Target species
Horses and ponies.
Indications for use for each target species
The veterinary medicinal product is indicated for treatment of infections caused by moxidectin sensitive strains of:
− Large strongyles:
. Strongylus vulgaris (adults and arterial stages)
. Strongylus edentatus (adults and visceral stages)
. Triodontophorus brevicauda (adults)
. Triodontophorus serratus (adults)
. Triodontophorus tenuicollis (adults)
− Small strongyles (adults and intraluminal larval stages):
. Cyathostomum spp.
. Cylicocyclus spp.
. Cylicostephanus spp.
. Cylicodontophorus spp.
. Gyalocephalus spp.
− Ascarids:
. Parascaris equorum (adult and larval stages)
− Other species:
. Oxyuris equi (adult and larval stages)
. Habronema muscae (adults)
. Gasterophilus intestinalis (L2, L3)
. Gasterophilus nasalis (L2, L3)
. Strongyloides westeri (adults)
. Trichostrongylus axei
The veterinary medicinal product has a persistent efficacy of two weeks against small strongyles. The excretion of small strongyles eggs is suppressed for 90 days.
The veterinary medicinal product is effective against (developing) intramucosal L4 stages of small strongyles. At 8 weeks after treatment, early (hypobiotic) EL3 stages of small strongyles are eliminated.
Contraindications
Do not administer to young foals less than 4 months.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients or other milbemycins.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
To avoid overdosing, care should be taken to accurately dose foals, especially low bodyweight foals or pony foals.
Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other in the same premises. The veterinary medicinal product has been formulated specifically for use in horses only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid direct contact with skin and eyes.
Personal protective equipment consisting of protective gloves should be worn when handling the veterinary medicinal product.
Wash hands or any exposed area after use.
Do not smoke, drink or eat while handling the veterinary medicinal product.
In case of eye contact, flush the eye with copious amounts of clean water and seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible. Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level. In order to reduce the emission of moxidectin to surface water and based on the excretion profile of moxidectin when administered as the oral formulation to horses, treated animals should not have access to watercourses during the first week after treatment.
Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:
∙ Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms. Following treatment of horses with the product, levels of moxidectin that are potentially toxic to dung beetles and flies may be excreted over a period of more than 1 week and may decrease dung fauna abundance.
Moxidectin is inherently toxic to aquatic organisms including fish. The product should be used only according to the label instructions.
Other precautions:
The veterinary medicinal product has been formulated specifically for use in horses only. Dogs or cats may be adversely affected by the concentration of moxidectin in this veterinary medicinal product if they are allowed to ingest spilled paste or have access to used syringes. Neurological signs (such as ataxia, muscle tremor and convulsions) and digestive clinical signs (such as hypersalivation) were recorded.
Adverse events
Horses and ponies:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Abdominal pain1 Swollen muzzle1 Ataxia1, muscle tremor1, droopy lower lip1 Depression1 |
1 In young animals. These adverse effects are usually transient and disappear spontaneously in most cases.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The veterinary medicinal product has been shown to be safe for use in pregnant and lactating mares.
Interaction with other medicinal products and other forms of interaction
None known.
Administration routes and dosage
Oral use.
Single administration of 400 µg moxidectin/kg bodyweight using the calibrated syringe.
Each syringe treats a 700 kg horse.
Bodyweight and dosage should be accurately determined prior to treatment. Underdosing could result in ineffective use and may favour resistance development.
Use of a scale or weight tape is recommended to ensure accurate dosing.
Dosing instructions
Before the first dose, hold the syringe with the capped end pointing to the left and so that you can see the weight measurements and tick marks (small black lines). Set the syringe to zero by moving the dial ring so the left side is set at the first full black mark and depress the plunger, safely discarding any paste that is expelled.
To dose the product, hold the syringe as previously described. Each tick mark relates to 25 kg of bodyweight and to 10 mg moxidectin. Turn the dial ring until the left side of the ring lines up with the weight of the animal.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Adverse reactions may occur at 2 times the recommended dose in foals and 3 times the recommended dose in adults. The symptoms are depression, inappetence, ataxia and flaccid lower lip in the 8 to 24 hours following treatment. Symptoms of moxidectin overdose are the same as those observed in very rare occasions at the recommended dosage. In addition, hypothermia and lack of appetite may occur. There is no specific antidote.
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.
Withdrawal periods
Meat and offal: 32 days.