SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Molemec Plus Paste for Horses 15.5 mg/g / 77.5 mg/g Oral Paste (UK)

EQVALAN DUO EQUIPACK (France)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each syringe contains 7.74 g of paste and delivers:

Active substances:

Ivermectin 0.120 g (15.5 mg/g)

Praziquantel 0.600 g (77.5 mg/g)

Excipients:

Butylhydroxyanisole (E320): 0.002 g

Sunset Yellow (E110): 0.003 g

Titanium dioxide (E171): 0.155 g

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral paste.

Smooth, homogeneous orange paste.

4. CLINICAL PARTICULARS

Horses

For the treatment of mixed cestode and nematode or arthropod infestations in horses. The following parasites of horses are sensitive to the antiparasitic effects of the product:

Adult Tapeworms:

Anoplocephala perfoliata

Anoplocephala magna

Large strongyles:

Strongylus vulgaris (adults and arterial larval stages)

Strongylus edentatus(adults and tissue larval stages)

Strongylus equinus (adults)

Triodontophorus spp(adults)

Triodontophorus brevicauda

Triodontophorus serratus

Craterostomum acuticaudatum(adults)

Adult and immature (intraluminal fourth-stage larvae) of small strongyles or cyathostomes, including benzimidazole-resistant strains:

Coronocyclusspp

Coronocyclus coronatus

Coronocyclus labiatus

Coronocyclus labratus

Cyathostomumspp

Cyathostomum catinatum

Cyathostomum pateratum

Cylicocyclusspp

Cylicocyclus ashworthi

Cylicocyclus elongatus

Cylicocyclus insigne

Cylicocyclus leptostomum

Cylicocyclus nassatus

Cylicodontophorus spp

Cylicodontophorus bicornatus

Cylicostephanus spp

Cylicostephanus calicatus

Cylicostephanus goldi

Cylicostephanus longibursatus

Cylicostephanus minutus

Parapoteriostomum spp

Parapoteriostomum mettami

Petrovinemaspp

Petrovinema poculatum

Poteriostomumspp

Adult hairworms: Trichostrongylus axei

Adult and immature (fourth stage Larvae) pinworms: Oxyuris equi

Adult, third- and fourth-stage larvae of roundworms(ascarids): Parascaris equorum

Microfilariae of neck threadworms:Onchocercaspp

Adult intestinal threadworms: Strongyloides westeri

Adult large-mouth stomach worms: Habronema muscae

Oral and, gastric stages of bots: Gasterophilusspp

Adult and immature (inhibited fourth stage larvae) lungworms: Dictyocaulus arnfieldi

4.3 Contraindications

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

4.4 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:

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 the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of gastro-intestinal nematodes and recommendations on how to limit further selection for resistance to anthelmintics

4.5 Special precautions for use

Special precautions for use in animals

Safety studies were not conducted in foals younger than 2 months of age, or in stallions, the use of the product is not recommended in these categories of animals.

Avermectins may not be well tolerated in all non target animals. Cases of intolerance are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtle and tortoises.

Dogs and cats should not be allowed to ingest spilled paste or access to used syringes due to the potential for adverse effects related to ivermectin toxicity.

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

Wash hands after use.

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

This product may cause skin and eye irritation. Therefore, the user should avoid contact of the product with the skin and the eyes. In 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.

4.6 Adverse reactions (frequency and seriousness)

Some horses with heavy infections of Onchocercaspp. microfilariaehave experienced oedema and pruritis following treatment; such reactions were assumed to be the result of the death of large numbers of microfilariae. These signs resolve within a few days but symptomatic treatment may be advisable.

In cases of very high levels of infestations, destruction of the parasites may cause a mild transient colic and loose faeces in the treated horse.

Following administration of the product, there have been rare reports of inflammation of the mouth, lip and tongue, which results in various clinical signs such as oedema, hypersalivation, erythema, tongue disorder and stomatitis. These reactions have been transitory in nature, appearing within 1 hour and abating within 24 to 48 hours following administration.In case of severe oral reactions symptomatic treatment is recommended

4.7 Use during pregnancy, lactation or lay

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

Ivermectin-Praziquantel combination can be used after the first three months of gestation and during lactation. In the absence of clinical data in early pregnancy the product can only be used in the first three months of gestation according to a risk benefit analysis by the veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

No data available.

4.9 Amounts to be administered and administration route

For a single oral administration

The recommended dosage is 200 mcg ivermectin per kilogram of bodyweight and 1mg praziquantel per kilogram of bodyweight corresponding to 1.29 g of paste per 100 kg bodyweight in a single administration.

