ADVOCATE FOR DOGS OVER 25KG

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MOXIDECTIN; IMIDACLOPRID

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

imidacloprid(100g/L)+moxidectin(25g/L)

Pharmaceutical form:

TOPICAL SOLUTION/SUSPENSION

Composition:

MOXIDECTIN ANTHELMINTIC Active 25.0 g/L; IMIDACLOPRID GUANIDINE Active 100.0 g/L

Units in package:

1 x 4mL pipettes; 2 x 4mL pipettes; 3 x 4mL pipettes; 6 x 4mL pipettes

Class:

VP - Veterinary Pesticide

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

DOG - OVER 25 KG

Therapeutic area:

PARASITICIDES

Therapeutic indications:

CANINE SUMMER ECZEMA | DEMODECTIC MANGE | DOGBITING LOUSE | DOGSUCKING LOUSE | EAR MANGE MITE | FLEA - CTENOCEPHALIDES SPP. | HEARTWORM - PREVENTION OF | HOOKWORM - ANCYLOSTOMA BRAZILIENSE | HOOKWORM - ANCYLOSTOMA CANINUM | HOOKWORM - ANCYLOSTOMA CEYLANICUM | HOOKWORM - UNCINARIA STENOCEPHALA | ROUNDWORM - TOXASCARIS LEONINA | ROUNDWORM - TOXOCARA CANIS | WHIPWORM - TRICHURIS VULPIS | ASCARID | EAR MITES | FLEA ALLERGY DERMATITIS | HUMAN INTESTINAL ROUNDWORM | SUMMER ECZEMA | TO PREVENT HEARTWORM

Product summary:

Poison schedule: 6; Withholding period: WHP: N/A; Host/pest details: DOG - OVER 25 KG: [AID IN THE PREVENTION OF THE FLEA TAPEWORM (DIPYLIDIUM CANINUM) THROUGH EFFECTIVE FLEA CONTROL., CANINE SUMMER ECZEMA, DEMODECTIC MANGE, DOGBITING LOUSE, DOGSUCKING LOUSE, EAR MANGE MITE, FLEA - CTENOCEPHALIDES SPP., HEARTWORM - PREVENTION OF, HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, PREVENTS OESOPHAGEAL WORM (SPIROCERCA LUPI)., ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, SARCOPTIC MANGE SCABIES MITE, WHIPWORM - TRICHURIS VULPIS]; Poison schedule: 6; Withholding period: WHP: N/A; Host/pest details: DOG - OVER 25 KG: [CANINE SUMMER ECZEMA, DEMODECTIC MANGE, DOGBITING LOUSE, DOGSUCKING LOUSE, EAR MANGE MITE, FLEA - CTENOCEPHALIDES SPP., HEARTWORM - PREVENTION OF, HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, SARCOPTIC MANGE SCABIES MITE, WHIPWORM - TRICHURIS VULPIS]; Poison schedule: 6; Withholding period: ; Host/pest details: DOG - OVER 25 KG: [CANINE SUMMER ECZEMA, DEMODECTIC MANGE, DOGBITING LOUSE, DOGSUCKING LOUSE, EAR MANGE MITE, FLEA - CTENOCEPHALIDES SPP., HEARTWORM - PREVENTION OF, HOOKWORM - ANCYLOSTOMA BRAZILIENSE, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - ANCYLOSTOMA CEYLANICUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS, SARCOPTIC MANGE SCABIES MITE, WHIPWORM - TRICHURIS VULPIS]; Once a month topical flea and worm treatment. Stops fleas feeding in 3-5 minutes. Prevents heartworm and controls intestinal worms and larvae. Water resistant formulation.Do NOT apply to cats. Use with caution in sick, debilitated or underweight animals. For external use only. DO NOT GIVE PRODUCT BY MOUTH.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ADVOCATE FOR DOGS OVER 25KG
55323/131521
Product Name:
APVMA Approval No:
Label Name:
ADVOCATE FOR DOGS OVER 25KG
Signal Headings:
POISON
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
100 g/L IMIDACLOPRID
25 g/L MOXIDECTIN
Claims:
Fleas, Heartworms & Worms
Once a month topical flea, heartworm and worm treatment
Doesn’t rely on fleas having to bite to be killed
Treatment and control of intestinal worms and worm larvae
Prevents heartworm and oesophageal worm
Water resistant, convenient, easy to apply
FOR:
Treatment and prevention of fleas (Ctenocephalides spp.). Reduces the
incidence of Flea
Allergy Dermatitis (FAD). Larval flea stages are killed in the
surroundings of ADVOCATE
treated dogs.
Aid in the prevention of the flea tapeworm (Dipylidium caninum)
through effective flea
control.
Prevention of heartworm (Dirofilaria immitis) and oesophageal worm
(Spirocerca lupi).
FOR THE TREATMENT AND CONTROL OF:
roundworms: (Toxocara canis, Toxascaris leonina), kills larval (L4) ,
immature adult (L5)
and adult worms;
hookworms: (Ancylostoma caninum, Ancylostoma braziliense (this
hookworm is usually
restricted to tropical areas in Australia), Ancylostoma ceylanicum,
Uncinaria stenocephala),
kills larval (L4), immature adult (L5) and adult worms of all species;
whipworm: (Trichuris vulpis);
generalised demodicosis (Demodex canis);
sarcoptic mange (Sarcoptes scabiei);
ear mites (Otodectes cynotis);
lice (Trichodectes canis, Linognathus setosus) for up to 6 weeks;
in dogs.
One application lasts for a month.
Advocate contains imidacloprid (a neonicotinoid) and moxidectin (a
macrocyclic lactone).
If problems persist, consult a veterinarian. RLP APPROVED
Net Contents:
1 x 4 mL
2 x 4 mL
3 x 4 mL
6 x 4 mL
pipettes
It is illegal to sell pipettes separately.
Directions for Use:
Restraints:
Contraindications:
Precautions:
Use with caution in sick, debilitated or underweight animals. Take
care to avoid the product
coming into contact with the eyes or mouth of the pet. Ingestion

