Prinovox Spot-on for Small Dogs up to 4kg (4 pipettes)

Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is effective against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.

Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis. It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.

Active substances:
imidacloprid 40 mg
Moxidectin 10 mg

Prinovox is a prescription product and must be applied according to the instructions by your veterinary surgeon.
Please read the product leaflet thoroughly before applying to your pet.

Marketing Authorisation Holder
Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
UK

Marketing Authorisation Number
Vm 00010/4190

Contra-indications

• Do not use in puppies under 7 weeks of age.
• Do not use in animals that are known to be hypersensitive 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 “Prinovox for cat” product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used.
• For ferrets: Do not use Prinovox for dogs. Only “Prinovox for small cats and ferrets” (0.4 ml) must be used.

Special warnings for each target species

• 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.
• The product has not been shown to have an adulticidal effect against D. repens.

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 content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals. 
• 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 dosage schedule; 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 this product has not been evaluated when administered on the same day as an adulticide.

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 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 the label to the physician.

Other precautions

• 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.

Adverse reactions

• 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.
• 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.

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 according to the benefit-risk assessment by the responsible veterinarian.

Interactions

• During treatment with this veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.
• No interactions between this veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
• Safety of this veterinary medicinal product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.