Maximec Horse Oral Paste, 18.7 mg/g

Composition

Each gram contains:

Active substance:

Ivermectin 18.7 mg

Excipients:

Qualitative composition of excipients and other constituents

Maize Oil

Polysorbate 80

Colloidal Anhydrous Silica

Apple Flavour (In-house)

A yellow, gel-like paste of uniform consistency.

3

Pharmacological properties

4.1 ATCvet code:

QP54AA01

4.2 Pharmacodynamics

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 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 veterinary medicinal product, 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 0.2 mg ivermectin per kilogram of bodyweight, plasma levels of ivermectin reach a mean Cmax concentration of 40.44 ng/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.

3

Target species

Horses.

3

Indications

This veterinary medicinal product is indicated for the treatment of parasitic infestations in horses due to:

Large strongyles

Strongylus vulgaris (adult and arterial larval stages)

Strongylus edentatus (adult and tissue larval stages)

Strongylus 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.

3

Dosage

Administer orally as a single dose rate to horses 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.

Dosing Instructions: Each weight marking on the syringe plunger will deliver sufficient paste to treat 100 kg 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.

Parasite control program: All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.

3

Contraindications

This veterinary medicinal product has been formulated specifically for use in horses only. Dogs or cats 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

Adverse reactions

Horses:

Undetermined frequency (cannot be estimated from the available data)

Oedema1, Pruritus1

1Some 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.

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.

3

Warnings

Special precautions for safe use in the target species:

Where there is significant tissue damage following Habronema infestation, additional medical therapies may be required.

Dogs or cats 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.

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

Do not smoke, drink or eat while handling this veterinary medicinal product.

Wash hands after use.

Special precautions for the protection of the environment:

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container.

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.

3

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy. Horses of all ages, including pregnant mares and breeding stallions, have been treated with no adverse effect. For use in lactating mares please see section 3.12.

3

Interactions

None known.

3

Overdose

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 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.

3

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 bodyweight or misadministration of the veterinary medicinal product.

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 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.

3

Withdrawal period

Meat and offal: 21 days.

Milk: Not permitted for use in lactating mares producing milk for human consumption.

3

Incompatibilities

No major incompatibility has been identified.

Do not mix with other veterinary medicinal products.

3

Immediate packaging

Dose graduated disposable polyethylene oral syringe containing 6.42 g of a yellow gel-like, apple flavoured, paste of uniform consistency.

Each syringe is packed into an individual cardboard carton which in turn is packed into an outer display carton containing 24 packed syringes.

3

Storage

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

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

3

Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

The veterinary medicinal product should not enter water courses as ivermectin may be dangerous for fish and other aquatic organisms. Do not contaminate surface waters or ditches with the veterinary medicinal product or used container.

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.

3

Additional information

Vm 50146/5008

8 DATE OF FIRST AUTHORISATION

22 September 2005

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

March 2025

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.

3

Registration holder

Bimeda Animal Health Limited

3