Milbemax Chewy Tablet for dogs over 5kg x 4

Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis.

The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite.

Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.

Active substances:

Milbemycin oxime 12.5 mg

Praziquantel 125.0 mg

Excipients:

Glycerol (E422) 460.46 mg

Propylene glycol (E 1520) 4.54 mg

Iron oxide, brown (E 172) 3.29 mg

Butylhydroxyanisole (E 320) 1.32 mg

Propyl gallate (E 310) 0.46 mg

Marketing Authorisation Holder
Elanco Europe Ltd
Lilly House
Priestley Road
Basingstoke
Hampshire
RG24 9NL
UNITED KINGDOM

Marketing Authorisation Number
Vm 00879/4043

Contraindications

• Do not use in dogs weighing less than 5 kg.
• Do not use in case of hypersensitivity to the active substances or to any of excipients.

Special warnings for each target species

• None.

Special precautions for use in animals

• Studies with milbemycin oxime indicate that the margin of safety in certain dogs of Collie or related breeds is less than in other breeds. In these dogs, the recommended dose should be strictly observed.
• The tolerance of the product in young puppies from these breeds has not been investigated. Clinical signs in Collies are similar to those seen in the general dog population when overdosed.
• Treatment of dogs with a high number of circulating microfilariae can sometimes lead to the appearance of hypersensitivity reactions, such as pale mucous membranes, vomiting, trembling, laboured breathing or excessive salivation. These reactions are associated with the release of proteins from dead or dying microfilariae and are not a direct toxic effect of the product. The use in dogs suffering from microfilaremia is thus not recommended.
• In heartworm risk-areas, or in the case it is known that a dog has been travelling to and from heartworm risk regions, before using the product, a veterinary consultation is advised to exclude the presence of any concurrent infestation of Dirofilaria immitis. In the case of a positive diagnosis, adulticidal therapy is indicated before administering the product.
• No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function. The product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian.
• In dogs less than 4 weeks old, tape worm infection is unusual. Treatment of animals less than 4 weeks old with a combination product may therefore not be necessary.
• Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

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

• Wash hands after use.
• People with known hypersensivity to any of the ingredients should avoid contact with the veterinary medicinal product.
• In case of accidental ingestion of the tablets, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the doctor.
• Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific guidelines on the treatment and follow up and on the safeguard of persons have to be followed. Experts or institutes of parasitology should be consulted.

Adverse reactions (frequency and seriousness)

• In very rare occasions, systemic signs (such as lethargy), neurological signs (such as muscle tremors, ataxia and convulsions) and/or gastrointestinal signs (such as emesis, drooling, diarrhoea and anorexia) have been observed in dogs after administration of the veterinary medicinal product.
• The frequency of possible adverse effects is defined using the following convention:

-          very common (affects more than 1 animal in 10)

-          common (affects 1 to 10 animals in 100)

-          uncommon (affects 1 to 10 animals in 1,000)

-          rare (affects 1 to 10 animals in 10,000)

-          very rare (affects less than 1 animals in 10,000)

-          not known (frequency cannot be estimated from the available data)

Use during pregnancy, lactation or lay

• The safety of the veterinary medicinal product has been established during pregnancy and lactation.
• Can be used in pregnant and lactating bitches.
• Can be used in breeding animals.

Interaction with other medicinal products and other forms of interaction

• No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the product at the recommended dose.
• Although not recommended, the concomitant use of the product with a spot on containing moxidectin and imidacloprid at recommended dose rates following a single application was well tolerated in one experimental study by beagle dogs at the age 11 months or older. Transient neurological adverse reactions (poor proprioception, flaccid frontal and hind legs, incoordination, slight tremors and high stepping gait of the hind limbs only) were observed after administration of both products or of the spot-on only in another study conducted in puppies aged 8-12 weeks.
• The safety and efficacy of this combination have not been investigated in field studies.
• In the absence of further studies, caution should be taken in the case of concurrent use of MILBEMAX and any other macrocyclic lactone. Also, no such studies have been performed with reproducing animals, Collies, related breeds and their crosses.