Milbemycin Oxime Praziquantel Alfamed 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.

Issued: June 2024
AN: 01058/2023
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 Ancylostoma caninum 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 use in animals
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
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.

Issued: June 2024
AN: 01058/2023
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
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).
Special precautions for the protection of the environment:
Not applicable.