Milprazon Chewable (1 - 5 kg)

12 x 4 pc

Film-coated tablet

Active substance

Praziquantel : 25 mg

Milbemycinoxim : 2,5 mg

ATC code

QP54AB51 Milbemycin oxime, comb.

QP54AB Milbemycins

QP54A Macrocyclic lactones

QP54 Endectocides

QP Antiparasitic products, insecticides and repellents

Species

Dogs (small dogs and puppies).

Indications

Treatment of mixed infections by adult cestodes and nematodes of the following species:

- Cestodes: Dipylidium caninum Taenia spp.

Echinococcus spp.

Mesocestoides spp.

- Nematodes:

Ancylostoma caninum

Toxocara canis

Toxascaris leonina

Trichuris vulpis

Crenosoma vulpis (Reduction of the level of infection).

Angiostrongylus vasorum (Reduction of the level of infection by immature adult (L5) and adult parasite stages; see specific treatment and disease prevention schedules under section 4.9 Amounts to be administered and administration route).

Thelazia callipaeda (see specific treatment schedule under section 4.9 Amounts to be administered and administration route).

The veterinary medicinal product can also be used in the prevention of heartworm disease (Dirofilaria immitis), if concomitant treatment against cestodes is indicated.

Dose to be administered and administration route

Oral use.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Minimum recommended dose rate: 0.5 mg of milbemycin oxime and 5 mg of praziquantel per kg are given once orally.

The veterinary medicinal product should be administered with or after some food. The veterinary medicinal product is palatable i.e. it is usually taken voluntarily by dogs (voluntary consumption on > 80% of occasions in animals studied). If the dog does not voluntarily accept the tablet, it can also be administered into the mouth.

Depending on the bodyweight of the dog, the practical dosing is as follows:

Body weight	Film-coated tablets
0.5 – 1 kg	1/2 tablet
>1 – 5 kg	1 tablet
>5 – 10 kg	2 tablets

In cases when heartworm disease prevention is used and at the same time treatment against tapeworm is required, the veterinary medicinal product can replace the monosubstance veterinary medicinal product for the prevention of heartworm disease.

For treatment of Angiostrongylus vasorum infections, milbemycin oxime should be given four times at weekly intervals. It is recommended, where concomitant treatment against cestodes is indicated, to treat once with the veterinary medicinal product and continue with the monovalent veterinary medicinal product containing milbemycin oxime alone, for the remaining three weekly treatments.

In endemic areas administration of the veterinary medicinal product every four weeks will prevent angiostrongylosis by reducing immature adult (L5) and adult parasite burden, where concomitant treatment against cestodes is indicated.

For the treatment of Thelazia callipaeda, milbemycin oxime should be given in 2 treatments, seven days apart. Where concomitant treatment against cestodes is indicated, the veterinary medicinal product can replace the monosubstance veterinary medicinal product containing milbemycin oxime alone.

Adverse reactions

Dogs:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Hypersensitivity reaction;

Systemic disorders (e.g. lethargy);

Neurological disorders (e.g. muscle tremors and ataxia);

Digestive tract disorders (e.g. emesis, diarrhoea, anorexia and drooling).

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.