Equimax & Eraquell Oral Gel for Horses Annual Wormer Pack [active ingredients: Ivermectin & Praziquantel] (POM-VPS)
Revised AN Equimax Oral Gel for Horses January 2013 01009/2012 Eraquell Oral Gel for Horses December 2015 01163/2015
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Equimax Oral Gel for Horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Equimax contains
Active substances Ivermectin ...... 18.7 mg Praziquantel ...... 140.3 mg
Excipients Titanium dioxide (E171) ...... 20 mg Propylene glycol ...... 731 mg
For a full list of excipents, see section 6.1
3. PHARMACEUTICAL FORM
Oral gel.
4. CLINICAL PARTICULARS
4.1 Target species
Horses.
4.2 Indications for use, specifying the target species
For the treatment of mixed cestode and nematode or arthropod infestations, due to adult and immature roundworms, lungworms, bots and tapeworms in horses:
Nematodes Large-strongyle: Strongylus vulgaris (adult and arterial larvae) Strongylus edentatus (adult and L4 tissue larval stages) Strongylus equinus (adult) Triodontophorus spp. (adult)
Small-strongyle: Cyathostomum: Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Gyalocephalus spp. (adult and non-inhibited mucosal larvae).
Parascaris: Parascaris equorum (adult and larvae).
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Oxyuris: Oxyuris equi (larvae).
Trichostrongylus:Trichostrongylus axei (adult).
Strongyloides: Strongyloides westeri (adult).
Habronema: Habronema spp. (adult),
Onchocerca: Onchocerca spp. microfilariae i.e. cutaneous onchocerciasis
Lungworm: Dictyocaulus arnfieldi (adult and larvae).
Cestodes (Tapeworm): Anoplocephala perfoliata, Anoplocephala magna, Paranoplocephala mamillana.
Dipteran insects: Gasterophilus spp. (larvae)
As tapeworm infestation is unlikely to occur in horses before two months of age, treatment of foals below this age is not considered necessary.
4.3 Contraindications
Do not use in foals under 2 weeks of age.
Do not use in mares from which milk is taken for human consumption.
Do not use in horses known to be hypersensitive to active ingredients or to any other ingredients
4.4 Special warnings for each target species
The product can be used safely in stallions.
Care should be taken to avoid the following practices because they increase the risk of the 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 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.
Resistance to ivermectin (an avermectin) has been reported in Parascaris equorum in horses in a number of countries including the EU. Therefore the use of this product should be based on local (regional farm) epidemiological
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information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
4.5 Special precautions for use
i. Special precautions for use in animals
Avermectins may not be well tolerated in all non target species. Cases of intolerance are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles and tortoises.
Dogs and cats should not be allowed to ingest spilled paste or access to used syringes due to the potential for adverse effects related to ivermectin toxicity.
Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use (to be sure that eye contamination can not occur). Avoid contact with the eyes. In the case of accidental contact, rinse with abundant quantities of water. In case of eye irritation, seek medical attention. Do not eat, drink or smoke while handling this product. In the event of accidental ingestion, seek medical advice and show the doctor the leaflet so that he knows what you have taken.
4.6 Adverse reactions (frequency and seriousness)
Horses carrying heavy infection of Onchocerca microfilariae have experienced such reactions as swelling and itching after treatment. It is assumed that these reactions are the result of the destruction of large numbers of microfilariae.
In case of very high levels of infestation, destruction of the parasites may cause a mild transient colic and loose faeces in the treated horse.
Colic, diarrhea and anorexia have been reported in vary rare occasions post treatment, in particular when there is heavy worm burden.
In very rare occasions, allergic reactions such as hypersalivation, lingual oedema and urticaria, tachycardia, congested mucus membranes, and subcutaneous oedema have been reported following treatment with the product.
A veterinarian should be consulted if these signs persist.
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4.7 Use during pregnancy, lactation or lay
The product can be used safely in mares during the whole pregnancy period and lactation period.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Posology Single administration. 200 µg of Ivermectin and 1.5 mg of praziquantel per kg of bodyweight corresponding to 1.07 g of paste per 100 kg bodyweight.
To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked as underdosing might lead to an increased risk of development of resistance to anthelmintic drugs.
Weight Dosage Weight Dosage Up to 100 kg 1.070 g 401-450 kg 4.815 g 101-150 kg 1.605 g 451-500 kg 5.350 g 151-200 kg 2.140 g 501-550 kg 5.885 g 201-250 kg 2.675 g 551-600 kg 6.420 g 251-300 kg 3.210 g 601–650 kg* 6.955 g 301-350 kg 3.745 g 651-700 kg* 7.490 g 351-400 kg 4.280 g * Concerns the 7.49g syringe only
The first division delivers enough paste to treat 100 kg. Each subsequent syringe division delivers enough paste to treat 50 kg of bodyweight. The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger.
