FRONTLINE ORIGINAL FOR EXTRA LARGE DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

FIPRONIL

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

fipronil(100g/L)

Pharmaceutical form:

TOPICAL SOLUTION/SUSPENSION

Composition:

FIPRONIL NITRILE Active 100.0 g/L

Units in package:

1x4.02mL; 3x4.02mL; 4*4.02mL; 6x4.02mL

Class:

VM - Veterinary Medicine

Manufactured by:

MERIAL AUSTRALIA

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

PARASITICIDES

Therapeutic indications:

BITING LOUSE | BROWN DOG TICK | FLEA | PARALYSIS TICK | SARCOPTIC MANGE SCABIES MITE | AUSTRALIAN PARALYSIS TICK | CTENOCEPHALIDES SPP. | DOG TICK | GROUND FLEAS | SCRUB TICK

Product summary:

Poison schedule: 5; Withholding period: WHP: N/A; Host/pest details: DOG: [BITING LOUSE, BROWN DOG TICK, FLEA, FLEA ALLERGIC DERMATITIS, PARALYSIS TICK, SARCOPTIC MANGE SCABIES MITE]; Poison schedule: 5; Withholding period: ; Host/pest details: DOG: [BITING LOUSE, BROWN DOG TICK, FLEA, FLEA ALLERGIC DERMATITIS, PARALYSIS TICK, SARCOPTIC MANGE SCABIES MITE]; For the treatment and prevention of flea infestations, control of flea allergy dermatitis, control of ticks (including paralysis tick) and biting lice on dogs. For extra large dogs 40-60kg.For use on puppies from 8 weeks of age. For use only on dogs. DO NOT use on rabbits.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
MERIAL AUSTRALIA PTY LTD
PRODUCT NAME:
FRONTLINE ORIGINAL FOR EXTRA LARGE DOGS
ELABEL APPLICATION NO:
DC12-61337396E1
APVMA APPROVAL NO:
65663/102998
PRODUCT NO:
65663
VERSION NO:
4.0
APPLICATION STARTED:
2015-Mar-26 16:04:01
VERSION CREATED:
2015-Sep-09 11:08:27
STARTED BY:
Vanessa Watson
PRINTED:
2015-Sep-09 11:19:45
LABEL NAME:
FRONTLINE ORIGINAL FOR EXTRA LARGE DOGS
SIGNAL HEADINGS:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
CONSTITUENT
STATEMENTS:
100 g/L FIPRONIL
CLAIMS:
For the treatment and prevention of flea infestations, control of flea
allergy dermatitis,
control of ticks (including paralysis tick) and biting lice on dogs.
• Water fast
• Monthly application for fleas
• Two weekly application for paralysis ticks.
FOR EXTRA LARGE DOGS 40-60 kg
INDICATIONS:
For the treatment and prevention of flea (Ctenocephalides felis)
infestations for one month
on dogs. For control of flea allergy dermatitis on dogs.
For control of Paralysis Tick (Ixodes holocyclus) infestations on dogs
for up to 2 weeks.
Ixodes holocyclus ticks do not occur in Western Australia. For the
control of Brown
Dog Ticks (Rhipicephalus sanguineus) on dogs for up to 1 month. In
tick season, daily
searching for, and removal of, any ticks found is recommended.
For the treatment of biting lice (Trichodectes canis) on dogs.
Aids in control of sarcoptic mange (Sarcoptes scabiei var. canis) on
dogs.
For use on puppies from 8 weeks of age.
NET CONTENTS:
1 x 4.02mL pipette / 3 x 4.02mL pipettes/ 4 x 4.02mL pipettes/ 6 x
4.02mL pipettes
It is illegal to sell pipettes separately
DIRECTIONS FOR USE: RLP APPROVED
For Official Use Only
RESTRAINTS:
CONTRAINDICATIONS:
DO NOT USE on rabbits
PRECAUTIONS:
SIDE EFFECTS:
DOSAGE AND
ADMINISTRATION:
For dogs less than 60kg in weight, use a single pipette from a pack
indicated for dogs of
the appropriate weight range. For dogs over 60kg, pipettes of
different volumes may be
combined to provide a suitable

Summary of Product characteristics

Page 1 of
12
Version Date: 'HFHPEHU
SAFETY DATA SHEET
Version Date: 20 December 2012
Supersedes: 28 April 2011
1.
PRODUCT AND COMPANY IDENTIFICATION
PRODUCT NAME:
Fipronil (10%) Spot-On Solution for Dogs, Puppies, Cats and Kittens
TRADE NAME(S):
FRONTLINE
FRONTLINE 10% SOLUCION TOPICA
FRONTLINE ORIGINAL FOR DOGS
FRONTLINE ORIGINAL FOR CATS
FRONTLINE SPOT ON CAT AND DOG SOL. A.U.V.
FRONTLINE SPOT ON CHAT / KAT / KATZE
FRONTLINE SPOT ON CHIEN - CHAT
FRONTLINE SPOT ON CHIEN XL
FRONTLINE SPOT ON DOG
FRONTLINE SPOT ON DOG AND CAT
FRONTLINE SPOT ON DOG XL
FRONTLINE SPOT ON DOG XL SOL.
FRONTLINE SPOT ON DOGS AND CATS
FRONTLINE SPOT-ON
FRONTLINE SPOT-ON 10% - LOSUNG ZUR KUTANEN
FRONTLINE SPOT-ON CAES
FRONTLINE SPOT-ON CANI & GATTI
FRONTLINE SPOT-ON CAT
FRONTLINE SPOT-ON CATS
FRONTLINE SPOT-ON CHAT
FRONTLINE SPOT-ON CHIEN
FRONTLINE SPOT-ON CHIEN (S-M-L)
FRONTLINE SPOT-ON CHIEN/HOND/HUND
FRONTLINE SPOT-ON CHIENS (S-M-L-XL)
FRONTLINE SPOT-ON DOG
FRONTLINE SPOT-ON GATO
FRONTLINE SPOT-ON GATOS
FRONTLINE SPOT-ON H (10-
20-40) & K
FRONTLINE SPOT-ON PERROS
FRONTLINE SPOT-ON VET. - SOLUTION FOR EXTERNAL USE
FRONTLINE TOP SPOT
FRONTLINE TOP SPOT CATS
FRONTLINE TOP SPOT DOGS
FRONTLINE TOP SPOT DOGS AND CATS
FRONTLINE TOP-SPOT HOND & KAT
T h e
f o l l o w i n g
i n f o r m a t i o n
i s
i n t e n d e d
t o
g i v e
g e n e r a l
h e a l t h
a n d
s a f e t y
g u i d a n c e
o n
t h e
manufacturing,
storage
and
transport
of
the
mixture.
Professional
and
non-professional
users
should consult label and package inserts for the proper use, storage
and disposal of this mixture.
MSDS:
Fipronil (10%) Spot-On Solution for Dogs, Puppies, Cats and Kittens
Page
2 of 12
Version Date: 'HFHPEHU
CHEMICAL FAMILY:
Mixture: phenylpyrazole
CHEMICAL NAME:
Mixture - NA
SYNONYMS:
NA
FORMULA:
None
PRODUCT USE:
Fipronil
(10%)
Solution
is
used
in
veterinary
medicine
for
the
treatment
and prevention of fleas, ticks a
nd biting
lice infestation on dogs and cats.
COMPANY ADDRESS
Merial Limited
3239 Satellite Boulevard
Duluth, Georgia 30096-4640
M