SIMPARICA Chews for Dogs 10.1 - 20 Kg

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

SAROLANER

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

sarolaner(40mg/chew)

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

SAROLANER Active 40.0 mg/chew

Units in package:

1xtablet/*; 3xtablet/^; 6xtablet/"; blister"; blister*; blister^; card"; card*; card^

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic area:

PARASITICIDES

Product summary:

Poison schedule: 5; Withholding period: WHP: N/A; Host/pest details: DOG: [DOG MANGE MITE, EAR MANGE MITE, FLEA, SARCOPTIC MANGE, TICK]; For the treatment & prevention of flea infestations and the treatment & control of ticks on dogs & puppies. Also for the treatment of ear mites, Demodex mites & Sarcoptic mange.The safe use of this product has not been evaluated in breeding dogs and pregnant or lactating bitches. Puppies should be at least 8 weeks of age and weigh over 1.3kg.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ZOETIS AUSTRALIA PTY LTD
SIMPARICA Chews for Dogs 10.1 - 20 Kg
80948/101987
Company Name:
Product Name:
APVMA Approval No:
Label Name:
SIMPARICA Chews for Dogs 10.1 - 20 Kg
Signal Headings:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
Each chew contains 40 mg sarolaner
Claims:
• Protects for 1 month
• Kills fleas fast
• Kills paralysis ticks
• [1, 3, 6] Tasty chews
For the treatment and prevention of flea infestations and the
treatment and control of ticks
on dogs and puppies. Also for the treatment and control of ear mites,
demodex mites and
sarcoptic mange.
- Rapidly kills fleas before they lay eggs
- Treats and controls paralysis ticks, brown dog ticks and bush ticks
- Treats and controls demodex mites, ear mites and sarcoptic mange
- Controls flea allergy dermatitis
- Highly palatable and effective for one full month
Indications
SIMPARICA rapidly kills fleas within four to eight hours of treatment
and is indicated for the
treatment and prevention of flea (Ctenocephalides spp.) infestations.
SIMPARICA breaks the flea life cycle by killing adult fleas before
they can lay eggs,
therefore eliminating the risk of further environmental infestation.
The product can be used
as part of a treatment strategy for the control of Flea Allergy
Dermatitis (FAD).
SIMPARICA treats and controls paralysis ticks (Ixodes holocyclus),
brown dog ticks
(Rhipicephalus sanguineus) and bush ticks (Haemaphysalis longicornis).
The product has persistent flea and tick killing activity for 5 weeks
(35 days). RLP APPROVED
SIMPARICA is effective for the treatment and control of ear mites
(Otodectes cynotis),
demodex mites (Demodex canis) and sarcoptic mange (Sarcoptes scabiei).
Ixodes holocyclus ticks do not occur in Western Australia.
In tick season, daily searching for, and removal of, any ticks found
is recommended.
For use in puppies from 8 weeks of age and weighing 1.3 kg or more.
Net Contents:
[1, 3, 6] chews
Illegal to sell chews separately
Directions for Use:
Re

Summary of Product characteristics

Issue date: 12-February-2016
Supersedes date: 03-October-2016
Revision Date: 29-November-2016
Version number: 04
SAFETY DATA SHEET
1. IDENTIFICATION
SIMPARICA™ (SAROLANER) CHEWABLE TABLETS
PRODUCT IDENTIFIER
OTHER MEANS OF IDENTIFICATION
Simparica * Simparica™ Chews for Dogs * Simparica™ (sarolaner)
Chewables * Sarolaner
SYNONYMS
RECOMMENDED USE OF THE CHEMICAL AND RESTRICTIONS ON USE
Veterinary product used as antiparasitic
RECOMMENDED USE
Not for human use
RESTRICTIONS ON USE
DETAILS OF MANUFACTURER OR IMPORTER
COMPANY NAME (AU)
Zoetis Australia Pty Ltd
ABN 94 156 476 425
Level 6, 5 Rider Boulevard
Rhodes NSW 2138 AUSTRALIA
TEL
1800 814 883
FAX
[phone]
EMAIL
[e-mail]
EMERGENCY PHONE
1800 814 883 (all hours)
POLICE AND FIRE BRIGADE
Dial 000
IF INEFFECTIVE
Dial Poisons Information Centre (13 1126 from anywhere in Australia)
2. HAZARD(S) IDENTIFICATION
CLASSIFICATION OF THE HAZARDOUS CHEMICAL
Not classified.
PHYSICAL HAZARDS
Not classified.
HEALTH HAZARDS
Category 2
Hazardous to the aquatic environment, acute
hazard
ENVIRONMENTAL HAZARDS
Category 2
Hazardous to the aquatic environment,
long-term hazard
LABEL ELEMENTS, INCLUDING PRECAUTIONARY STATEMENTS
HAZARD SYMBOL(S)
Environment
SIGNAL WORD
None.
HAZARD STATEMENT(S)
Toxic to aquatic life with long lasting effects.
PRECAUTIONARY STATEMENT(S)
PREVENTION
Avoid release to the environment.
RESPONSE
Collect spillage.
STORAGE
Store away from incompatible materials.
DISPOSAL
Dispose of contents/container in accordance with
local/regional/national/international regulations.
OTHER HAZARDS WHICH DO NOT
RESULT IN CLASSIFICATION
None known.
SUPPLEMENTAL INFORMATION
Direct contact with eyes may cause temporary irritation.
3. COMPOSITION/INFORMATION ON INGREDIENTS
MIXTURE
1 / 10
Material name: Simparica™ (Sarolaner) Chewable Tablets
757
SDS AUSTRALIA
CONCENTRATION OF
INGREDIENTS
IDENTITY OF CHEMICAL INGREDIENTS
4
CAS NUMBER AND OTHER
UNIQUE IDENTIFIERS
1398609-39-6
Sarolaner
Isoxazoline
<1
557-04-0
Magnesium Stearate
<1
7631-86-9
Silicon