The syringe containing 6.42 g of paste delivers sufficient paste to treat 600 kg of bodyweight at the recommended dose rate. The syringe containing 7.49 g of paste delivers sufficient paste to treat 700 kg of bodyweight at the recommended dose rate.
Directions for use
Oral use
Before administration, adjust the syringe to the calculated dosage by setting the ring on the plunger. The paste is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of paste on the back of the tongue. The animal's mouth should be free of any food. Immediately after administration, elevate the head of the horse for a few seconds to ensure the dose is swallowed. Page 5 of 15
The veterinary surgeon should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control for both tapeworm and roundworm infestations.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
A tolerance study performed in foals from 2 weeks of age with doses up to 5 times the recommended dosage showed no adverse reactions.
Safety studies conducted with the veterinary medicinal product administered to mares at 3 times the recommended dosage at 14 day intervals during the whole gestation and lactation did not show any abortions, any adverse effects on the gestation, parturition and on the mares general health, nor any abnormalities on the foals.
Safety studies conducted with the veterinary medicinal product administered to stallions at 3 times the recommended dosage did not show any adverse effects in particular on the reproductive performances.
4.11 Withdrawal period(s).
In Horses: Meat and Offal: 35 days Not permitted for use in horses producing milk for human consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelmintics ATCvet code: QP 54AA51
5.1 Pharmacodynamic properties
Ivermectin is a macrocyclic-lactone derivative which has a broad antiparasitic activity against nematodes and arthropods. It acts by inhibiting nerve impulses. Its mode of action includes the glutamate-gated chloride ion channels. Ivermectin binds selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the relevant parasites. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels.
Praziquantel is a pyrazinoisoquinoline derivative which exerts its anthelmintic activity against many species of cestodes and trematodes. It primarily acts by impairing both motility and function of the suckers of cestodes. Its mode of action includes the impairing of neuromuscular co-ordination but also influencing the permeability of the integument of the worms, which leads to excessive calcium and glucose loss. This induces spastic paralysis of the parasite musculature. Page 6 of 15
5.2 Pharmacokinetic particulars
After administration of the recommended dosage to horses, the ivermectin plasma peak was reached within 24 hours. The ivermectin concentration was still over 2 ng/ml 14 days after administration. The elimination half-life of ivermectin was 90h. With regard to praziquantel, the plasma peak was reached within 1 hour. The praziquantel was rapidly eliminated and was not detected after 8 h post treatment. The elimination half-life of praziquantel was 40 min.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrogenated castor oil Hydroxypropylcellulose Titanium dioxide (E171) Propylene glycol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale : 2 years. Shelf-life after first opening the immediate packaging: 6 months.
6.4 Special precautions for storage
Do not store above 30C. Store opened syringes below 25°C.
6.5 Nature and composition of immediate packaging
An adjustable multidose syringe consisting of high density polyethylene (white) and low density polyethylene (white). The syringe contains 6.42 or 7.49 grams of product and is fitted with variable dose capacity.
Product presentations: Box of 1, 2, 12, 40 or 48 syringes. Blister of one syringe.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste material should be disposed of in accordance with national requirements. EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container.
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7. MARKETING AUTHORISATION HOLDER
Virbac S.A. 1ére Avenue — 2065m — L.I.D. 06516 Carros Cedex France
8. MARKETING AUTHORISATION NUMBER(S)
Vm 05653/4176
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date: 06 July 2001
10. DATE OF REVISION OF THE TEXT
Date: January 2013
Approved: 09/01/13
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ERAQUELL 18.7 mg/g Oral Paste (AT, BE, DE, EL, FI, FR, IT, IR, LU, NL, UK) ERAQUELL vet. 18.7 mg/g Oral Paste (NO, SE) EQUIMEL 18.7 mg/g Oral Paste (ES, PT) VIRBALAN vet. 18.7 mg/g Oral Paste (DK)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance: Ivermectin ...... 18.7 mg/g.
Excipients: Titanium dioxide (E171) ...... 0.02 g/g. For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral paste. White and thick paste.
4. CLINICAL PARTICULARS
4.1 Target species
Horses.
4.2 Indications for use, specifying the target species
Roundworms in the stomach and intestines.
Large strongyles: Strongylus vulgaris: adults and 4th larval (arterial) stages Strongylus edentatus: adults and 4th larval (tissue) stages Strongylus equinus: adults
Small strongyles, adults: Cyathostomum spp. Cylicocyclus spp. Cylicodontophorus spp. Cylicostephanus spp. Gyalocephalus spp.
