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Date: Tuesday, March 5, 2024 10:08

Release 2.62
Eqvalan Oral Paste for Horses (Ivermectin 18.7 mg/g)
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for horses
Active ingredient: Ivermectin
Product:Eqvalan Oral Paste for Horses (Ivermectin 18.7 mg/g)
Product index: Eqvalan
Withdrawal notes: Horses and Donkeys: Meat: 21 days. Do not use in mares producing milk for human consumption.
Incorporating:
Qualitative and quantitative composition
Each gram contains:
Active substance: Ivermectin: 18.7 mg
Excipients: Titanium dioxide (E171) 20.0 mg
For the full list of excipients see 'Pharmaceutical Particulars' section
Pharmaceutical form
Oral paste. Clean, white, homogenous paste.
Clinical particulars
Target species
Horses and donkeys.
Indications for use
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 and 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 and fourth stage larvae)
Parascaris equorum
Hairworms (adults)
Trichostrongylus axei
Large-mouth stomach worms (adults)
Habronema muscae
Neck threadworms (microfilariae)
Onchocerca spp.
Adult intestinal threadworms
Strongyloides westeri
Oral and, gastric stages of bots:
Gastrophilus spp.
Contra-indications
The product has been formulated 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.
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 gastrointestinal nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use in animals
No special precautions are required.
Special precautions to be taken by the person administering the product
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.
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.
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.
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.
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.
Bodyweight and dosage should be accurately determined prior to treatment. For syringes intended to treat horses up to 600 kg and 1100 kg calibrated markings are provided at 100 kg bodyweight intervals. For the syringe intended to treat horses up to 750 kg, calibrated markings are provided at 125 kg bodyweight intervals. The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger
Dosing instructions
Unlock the knurled ring by making a ¼ 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 ¼ 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
Veterinary advice should be given on appropriate dosing programs and stock management to achieve adequate parasite control for both tapeworm and roundworm infestations. Foals may be treated initially at 6-8 weeks of age if indicated. Discard any unused material.
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.
Withdrawal periods
Donkeys – meat: 21 days
Horses – meat: 21 days
Do not use in mares producing milk for human consumption
Pharmaceutical particulars
Excipients
Titanium dioxide (E171), Hyprolose, Hydrogenated castor oil, Propylene glycol.
Major Incompatibilities
None known.
Shelf life
Shelf life of the product as packaged for sale: 3 years
Shelf life after first opening the immediate packaging: use immediately.
Special precautions for storage
Do not store above 25 °C. Protect from light.
Nature and composition of immediate packaging
The product is available in syringes containing 6.42g, 8,03g or 11.77g of paste.
For syringe intended for the treatment of horses up to 600 kg, containing 6.42g of paste: White polypropylene syringes barrel with a white LDPE cap, a rubber rod tip and a white polypropylene plunger rod, with dose divisions calibrated by body weight with a white polypropylene stop ring.
For syringes intended for the treatment of horses up to 750 kg and 1100 kg, containing 8.03g or 11.77g of paste respectively: White polypropylene syringes barrel with a white rubber cap, a rubber rod tip and a white polypropylene plunger rod, with dose divisions calibrated by body weight with a white polypropylene stop ring. Box of 1 syringe for oral administration of 6.42g
Box of 1 syringe for oral administration of 8.03g
Box of 1 syringe for oral administration of 11.77g
Box of 50 syringes for oral administration of 6.42g
Box of 50 syringes for oral administration of 8.03g
Box of 50 syringes for oral administration of 11.77g
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate ponds, waterways or ditches with the product or used container. Any unused product or waste materials derived from such products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 08327/4177
Significant changes
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Eqvalan Oral Paste for Horses
GTIN:3661103025566