Milprazon CHEWABLE 4mg/10mg film coated tablets for small cats and kittens weighing at least 0.5kg. Brownish orange, oval biconvex film coated tablets with score on one side. Milprazon CHEWABLE 16mg/40mg film-coated tablets for cats weighing at least 2kg. Brown,oval, bi convex, film coated tablets with score line on one side. The tablets can be divided into equal halves.

	Milbemycin Oxime (mg)	Praziqunatel (mg)
Milprazon CHEWABLE Tablets for Small Cats and Kittens	4	10
Milprazon CHEWABLE Tablets for Cats	16	40

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

Cestodes: Dipylidium caninum, Taenia spp., Echinoccus multicularis.

Prevention of heartworm disease (Dirofilaria immitis) if the concomitant treatments against cestodes is indicated.

FOR ORAL USE;

Oral use.

Animals should be weighed to ensure accurate dosing. Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of praziquantel per kg are given orally as a single dose. The product should be administered with or after some food. Doing so ensures optimum protection against heartworm disease.

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

Body Weight	Milprazon CHEWABLE 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg
0.5 - 1 kg	1/2 tablet
> 1 -2 kg	1 tablet
Body Weight	Milprazon CHEWABLE 16 mg/40 mg film-coated tablets for cats weighing at least 2 kg
2-4 kg	1/2 tablet
>4 - 8 kg	1 tablet
>8 - 12 kg	1 1/2 tablets

The product can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. For the prevention of heartworm disease: the product kills Dirofilaria immitis larvae up to one month after Unlimited Renewal: February 2023 AN: 03298/2022 Page 4 of 6 their transmission by mosquitoes. For regular prevention of heartworm disease the use of a monosubstance is preferred.

Use during pregnancy and lactation: The veterinary medicinal product can be used in breeding cats including pregnant and lactating queens.

Milprazon CHEWABLE 4 mg/10 mg film-coated tablets for small cats and kittens weighing at least 0.5 kg. Do not use in cats of less than 6 weeks of age and/or weighing less than 0.5 kg.

Milprazon CHEWABLE 16 mg/40mg film-coated tablets for cats weighing at least 2 kg. Do not use in cats weighing less than 2kg. Do not use in case of hypersensitivity to the active substances or to any of the excipients.

It is recommended to treat all the animals living in the same household concomitantly. In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the cat should be taken into account, and it is recommended to seek professional (e. g. veterinary) advice. When D. caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Special precautions for use in animals: It is recommended to treat all the animals living in the same household concomitantly. In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the cat should be taken into account. When D. caninum infection is present, concomitant treatment against intermediate hosts, such as fleas and lice, should be considered to prevent re-infection. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian.

User safety: Accidental ingestion of a tablet by a child may be harmful. In order to prevent children from accessing the product, tablets should be administered and stored out of sight and reach of children. Part tablets should be returned to the open blister pocket and inserted into the outer carton. In the event of accidental ingestion of one or more tablets, seek medical advice immediately and show the package leaflet or the label to the doctor. Wash hands after use. Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

Adverse reactions: On very rare occasions, especially in young cats, systemic signs (such as lethargy), neurological signs (such as ataxia and muscle tremors) and/or gastrointestinal signs (such as emesis and diarrhoea) have been observed after administration of the combination milbemycin/praziquantel.

Overdose: In case of overdose, in addition to signs observed at the recommended dose, drooling may be observed. This sign will usually disappear spontaneously within a day.

Interactions: No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the combination of milbemycin oxime and praziquantel at the recommended dose. In the absence of further studies, caution should be taken in the case of concurrent use of the product and other macrocyclic lactones. Also, no such studies have been performed with reproducing animals.

Environmental safety: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.

Pharmaceutical precautions: Store in the original package in order to protect from moisture. This veterinary medicinal product does not require any special temperature storage conditions.

Shelf life of unopened packaging: 3 years.

Shelf life of opened packaging: Halved tablets should be stored below 25°C in the original blister for 6 months. Keep the blister in the outer carton.

Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil.

Cardboard box with 1 blister of 4 tablets.

Cardboard box with 12 blisters, each blister contains 4 tablets (total 48 tablets).

Not all pack sizes may be marketed.

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Endectocides, Macrocyclic lactones, milbemycin, combinations.

ATCvet code: QP54AB51

Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis.

The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite.

Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.

In cats under fed condition, praziquantel reaches peak plasma concentrations within 3 hours after oral administration.

The half life of elimination is around 2 hours.

After oral administration in cats under fed condition, milbemycin oxime reaches peak plasma concentrations within 5 hours. The half life of elimination is around 43 hours (± 21 hours).

Cellulose microcrystalline, Lactose monohydrate, Povidone, Croscarmellose sodium, Silica colloidal anhydrous, Magnesium stearate

Hypromellose, Talc, Propylene glycol, Titanium dioxide (E171), Liver Flavour, Yeast powder, Iron Oxide yellow (E172), Iron Oxide red (E172), Iron Oxide black (E172)

Milprazon CHEWABLE Tablets for Small Cats and Kittens: Vm 01656/4170

Milprazon CHEWABLE Tablets for Cats: Vm 01656/4171