MOXICLEAR MEDIUM DOG 4-10KG 1ML 4 PIP

4.1 Target species Dogs 4.2 Indications for use, specifying the target species For dogs suffering from, or at risk from, mixed parasitic infections: • For the treatment and prevention of flea infestation (Ctenocephalides felis), • the treatment of biting lice (Trichodectes canis), • the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), , • the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis), • the treatment of circulating microfilariae (Dirofilaria immitis), • the treatment of cutaneous dirofilariosis (adult stages of Dirofilaria repens) • the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens), • the reduction of circulating microfilariae (Dirofilaria repens), • the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum), • the treatment of Angiostrongylus vasorum and Crenosoma vulpis, • the prevention of spirocercosis (Spirocerca lupi), • the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis). The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). 4.3 Contraindications Do not use in puppies under 7 weeks of age. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group. For cats, the corresponding “Moxiclear for cat” product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used. For ferrets: Do not use Moxiclear for dogs. Only “Moxiclear for small cats and ferrets” (0.4 ml) must be used. Do not use on canaries. 4.4 Special warnings for each target species Please refer to section 4.5. Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the product. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance. The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see also sections 4.2 and 4.9). The product has not been shown to have an adulticidal effect against D. repens. 4.5 Special precautions for use Special precautions for use in animals The treatment of animals weighing less than 1 kg should be based on a risk-benefit assessment. There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals. Care should be taken that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals. Do not allow recently treated animals to groom each other. When the product is applied in 3 to 4 separate spots (see section 4.9), specific care should be taken to prevent the animal licking the application sites. This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described under section 4.9; in particular, oral uptake by the recipient and/or other animals in close contact should be prevented. The product should not enter water courses as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment. The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian. Although experimental overdosage studies have shown that the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of the product has not been evaluated when administered on the same day as an adulticide. Imidacloprid is toxic for birds, especially canaries. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contact with skin, eyes or mouth. Do not eat, drink or smoke during application. Wash hands thoroughly after use. After application do not stroke or groom animals until the application site is dry. In case of accidental spillage onto skin, wash off immediately with soap and water. People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In very rare cases the product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation). In very rare cases the product may cause respiratory irritation in sensitive individuals. If the product accidentally gets into eyes, they should be thoroughly flushed with water. If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical advice immediately and show the package leaflet or label to the physician. Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In order to prevent children from getting access to pipettes, keep the pipette in the original packaging until ready for use and dispose of used pipettes immediately. Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended that animals are not treated during the day, but should be treated during the early evening, and that recently treated animals are not allowed to sleep with owners, especially children. The solvent in the product may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials. 4.6 Adverse reactions (frequency and seriousness) Use of the product may result in transient pruritus in dogs. On rare occasions greasy hair, erythema and vomiting can occur. These signs disappear without further treatment. The product may, in rare cases, cause local hypersensitivity reactions. If the animal licks the application site after treatment, neurological signs (most of which are transient) may be observed in very rare cases (see section 4.10). The product tastes bitter. Salivation may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application sites. The product may in very rare cases cause at the application site a sensation resulting in transient behavioural changes such as lethargy, agitation, and inappetence. A field study has shown that in heartworm positive dogs with microfilaraemia there is a risk of severe respiratory signs (coughing, tachypnea and dyspnea) that may require prompt veterinary treatment. In the study these reactions were common (seen in 2 of 106 treated dogs). Gastrointestinal signs (vomiting, diarrhoea, inappetence) and lethargy are also common adverse reactions following treatment in such dogs. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only accordingly to the benefit-risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction During treatment with the product no other antiparasitic macrocyclic lactone should be administered. No interactions between the product and routinely used veterinary medicinal products or medical or surgical procedures have been observed. Safety of the product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.