Dogs

PROGRAM Plus is used for the prevention of fleas (Ct. felis, Ct. canis, preadult stages), and for the concurrent prevention of heartworm (elimination of L3/L4 larval stages of Dirofilaria immitis) and/or treatment of adult stages of gastrointestinal nematodes such as hookworms (Ancylostoma caninum), roundworms (Toxocara canis) and whipworms (Trichuris vulpis).

Do not use in case of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.

Ideally, tablets are administered on the same day each month. If an interval is greater than 6 weeks, treatment should be resumed immediately and be continued at monthly intervals and, in case of heartworm prevention, a veterinarian should be consulted.

i)Special precautions for use in animals

In heartworm risk regions, or in case it is known that a dog has been travelling to and from heartworm risk regions, before commencing PROGRAM Plus treatment as with any other heartworm preventive, a veterinary consultation is advised to exclude the presence of any concurrent infestation of Dirofilaria immitis. In the case of a positive diagnosis, adulticidal therapy is indicated before administering PROGRAM Plus.

ii)Special precautions to be taken by the person administering the veterinary medicinal product to animals

None.

In the case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

Pale mucous membranes, increased intestinal peristalsis, lethargy, diarrhea have been observed very rarely after treatment. The treatment of dogs with a high number of circulating microfilariae can sometimes lead to the appearance of moderate and transitory hypersensitivity reactions, such as pale

mucous membranes, vomiting, laboured breathing, or excessive salivation. These reactions are associated with the release of proteins from dead or dying microfilariae and are not a direct toxic effect of the product.

Can be used during pregnancy.

Can be used during lactation.

During treatment with PROGRAM Plus, no other antiparasitic macrocyclic lactones should be administered.

PROGRAM Plus tablets, available in four sizes, are given according to the weight of the dog, consistent with the administration of a minimum dose of 0.5 mg milbemycin oxime and 10 mg lufenuron per kg body weight.

PROGRAM Plus should be administered in the following situations:

To prevent flea infestations with concurrent heartworm prevention and/or gastrointestinal nematode infection treatment should start from 2 weeks of age, or from a minimum weight of 1 kg.

Program Plus can be used as part of the seasonal prevention of fleas replacing lufenuron mono (PROGRAM tablets) in cases with diagnosed concurrent gastrointestinal nematode infection. After elimination of the nematode infection confirmed by faecal examination, prevention of fleas should continue with PROGRAM tablets if indicated.

In puppies, treatment with Program Plus is recommended up to one month after weaning. Thereafter, prevention of fleas can be continued with lufenuron mono (Program).

To prevent flea infestations with concurrent heartworm prevention, dogs travelling to a heartworm risk region should begin medication within one month after arrival. Treatment should continue monthly, with the last administration given after the dog has left the region.

To prevent flea infestations and to prevent heartworm, medication should begin within one month after the appearance of mosquitoes, or one month before the appearance of fleas, and continue throughout the risk period with the last dose given within one month after the mosquito and flea season finishes.

If dogs have a high level of flea infestation at the start of treatment, it may be necessary to apply a flea adulticide during the first one to two months. It is important to treat all dogs and cats in the household for fleas. Cats in the same household should be treated with PROGRAM oral or injectable suspension.

At 10x recommended dose rate (i.e. 5 mg milbemycin oxime, 100 mg lufenuron per kg) and higher dose rates clinical signs such as transient ataxia, trembling, depression, salivation, and mydriasis may be observed. There is no specific antidote.

Not applicable.