Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction 
Company name: Elanco Companion Animal Health
Address: Eli Lilly and Company Limited
Lilly House
Priestley Road, Basingstoke
Hampshire, RG24 9NL
Telephone: 01256 353131
Technical and Academic Services (24hr response) 01256 779956
Fax: 01256 779510
Email: ElancoCAH.UK@lilly.com
Website: www.elanco.com
Presentation
Comfortis chewable tablets are unscored tan to brown, or speckled, round, flat, bevelled-edge tablets, plain on one side and debossed with a number as listed below on the other side:
270mg: 4223
425mg: 4229
665mg: 4230
1040mg: 4231
1620mg: 4227
Uses
Comfortis chewable tablets are indicated for the treatment and prevention of flea infestation with Ctenocephalides felis in dogs and as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Dosage and administration
Comfortis tablets are administered orally at a recommended dose of 45-70mg/kg bodyweight.
Weight of dog (kg)
| Number of tablets and Tablet Strength (mg spinosad)
| 3.9 - 6.0
| 1 x 270 tablet
| 6.1 - 9.4
| 1 x 425 tablet
| 9.5 - 14.7
| 1 x 665 tablet
| 14.8 - 23.1
| 1 x 1040 tablet
| 23.2 - 36.0
| 1 x 1620 tablet
| 36.1 - 50.7
| 1 x 1620 + 1 x 665 tablets
| 50.8 - 72.0
| 2 x 1620 tablets
|
Comfortis chewable tablets can be administered at the recommended dose with the following advice:
Comfortis tablets can be administered by the oral route with or without food. If given without food, administration should immediately follow feeding. Dosing on an empty stomach may reduce the residual efficacy of Comfortis tablets.
The tablets should be administered at monthly intervals.
If vomiting occurs within an hour of administration and the tablet is visible, re-dose with another full dose.
If a dose is missed, administer the veterinary medicinal product with the next offering of food and resume a monthly dosing schedule.
In the case of heavy flea infestations, fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already in the environment. Regular monthly treatmnet with Comfortis breaks the fleas' life cycle. This is achieved by the capability of spinosad to rapidly kill adult fleas and therefore greatly reduce egg production.
Contra-indications, warnings, etc
Do not use in dogs under 14 weeks of age.
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
Special precautions for use in animals
Use with caution in dogs with pre-existing epilepsy.
Accurate dosing is not possible in dogs weighing less than 3.9kg and therefore the use of Comfortis tablets is not recommended in these patients.
Special precautions to be taken by the person administering Comfortis tablets to animals
Accidental ingestion may cause adverse reactions.
In case of accidental ingestion, seek medical advise immediately and show package leaflet or label to the physician.
Wash hands after administering product.
Pharmaceutical precautions
For animal treatment only.
Spinosad has been shown to be a substrate for P-glycoprotein (PgP). Spinosad could therefore interact with other PgP-substrates (for example, digoxin and doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.
Post marketing reports following the concomitant use of Comfortis with 'off label' high doses of ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Legal category
POM-V
Packaging Quantities
Clear PTCFE/PE/PVC blister pack sealed with aluminium foil containing six chewable tablets.
Carton packages containing one or six blister packs.
Further information
The most frequently observed adverse event is vomiting, which most commonly occurs in the first 48 hours after dosing. In the majority of cases, vomiting is transient, mild and does not require symptomatic treatment.
Other adverse reactions were uncommon or rare, and included lethargy, anorexia, diarrhoea, ataxia and seizures.
At doses up to 100mg/kg bodyweight per day for 10 days, the only clinical symptom of overdose was vomiting. Mild elevations of ALT (alanine aminotransferase) occurred in all dogs treated with Comfortis, although values returned to their baseline by day 24. Phospholipidosis (vacuolation of lymphoid tissues) also occurred; although this was not related to clinical signs in dogs treated up to 6 months.
In laboratory species (rats and rabbits) spinosad has neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor shown any effect on the reproductive capacity in males and females.
In pregnant bitches and during lactation, the safety of spinosad has not been sufficiently established.
The safety of the product in male dogs used for breeding has not been determined.
Marketing authorisation number
EU/2/10/115/001 to 010.
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