Milbeguard Duo 2.5 mg / 25 mg Chewable Tablets for Small Dogs and Puppies

It is recommended to treat all the animals living in the same household concomitantly.
When infection with the cestode
treatment against intermediate hosts, such as fleas and lice, should be discussed with
a veterinarian to prevent re-infection.
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 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.
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 to praziquantel as well as
cases of multi-drug resistance of to milbemycin oxime and
resistance of Dirofilaria immitis to macrocyclic lactones have already 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.
In the absence of risk of co-infection with nematodes or cestodes, a narrow spectrum
product should be used.
The use of this product should take into account local information about susceptibility
of the target parasites, where available.

Special precautions for safe use in the target species:
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 . In the case
of a positive diagnosis, adulticidal therapy is indicated before administering the
product.
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.
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.
Studies with milbemycin oxime indicate that the margin of safety in MDR1 mutant (-/-)
dogs of Collie or related breeds is lower compared to the non-mutant population. 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 3.10 “Symptoms of overdose”).
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.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out
of reach of the animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This veterinary medicinal product may be harmful when ingested, particularly for
children. To avoid accidental ingestion, the product should be stored out of sight and
reach of children. Any unused tablet parts should be returned to the opened blister,
inserted back into the outer packaging and used at the next administration or securely
discarded (see section 5.5).
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.
The product may cause a weak skin sensitisation. Do not handle this product in case
of known hypersensitivity to the active substances or to any of the excipients.
If symptoms such as skin rash persist, seek medical advice 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).