Bimectin 18.7 mg/g Oral Paste for Horses

Composition

Each gram contains:

Active substance:

Ivermectin 18.7 mg

Excipients:

A yellow, gel-like paste of uniform consistency.

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Pharmacological properties

4.1 ATCvet code: QP54AA01

4.2 Pharmacodynamics

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.

4.3 Pharmacokinetics

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 residue levels are found in 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 3 ng/ml at 10 days.

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Target species

Horses

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Indications

Bimectin is indicated for the treatment of nematode or arthropod infestations in horses due to:

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.

Intestinal threadworms (adults)

Strongyloides westeri

Stomach bots (oral and gastric stages)

Gasterophilus spp.

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Dosage

Oral use.

Administer orally as a single dose rate to horses at the recommended dose level of 0.2mg ivermectin per kilogram of bodyweight. The smaller syringe delivers 120mg ivermectin, sufficient to treat 600kg of bodyweight. The bigger syringe delivers 160mg ivermectin, sufficient to treat 800kg of bodyweight.

To ensure administration of the 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 dose 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.

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Contraindications

None.

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Adverse reactions

Horses:

Undetermined frequency (cannot be estimated from the available data): Oedema1, Pruritus1

1Experienced by some horses carrying heavy infection of Onchocerca microfilariae 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.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Do not eat, drink or smoke while handling the veterinary medicinal 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, seek medical advice and show the package leaflet or the label to the physician.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

Special warning for non-target species: The veterinary medicinal 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 veterinary medicinal product if they are allowed to ingest spilled paste or have access to used syringes.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Studies performed in laboratory animals showed no teratogenic or embryotoxic effect of ivermectin at the recommended doses during therapy.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to risk/benefit analysis by the responsible veterinary surgeon.

Please refer also to 3.12.

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Interactions

The effects of GABA agonists are increased by ivermectin.

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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.

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Special warnings

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 veterinary medicinal 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 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 veterinary medicinal 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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Withdrawal period

Meat and offal 34 days

Not permitted for use in animals producing milk for human consumption.

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Incompatibilities

None known.

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Immediate packaging

High density polyethylene pre-filled dose-graduated disposable syringe containing 6.42 g (smaller syringe) or 8.56 g (bigger syringe) of product.

Pack sizes:

Cardboard box with 1 oral syringe of 6.42 g.

Cardboard box with 1 oral syringe of 8.56 g.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. To be used immediately after first opening of the oral syringe.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as ivermectin is extremely dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 50146/4036

8 DATE OF FIRST AUTHORISATION

25 September 2003

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

June 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Bimeda Animal Health Limited

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