Milbemycin Oxime Praziquantel Alfamed II 12.5 mg / 125.0 mg Chewable Tablets for Dogs

The possibility that other animals in the same household can be a source of re-
infection with cestodes and nematodes should be considered, and these should be
treated as necessary with an appropriate veterinary medicinal product.
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 veterinarian
responsible.
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.
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.
In third countries (USA), resistance of Dipylidium caninum to praziquantel as well as
cases of multiple-drug resistance of and resistance of
Dirofilaria immitis to macrocyclic lactones have already been reported.
The use of this veterinary medicinal product should take into account local
information about susceptibility of the target parasites, where available.
In the absence of risk of co-infection with the indicated parasites, a narrow spectrum
veterinary medicinal product should be used, when available.
It is recommended to further investigate cases of suspected resistance, using an
appropriate diagnostic method. Confirmed resistance should be reported to the
marketing holder or to the competent authority.

Special precautions for safe use in the target species:
Studies with milbemycin oxime indicate that the margin of safety in MDR1 mutant
(-/-) dogs of Collie or related breeds is lower 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 (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 product. The use in dogs suffering from microfilaremia is thus
not recommended.
In heartworm risk-areas, or if 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, tapeworm 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:
This veterinary medicinal product may cause hypersensitivity reactions. People with
known hypersensitivity to butylhydroxyanisole, macrogols or soya (bean) oil should
avoid contact with the veterinary medicinal product. If contact occurs, wash hands and
seek medical advice in case of hypersensitivity reactions.
This veterinary medicinal product may be harmful after accidental ingestion. To avoid
accidental ingestion, particularly by a child, blister cards should be inserted back into
the carton and kept out of sight and reach of children. In case of accidental ingestion
of the tablets, seek medical advice immediately and show the package leaflet or the
label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
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).