Maxpramil 12.5 mg/125 mg Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Excipients:

Qualitative composition of excipients and other constituents

Microcrystalline cellulose

Croscarmellose sodium

Povidone

Lactose monohydrate

Yeast extract

Magnesium stearate

Silica, colloidal hydrated

White to off-white with brown spots, round and convex quadrisect tablet.

3

Pharmacological properties

4.1 ATCvet code: QP54AB51

4.2 Pharmacodynamics

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.

4.3 Pharmacokinetics

After oral administration of praziquantel in the dog, peak serum levels of parent are rapidly attained (Tmax approximately 0.5-4 hours) and decline quickly (T1/2 approximately 1.5 hours). There is a substantial hepatic first-pass effect, with very rapid and almost complete hepatic biotransformation, principally to monohydroxylated (also some di- and tri-hydroxylated) derivatives, which are mostly glucuronide and/or sulfate conjugated before excretion. Plasma binding is about 80%. Excretion is fast and complete (about 90% in 2 days); the principal route of elimination is renal.

After oral administration of milbemycin oxime in dogs, peak plasma levels occur at about 2-4 hours, and decline with a half-life of the unmetabolised milbemycin oxime of 1-4 days. Bioavailability is about 80%.

In the rat, metabolism appears to be complete although slow, since unchanged milbemycin oxime has not been found in urine or faeces. 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.

3

Target species

Dogs (≥ 5 kg)

3

Indications

For dogs with, or at risk of, mixed infections with cestodes, gastrointestinal nematodes, eyeworm, lungworms and/or heartworm. This veterinary medicinal product is only indicated when use against both cestodes and nematodes or for the prevention of heartworm disease/angiostrongylosis is indicated at the same time.

Cestodes:

Treatment of tapeworms: Dipylidium caninum, Taenia spp., Echinococcus spp., Mesocestoides spp.

Gastrointestinal nematodes:

Treatment of:

Hookworm: Ancylostoma caninum

Roundworms: Toxocara canis, Toxascaris leonina

Whipworm: Trichuris vulpis

Eyeworm

Treatment of Thelazia callipaeda (see specific treatment schedule under section 3.9 “Administration routes and dosage”).

Lungworms

Treatment of:

Angiostrongylus vasorum (Reduction of the level of infection by immature adult (L5) and adult parasites; see disease-specific prevention and treatment schedules in section 3.9 “Administration routes and dosage”).

Crenosoma vulpis (Reduction of the level of infection).

Heartworm

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

3

Dosage

Oral use.

The need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.

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: 0.5 mg of milbemycin oxime and 5 mg of praziquantel per kg given once orally.

The veterinary medicinal product should be administered with or after some food. Depending on the bodyweight of the dog, the practical dosing is as follows:

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 monovalent 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, 7 days apart. Where concomitant treatment against cestodes is indicated, the veterinary medicinal product can replace the monovalent product containing milbemycin oxime alone.

3

Contraindications

Do not use in dogs weighing less than 5 kg.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

See also section 3.5 “Special precautions for use”.

3

Adverse reactions

Dogs:

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

Digestive tract disorders (e.g. vomiting, diarrhoea, drooling)

Hypersensitivity reaction

Neurological disorders (e.g. muscle tremor, ataxia)

Systemic disorder (e.g. anorexia and 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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

Treatment of dogs with a high number of circulating microfilariae can sometimes lead to the appearance of hypersensitivity reactions, such as pale mucous membranes, vomiting, trembling, laboured breathing or excessive salivation. These reactions are associated with the release of proteins from dead or dying microfilariae and are not a direct toxic effect of the veterinary medicinal product.

The use in dogs suffering from microfilaremia is thus not recommended.

In heartworm risk-areas, or if it is known that a dog has been travelling to and from heartworm risk regions, before using the veterinary medicinal product, a veterinary consultation is advised to exclude the presence of any concurrent infestation of Dirofilaria immitis.

In the case of a positive diagnosis, adulticidal therapy is indicated before administering veterinary medicinal product.

No studies have been performed with severely debilitated dogs 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.

In dogs less than 4 weeks old, tape worm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary.

Studies with milbemycin oxime indicate that the margin of safety in MDR1 mutant (-/- ) dogs of Collie or related breeds is less than in other breeds. In these dogs, the recommended dose should be strictly observed.

The tolerance of the veterinary medicinal product in young puppies from these breeds has not been investigated.

Clinical signs in Collies are similar to those seen in the general dog population when overdosed (see section 3.10 ”Symptoms of overdose (and where applicable, emergency procedures and antidotes)”).

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

This veterinary medicinal product may be harmful after accidental ingestion. To avoid accidental ingestion, particularly by a child, blister packs should be inserted back into the carton.

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. Wash hands after use.

Special precautions for the protection of the environment:

See section 5.5 (“Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products“).

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).

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Fertility:

Can be used in breeding animals.

3

Interactions

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. In the absence of further studies, caution should be taken in the case of concurrent use of the veterinary medicinal product and other macrocyclic lactones. Also, no such studies have been performed with breeding animals.

3

Overdose

No other signs than those observed at the recommended dose have been observed (see section 3.6 “Adverse events“).

3

Special warnings

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

It is recommended to treat all animals living in the same household concomitantly. When infection with the cestode D. caninum is confirmed, concomitant treatment against intermediate hosts, such as fleas and lice, should be discussed with a veterinarian to prevent re-infection.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

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.

In third countries (USA), resistance of Dipylidium caninum to praziquantel as well as cases of multi-drug resistance of Ancylostoma caninum and resistance of Dirofilaria immitis to macrocyclic lactones have been reported.

It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method. Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.

The use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available.

The use of the veterinary medicinal product should follow the implementation of appropriate diagnostic measures towards mixed infections by nematodes and cestodes with consideration of animal history and characteristics (e.g. age, health status), environment (e.g. kennelled dogs, hunting dogs), feeding (e.g. access to raw meat), geographical location and travel. Judgement of the administration of the veterinary medicinal product in dogs at risk from mixed re-infections or in specific at risk situations (such as zoonotic risks), should be made by the responsible veterinarian.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Aluminium-Aluminium blister in an outer cardboard box.

Cardboard box with 4 tablets (1 blister of 4 tablets).

Cardboard box with 8 tablets (2 blisters of 4 tablets).

Cardboard box with 20 tablets (5 blisters of 4 tablets).

Cardboard box with 100 tablets (25 blisters of 4 tablets).

Cardboard box with 200 tablets (50 blisters of 4 tablets).

Cardboard box with 10 tablets (1 blister of 10 tablets).

Cardboard box with 20 tablets (2 blisters of 10 tablets).

Cardboard box with 100 tablets (10 blisters of 10 tablets).

Cardboard box with 200 tablets (20 blisters of 10 tablets).

Not all pack sizes may be marketed.

3

Storage

This veterinary medicinal product does not require any special storage conditions.

3

Shelf life

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

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

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

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 31223/5005

8 DATE OF FIRST AUTHORISATION

31 July 2026

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

July 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

3

Registration holder

Laboratorios Karizoo, S.A.

3