IBAFLIN 3% GEL FOR DOGS AND CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

IBAFLOXACIN

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

ibafloxacin(30mg/mL)

Pharmaceutical form:

ORAL GEL

Composition:

IBAFLOXACIN ANTIBIOTIC Active 30.0 mg/ml

Units in package:

15 mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, PYODERMA, SOFT TISSUE INFECTIONS]; DOG: [INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, PYODERMA, SOFT TISSUE INFECTIONS]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, PYODERMA, SOFT TISSUE INFECTIONS]; DOG: [INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, PYODERMA, SOFT TISSUE INFECTIONS]; For the treatment of urinary tract, respiratory tract, skin & soft tissue infections sensitive to ibafloxacin in dogs & cats.DO NOT USE in food producing species of animals. DO NOT USE in dogs with known fluoroquinone sensitivity or with weight <3kg. DO NOT USE in cats up to 8 months of age. See also CONTRAINDICATIONS on product leaflet.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

59708-36596-15mL-label-txl-v2
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF THE REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
IBAFLIN
®
3% GEL FOR DOGS AND CATS
ACTIVE CONSTITUENT:
IBAFLOXACIN 30 mg/mL
For the treatment of urinary tract, respiratory tract, skin and soft
tissue infections
sensitive to ibafloxacin in Dogs and Cats.
15mL
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
STORAGE:
Store below 25
°
C (Air conditioning. Do not freeze.).
Batch No.:
Expiry Date:
APVMA Approval No.: 59708/15M/0708
[Intervet Logo]
APPROVED
LABEL
Info
PEST

Verified
59708-36596-15mL-carton-txl-v3
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF THE REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
IBAFLIN
®
3% GEL FOR DOGS AND CATS
ACTIVE CONSTITUENT:
IBAFLOXACIN 30 mg/mL
For the treatment of urinary tract, respiratory tract, skin and soft
tissue infections
sensitive to ibafloxacin in Dogs and Cats.
1 x 15mL
[Intervet Logo]
APPROVED
LABEL
59708-36596-15mL-carton-txl-v3
_ _
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
RESTRAINTS:
DO NOT USE in food producing species of animal.
FOR USE ONLY in dogs where indicated by antibiotic sensitivity testing
according to
principles of prudent use.
FIRST AID:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia
131126.
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage.
STORAGE:
Store below 25
°
C (Air conditioning. Do not freeze).
Batch No.:
Expiry Date:
APVMA Approval No.: 59708/15M/0708
INTERVET AUSTRALIA PTY LIMITED
91-105 Harpin Street
BENDIGO EAST VIC 3550
Phone: (03) 5440 9888
APPROVED
LABEL
59708 -36596 -15mL-leaflet-txl-v3
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF THE REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
IBAFLIN
®
3% GEL FOR DOGS AND CATS
ACTIVE CONSTITUENT:
IBAFLOXACIN 30 mg/mL
For the treatment of urinary tract, respiratory tract, skin and soft
tissue infections
sensitive to ibafloxacin in Dogs and Cats.
INDICATIONS:
IBAFLIN
®
gel is indicated in Dogs for the treatment of the following
conditions:

Read the complete document

Summary of Product characteristics

PRODUCT NAME: IBAFLIN 3% GEL FOR DOGS AND CATS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JANUARY, 2010
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)
CHEMICAL NATURE:
Ibafloxacin is a synthetic antimicrobial substance of the
fluoroquinolone class.
TRADE NAME:
IBAFLIN 3% GEL FOR DOGS AND CATS
RECOMMENDED USE:
For the treatment of urinary tract, respiratory tract, skin and soft
tissue infections sensitive
to ibafloxacin in dogs and cats.
APVMA NO:
59708
CREATION DATE:
January, 2010
THIS VERSION ISSUED:
January, 2010
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:
S25. Avoid contact with eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Clear gel.
ODOUR:
No data; expected to be 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. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful.

Read the complete document