Milbemax 12.5 mg/125 mg Chewable Tablets for Dogs

The possibility that other animals in the same household can be a source of re-
infection should be considered, and these should be treated as necessary with
an appropriate veterinary medicinal product.
It is recommended to treat all the animals living in the same household
concomitantly. When infection with the cestode D. caninum has been
confirmed, concomitant treatment against intermediate hosts, such as fleas and
lice, should be discussed with a veterinarian to prevent re-infection.
Parasite resistance to any particular class of anthelmintic may develop following
frequent, repeated use of an anthelmintic of that class.
Unnecessary use of antiparasitics or use deviating from the instructions given in
the SPC may increase the resistance selection pressure and lead to reduced
efficacy. The decision to use the veterinary medicinal product should be based
on confirmation of the parasitic species and burden, or of the risk of infection
based on its epidemiological features, for each individual animal.
The use of the veterinary medicinal product should follow the implementation of
appropriate diagnostic measures towards mixed infections by nematodes and
cestodes with consideration of animal history and characteristics (e.g.age,
health status), environment (e.g. kennelled dogs, hunting dogs), feeding (e.g.
access to raw meat), geographical location and travel. Judgement of the

Revised: May 2025
AN: 00219/2025
administration of the veterinary medicinal product in dogs at risk from mixed re-
infections or in specific at risk situations (such as zoonotic risks), should be
made by the veterinarian responsible.
In the absence of risk of co-infection with nematodes or cestodes, a narrow
spectrum veterinary medicinal product should be used.
Resistance of to praziquantel as well as cases of multi-drug
resistance of Ancylostoma caninum to milbemycin oxime and resistance of
Dirofilaria immitis to macrocyclic lactones have been reported.
It is recommended to further investigate cases of suspected resistance, using
an appropriate diagnostic method. Confirmed resistance should be reported to
the marketing authorisation holder or to the competent authorities.
The use of this veterinary medicinal product should take into account local
information about susceptibility of the target parasites, where available.

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 veterinary medicinal 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 (see section 4.10
“Overdose”).
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 veterinary medicinal 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 veterinary medicinal
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 veterinary medicinal
product.
No studies have been performed with severely debilitated dogs or individuals
with seriously compromised kidney or liver function. The veterinary medicinal
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, tapeworm infection is unusual. Treatment of
animals less than 4 weeks old with a combination veterinary medicinal product
may therefore not be necessary.

Revised: May 2025
AN: 00219/2025
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Wash hands after use.
People with known hypersensitivity 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
physician.
Special precautions for the protection of the environment
See section 6.6.
Other precautions
Echinococcosis represents a hazard for humans. As Echinococcosis is a
notifiable disease to the World Organisation for Animal Health (WOAH), specific
guidelines on the treatment and follow up and on the safeguard of persons need
to be obtained from the relevant competent authority (e.g. experts or institutes
of parasitology).