Frontpro 3Cpr Mast 28.3Mg Dogs 4-10Kg

FRONTPRO 11 mg chewable tablets for dogs 2–4 kg
FRONTPRO 28 mg chewable tablets for dogs >4–10 kg
FRONTPRO 68 mg chewable tablets for dogs >10–25 kg
FRONTPRO 136 mg chewable tablets for dogs >25–50 kg

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each chewable tablet contains:
Active principle:
FRONTPRO Afoxolaner (mg)
Chewable tablets for dogs 2–4 kg 11.3
Chewable tablets for dogs >4–10 kg 28.3
Chewable tablets for dogs >10–25 kg 68
Chewable tablets for dogs >25–50 kg 136
For the full list of excipients, see paragraph 6.1.

PHARMACEUTICAL FORM
Chewable tablets.
Tablets variegated in color from red to reddish-brown, round in shape (for dogs weighing
between 2 and 4 kg) or rectangular (for dogs weighing
between >4 and 10 kg, and for dogs weighing >10 and 25 kg and for dogs weighing
between >25 and 50 kg).

4. CLINICAL INFORMATION
4.1 Target species
Dogs.

4.2 Indications for use, specifying target species
Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs, for at least 5
weeks. The product can be used as part of a treatment strategy to control
flea allergy dermatitis (FAD).
Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus
sanguineus) in dogs. One treatment eliminates ticks for up to one month.
For fleas and ticks to be exposed to the active substance, they must attach to the host and
begin blood feeding.
Treatment of demodicosis (caused by Demodex canis).
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).

4.3 Contraindications
Do not use in cases of hypersensitivity to the active ingredient or to any excipient.

4.4 Special warnings for each target species
To allow parasites exposure to afoxolaner, they must start blood feeding on the host; therefore,
it is not possible to exclude the risk of disease transmission from the parasite.

4.5 Special precautions for use
Special precautions for use in animals
In the absence of available data, treatment of puppies under 8 weeks of age and/or dogs weighing
less than 2 kg should be based on a risk-benefit assessment by the responsible veterinarian.
Precautions that must be taken by the person administering the veterinary medicine to animals
To prevent children from accessing the veterinary drug, remove only one tablet from the blister at a time. Store the blister with the remaining chewable tablets in the box.
Wash hands after handling the product.

4.6 Undesirable reactions (frequency and severity)
Mild gastrointestinal disturbances (vomiting, diarrhea), pruritus, lethargy, anorexia and neurological symptoms
(seizures, ataxia, and muscle tremors) have been very rarely reported. Most of the adverse reactions reported were self-limiting and short-lived.
The frequency of adverse reactions is defined using the following conventions:
- very common (more than 1 in 10 treated animals show adverse reactions)
- common (more than 1 but less than 10 animals in 100 treated animals)
- uncommon (more than 1 but less than 10 animals in 1,000 treated animals)
- rare (more than 1 but less than 10 animals in 10,000 treated animals)
- very rare (less than 1 animal in 10,000 treated animals, including isolated reports)

4.7 Use during pregnancy, lactation or ovodeposition
Laboratory studies in rats and rabbits have not shown teratogenic effects or any adverse reaction
on the reproductive capacity of males and females.
The safety of the veterinary medicinal product during pregnancy and lactation or in breeding dogs has not been established. Use only according to the benefit-risk assessment by the responsible veterinarian.

4.8 Interaction with other veterinary medicines and other forms of interaction
None known.

4.9 Posology and method of administration
For oral use.

Dosage:
The product should be administered at doses from 2.7 to 7 mg/kg of body weight according to the following table:

Body weight
of the dog (kg)       

Dosage and number of chewable tablets to be administered

FRONTPRO 11 mg   2-4 1
FRONTPRO 28 mg   >4-10 1
FRONTPRO 68 mg   >10-25 1
FRONTPRO 136 mg  >25-50 1  

For dogs weighing more than 50 kg, use an appropriate combination of chewable tablets with different/similar dosages. Tablets must not be divided.
Mode of administration:
The tablets are chewable and palatable for most dogs. They can be given with food if the dog refuses to take them directly.

Treatment schedule:
Treatment of flea and tick infestations:
Monthly intervals during peak season for fleas and/or ticks, depending on the local epidemiological situation.
Treatment of demodicosis (caused by Demodex canis):
Continue monthly administration of the product until two skin scrapes are negative one month apart. Severe cases may require prolonged monthly treatments. Since demodicosis is a multifactorial disease, where possible, also treat any underlying conditions accordingly.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Monthly administration of the product for two consecutive months. Based on clinical assessment and skin scrapes, additional monthly treatments may be necessary.