MilbeVet 4 mg/10 mg Film-coated Tablets for Small Cats and Kittens

Composition

Each tablet contains:

Active substances:

Milbemycin oxime 4 mg

Praziquantel 10 mg

For a full list of excipients, see section 6.1.

6.1 List of excipients

Core:

Cellulose, microcristalline

Croscarmellose sodium

Povidone

Lactose monohydrate

Silica, colloidal anhydrous

Magnesium stearate

Coat:

Hypromellose

Macrogol

Talc

Artificial beef flavour

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Pharmaceutical form

Oblong shaped, beige to brown, artificial beef flavoured film-coated tablet with a score on both sides. One side bears the imprint “BC”, the other side “NA”.

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Pharmacological properties

Pharmacotherapeutic group: Antiparasitic products, insecticides and repellants - endectocides

ATCvet code: QP54AB51 (milbemycin oxime, combinations)

5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic particulars

In the cat, praziquantel reaches peak plasma concentrations within an hour after oral administration.

The half-life of elimination is around 3 hours.

In the dog, there is rapid hepatic biotransformation, principally to monohydroxylated derivatives.

The principal route of elimination in the dog is renal.

After oral administration in the cat, milbemycin oxime reaches peak plasma concentrations within 2 hours. The half life of elimination is around 13 hours (± 9 hours). In the rat, metabolism appears to be complete although slow, since unchanged milbemycin oxime has not been found in urine or feces. Main metabolites in the rat are monohydroxylated derivatives, attributable to hepatic biotransformation. In addition to relatively high liver concentrations, there is some concentration in fat, reflecting its lipophilicity.

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Target species

Cats (≥ 0.5 - 2 kg).

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Indications

For cats with, or at risk from mixed infections of cestodes, gastrointestinal nematodes, and/or heartworm. This veterinary medicinal product is only indicated when use against cestodes and nematodes or prevention of heartworm disease is indicated at the same time.

Cestodes

Treatment of tapeworms:

Dipylidium caninum, Taenia spp., Echinococcus multilocularis.

Gastrointestinal nematodes

Treatment of:

Hookworm: Ancylostoma tubaeforme, Roundworm: Toxocara cati.

Heartworm

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

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Dosage

Oral use.

Underdosing could result in ineffective use and may favour resistance development.

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

Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of praziquantel per kg are given as a single dose. The veterinary medicinal 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:

The veterinary medicinal product can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. The duration of heartworm prevention is one month. For regular prevention of heartworm disease the use of a monosubstance is preferred.

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Contraindications

Do not use in cats of less than 6 weeks of age and/or weighing less than 0.5 kg. Do not use in cases of hypersensitivity to the active substances or to any of excipients.

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Adverse reactions

Cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Digestive tract disorders (such as Diarrhoea, Emesis); Hypersensitivity reaction; Neurological disorders (such as Ataxia and Muscle tremor); Systemic disorders (such as Lethargy)

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 the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.

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Warnings

Special precautions for use in animals

Ensure cats and kittens weighing between 0.5 kg and ≤2 kg receive the appropriate tablet strength (4 mg MBO/10 mg praziquantel) and the appropriate dose.

See also section 4.9.

No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The veterinary medicinal product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after use.

In case of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment

See section 6.6.

Other precautions

Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (WOAH), specific guidelines on the treatment and follow up and on the safeguard of persons need to be obtained from the relevant competent authority (e.g. experts or institutes of parasitology).

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Fertility:

Can be used in breeding animals.

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Interactions

The concurrent use of the veterinary medicinal product with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the veterinary medicinal product at the recommended dose.

Although not recommended, the concomitant use of the veterinary medicinal product with a spot on containing moxidectin and imidacloprid at recommended dose rates following a single application was well tolerated in one laboratory study in 10 kittens.

The safety and efficacy of the concurrent use have not been investigated in field studies. In the absence of further studies, caution should be taken in the case of concurrent use with any other macrocyclic lactone. Also, no such studies have been performed with breeding animals.

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Overdose

In case of overdose, in addition to signs observed at the recommended dose (see section 4.6 ‘Adverse reactions’), drooling was observed. This sign will usually disappear spontaneously within a day.

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Special warnings

The possibility that other animals in the same household can be a source of re- infection should be considered, and these should be treated as necessary with an appropriate veterinary medicinal product.

It is recommended to treat all the animals living in the same household concomitantly.

When infection with the cestode D. caninum has been confirmed, concomitant treatment against intermediate hosts, such as fleas and lice, should be discussed with a veterinarian to prevent re-infection.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each individual animal.

In the absence of risk of co-infection with nematodes or cestodes, a narrow spectrum veterinary medicinal product should be used when available. The use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

PVC/PE/PVdC/aluminium blisters in an outer cardboard box.

Cardboard box with 1 blister of 2 or 4 film-coated tablets.

Cardboard box with 1, 2, 5 or 10 blisters of 10 film-coated tablets.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Keep the blister in the outer carton in order to protect from light.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening of the immediate packaging: 6 months (half tablet).

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Disposal of unused product

Medicines should not be disposed of via wastewater. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

The veterinary medicinal product should not enter water courses as it may be dangerous for fish and other aquatic organisms.

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Additional information

Vm 52127/5131

9 DATE OF FIRST AUTHORISATION

25 March 2021

10 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2025

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

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Registration holder

Elanco GmbH

Heinz-Lohmann Strasse 4

Groden

27472 Cuxhaven

Germany

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