Trifexis - patient leaflet, side effects, dosage

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Eli Lilly and Company Ltd

Speke Operations

Fleming Road

Liverpool

L24 9LN

UNITED KINGDOM

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR U

To be supplied only on veterinary prescription.

D. OTHER CONDITIONS AND REQUIREMENTS O AUTHORISATION

Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 – 6.0 kg)

Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 – 9.4 kg)

Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 – 14.7 kg)

Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 – 23.1 kg)

Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 – 36.0 kg) spinosad 270 mg/milbemycin oxime 4.5 mg spinosad 425 mg/milbemycin oxime 7.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg spinosad 1040 mg/milbemycin oxime 17.4 mg spinosad 1620 mg/milbemycin oxime 27 mg

OD AND ROUTE(S) OF ADMINISTRATION :r with food.

Read the package leaflet before use.

• 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Disposal: read package leaflet.

• 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only. To be supplied only on veterinary prescription.

• 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the sight and reach of chi

• 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Eli Lilly and Company Lt Elanco Animal Health Priestley Road Basingstoke Hampshire

RG24 9NL

UNITED KINGDOM

• 16. MARKETING AUTHORISATION NUMBER(S)

EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg)

EU/2/13/155/002 (1 × 3 tablets, 270 mg/4.5 mg)

EU/2/13/155/003 (1 × 6 tablets, 270 mg/4.5 mg)

EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg)

EU/2/13/155/005 (1 × 3 tablets, 425 mg/7.1 mg)

EU/2/13/155/006 (1 × 6 tablets, 425 mg/7.1 mg)

EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg)

EU/2/13/155/008 (1 × 3 tablets, 665 mg/11.1 mg)

EU/2/13/155/009 (1 × 6 tablets, 665 mg/11.1 mg)

EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg)

EU/2/13/155/011 (1 × 3 tablets, 1040 mg/17.4 mg)

EU/2/13/155/012 (1 × 6 tablets, 1040 mg/17.4 mg)

EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg)

EU/2/13/155/014 (1 × 3 tablets, 1620 mg/27.0 mg)

EU/2/13/155/015 (1 × 6 tablets, 1620 mg/27.0 mg)

MINIMUM PARTICULARS TO APPEAR ON BLISTERS

BLISTER

Eli Lilly and Company Ltd

EXP {month/year}

Lot {number}

For animal treatment only.

2. NAME OF THE MARKETING AUTHORISATION HOLDER

3. EXPIRY DATE

4. BATCH NUMBER

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

5. THE WORDS “FOR ANIMAL

Trifexis 270 mg/4.5 mg for dogs (3.9 – 6.0 kg)

Trifexis 425 mg/7.1 mg for dogs (6.1 – 9.4 kg)

Trifexis 665 mg/11.1 mg for dogs (9.5 – 14.7 kg)

Trifexis 1040 mg/17.4 mg for dogs (14.8 – 23.1 kg)

Trifexis 1620 mg/27 mg for dogs (23.2 – 36.0 kg)

ENT ONLY

PACKAGE LEAFLET FOR:

Trifexis 270 mg/4.5 mg chewable tablets for dogs

Trifexis 425 mg/7.1 mg chewable tablets for dogs

Trifexis 665 mg/11.1 mg chewable tablets for dogs

Trifexis 1040 mg/17.4 mg chewable tablets for dogs

Trifexis 1620 mg/27 mg chewable tablets for dogs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLD THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBL RELEASE, IF DIFFERENT

Marketing authorisation holder:

Eli Lilly and Company Ltd Elanco Animal Health Priestley Road Basingstoke Hampshire

RG24 9NL

UNITED KINGDOM

Manufacturer responsible for batch release :

Eli Lilly and Company Ltd

Speke Operations

Fleming Road

Liverpool

L24 9LN

UNITED KINGDOM

• 2. NAME OF THE VETERINARY ME

Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 – 6.0 kg)

