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 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 responsible
veterinarian.
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 safe use in the target species:
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 3.10 “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.
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 5.5.
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).