EQUIVERM – Oral Paste for horses

Oral paste intended for the treatment of parasitic diseases in horses that contains ivermectine and praziquantel and is called EQUIVERM is a new product in the portfolio of products offered by Bioveta company

• oral olive-green paste for the treatment of parasitic diseases in horses including warble-fly scirrhuses
• 1 ml of the paste contains: Ivermectinum 20 mg, Praziquantel 100 mg
• should be administered in a single dose of 1 ml of the paste per 100 kg of body weight
• the volume of one applicator is sufficient for the treatment of horse with up to 700 kg of body weight
• each marking on the applicator corresponds to 100 kg of body weight
• withdrawal period: meat 30 days
• package: 1 applicator 7 ml; 10 applicators, each 7 ml

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

1 ml of olive green, homogenous paste contains:

• Ivermectinum    20 mg
• Praziquantelum  100 mg

Excipients:

Butylated hydroxyanisole (E 320)  0.2 mg

INDICATION(S)

Treatment of parasitic diseases caused by the species of helminths mentioned below. Treatment of bots. The following parasites of horses are sensitive to the antiparasitic effects of EQUIVERM oral paste:

Tapeworms (adults):

Anoplocephala perfoliata
Large strongyles:
Strongylus vulgaris (adults and arterial larval stages)
Strongylus edentatus (adults and tissue larval stages)
Strongylus equinus (adults)
Triodontophorus spp. (adults)
       Triodontophorus brevicauda
       Triodontophorus serratus
Craterostomum acuticaudatum (adults)
Adults and developmental stages (intraluminal fourth larval stage) of small strongyles or cyathostomes, including strains resistant to benzimidazole:
Coronocyclus spp.
       Coronocyclus coronatus
       Coronocyclus labiatus
       Coronocyclus labratus
Cyathostomum spp.
      Cyathostomum catinatum
      Cyathostomum pateratum
Cylicocyclus spp.
       Cylicocyclus ashworthi
       Cylicocyclus elongatus
       Cylicocyclus insigne
       Cylicocyclus leptostomum
       Cylicocyclus nassatus
Cylicodontophorus spp.
       Cylicodontophorus bicornatus
Cylicostephanus spp.
       Cylicostephanus calicatus
       Cylicostephanus goldi
       Cylicostephanus longibursatus
       Cylicostephanus minutus
Parapoteriostomum spp.
        Parapoteriostomum mettami
Petrovinema spp.
        Petrovinema poculatum
Poteriostomum spp.
Hairworms (adults): Trichostrongylus axei
Pinworms ((adults and fourth developmental stage): Oxyuris equi
Adults and third and fourth larval stage of roundworms: Parascaris equorum
Microfilariae: Onchocerca spp.
Intestinal strongyles (adults): Strongyloides westeri
Stomach nematodes (adults): Habronema muscae
Gastrointestinal stages of botfly larvae: Gasterophilus spp.
Lungworms (adults and fourth developmental stage): Dictyocaulus arnfieldi

CONTRAINDICATIONS

Do not use in horses hypersensitive to the active substances or to any of the excipients.

Do not use in mares producing milk for human consumption.

The product is intended only for horses. The concentration of ivermectin in the product may have an adverse effect on cats, dogs, especially collies, bobtails and related breeds or crossbreeds, and also on marine and freshwater turtles, if they ingest the product or come into contact with a used applicator.

ADVERSE REACTIONS

Some horses heavily infested with Onchocerca microfilariae manifested post-treatment oedema and pruritus, probably because of killing of large numbers of microfilariae. These symptoms disappeared within a few days, but symptomatic treatment may be appropriate. In cases of heavy infestations with tapeworms, signs of mild, transient colic and loose stools may appear.

Inflammations of the lips, mouth and tongue have been reported rarely after administration of the drug, which resulted in various clinical symptoms, such as oedema, hypersalivation, erythema, tongue disease, and stomatitis. These reactions, which occur within 1 hour and disappear within 24 to 48, are temporary in nature. If more severe oral reactions occur, it is recommended to proceed to symptomatic treatment.

