Target species
Horses.
Indications for use, specifying the target species
For the treatment of mixed cestodes and nematodes or arthropods infections, caused by moxidectin and praziquantel sensitive strains of:
− Large strongyles:
• Strongylus vulgaris (adult stages)
• Strongylus edentatus (adult 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 (adults)
− Other species:
• Oxyuris equi (adult stages)
• Habronema muscae (adults)
• Gasterophilus intestinalis (L2, L3)
• Gasterophilus nasalis (L2, L3)
• Strongyloides westeri (adults)
• Trichostrongylus axei (adult stages)
− Tapeworm (adults):
• Anoplocephala perfoliata
• Anoplocephala magna
• Paranoplocephala mammillana
The egg reappearance period of small strongyles is 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 6.5 months old.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
The veterinary medicinal product has been formulated specifically for use in horses only. Dogs and cats may be adversely affected by the concentration of moxidectin in this veterinary medicinal product if they are allowed to ingest spilled gel 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;
- Under-dosing which may 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.
For optimum control of bots, the veterinary medicinal product should be administered in the autumn, after the end of the fly season and before spring as the larvae may start to pupate and therefore are less sensitive to treatment.
Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. The veterinarian should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control for both tapeworm and roundworm infestations.
Special precautions for use
Special precautions for use in animals
To avoid overdosing, care should be taken to accurately dose foals, especially low body weight 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product may cause eye irritation, skin irritation and skin sensitisation.
Avoid 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.
In case of accidental ingestion, 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 veterinary medicinal 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 veterinary medicinal product should be used only according to the label instructions.
In order to limit the impact of moxidectin on dung fauna, and due to insufficient data regarding environmental risk of praziquantel, horses should not be turned out onto pasture within 3 days of treatment.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
Horses:
Rare (1 to 10 animals / 10,000 animals treated, including isolated reports): | Hypersalivation1, Mouth pain1 Swollen muzzle1 Ataxia1, Droopy lower lip1 Anorexia1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Digestive tract disorder (e.g. colic, loose stool) Tremor1 Lethargy1 |
1 These adverse effects are transient and disappear spontaneously.
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
The veterinary medicinal product has been shown to be safe for use in breeding, pregnant and lactating mares.
The administration of the veterinary medicinal product does not adversely affect the fertility of the mares.
Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by moxidectin.
Amount(s) to be administered and administration route
Oral use.
A single oral dose of 400 µg moxidectin/kg body weight and 2.5 mg praziquantel/kg body weight using the calibrated syringe of one gradation per 25 kg live weight.
A single syringe treats a 700 kg horse.
To ensure administration of a correct dosage, body weight should be determined as accurately as possible; accuracy of the dosing should be checked.
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 veterinary medicinal product, hold the syringe as previously described. Each tick mark relates to 25 kg of body weight and to 10 mg moxidectin/62.5 mg praziquantel. Turn the dial ring until the left side of the ring lines up with the weight of the animal.
In the case of cestode treatment the dose of praziquantel in the veterinary medicinal product has been selected to the top end of the dosing range.
Veterinary advice should be given on appropriate dosing programmes and stock management to achieve optimum parasite control.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Transient adverse reactions may occur at the recommended treatment dose in foals. In adults transient adverse reactions may occur at 3 times the recommended dose. The symptoms are depression, inappetence, ataxia, flaccid lower lip in the 8 to 24 hours following treatment. Symptomatic treatment is not generally necessary and recovery is generally complete within 24 to 72 hours. There is no specific antidote.
Withdrawal period(s)
Meat and offal: 64 days.
Milk: Not authorised for use in animals producing milk for human consumption.