COMFORTIS (SPINOSAD) CHEWABLE TABLETS FOR DOGS 18.1 - 27KG

Nchi: Australia

Lugha: Kiingereza

Chanzo: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
20-06-2017
Shusha Tabia za bidhaa (SPC)
20-06-2017

Viambatanisho vya kazi:

SPINOSAD MANUFACTURING CONCENTRATE

Inapatikana kutoka:

ELANCO AUSTRALASIA PTY LTD

INN (Jina la Kimataifa):

spinosad(810mg/Tb)

Dawa fomu:

ORAL TABLET

Tungo:

SPINOSAD MANUFACTURING CONCENTRATE UNGROUPED Active 810.0 mg/Tb

Vitengo katika mfuko:

*chewable; 1 tablet; 3 Tablets Chewable; 6 Tablets chewable

Darasa:

VM - Veterinary Medicine

Viwandani na:

ELANCO ANIMAL HEALTH

Kundi la matibabu:

DOG - WITH EXCLUSIONS SEE LABEL

Eneo la matibabu:

PARASITICIDES

Matibabu dalili:

CANINE SUMMER ECZEMA | CAT FLEA | FLEA ALLERGY DERMATITIS | SUMMER ECZEMA

Bidhaa muhtasari:

Poison schedule: 5; Withholding period: ; Host/pest details: DOG - WITH EXCLUSIONS SEE LABEL: [CANINE SUMMER ECZEMA, CAT FLEA]; Rapidly kills fleas. For the treatment, prevention & control of flea infestations. For the control of flea allergy dermatitis.NOT recommended for use in puppies less than 14 weeks of age

Idhini hali ya:

Registered

Idhini ya tarehe:

2023-07-01

Taarifa za kipeperushi

                                ELANCO ANIMAL HEALTH A DIV OF ELI LILLY AUST PTY LTD
COMFORTIS (SPINOSAD) CHEWABLE TABLETS FOR DOGS 18.1 - 27KG
62648/108698
Company Name:
Product Name:
APVMA Approval No:
Label Name:
COMFORTIS (SPINOSAD) CHEWABLE TABLETS FOR DOGS 18.1 - 27KG
Signal Headings:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each tablet contains 810 mg SPINOSAD
Claims:
Comfortis rapidly kills fleas (
Ctenocephalides felis
) and is intended for the treatment,
prevention and control of flea infestations and for the control of
flea allergy dermatitis in
dogs for one month following a single administration.
Monthly administration. Give with a meal.
Comfortis Chewable Tablets are not recommended for use in puppies less
than 14 weeks
of age.
Net Contents:
6 chewable tablets
3 chewable tablets
1 chewable tablet
Directions for Use:
Precautions:
Comfortis should not be administered to puppies less than 14 weeks of
age.
Seek veterinary advice regarding use of 'Comfortis' in pregnant and
lactating females and
in dogs with pre-existing epilepsy.
The safe use of Comfortis Chewable Tablets in breeding males has not
been evaluated.
Concurrent use of 'Comfortis' with high off-label doses of ivermectin
for parasitic mange
or demodicosis has been associated with an increased risk of
developing neurological
signs typically associated with ivermectin toxicity. 'Comfortis'
should not be administered
concurrently with high doses of macrocyclic lactones significantly in
excess of those
approved for heartworm prophylaxis. Post approval experience continues
to support the
safety of 'Comfortis' when used concurrently with heartworm
preventatives according to
label directions.
Page 1 of 4 RLP APPROVED
Dosage and
Administration:
Administer one tablet by mouth, once a month for dogs between 27.1 and
54 kg.
Comfortis Chewable Tablets should be administered with food for
maximum effectiveness.
Not recommended for use in puppies less than 14 weeks of age.
Common leaflet Dosage & Administration (attached at Page 3.)
General 
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                Issue date: 04-September-2015
Version number: 01
SAFETY DATA SHEET
1. Identification
Product identifier
Comfortis (Spinosad) Chewable Tablets for Dogs 18.1 - 27KG
Other means of identification
Item Code
CA4226, CA4228, CA4221, CA4231, CA4230, CA4229, CA4222, CA4227,
CA4225, CA4224, CA4223
Recommended use of the chemical and restrictions on use
Recommended use
Veterinary Pharmaceutical
Restrictions on use
Not available.
Details of manufacturer or importer
Manufacturer
Company name
Elanco Animal Health
A Division of Eli Lilly Australia Pty Ltd
Address
A.B.N. 39 000 233 992
112 Wharf Road, West Ryde, N.S.W. 2114, Australia
Telephone
(02) 9878 7777
Fax
(02) 9878 7720
e-mail
lilly_msds@lilly.com
Emergency phone
number
Elanco Animal Health: 1800 226 324 (Toll free)
OR Poisons Information Centre: 131126 (Australia-wide)
24 hr emergency contact
number
CHEMWATCH 1800 039 008 (spills and accidents)
24 hr emergency contact
number (Local)
CHEMWATCH +61 2 9186 1132 (spills and accidents)
2. Hazard(s) identification
Classification of the hazardous chemical
Not classified.
Physical hazards
Not classified.
Health hazards
Category 1
Hazardous to the aquatic environment, acute
hazard
Environmental hazards
Category 1
Hazardous to the aquatic environment,
long-term hazard
Label elements, including precautionary statements
Hazard symbol(s)
Environment
Signal word
Warning
Hazard Statement(s)
Very toxic to aquatic life with long lasting effects.
Precautionary Statement(s)
Prevention
Avoid release to the environment.
Response
Not available.
Storage
Not available.
Disposal
Not available.
Other hazards which do not
result in classification
None known.
Supplemental information
None.
1 / 8
Material name: Comfortis (Spinosad) Chewable Tablets for Dogs 18.1 -
27KG
5066
SDS AUSTRALIA
3. Composition/information on ingredients
Mixture
Concentration of
ingredients
Identity of chemical ingredients
57 - 60
CAS number and
other unique
identifiers
168316-95-8
SPINOSAD
Composition comments
Remaining components of this product are non-hazardous and/or 
                                
                                Soma hati kamili