEL BACK PANEL
Issue Date: 8-3-11
Page: 3 of 1111
_The information in this header block is not included in the label _
BAYTRIL
OTIC
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
PRECAUTIONS
FOR USE IN COMPANION ANIMALS WHERE CULTURE AND SENSITIVITY TESTING
INDICATES NO SUITABLE
ALTERNATIVES.
SHAKE WELL BEFORE USE.
If indicated, perform aural lavage to remove exudate and debris before
treatment.
Dogs <16 kg, 5-10 drops
Dogs >16 kg, 10-15 drops
Administer twice daily for up to 14 days
SAFETY DIRECTIONS
May irritate the eyes. Avoid contact with eyes. Wash hands after use.
DISPOSAL
Dispose of empty container by wrapping with paper and putting in
garbage.
Bayer Australi
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SPC
PAGE 1 OF 6
SAFETY DATA SHEET
A18167/05/AUS
BAYTRIL OTIC ANTIBACTERIAL DROPS
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 OTIC ANTIBACTERIAL DROPS
Product Use
Antibacterial/antifungal ear drops for dogs.
PRESCRIPTION ANIMAL REMEDY
Other Names
Enrofloxacin, silver sulfadiazine
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
0.5%
Silver sulfadiazine**
22199-08-2
1%
Other ingredients 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.
**Silver sulfadiazine is a sulphonamide antibiotic: Benzenesulfonamide,
4-amino-N-2-
pyrimidinyl-monosilver (+1) salt.
A18167/04/AUS BAYTRIL OTIC ANTIBACTERIAL DROPS
PAGE 2 OF 6
SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
If poisoning occurs, contact a doctor or Poisons Information
Centre.
Phone Australia 131126.
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 capita
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