Aloquantel Ivermectin and Praziquantel Oral Gel for Horses

Composition

Each gram contains:

Active substances

Ivermectin .................................................................... 18.7 mg

Praziquantel................................................................. 140.3 mg

Excipients

Almost white to cream, thick gel.

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Pharmacological properties

4.1 ATCvet code: QP54AA51

4.2 Pharmacodynamics

Ivermectin is a macrocyclic-lactone derivative which has a broad antiparasitic activity against nematodes and arthropods. It acts by inhibiting nerve impulses. Its mode of action includes the glutamate-gated chloride-ion channels. Ivermectin binds selectively and with high affinity to glutamate-gated chloride-ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the relevant parasites. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels.

Praziquantel is a pyrazinoisoquinoline derivative which exerts its anthelmintic activity against many species of cestodes and trematodes. It primarily acts by impairing both motility and function of the suckers of cestodes. Its mode of action includes the impairing of neuromuscular coordination but also influencing the permeability of the integument of the worms, which leads to excessive calcium and glucose loss. This induces spastic paralysis of the parasite musculature.

4.3 Pharmacokinetics

After administration of the recommended dosage to horses, the ivermectin plasma peak was reached within 24 hours. The ivermectin concentration was still over 2 ng/ml 14 days after administration. The elimination half-life of ivermectin was 90 h. With regard to praziquantel, the plasma peak was reached within 1 hour. The praziquantel was rapidly eliminated and was not detected after 8 h post treatment. The elimination half-life of praziquantel was 40 min.

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Target species

Horses.

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Indications

For the treatment of mixed cestode and nematode or arthropod infestations, due to adult and immature roundworms, lungworms, bots and tapeworms in horses.

Nematodes

Large strongyle:

Strongylus vulgaris (adult and arterial larvae)

Strongylus edentatus (adult and L4 tissue larval stages)

Strongylus equinus (adult)

Triodontophorus spp. (adult).

Small strongyle:

Cyathostomum: Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Gyalocephalus spp. (adult and non-inhibited mucosal larvae).

Parascaris: Parascaris equorum (adult and larvae).

Oxyuris: Oxyuris equi (larvae).

Trichostrongylus: Trichostrongylus axei (adult).

Strongyloides: Strongyloides westeri (adult).

Habronema: Habronema spp. (adult).

Onchocerca: Onchocerca spp. microfilariae i.e. cutaneous onchocerciasis.

Lungworm: Dictyocaulus arnfieldi (adult and larvae).

Cestodes (tapeworm): Anoplocephala perfoliata, Anoplocephala magna, Paranoplocephala mamillana.

Dipteran insects: Gasterophilus spp. (larvae).

As tapeworm infestation is unlikely to occur in horses before two months of age, treatment of foals below this age is not considered necessary.

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Dosage

Oral use

Posology

Single administration.

200 µg of ivermectin and 1.5 mg of praziquantel per kg of bodyweight corresponding to 1.07 g of gel per 100 kg bodyweight.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing devices should be checked as underdosing might lead to an increased risk of development of resistance to anthelmintic drugs.

* Concerns the 7.49g syringe only

The first division delivers enough gel to treat 100 kg.

Each subsequent syringe division delivers enough gel to treat 50 kg of bodyweight.

The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger.

The syringe containing 6.42 g of gel delivers sufficient paste to treat 600 kg of bodyweight at the recommended dose rate.

The syringe containing 7.49 g of gel delivers sufficient paste to treat 700 kg of bodyweight at the recommended dose rate.

Directions for use:

Before the first administration, the syringe must be primed. Place the ring on the first graduation mark and remove the first jet of paste by pressing the plunger. The syringe is then ready for use.

Before administration, adjust the syringe to the calculated dosage by setting the ring on the plunger. The gel is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of gel on the back of the tongue. The animal's mouth should be free of any food. Immediately after administration, elevate the head of the horse for a few seconds to ensure the dose is swallowed.

The veterinary surgeon should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control for both tapeworm and roundworm infestations.

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Contraindications

Do not use in foals under 2 weeks of age.

Do not use in mares from which milk is taken for human consumption.

Do not use in horses known to be hypersensitive to the active substances or to any other ingredients.

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Adverse reactions

Horses :

1 Mild transient in case of very high levels of infestation, caused by destruction of the parasites

2 In case of very high levels of infestation, caused by destruction of the parasites

3 In particular when there is heavy worm burden.

4 For horses carrying heavy infection of Onchocerca microfilariae. It is assumed that these reactions are the result of the destruction of large numbers of microfilariae.

A veterinarian should be consulted if these signs persist.

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.

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Warnings

Special precautions for safe use in the target species:

Avermectins may not be well tolerated in all non-target species. Cases of intolerance are reported in dogs, especially collies, old English sheepdogs and related breeds or crosses and also in turtles and tortoises.

Dogs and cats should not be allowed to ingest spilled gel or access to used syringes due to the potential for adverse effects related to ivermectin toxicity.

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

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

Avoid contact with the eyes as the veterinary medicinal product may cause eye irritation.

Wash hands after use, to be sure that eye contamination does not occur.

In case of accidental eye contact, rinse immediately with plenty of water.

Do not eat, drink or smoke while handling this veterinary medicinal product. In case of accidental ingestion or eye irritation, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment:

Not applicable.

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.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

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Interactions

None known.

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Overdose

A tolerance study performed in foals from 2 weeks of age with doses up to 5 times the recommended dosage showed no adverse reactions.

Safety studies conducted with the veterinary medicinal product administered to mares at 3 times the recommended dosage at 14-day intervals during the whole gestation and lactation did not show any abortions, any adverse effects on the gestation, parturition and on the mare general health, nor any abnormalities on the foals.

Safety studies conducted with the veterinary medicinal product administered to stallions at 3 times the recommended dosage did not show any adverse effects, in particular on the reproductive performances.

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Special warnings

The veterinary medicinal product can be used safely in stallions.

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

• Underdosing, which may be due to underestimation of body weight, misadministration of the veterinary medicinal product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to ivermectin (an avermectin) has been reported in Parascaris equorum in horses in a number of countries including the EU. Therefore the use of this product should be based on local (regional farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

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Withdrawal period

Meat and offal: 35 days.

Not permitted for use in horses producing milk for human consumption.

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Incompatibilities

None known.

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Immediate packaging

An adjustable multidose syringe consisting of high density polyethylene (white) and low density polyethylene (white). The syringe contains 6.42 or 7.49 grams of product and is fitted with variable dose capacity.

Box of 1, 12, or 48 syringes.

Blister of one syringe.

Not all pack sizes may be marketed.

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Storage

Do not store above 30°C.

Store opened syringes below 25°C.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 6 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as ivermectin is extremely dangerous to 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.

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Additional information

7. MARKETING AUTORISATION NUMBER

Vm 05653/4175

8. DATE OF FIRST AUTORISATION

20 April 2005

9. DATE OF THE LAS REVISION OF THE SUMMARY OF THE PRODUCT

CHARACTERISTICS

April 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.

Approved 11 May 2026

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Registration holder

Virbac

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