NOAH Compendium

Printed from NOAH Compendium (http://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2021. All Rights Reserved.
Date: Tuesday, October 19, 2021 15:35

Description: Bimeda logo
Release 3.38
Bimectin Horse Oral Paste 1.87% w/w
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for horses
Active ingredient: Ivermectin
Product:Bimectin Horse Oral Paste 1.87% w/w
Product index: Bimectin Horse Oral Paste 1.87% w/w
Withdrawal notes: Horses: 34 days
Qualitative and quantitative composition
Active Substances:
Ivermectin 1.87% w/w
Pharmaceutical form
A yellow, gel-like oral paste of uniform consistency.
Clinical particulars
Target species
Horses.
Indications for use
Bimectin is indicated for the treatment of nematode and immature stages of arthropod infestations in horses due to:
Intestinal threadworms (adults)
Strongyloides westeri
Stomach bots (oral and gastric stages)
Gasterophilus spp.
Large strongyles
Strongylus vulgaris (adults and 4th larval [arterial] stages)
S. edentatus (adults and 4th larval [tissue] stages)
S. equinus (adults)
Triodontophorus spp. (adults)
Triodontophorus brevicauda
Triodontophorus serratus
Small Strongyles
Adults and immatures (fourth stage larvae) small strongyles or cyathostomes unless otherwise stated. Ivermectin is not effective against the encysted larval stages of the small strongyles
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
Cylicostephanus spp.
Cylicostephanus calicatus
Cylicostephanus goldi
Cylicostephanus longibursatus
Cylicostephanus minutus
Cylicodontophorus spp.
Cylicodontophorus bicornatus
Parapoteriostomum spp.
Parapoteriostomum mettami
Petrovinema spp.
Petrovinema poculatum
Poteriostomum spp.
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.
Contra-indications
None.
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 tests(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 information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Adverse reactions
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.
Special precautions for use
(i) Precautions for use in animals
Special warning for non-target species: The product has been formulated for use in horses only. Cats, Dogs, especially Collies, Old English Sheepdogs and related breed or crosses, and also turtles and tortoises 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.
Parasite resistance to any particular class of anthehelminthic may develop following frequent, repeated use of an anthehelminthic of that class.
(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.
Use during pregnancy, lactation or lay
Do not use in mares producing milk for human consumption.
Interactions
The effects of GABA agonists are increased by ivermectin.
Amounts to be administered and administration route
Administer orally as a single dose rate to horses at the recommended dose level of 0.2mg ivermectin per kilogram of bodyweight. Each syringe delivers 120mg ivermectin, sufficient to treat 600kg of bodyweight.
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or over-dosing.
This is a single use product. Discard after use.
Dosing Instructions:
Each weight marking on the syringe plunger will deliver sufficient paste to treat 100kg bodyweight. Unlock the knurled ring by making 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. Make sure the horse’s mouth contains no feed. Remove the plastic cap from the tip of the nozzle. 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. Immediately raise the horse’s head for a few seconds after dosing.
The treatment schedule should be based on the local epidemiological situation.
Overdose
Mild transitory signs (slowed pupillary light response and depression) have been seen at a dose of 1.8mg/kg (9 times the recommended dose level). Other signs seen at higher doses includes 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
Meat and offal 34 days.
Do not use in mares producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Endectocide. ATC vet code QP54AA01.
Ivermectin is a member of the macrocyclic lactone class of endectocides. 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 and 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-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride and they do not readily cross the blood-brain barrier.
Pharmacokinetic Properties
Following administration of Bimectin, ivermectin is rapidly absorbed to reach peak plasma concentration in several hours. This peak falls off gradually over several days. Ivermectin is eliminated primarily via the faeces. The highest residues are found in the fat.
At a dose rate of 0.2mg ivermectin per kilogram of bodyweight, plasma levels of ivermectin reach a mean Cmax concentration of 40.44ng/ml and a mean Tmax at 8.35 hours. This peak falls off gradually to an average level of 3ng/ml at 10 days.
Pharmaceutical particulars
Excipients
Maize Oil
Polysorbate 80
Apple Flavour
Silica Colloidal Anhydrous
Major incompatibilities
None known.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
To be used immediately after first opening of the oral syringe.
Protect from light.
Immediate packaging
White, disposable, high-density polyethylene syringe barrel, plunger and multidose ring with low density polyethylene seal, with low-density push-fit polyethylene cap containing 6.42 g of product.
Disposal
EXREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used containers.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 50146/4036
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 25 September 2003
Date of revision of the text
October 2018
Any other information
Nil
Legal category
Legal category: POM-VPS
GTIN
GTIN description:BIMECTIN Paste 1's
GTIN:5391510230106