Eqvalan oral paste for horses 6.42 g
Treatment of parasitic infestations in horses and donkeys
EQVALAN Oral Paste for Horses (Ivermectin 1.87% w/w)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF EQVALAN Oral Paste
Ivermectin: 1.87% w/w.
Also contains Titanium Dioxide (E171) 2.0% w/w.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM OF EQVALAN Oral Paste
Oral paste. White paste for oral administration.
4. CLINICAL PARTICULARS OF EQVALAN Oral Paste
4.1 Target species
Horses and donkeys.
4.2 Indications for use, specifying the target species
The product is indicated for the treatment of parasitic infestations in horses and donkeys due to:
Large strongyles Strongylus vulgaris (adults and arterial larval stages) S. edentatus (adults & tissue larval stages) S. equinus (adults) Triodontophorus spp. (adults) Triodontophorus brevicauda Triodontophorus serratus Craterostomum acuticaudatum (adults)
Small Strongyles Adult and immature (fourth stage larvae) 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 Cylicocyclus radiatus Cylicostephanus spp. Cylicostephanus asymetricus Cylicostephanus bidentatus Cylicostephanus calicatus Cylicostephanus goldi Cylicostephanus longibursatus Cylicostephanus minutus Cylicodontophorus spp. Cylicodontophorus bicornatus Gyalocephalus capitatus Parapoteriostomum spp. Parapoteriostomum euproctus Parapoteriostomum mettami Petrovinema spp. Petrovinema poculatum Poteriostomum spp. Poteriostomum imparidentatum
Lungworms (adult and immatures) Dictyocaulus arnfieldi
Pinworms (adult and immatures) Oxyuris equi
Ascarids (adults and third & fourth stage larvae) Parascaris equorum
Hairworms (adults) Trichostrongylus axei
Large-mouth stomach worms (adults) Habronema muscae
Neck threadworms (microfilariae) Onchocerca spp.
Intestinal threadworms (adults) Strongyloides westeri
Stomach bots Oral and gastric stages of Gastrophilus spp.
The product has been formulated specifically for use in horses and donkeys only. Dogs and cats 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.
4.4 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 body weight, misadministration of the product, or lack of calibration of the dosing device.
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 a number of countries within the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of gastro-intestinal 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
No special precautions are required.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to the animals
Do not smoke, eat or drink while handling the product. Wash hands after use. This product may cause skin and eye irritation. Therefore, the user should avoid contact of the product with the skin and the eyes. In the case of contact, rinse immediately with plenty of water. In the case of accidental ingestion or eye irritation after contact seek medical advice immediately and show the package insert or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
Some horses carrying heavy infection of Onchocerca microfilariae have experienced oedema and pruritus 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
Horses and donkeys of all ages, including pregnant mares and breeding stallions, have been treated with no adverse effect.
4.8 Interaction with other medicinal products and other forms of interaction
The product has been used in conjunction with other equine health care products and no interactions have been identified.
4.9 Amounts to be administered and administration route
Administer orally to both horses and donkeys at the recommended dose level of 0.2 mg ivermectin per kilogram of bodyweight. Each syringe delivers 120 mg ivermectin, sufficient to treat 600 kg of 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.
Dosing instructions Each weight marking on the syringe plunger will deliver sufficient paste to treat 100 kg bodyweight. Unlock the knurled ring by making 1/4 turn and slide the knurled ring up the plunger shaft so that the side nearest the barrel is at the prescribed weight marking. Turn the knurled ring 1/4 turn to lock in place. Remove the plastic cap from the tip of the nozzle. Make sure the horse's mouth contains no feed. Insert the syringe into the horse's mouth at the interdental space. Advance the plunger as far as it will go, depositing the medication on the base of the tongue.
Parasite control program All horses and donkeys should be included in a regular parasite control program, with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. The product is highly effective against gastro-intestinal, cutaneous and pulmonary nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis and colic caused by Strongylus vulgaris. With its broad spectrum, the product is well suited to be the major medication in parasite control programs and is well suited to be the major component in a rotational program.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Mild transitory signs (slowed pupillary light response and depression) have been seen at a 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. No antidote has been identified; however, symptomatic therapy may be beneficial.
4.11 Withdrawal periods
Donkeys - meat: 21 days Horses - meat: 21 days
5. PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES OF EQVALAN Oral Paste
ATC Vet Code: QP54AA01
5.1 Pharmacodynamic properties
Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind 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 parasite. 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-gates 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.
5.2 Pharmacokinetic properties
Maximum plasma concentration In the horse the maximum plasma concentration (average of 32 ng/ml) is reached 6 hours after administration of a dose rate of 0.3 mg ivermectin per kg bodyweight. This peak falls off gradually to an average level of 2 ng/ml at 10 days.
Excretion: length of time and route Ivermectin residues (expressed as dihydro B1a) in the liver, muscle, kidney, fat and blood were determined with a liquid chromatographic method with fluorescence detection. No residue (except one 28 day fat sample) reached the limit of detection of > 2 ppb 21, 28 and 42 days post dose.
6. PHARMACEUTICAL PARTICULARS OF EQVALAN Oral Paste
6.1 List of excipients
Titanium dioxide (E171) Hyprolose Hydrogenated Castor Oil Propylene Glycol
6.2 Major incompatibilities
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
Do not store above 25oC. Protect from light.