Trifexis 425 mg/7.1 mg chewable tablets gs (6.1 – 9.4 kg)

Trifexis 665 mg/11.1 mg chewable tablogs (9.5 – 14.7 kg)

Trifexis 1040 mg/17.4 mg chewable tableor dogs (14.8 – 23.1 kg)

Trifexis 1620 mg/27 mg chewabler dogs (23.2 – 36.0 kg)

Active substances:

Each tablet contains:

spinosad 270 mg/milbemycin oxime 4.5 mg

spinosad 425 mg/milbemycin oxime 7.1 mg

spinosad 665 mg/milbemycin oxime 11.1 mg

spinosad 1040 mg/milbemycin oxime 17.4 mg spinosad 1620 mg/milbemycin oxime 27.0 mg

The tablets are a mottled tan to brown colour, and are round and chewable. The following list shows the code and the number of dimples marked on each strength of tablet:

4333 and 2 dimples

4346 and 3 dimples

4347 and no dimples

Trifexis 1040 mg/17.4 mg tablets:

Trifexis 1620 mg/27 mg tablets: 4. INDICATION(S)

For the treatment and prevention of flea (Ctenocephalides felis ) infestations in dogs wher more of the following indications are required concurrently:

• – prevention of heartworm disease (L3, L4 Dirofilaria immitis ),

• – prevention of angiostrongylosis by reducing the level of infection with immat Angiostrongylus vasorum,

• – treatment of gastrointestinal nematode infections caused by hookworm (L4,

  
  

and adult Ancylostoma caninum ), roundworms (immature adult L5, and adult Toxocara canis and adult Toxascaris leonina ) and whipworm (adult Trichuris vulpis ).

The flea preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of this product.

The veterinary medicinal product can be used as part of a treatme allergy dermatitis (FAD).

If you notice any serious effects or other effects not mentioned in this package leaflet, please, inform your veterinary surgeon.

7.

ET SPECIES

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATIO

For oral use.

Dosage:

The veterinary medicinal product should be administered in accordance with the following table t ensure a dose of 45 to 70 mg spinosad and 0.75 to 1.18 mg milbemycin oxime/kg bodyweight.

Bodyweight (kg) of dog	Strength and number of tablets to be administered:
	Trifexis 270 mg/4.5mg	Trifexis 425 mg/7.1 mg	Trifexis 665 mg/11.1 mg	Trifexis 1040 mg/17.4 mg	Trifexis 1620 mg/27 mg
3.9–6.0	1
6.1–9.4		1
9.5–14.7			1
14.8–23.1				v 1
23.2–36.0					1
36.1–50.7			1		1
50.8–72.0					2

Method of administration:

Trifexis tablets should be administered to the dog with its food, or immediately after feeding.

Based on the local epidemiological situation and the decision of the prescribing veterinarian, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below. This combination product (Trifexis) must, however, not be given for more than 6 consecutive months in any one year.

If the dog does not accept the tablet(s) directly in its mouth, then the tablet(s) may be administered with the dog’s food. The duration of efficacy may be reduced if the dose is administered on an empty stomach.

After administration of the tablet monitor the dog closely. 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. Then start a new monthly dosing schedule from that day.

The product can be administered as part of a seasonal prevention strategy when fleas and mosquitoes or snails/slugs are present.

Dogs living in non-heartworm endemic areas:

Trifexis can be used as part of the seasonal prevention of fleas (replacing treatment with a monovalent flea product) in dogs with diagnosed concurrent gastrointestinal nematode infections. A single treatment is effective for the treatment of gastrointestinal nematodes. After treatment of the nematode infection, further flea prevention should be continued with a monovalent product.

Dogs living in heartworm endemic areas:

Prior to treatment with Trifexis the advice in section 12 should be considered.

