NexGard Spectra Chewables for Dogs 2 - 3.5 kg

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

AFOXOLANER; MILBEMYCIN OXIME

Available from:

Boehringer Ingelheim Animal Health Australia Pty. Ltd.

INN (International Name):

afoxolaner(9.4mg/chew)+milbemycin oxime(1.9mg/chew)

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

AFOXOLANER Active 9.4 mg/chew; MILBEMYCIN OXIME ANTIBIOTIC Active 1.9 mg/chew

Units in package:

1xTablet; 3xTablet; 6xTablet

Class:

VM - Veterinary Medicine

Manufactured by:

MERIAL AUSTRALIA

Therapeutic area:

PARASITICIDES

Product summary:

Poison schedule: 5; Withholding period: ; Host/pest details: DOG - WITH EXCLUSIONS SEE LABEL: [BROWN DOG TICK, BUSH TICK, CANINE SUMMER ECZEMA, DEMODEX SPP., DOG FLEA, EAR MANGE MITE, HEARTWORM - PREVENTION OF, HOOKWORM - ANCYLOSTOMA CEYLANICUM, PARALYSIS TICK, ROUNDWORM - TOXASCARIS SPP., SARCOPTIC MANGE, TAPEWORM - DIPYLIDIUM CANINUM, WHIPWORM - TRICHURIS VULPIS]; Rapidly kills fleas. Treats and controls ticks. Prevents heartworm disease. Treats and controls roundworms, hookworms and whipworms. Controls flea allergy dermatitis. Monthly treatment. Tasty chew.Safe use of product in breeding males & females has not been evaluated

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

NexGard Spectra Chewables for Dogs 2 - 3.5 kg
81008 / 136627
Product Name:
APVMA Approval No:
Label Name:
NexGard Spectra Chewables for Dogs 2 - 3.5 kg
Signal Headings:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
Each chewable contains:
9.4 mg AFOXOLANER
1.9 mg MILBEMYCIN OXIME
Claims:
• Rapidly kills fleas
• Treats and controls ticks
• Treats and controls mange and mites
• Prevents heartworm disease
• Treats and controls roundworms, hookworms and whipworms
• Controls flea allergy dermatitis
• Prevents flea tapeworm infestations
• Monthly treatment
• Tasty chew
For 2 - 3.5 kg dogs
For the treatment and prevention of flea infestations, control of
ticks and mites, prevention
of heartworm, and treatment and control of intestinal worms in dogs
and puppies from 8
weeks of age.
NexGard Spectra rapidly kills adult fleas and is indicated for the
treatment and prevention
of flea (Ctenocephalides spp.) infestations for 5 weeks (35 days), for
the control of newly
acquired adult fleas and for the control of flea allergy dermatitis.
Following administration,
fleas are killed within 6-8 hours. Rapid onset of action kills newly
acquired fleas before they
can lay eggs. Fleas can transmit flea tapeworm (Dipylidium caninum).
Effective flea control
with NexGard Spectra prevents flea tapeworm infestation in dogs.
NexGard Spectra treats and controls Paralysis ticks (Ixodes
holocyclus), Brown Dog ticks
(Rhipicephalus sanguineus) and Bush ticks (Haemaphysalis longicornis)
for 5 weeks (35
days). NexGard Spectra provides effective control of pre-existing
Paralysis tick infestations
within 24 hours. Ixodes holocyclus ticks do not occur in Western
Australia. In tick season,
daily searching for and removal of any ticks found is recommended. RLP APPROVED
NexGard Spectra treats and controls demodectic mange caused by Demodex
spp.,
sarcoptic mange caused by Sarcoptes scabiei and ear mite (Otodectes
cynotis)
infestations.
NexGard Spectra prevents heartworm dise

Summary of Product characteristics

NEXGARD SPECTRA CHEWABLES FOR DOGS
Version 2
Issue Date: 21 FEBRUARY, 2018
Page 1 of 5
SAFETY DATA SHEET
SAFETY DATA SHEET
Issued by:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Product name:
NEXGARD SPECTRA CHEWABLES FOR DOGS
OTHER NAMES:
This SDS is intended for several product sizes meant for different
sized dogs.
NexGard Spectra Chewables for Dogs 2-3.5 kg
NexGard Spectra Chewables for Dogs 3.6-7.5 kg
NexGard Spectra Chewables for Dogs 7.6-15 kg
NexGard Spectra Chewables for Dogs 15.1-30 kg
NexGard Spectra Chewables for Dogs 30.1-60 kg
Recommended Use:
For the treatment and prevention of endoparasite and ectoparasite
infestations on
dogs.
Supplier name:
BOEHRINGER INGELHEIM ANIMAL HEALTH AUSTRALIA PTY. LTD.
Address:
LEVEL 1
78 WATERLOO ROAD
NORTH RYDE NSW 2113 AUSTRALIA
Telephone number (toll-free):
1800 808 691
All hours emergency phone number - Poisons Information Centre 131126
anywhere in Australia
CHEMICAL NATURE:
Mixture – Afoxolaner and Milbemycin Oxime plus inert ingredients
THIS VERSION ISSUED:
SEPTEMBER, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S5
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P273: Avoid release to the environment.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED