SUMMARY OF PRODUCT CHARACTERISTICS

Pramoxiquest Oral Gel for Horses and Ponies

Each 1 g contains:

Active substance:

Moxidectin 19.5 mg

Praziquantel 121.7 mg

Excipients:

Benzyl alcohol 220.0 mg

Butylhydroxytoluene 0.8 mg

For a full list of excipients, see section 6.1.

Oral gel

Pale yellow to orange/pink gel

Horses and ponies.

Indicated for the treatment of mixed cestodes and nematodes or arthropods infections, caused by moxidectin and praziquantel sensitive strains of:

Large strongyles:

• Strongylus vulgaris (adult stages)

• Strongylus edentatus (adult stages)

• Triodontophorus brevicauda (adults)

• Triodontophorus serratus (adults)

• Triodontophorus tenuicollis (adults)

Small strongyles (adults and intraluminal larval stages):

• Cyathostomum spp.

• Cylicocyclus spp.

• Cylicostephanus spp.

• Cylicodontophorus spp.

• Gyalocephalus spp.
  
  

Ascarids:

Other species:

• Oxyuris equi (adult stages)

• Habronema muscae (adults)

• Gasterophilus intestinalis (L2, L3)

• Gasterophilus nasalis (L2, L3)

• Strongyloides westeri (adults)

• Trichostrongylus axei (adults)

Tapeworm (adults):

• Anoplocephala perfoliata

• Anoplocephala magna

• Paranoplocephala mammillana

The egg reappearance period of small strongyles is 90 days.

The veterinary medicinal product is effective against (developing) intramucosal L4 stages of small strongyles. At 8 weeks after treatment, early (hypobiotic) EL3 stages of small strongyles are eliminated.

Do not administer to young foals less than 6.5 months.

Do not administer in cases of known hypersensitivity to the active ingredients or to any of the excipients.

The product has been formulated specifically for use in horses only. Dogs and cats may be adversely affected by the concentration of moxidectin in this product if they are allowed to ingest spilled gel or have access to used syringes. See also section 4.7.

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;

- Under-dosing which may due to underestimation of body weight, misadministration of the 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 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.

For optimum control of bots, the product should be administered in the autumn, after the end of the fly season and before spring as the larvae may start to pupate and therefore are less sensitive to treatment.

Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. The veterinarian should give advice regarding appropriate dosing programmes and stock management to achieve adequate parasite control for both tapeworm and roundworm infestations.

To avoid overdosing, care should be taken to accurately dose foals, especially low body weight foals or pony foals.

Do not use the same syringe to treat more than one animal unless horses are
running together or in direct contact with each other in the same premises.

This product may cause eye irritation, skin irritation and skin sensitisation.

Avoid direct contact with skin and eyes.

Use protective gloves.

Wash hands or any exposed area after use.

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

In the event of eye contact, flush the eye with copious amounts of clean water and seek medical advice.

In the case of accidental ingestion, seek medical help and show the doctor the package leaflet.

In order to limit the impact of moxidectin on dung fauna, and due to insufficient data regarding environmental risk of praziquantel, horses should not be turned out onto pasture within 3 days of treatment.

Flaccid lower lip, ataxia and swelling of the muzzle could be observed on rare occasions in young animals. These adverse effects are usually transient and disappear spontaneously.

In case of very high worm burdens, destruction of the parasites may cause a mild transient colic and loose faeces in the treated horse.

Do not use during pregnancy and lactation inmares.

The effects of GABA agonists are increased by moxidectin.

A single oral dose of 400 µg moxidectin/kg bodyweight and 2.5 mg praziquantel/kg bodyweith using the calibrated syringe of one graduation per 25 kg bodyweight.

To ensure administration of a correct dosage, bodyweight should be determined as accurately as possible; accuracy of the dosing should be checked.

Use of a scale or weigh tape is recommended to ensure accurate dosing.

Hold the syringe with the capped end pointing to the left and so that you can see the weight measurements and tick marks (small black lines). Each tick mark relates to 25 kg of bodyweight. Turn the dial ring until the left side of the ring lines up with the weight of the animal.

A single syringe treats a 575kg horse.

In the case of cestodes treatment, the dose of praziquantel in the product has been selected to the top end of the dosing range.

Veterinary advice should be given on appropriate dosing programmes and stock management to achieve optimum parasite control.

Transient adverse reactions may occur at the recommended treatment dose in foals. In adults, transient adverse reactions may occur at 3 times the recommended dose. The symptoms are depression, inappetance, ataxia and flaccid lower lip in the 8 to 24 hours following treatment. Symptomatic treatment is not generally necessary and recovery is generally complete within 24 to 72 hours. There is no specific antidote.

Meat and offal: 64 days.

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

Pharmacotherapeutic group:Endectocides, moxidectin, combinations

ATCVet Code:QP54AB52

Moxidectin is a parasiticide active against a wide range of internal and external parasites and is a second generation macrocyclic lactone of the milbemycin family. Moxidectin interacts with GABA receptors and chloride channels. The net effect is to open the chloride channels on the postsynaptic junction to allow the inflow of chloride ions and induce an irreversible resting state. This results in flaccid paralysis and eventual death of parasites exposed to the drug.

Praziquantel is a parasiticide widely used in many species as an anthelmintic.

Praziquantel is quickly absorbed via the tegument of the parasite and distributed. In vitro and in vivo important lesions of the tegument of the parasite are seen that provoke contraction and paralysis of the parasite. Praziquantel modifies the permeability of the parasitic membrane to calcium ions, which disrupts the metabolism of the parasite.

The veterinary medicinal product is effective against benzimidazole resistant strains of cyathostomes.

Moxidectin is absorbed following oral administration with maximum blood concentrations being achieved 6 to 8 hours after administration.

The drug is distributed throughout the body tissues but due to its lipophilicity it is selectively concentrated in the fat.

The elimination half life is 11 days.

Moxidectin undergoes partial biotransformation by hydroxylation in the body and the only significant route of excretion is the faeces

Praziquantel is quickly and almost totally absorbed in the body, rapidly distributed to all organs, half life elimination is less than 1 hour in horses. Praziquantel is rapidly metabolised in the liver. Its principal metabolite is a related 4-hydroxycyclohexyl component.

Benzyl alcohol (E1519)

Butyl hydroxytoluene (E321)

Anhydrous colloidal silica

Ethanol, anhydrous

Polysorbate 80

Ethyl cellulose

Propylene glycol dicaprylate/dicaprate

None known.

Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.

Shelf-life after first opening the immediate packaging: 6 months.

Do not store above 25C.

High density polyethylenesyringe containing 11.8 g of gel with a graduated polypropylene plunger with a low density polyethylene cap packed as follows:

• Box containing one syringe.

• Box containing 10 individually boxed syringes.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.

The product is toxic to fish and aquatic organisms.

Do not contaminate ponds, waterways or ditches with the veterinary medicinal product or used syringes.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm:42058/4114

Date:18 July 2012

Date:June 2014

03 June 2014