Equest Pramox Oral Gel
Species:Horses and other equidae
Therapeutic indication:Pharmaceuticals: Endoparasiticides: Anthelmintics for horses, Tapeworm products
Active ingredient:Moxidectin, Praziquantel
Product:Equest® Pramox Oral Gel
Product index:Equest Pramox
Withdrawal notes:Horses: 64 days
Presentation
A pale yellow to orange/pink gel containing 19.5 mg/g moxidectin and 121.7 mg/g praziquantel as active ingredients and 220.0 mg/g benzyl alcohol and 0.80 mg/g butyl hydroxytoluene as preservatives/antioxidants.
Uses
Moxidectin is a second-generation macrocyclic lactone of the milbemycin family. Praziquantel is a parasiticide widely used in many species for the specific control of tapeworm. For the treatment of mixed cestode and nematode or arthropod infections in horses, caused by moxidectin and praziquantel sensitive strains of:
Large redworm (large strongyles):
- Strongylus vulgaris (adults)
- Strongylus edentatus (adults)
- Triodontophorus brevicauda (adults)
- Triodontophorus serratus (adults)
- Triodontophorus tenuicollis (adults)
Small redworm (small strongyles/cyathostomin) (adults and intraluminal larval stages):
- Cyathostomum spp.
- Cylicocyclus spp.
- Cylicostephanus spp.
- Cylicodontophorus spp.
- Gyalocephalus spp.
Ascarids:
- Parascaris equorum (adults)
Other species:
- Pinworms: Oxyuris equi (adults)
- Stomach worms: Habronema muscae (adults)
- Threadworm: Strongyloides westeri (adults)
- Hairworm: Trichostrongylus axei (adults)
- Bots: Gasterophilus intestinalis (L2, L3)
- Bots: Gasterophilus nasalis (L2, L3)
Tapeworm (adults):
- Anoplocephala perfoliata
- Anoplocephala magna
- Anoplocephaloides mamillana
The egg reappearance period of small redworm is 90 days.
The product is effective against (developing) intramucosal L4 stages of small redworm (strongyles). At 8 weeks after treatment, early (hypobiotic/inhibited) EL3 stages of small redworm (strongyles) are eliminated.
The product is effective against benzimidazole resistant strains of cyathostomes.
Dosage and administration
For oral administration.
A single oral dose of 400 µg moxidectin/kg bodyweight and 2.5 mg praziquantel/kg bodyweight using the calibrated syringe of one graduation per 25 kg bodyweight.
To ensure administration of a correct dosage, bodyweight 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.
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 past 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/62.5 mg praziquantel. Turn the dial ring until the left side of the ring lines up with the weight of the animal.
A single syringe treats a 700 kg horse.
To avoid overdosing, care should be taken to accurately dose foals, especially low bodyweight foals or pony foals. Veterinary advice should be given on appropriate dosing programmes and stock management to achieve optimum parasite control.
Contra-indications, warnings, etc
Do not administer to young foals less than 6.5 months of age.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Equest Pramox Oral Gel is formulated specifically for use in horses only. Dogs or cats may be adversely affected by the concentration of moxidectin in this product if they are allowed to ingest spilled gel or have access to used syringes.
Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other on the same premises.
Withdrawal period
Meat and offal: 64 days.
Milk: not permitted for use in lactating mares producing milk for human consumption.
Operator Warnings
This product may cause eye irritation, skin irritation and skin sensitisation.
Avoid direct contact with skin and eyes.
The use of protective gloves is recommended.
Wash hands or any exposed area after use.
Do not smoke, drink or eat while handling the product.
In the event of eye contact flush the eye with copious amounts of clean water and seek medical advice.
In case of accidental ingestion, seek medical help and show the doctor the package insert.
Other precautions regarding impact on 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.
Pharmaceutical precautions
Do not store above 25°C.
Use within 6 months after opening.
Do not use after the expiry date stated on the carton after "EXP".
Any unused veterinary medicinal products or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Do not contaminate watercourses with the product. The product is toxic for fish and aquatic organisms.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category:POM-VPS
Packaging quantities
HDPE syringe containing 14.4 g of gel with graduated polypropylene plunger and LDPE cap.
Further information
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 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.
For optimum control of bots, the 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 veterinary surgeon should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control for both tapeworm and roundworm infestations.
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.
In the case of cestode treatment the dose of praziquantel in the product has been selected at the top end of the dosing range.
Mouth pain, flaccid lower lip, ataxia, swelling of the muzzle, hypersensitivity and anorexia have been observed in rare (more than 1 but less than 10 animals in 10,000 animals treated) cases. Lethargy has been reported in very rare (less than 1 animal in 10,000 animals treated, including isolated reports) cases. These adverse effects are transient and disappear spontaneously. Transient adverse reactions may occur at the recommended dose in foals and at 3 times the recommended dose in adults. 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.
In case of very high worm burdens, destruction of the parasites may cause a mild transient colic and loose faeces in the treated horse.
Equest Pramox Oral Gel is specially formulated to be easily expelled by the syringe plunger. Once in the horse’s mouth, Equest Pramox Oral Gel liquefies. This facilitates dosing and reduces the risk of rejection.
Equest Pramox Oral Gel has been shown to be safe for use in breeding, pregnant and lactating mares. Administration does not adversely affect the fertility of mares.
Marketing Authorisation Number
Vm 42058/4058