Summary of Product characteristics

PAGE 1 OF 11
SAFETY DATA SHEET A18180/07/AUS
ADVOCATE FOR DOGS
SECTION 1 – IDENTIFICATION
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: [phone]
Product Name
ADVOCATE FOR DOGS
Product Use
Spot-on treatment for flea control, gastrointestinal worm control, and
prevention of heartworm infection in dogs.
Other Names
Imidacloprid, moxidectin, benzyl alcohol
This SDS covers the following four products:

Advocate for Puppies and Small Dogs up to 4 kg

Advocate for Dogs 4-10kg

Advocate for Dogs 10-25kg

Advocate for Dogs over 25kg
Creation Date
25
th
June 2003
Revision Date
15 December 2015 (SDS is current for 5 years from this date)
A18180/07/AUS ADVOCATE FOR DOGS
PAGE 2 OF 11
SECTION 2 – HAZARD IDENTIFICATION
Hazard Classification
HAZARDOUS SUBSTANCE
NOT CLASSIFIED AS DANGEROUS GOODS when transported by
road or rail within Australia under Special Provision AU01 of the
Australian Dangerous Goods Code, 7th Edition.
CLASSIFIED AS DANGEROUS GOODS when transported by sea or
air.
GHS-Classification
ACUTE TOXICITY, ORAL, CATEGORY 4 (H302)
ACUTE TOXICITY, INHALATION, CATEGORY 4 (H332)
EYE IRRITATION, CATEGORY 2 (H319)
HAZARDOUS TO THE AQUATIC ENVIRONMENT, CATEGORY 1 (H400)
HAZARDOUS TO THE AQUATIC ENVIRONMENT, CATEGORY 1 (H410)
Signal Word
WARNING
Hazard Statements
H302 + H332 HARMFUL IF SWALLOWED OR IF INHALED
H319 CAUSES SERIOUS EYE IRRITATION.
H410 VERY TOXIC TO AQUATIC LIFE WITH LONG LASTING EFFECTS.
Precautionary
statements
PREVENTION:
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P273 Avoid release to the environment.
P280 Wear protective gloves/ eye protection/ face protection.
RESPONSE:
P312 Call Poisons Information 131 126 or doctor/ physician if you feel
unwell.
P337 + P313 If eye irritation persists: Get medical advice/ attention.
P391 Collect spillage.
A18180/07/AUS ADVOCATE FOR DOGS
PAGE 3 OF 11
SE

Safety Data Sheet

More rapid resolution of heavy environmental infestations may be
obtained by
additional environmental control measures using a suitable registered
product.
It is recommended that all dogs in the same environment should be
protected by
ADVOCATE for Dogs and all cats with ADVOCATE for Cats.
HEARTWORM PREVENTION
Treatment with ADVOCATE should start one month before the fi rst
exposure to
mosquitoes. ADVOCATE must be applied at one month intervals during the
time
of the year when mosquitoes (which carry and transmit the heartworm
larvae) are
present. In many areas of Australia continuous, year-round heartworm
prevention
is recommended. To establish a routine, it is recommended that the
same day
or date be used each month to administer ADVOCATE. When replacing
another
heartworm preventive product, the fi rst treatment with ADVOCATE must
be given
within one month of the last dose of the previous product.
WORM CONTROL
ADVOCATE treats and controls the major gastrointestinal nematodes of
dogs but
does not control tapeworms. In order to control tapeworms use DRONTAL
®
or
DRONCIT
®
as appropriate. Dogs can become reinfested with worms but regular use
of ADVOCATE will remove them. IF WORM PROBLEMS PERSIST, CONSULT A
VETERINARIAN.
TREATMENT AND CONTROL OF GENERALISED DEMODICOSIS
ADVOCATE has been shown to be highly eff ective in the treatment of
generalised
demodicosis when administered at monthly intervals for 2 to 4
treatments. In
a laboratory study performed on dogs naturally infested with Demodex
canis,
treatment with ADVOCATE resulted in a decrease in the occurrence of
erythema,
casts, scales, crusts and alopecia and a signifi cant reduction (97.84
%) in mite
numbers found on skin scrapings. In a fi eld study, all dogs enrolled
in the study
were 100 % cured of Demodex mites.
TREATMENT AND CONTROL OF SARCOPTIC MANGE
ADVOCATE has been shown to eliminate 100 % of sarcoptic mites
(Sarcoptes
scabiei) aft er a single dose. A second dose of ADVOCATE a month later
will result
in continued improvement of the clinical signs asso