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 section 6.1.

PHARMACEUTICAL FORM
Chewable tablets.
Variegated tablets in color from red to reddish-brown, round (tablets for dogs weighing
between 2 and 4 kg) or rectangular (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 the control
of flea allergic 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 ingredient, they must attach to the host and start the
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 allow the parasites to be exposed to afoxolaner, they must start their blood meal on the host; therefore, it is not possible to exclude the risk of transmission of diseases from the parasite.

4.5 Special precautions for use
Special precautions for use in animals
In the absence of available data, treatment of puppies younger than 8 weeks and/or dogs weighing
less than 2 kg should be based on a risk-benefit assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to the animals
To prevent children from accessing the veterinary drug, only remove 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 of the
reported adverse reactions were self-limiting and of short duration.
The frequency of adverse reactions is defined using the following conventions:
- very common (more than 1 in 10 treated animals shows adverse reactions)
- common (more than 1 but less than 10 animals per 100 treated animals)
- uncommon (more than 1 but less than 10 animals per 1,000 treated animals)
- rare (more than 1 but less than 10 animals per 10,000 treated animals)
- very rare (less than 1 animal per 10,000 treated animals, including isolated reports)

4.7 Use during pregnancy, lactation, or egg-laying
Laboratory studies conducted in rats and rabbits have not demonstrated the existence of effects
teratogenic, or any adverse reaction 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 in accordance with the assessment of the risk-benefit ratio by the responsible veterinarian.

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

4.9 Dosage and route of administration
For oral use.

Dosage:
The product must be administered at doses from 2.7 to 7 mg/kg of body weight as per 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 over 50 kg, use an appropriate combination of chewable tablets with different/equal dosages. The tablets must not be divided.
Mode of administration:
The tablets are chewable and palatable for most dogs. It is possible to administer the
tablets with food if the dog does not accept them directly.

Treatment program:
Treatment of flea and tick infestations:
Monthly intervals during peak seasons for fleas and/or ticks, based on the local epidemiological situation.
Treatment of demodicosis (caused by Demodex canis):
Continue monthly administration of the product until achieving two negative skin scrapings at
one-month intervals. Severe cases may require extended monthly treatments. Since
demodicosis is a multifactorial disease, when possible, it is advisable to also adequately treat
any other underlying conditions.
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 scrapings, it may be necessary to continue with additional monthly administrations of the product.