Frontpro 3Cpr Mast 68Mg Dogs 10-25Kg

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 ingredient:
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 (tablets for dogs weighing between 2 and 4 kg) or rectangular in shape (tablets for dogs weighing between >4 and 10 kg, tablets for dogs weighing between >10 and 25 kg, and tablets 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 for controlling
flea allergy dermatitis (FAD).
Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus
sanguineus) in dogs. One treatment kills ticks for up to a month.
To be exposed to the active ingredient, fleas and ticks must attach to the host and begin their
blood meal.
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 of the excipients.

4.4 Special warnings for each target species
To enable parasite exposure to afoxolaner, it is necessary for them to start their blood meal on the host; therefore, the risk of disease transmission from the parasite cannot be excluded.

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 benefit-risk assessment by the responsible veterinarian.
Special precautions that must be observed by the person administering the veterinary medicinal product to animals
To prevent children from accessing the veterinary medicine, 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 Adverse reactions (frequency and severity)
Mild gastrointestinal disturbances (vomiting, diarrhea), itching, lethargy, anorexia, and neurological symptoms (seizures, ataxia, and muscle tremors) have been reported very rarely. Most reported adverse reactions were self-limiting and short-lived.
The frequency of adverse reactions is categorized as follows:
- very common (more than 1 in 10 treated animals experience adverse reactions)
- common (more than 1 but less than 10 in 100 treated animals)
- uncommon (more than 1 but less than 10 in 1,000 treated animals)
- rare (more than 1 but less than 10 in 10,000 treated animals)
- very rare (less than 1 in 10,000 treated animals, including isolated reports)

4.7 Use during pregnancy, lactation, or ovideposition
Laboratory studies in rats and rabbits have not shown evidence of teratogenic effects or adverse reactions on the reproductive capacity of male and female subjects.
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 Interactions 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/equal dosages. Tablets must not be divided.
Method 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:
Flea and tick infestations:
Monthly intervals during peak flea and/or tick seasons according to the local epidemiological situation.
Treatment of demodicosis (caused by Demodex canis):
Continue monthly administration until two skin scrapings test negative at one-month intervals. Severe cases may require prolonged monthly treatments. As demodicosis is a multifactorial disease, it is advisable to also treat any underlying conditions appropriately.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Monthly treatment for two consecutive months. Based on clinical evaluation and skin scrapings, additional monthly treatments may be necessary.