For the prevention of heartworm disease and the concurrent treatment and prevention of flea infestations, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when mosquitoes and fleas are present. The veterinary medicinal product must be

administered 1 month before the expected appearance of mosquitoes. It is recommended that heartworm prevention treatment should be continued at regular monthly intervals until at least 1 month after the last exposure to mosquitoes, but not for more than 6 consecutive months using Trifexis i one year.

When Trifexis is used to replace another heartworm preventive product, the first dose o be given within a month of the last dose of the former medication.

Dogs travelling to a heartworm region should start medication within a month after arr

Heartworm prevention treatment should be continued monthly, with the last adminis given one month after the dog has left the region, but not for more than 6 consecutiv Trifexis in any one year.

For the prevention of lungworm disease by reducing the level of infection with i Angiostrongylus vasorum larvae and the concurrent treatment and preventi veterinary medicinal product must be given at regular monthly intervals dur

when snails/slugs and fleas are present. It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails, but not for more than 6 consecutive months using Trifexis in any one year.

Seek veterinary advice regarding information on the optimal time to start treatment with this veterinary medicinal product.

• 9. ADVICE ON CORRECT ADMINISTRATION

The veterinary medicinal product should be administered with food or immediately after feeding. If

the dog does not accept the tablet(s) directly in its mouth then the tablet(s) may be mixed with food.

The duration of efficacy may be reduced if the dose is administered on an empty stomach.

After administration of the tablet monitor the dog closely. 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 product with the next offering of food. Then start a new monthly dosing schedule from that day.

10. WITHDRAWAL PERI

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

rinary medicinal product after the expiry date which is stated on the blister after icinal product does not require any special storage conditions.

autions for each target species:

s tablets should only be used when the veterinarian has confirmed diagnosis of mixed infection isk of infection, where prevention applies) at the same time (see section 4).

Prior to first use of this product, dogs in heartworm endemic areas or who have visited heartworm endemic areas mus ed for existing heartworm infection. At the discretion of the veterinarian, infected dogs musted with an adulticide to remove adult heartworms.

It is recommended to observe the treated dog up to 24 hours post-administration of the product for possible adverse reactions (see section 6). In case of adverse reactions consult your veterinarian.

recautions to be taken by the person administering the veterinary medicinal product to after use.

ntal ingestion may cause adverse reactions.

e of accidental ingestion, seek medical advice immediately and show the package leaflet or the to the physician.

Children must not come into contact with the veterinary medicinal product. Accidental ingestion m cause adverse reactions.

Pregnancy and lactation:

Laboratory studies (in rats and rabbits) on the effect of spinosad and milbemycin oxime have nei produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on th reproductive capacity in males and females.

In pregnant and lactating dogs (bitches), the safety of this veterinary medicinal product has not been sufficiently established. Spinosad is excreted in the colostrum and milk of lactating bitc excretion of milbemycin oxime in lactating dogs (bitches) has not been tested and the safety for suckling puppies has not been established. This product should therefore only be used during pregnancy and lactation according to the benefit-risk assessment by the responsible veterinarian.

Fertility:

As the safety of this veterinary medicinal product in male dogs used for br

determined, it should only be used according to the benefit-risk assessment by the responsible veterinarian

Interaction with other medicinal products and other forms of interac

Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones. Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.

Post-marketing reports: following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twit­ching, salivation/dro­oling, seizures, ataxia, mydriasis, blindness and disorientation. />

After spinosad administration, the incidence of vomiting on the day of, or the day after dosing has been observed to increase as a function of the dose. Vomiting is most likely caused by a local effect on the small intestine. At doses in excess of the recommended dose, vomiting becomes a very common event.

characterised by transient mild depression, ataxia, trembling, mydriasis, and excessive been observed in dogs given higher dose multiples of milbemycin oxime alone (5 to no antidote available. In case of adverse clinical signs, treat symptomatically.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WA MATERIALS, IF ANY

  s Agency

  
  

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European ( /).

• 15. OTHER INFORMATION