Target species
Horses.
Indications for use
For the treatment of mixed cestode and nematode or arthropod infestations in horses. The following parasites of horses are sensitive to the antiparasitic effects of the product:
Adult Tapeworms:
Anoplocephala perfoliata
Anoplocephala magna
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)
Adult and immature (intraluminal fourth-stage larvae) of small strongyles or cyathostomes, including benzimidazole-resistant strains:
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.
Adult hairworms: Trichostrongylus axei
Adult and immature (fourth stage larvae) pinworms: Oxyuris equi
Adult, third- and fourth-stage larvae of roundworms (ascarids): Parascaris equorum
Microfilariae of neck threadworms: Onchocerca spp.
Adult intestinal threadworms: Strongyloides westeri
Adult large-mouth stomach worms: Habronema muscae
Oral and, gastric stages of bots: Gasterophilus spp.
Adult and immature (inhibited fourth stage larvae) lungworms: Dictyocaulus arnfieldi
Contra-indications
Do not use in mares producing milk for human consumption. The product has been formulated for use in horses only. Cats, dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also turtles and tortoises may be adversely affected by the concentration of ivermectin in this product if they are allowed to ingest spilled paste or have access to used syringes.
Special warnings for each target species
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 bodyweight, 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 macrocyclic lactones (which includes ivermectin) has been reported in Parascaris equorum in horses in the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of gastrointestinal nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use in animals
Safety studies were not conducted in foals younger than 2 months of age, or in stallions. The use of the product is not recommended in these categories of animals.
Special precautions to be taken by the person administering the product
Wash hands after use.
Do not smoke, drink or eat while handling the product.
This product may cause skin and eye irritation. Therefore, the user should avoid contact of the product with the skin and the eyes. In case of contact, rinse immediately with plenty of water.
In case of accidental ingestion or eye irritation after contact, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Some horses with heavy infections of Onchocerca spp. microfilariae have experienced oedema and pruritus following treatment; such reactions were assumed to be the result of the death of large numbers of microfilariae. These signs resolve within a few days but symptomatic treatment may be advisable.
Following administration of the product, there have been rare reports of inflammation of the mouth, lip and tongue, which results in various clinical signs such as oedema, hypersalivation, erythema, tongue disorder and stomatitis. These reactions have been transitory in nature, appearing within 1 hour and abating within 24 to 48 hours following administration. In case of severe oral reactions symptomatic treatment is recommended.
Digestive discomfort (colic, loose stool) has been observed in very rare cases based on post-marketing surveillance data.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Studies performed in laboratory animals showed no teratogenic or embryotoxic effect of either ivermectin or praziquantel at the recommended doses during therapy.
Ivermectin-Praziquantel combination can be used after the first three months of gestation and during lactation. In the absence of clinical data in early pregnancy the product can only be used in the first three months of gestation according to a risk benefit analysis by the veterinarian.
Interactions
No data available.
Amounts to be administered and administration route
The recommended dosage is 200 mcg ivermectin per kilogram of bodyweight and 1 mg praziquantel per kilogram of bodyweight corresponding to 1.29 g of paste per 100 kg bodyweight in a single administration.
Bodyweight and dosage should be accurately determined prior to treatment. For syringes intended to treat horses up to 600 kg and 1100 kg, calibrated markings are provided at 100 kg bodyweight intervals. For the syringe intended to treat horses up to 750 kg, calibrated markings are provided at 125 kg bodyweight intervals. The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger.
Directions for use
The product is for oral administration only. While holding the plunger, turn the knurled ring on the plunger ¼ turn to the left and slide it so the stop ring is at the prescribed weight marking. Lock the ring in place by turning it ¼ turn to the right in order to bring the two arrows, the one visible on the ring and the one on the plunger rod, into alignment. Make sure the horse’s mouth contains no feed. Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the tongue. Immediately raise the horse’s head for a few seconds after dosing and ensure that the paste is consumed.
Parasite control program Veterinary advice should be given on appropriate dosing programs and stock management to achieve adequate parasite control for both tapeworm and roundworm infestations.
Overdose
No undesirable effects related to treatment were observed in 2 months old horses treated with the product at up to three times the recommended dose and in adult horses treated at ten times the recommended dose.
Transient decreased food consumption, increased body temperature, salivation and impairment of vision were noticed in horses treated twice with an ivermectin oral paste or once with the product at ten times the recommended dose (i.e., 2 mg/kg bodyweight). All changes disappeared within five days.
No antidote has been identified; however, symptomatic therapy may be beneficial.
Withdrawal periods
Meat and offal: 30 days
Do not use in mares producing milk for human consumption.