TARGET SPECIES

Horses.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral administration.

The recommended doseis 200 µg of ivermectin and 1 mg of praziquantel per kilogram of animal body weight, which corresponds to a single dose of 1 ml of paste per 100 kg of animal body weight.
The body weight of a horse and dosage should be determined precisely before starting treatment. The contents of one applicator will be sufficient for treatment of a horse weighing up to 700 kg. The applicator is calibrated by 100 kg of weight. The applicator should be adjusted to the calculated dose by setting the ring on a respective piston position.

ADVICE ON CORRECT ADMINISTRATION

Hold the piston of applicator, turn the grooved dosing ring on the piston so that the bottom edge of the ring is aligned with the mark of the desired weight. Make sure that the horse has no feed residues in its mouth. Remove the cap from the applicator, insert it into the horse’s mouth and apply the paste to the root of the tongue. After application lift the horse’s head immediately for a few seconds and make sure that the horse has swallowed the dose.

Antiparasitic programme:   In order to achieve an adequate level of prevention against parasitic infestation, it is necessary to provide veterinary consultancy on appropriate dosing and zoohygienic conditions.

WITHDRAWAL PERIOD

Meat: 30 days

Milk: Do not administer to mares producing milk for human consumption.

SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

Store below 25°C.

Store in a tightly closed applicator. After use, replace the cap again.

 

Do not use after the expiry date stated on the label and carton.

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

SPECIAL WARNING(S)

Due to increased risk of possible development of resistance, which could lead to ineffective therapy, the administration of the product should be approached cautiously and the following practices should be avoided:

• too frequent and repeated use of anthelmintics from the same group, too long time of administration
• underdosing because of wrong determination of body weight, incorrect administration or inadequate calibration of the dosing device (if used).

Using appropriate tests (e.g. Fecal Egg Count Reduction Test - FECRT), suspected clinical cases should be examined for resistance to anthelmintics. Where test results confirm the resistance to a certain anthelmintic, an anthelmintic belonging to another group and having a different mode of action should be used.

Resistance to macrocyclic lactones (which include ivermectin) was reported in Parascaris equorum in horses bred in the EU. Therefore, the use of the product should be based on local (region, farm) epidemiological information about sensitivity of gastrointestinal nematodes and recommendations on how to limit further selection of anthelmintic resistance.

Special precautions for use in animals

There is no study confirming the safety of this product for foals younger than 2 months or stallions, so the product is not recommended for these categories of animals.

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

When using do not eat, drink or smoke. Wash your hands with water and soap after using the product.

The product may cause skin and eye irritation. Avoid contact with skin and eyes. In case of accidental exposure to the product wash the affected area immediately under a stream of clean water.

In case of accidental ingestion or eye contact seek medical advice immediately and show the package leaflet or label to a practitioner.

People with known hypersensitivity to ivermectin, praziquantel or any of the excipients should administer the product with caution. Pregnant and lactating women should administer the product with caution. When handling the veterinary medicinal product (particularly in factory farms), personal protective equipment consisting of protective gloves should be used.

OTHER INFORMATION

Studies conducted on laboratory animals showed during the treatment no teratogenic or embryotoxic effect of ivermectin or praziquantel administered at the recommended doses.

The combination of ivermectin and praziquantel can be used after the first three months of pregnancy and during lactation.

Due to the absence of clinical data from the period of early pregnancy, the product can be used in the first three months of pregnancy only upon assessment of the risk/benefit ratio by a respective physician.

There were no side effects observed in horses aged 2 months and in adult horses who received up to five and ten times the recommended dose, respectively.

Temporarily decreased appetite, fever, ptyalism, and visual changes were observed in horses treated twice with ivermectin oral paste or once with oral paste at doses ten times higher than the recommended dose (i.e. 2 mg/kg of body weight). All changes subsided within five days.

No antidote has been identified, but symptomatic therapy may be beneficial.

For animal treatment only.

Veterinary medicinal product supplied only on veterinary prescription.

Package size: 1 x 7 ml, 10 x 7 ml