Each gram of Equimax contains

Ivermectin 18.7 mg

Praziquantel 140.3 mg

Almost white to creamy, thick, unctuous and smooth paste.

Horses.

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

Strongylus vulgaris (adult and arterial larvae)

Strongylus edentatus (adult and L4 tissue larval stages)

Strongylus equinus (adult) Triodontophorus spp. (adult)

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.

Oral Use

Single administration.

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

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device 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 paste to treat 100 kg.

Each subsequent syringe division delivers enough paste 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 7.49 g of paste delivers sufficient paste to treat 700 kg of bodyweight at the recommended dose rate.

Directions for use

Before administration, adjust the syringe to the calculated dosage by setting the ring on the plunger. The paste is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of paste 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.

Do not use in foals under 2 weeks of age.

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

Care should be taken to avoid the following practices because they increase the risk of the 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 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.

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

Wash hands after use (to be sure that eye contamination can not occur).

Avoid contact with the eyes. In the case of accidental contact, rinse with abundant quantities of water. In case of eye irritation, seek medical attention.

Do not eat, drink or smoke while handling this veterinary medicinal product.

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

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 paste or access to used syringes due to the potential for adverse effects related to ivermectin toxicity.

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.

Can be used during pregnancy and lactation.

The veterinary medicinal product can be used safely in stallions

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 mares 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.

In Horses: Meat and Offal: 35 days

Not permitted for use in horses producing milk for human consumption

Medicines should not be disposed of via wastewater or household waste.

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.

Keep out of the reach of children.

Store below 30° C.

Part-used syringes should be stored below 25° C.

Shelf-life of the veterinary medicinal product as packaged for sale : 2 years.

Shelf-life after first opening the immediate packaging: 6 months.

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.

Product presentations: Box of 1, 2, 12, 40 or 48 syringes.

Blister of one syringe.

ATCvet code: QP 54AA51

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 co-ordination 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.

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 90h. 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.

Not applicable.

VM 05653/3012