Hairworms: Trichostrongylus axei: adults
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Pinworms: Oxyuris equi: adults and immatures
Ascarids: Parascaris equorum: adults
Intestinal threadworms: Strongyloides westeri: adults
Large-mouth stomach worms: Habronema muscae: adults
Neck threadworms: Onchocerca spp. (microfilariae)
Lungworms: Dictyocaulus arnfieldi: adult and immature
Stomach bots: Gasterophilus spp.: oral and gastric larval stages
4.3 Contra-indications
Do not use in dogs or cats as severe adverse reactions may occur. Do not use in cases of known hypersensitivity to the active substance. See also section 4.11 “Withdrawal periods”.
4.4 Special warnings for each target species
Strategies that should be avoided because they might lead to an increased risk of development of resistance to anthelmintic drugs include:
• 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 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. 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 ivermectin has been reported in Parascaris equorum in horses. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
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4.5 Special precautions for use
i. Special precautions for use in animals
Avermectins may not be well tolerated in all non-target species (cases of intolerance with fatal outcome are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises). As ivermectin is extremely dangerous to fish and aquatic life treated animals should not have direct access to surface water and ditches during treatment. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Since ivermectin is highly bound to plasma proteins, special care should be taken in cases of sick animals or in nutritional conditions associated with low plasma protein levels. As with all anthelmintics, a veterinary surgeon should establish appropriate dosing programs and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke while handling the product. Avoid contact with skin and eyes. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and, if necessary, get medical attention. Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Some horses carrying heavy infection of Onchocerca microfilariae have experienced reactions with swelling and itching following dosing, assumed to be the result of death of large numbers of microfilariae. These signs resolve within a few days but symptomatic treatment may be advisable.
4.7 Use during pregnancy, lactation or lay
Can be used in pregnant mares. See also section 4.11 “Withdrawal periods”.
4.8 Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by ivermectin.
4.9 Amounts to be administered and administration route
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Posology A single administration of 200 µg ivermectin per kg of bodyweight.
Each syringe division mark plunger delivers enough paste to treat 100 kg of bodyweight (which corresponds to 1.07 g of product and 20 mg of ivermectin).
The syringe containing 6.42 g of paste delivers sufficient paste to treat 600 kg of bodyweight at the recommended dose range.
The syringe containing 7.49 g of paste delivers sufficient paste to treat 700 kg of bodyweight at the recommended dose range.
Directions for use Horse weight should be accurately determined for the correct use of the paste. The animal's mouth should be free of food. The syringe must be positioned between the front and back teeth and the paste must be placed on the base of the horse’s tongue. Immediately elevate the head of the horse for a few seconds to ensure deglutition. Re-treatment should be done according to the epidemiological situation, but not at less than 30 days interval.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Mild transitory signs (slowed pupillary light response and depression) have been seen at a higher dose of 1.8 mg/kg (9 times the recommended dose level). Other signs seen at higher doses include mydriasis, ataxia, tremors, stupor, coma and death. The less severe signs have been transitory. Although no antidote has been identified, symptomatic therapy may be beneficial.
4.11 Withdrawal period(s)
Meat and offal : 30 days. Do not use in mares producing milk for human consumption.
5. Pharmacological properties
Pharmacotherapeutic group: Endectocide, macrocyclic lactones.
ATCvet code : QP 54 AA 01
5.1 Pharmacodynamic properties
Ivermectin is a macrocyclic lactone derivative and acts by inhibiting nerve impulses. It binds selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the relevant parasites. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter Page 12 of 15 gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels. The macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.
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5.2 Pharmacokinetic particulars
After oral administration of the recommended doses to horses, the following parameters were observed: Cmax of 48.79 ng/ml, Tmax of 5.5 hours, elimination half-life of 61 hours. Ivermectin is eliminated primarily via the faeces.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Titanium dioxide E171 Hydrogenated castor oil Hydroxypropylcellulose Propylene glycol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening of the container: 6 months.
6.4 Special precautions for storage
Do not store above 30°C. Store in the original packaging.
6.5 Nature and composition of immediate packaging
The product is presented in 6.42 g or 7.49 g plastic syringes made from polyethylene and graduated in 100 kg body weight graduations.
Product presentations:
6.42 g syringe: Box of 1, 2, 12, 40 or 48 syringes. Transparent PVC blister sealed onto a carton sheet containing one syringe
7.49 g syringe: Box of 1, 2, 12, 40 or 48 syringes. Transparent PVC blister sealed onto a carton sheet containing one syringe
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Ivermectin is extremely dangerous to fish and aquatic life. Any unused veterinary medicinal product
or waste material derived from such veterinary medicinal product should be disposed of in
accordance with local requirements. Do not contaminate surface water or ditches with the product
or used containers.
7. MARKETING AUTHORISATION HOLDER
Virbac S.A. 1ère avenue, 2065m - LID 06516 Carros Cedex France
8. MARKETING AUTHORISATION NUMBER
Vm 05653/4202
9. DATE OF FIRST AUTHORISATION
16 November 2000
10. DATE OF REVISION OF THE TEXT
December 2015
Approved: 09 December 2015
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