Bodyweight and dosage should be accurately determined prior to treatment. The contents of one syringe will treat horses up to 600 kg. Calibrated markings are provided at 100 kg bodyweight intervals. The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger.

Directions for use

The product is for oral administration only. While holding the plunger, turn the knurled ring on the plunger ¼ turn to the left and slide it so the stop ring is at the prescribed weight marking. Lock the ring in place by turning it ¼ turn to the right in order to bring the two arrows, the one visible on the ring and the one on the plunger rod, into alignment. Make sure the horse’s mouth contains no feed.

Remove the cover from the tip of the syringe. Insert the syringe tip into the horse’s mouth at the interdental space and deposit the paste on the base of the tongue. Immediately raise the horse’s head for a few seconds after dosing and ensure that the paste is consumed.

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.

No undesirable effects related to treatment were observed in 2 month old horses treated with the product at up to three timesthe recommended dose and in adult horses treated at ten times the recommended dose.

Transient decreased food consumption, increased body temperature, salivation and impairment of vision were noticed in horses treated twice with an ivermectin oral paste or once with the product at ten times the recommended dose (i.e., 2 mg/kg b.w.). All changes disappeared within five days.

No antidote has been identified; however, symptomatic therapy may be beneficial.

4.11 Withdrawal period(s)

Meat and offal: 30 days.

Do not use in mares producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics

ATCvet code: QP54AA51 ivermectin, combinations.

The product is an endectocide containing an association of an anthelmintic active ingredient, ivermectin, and a cestocide active ingredient, praziquantel.

Ivermectinis 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 with hyperpolarization of the nerve or muscle cell, which results 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 channels, and macrocyclic lactones do not readily cross the blood-brain barrier.

Praziquantelis a synthetic isoquinoline-pyrazine derivative with activity against several trematode and cestode parasites. In vitro and in vivo studies have found that trematodes and cestodes rapidly take up praziquantel within minutes; praziquantel causes tetanic contraction of the parasites' musculature and a rapid vacuolisation of their tegument. The net effect is that the parasite detaches from the host. Praziquantel affects membrane permeability in trematodes and cestodes, and influences divalent cation fluxes, particularly calcium ion homeostasis, which is thought to contribute to the rapid muscle contraction and vacuolisation. The margin of safety for the praziquantel is due to its rapid metabolism and excretion as well as its selective effect on susceptible parasites.

5.2 Pharmacokinetic particulars

After oral administration to horses of the recommended dose of the product, praziquantel is rapidly absorbed and excreted, whereas ivermectin is more slowly absorbed and persists during a longer period in the body. Praziquantel maximum plasma concentrations (of the order of 1 µg/ml) are reached rapidly (approximately in the hour following treatment). The praziquantel plasma residue depletes rapidly to non-quantifiable levels by 7.5 hours post dose. Praziquantel is excreted as metabolites in the urine and faeces and the total amount excreted accounts for 31% and 24%, respectively of the administered dose within 24 hours.

Ivermectin maximum plasma concentrations (Cmax: 37.9 ng/ml) are reached in a longer period (tmax: approximately 9 hours after treatment) and levels fell to non detectable / no quantifiable values on or before 28 days after administration.

Faecal excretion is the major pathway of ivermectin elimination in all species studied.

No pharmacological interference between ivermectin and praziquantel was noted.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sunset yellow FCF (E110)

Titanium oxide (E171),

Butylhydroxyanisole (E320)

Hydroxypropylcellulose

Hydrogenated castor oil

Glycerol formal

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life after first opening the immediate packaging: 2 years

6.4. Special precautions for storage

Store in the original container. Replace the cap after use.

6.5 Nature and composition of immediate packaging

Immediate package

The product is available in syringes containing 7.74 g 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.

Outer package and sales presentations

Each syringe is sealed in a transparent polypropylene bag.

Carton box of 1 individual syringe.

Carton box of 50 individual syringes.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

EXTREMELY DANGEROUS FOR FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used syringes. Any unused veterinary medicinal product or waste material derived from such veterinary medicinal productshould be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Merial Animal Health Limited

PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex

CM19 5TG

8. MARKETING AUTHORISATION NUMBER

Vm 08327/4252

9. DATE OF FIRST AUTHORISATION

05 July 2011

10. DATE OF REVISION OF THE TEXT

August 2016

09 August 2016