Eqvalan Gold Paste (Canada)

Company: Boehringer Ingelheim Animal Health

(ivermectin and praziquantel)

Oral Paste for Horses

VETERINARY USE ONLY

DIN 02290162

For the treatment of infections with internal parasites, including bots and tapeworms, in horses.

Introduction

EQVALAN GOLD contains ivermectin, a unique chemical entity, and praziquantel. Its convenience, broad spectrum efficacy and wide safety margin make it an excellent antiparasitic product for horses.

Description

EQVALAN GOLD is a smooth, orange, semi-solid, homogeneous, ready-to-use paste contained in a disposable plastic syringe. The formulation contains 1.55% w/w ivermectin and 7.75% w/w praziquantel.

Eqvalan Gold Paste Indications

EQVALAN GOLD is indicated in horses for the treatment of parasitic infections due to:

Tapeworms: Anoplocephala perfoliata

Large strongyles: adult and arterial larval stages of Strongylus vulgaris, and adult stage of S. edentatus, S. equinus, Craterostomum acuticaudatum, Triodontophorus brevicauda and T. serratus.

Small strongyles (including those resistant to certain benzimidazole class compounds): adult and luminal larval (L₄) stages of Coronocyclus coronatus, C. labiatus, C. labratus; Cyathostomum catinatum, C. pateratum; Cylicocyclus elongatus, C. insigne, C. leptostomum, C. nassatus, C. radiatus; Cylicostephanus asymetricus, C. bidentatus, C. calicatus, C. goldi, C. longibursatus, C. minutus; Parapoteriostomum mettami, P. euproctus; Petrovinema poculatum, Poteriostomum imparidentatum, Cylicodontophorus spp. and Gyalocephalus spp.

Intestinal threadworms (adults): Strongyloides westeri

Pinworms (adult and luminal larval (L₄) stages): Oxyuris equi

Ascarids (adult and third and fourth stage larvae): Parascaris equorum

Hairworms (adult): Trichostrongylus axei

Large-mouth stomach worms (adult): Habronema muscae

Neck threadworms (microfilariae): Onchocerca cervicalis

Bots (oral and gastric stages): Gastrophilus intestinalis, G. nasalis

EQVALAN GOLD may aid in the clinical improvement of dermatoses caused by cutaneous larvae of Habronema spp. and Draschia megastoma, and microfilariae of Onchocerca cervicalis.

Consult your veterinarian for the diagnosis, treatment and control of parasites in horses.

Eqvalan Gold Paste Dosage And Administration

EQVALAN GOLD is given orally at the recommended dosage level of 200 µg of ivermectin per kilogram of body weight and 1 mg praziquantel per kilogram of body weight.

Each syringe delivers 120 mg of ivermectin and 600 mg of praziquantel sufficient to treat 600 kg of body weight.

Each weight marking on the syringe plunger will deliver sufficient paste to treat 100 kg of body weight. To set the syringe plunger, unlock the knurled ring by rotating it 1/4 turn. Slide the knurled ring along the plunger shaft so that the arrow on the plunger indicating the prescribed weight marking is aligned with the notch on the ring. Rotate the knurled ring 1/4 turn to lock it in place and ensure it is locked. Remove the plastic cap from the tip of the nozzle. Make sure the horse’s mouth contains no feed. Insert the syringe into the horse’s mouth at the interdental space. Advance the plunger as far as it will go, depositing the medication at the base of the tongue. Immediately raise the horse’s head for a few seconds after dosing.

CAUTIONS

1. Some horses have experienced reactions with swelling and itching shortly after treatment. In most such cases, the horses have been diagnosed as carrying heavy infections of Onchocerca microfilariae, and it is assumed the reactions were the result of microfilariae dying in large numbers. Although the signs have resolved spontaneously in a few days, symptomatic treatment may be advisable. Consult your veterinarian should these symptoms persist.

2. Reasonable care should be taken in the handling of sick or debilitated animals.

3. EQVALAN GOLD Paste has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

4. EQVALAN GOLD has not been tested in foals younger than two months, in pregnant mares, or in breeding stallions.

Warnings

This drug is not to be administered to horses that are to be slaughtered for use as food. Keep this and all drugs out of the reach of children. In case of human ingestion, clients should be advised to contact a physician immediately. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes.

Post-approval Experience

Although not all adverse reactions are reported, the following reactions are based on voluntary post-approval drug experience reporting. These have been rare reports of swelling and irritation of the mouth, lips, and tongue following administration of EQVALAN GOLD. These reactions have been transitory in nature.

Animal Safety

In a safety study in younger horses, EQVALAN GOLD Paste was found safe up to 3-times the maximum recommended dose in foals of 2 months of age.

Note To User

Resolution of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with EQVALAN GOLD Paste treatment. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian for the diagnosis, treatment and control of parasitism in horses.

Mode Of Action

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind 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 parasite. 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, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

Praziquantel is a synthetic isoquinoline-pyrazine derivative with activity against several trematode and cestode parasites. In vitro and in vivo studies indicate that trematodes and cestodes rapidly take up praziquantel and that its effects on calcium cation flux across membranes result in tetanic contraction of the parasites’ musculature and vacuolization of the tegument. The net effect is that the parasite becomes paralyzed and detaches from the host. The wide margin of safety of praziquantel is attributable to its rapid metabolism and excretion, as well as its selective effect on susceptible parasites.

Product Advantages

Broad Spectrum

EQVALAN GOLD kills important internal parasites, including tapeworms, oral and gastric stages of bots, and the arterial larval stages of Strongylus vulgaris at the recommended dose.

Unique Chemical Compound

EQVALAN GOLD contains ivermectin, a unique, highly active antiparasitic agent, as well as praziquantel.

Storage

Store below 30 °C, in the original container.

Environmental Safety

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Drug containers and any residual contents should be disposed of safely (e.g. by burying or incinerating) since free ivermectin may adversely affect fish and certain water-borne organisms.

Packaging

EQVALAN GOLD Oral Paste for Horses is available in disposable, plastic, adjustable dosage syringes, packaged in individual cartons or 50 syringes per carton.

Boehringer Ingelheim Animal Health Canada Inc., 5180 South Service Road, Burlington ON L7L 5H4

Eqvalan^® Gold is a registered trademark of the Boehringer Ingelheim Group.

147470-003

CPN: 1182129.4