Wormit Plus 12.5mg/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
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
“Symptoms of overdose (and where applicable, emergency procedures and
antidotes)”).
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, tape worm infection is unusual. Treatment of
animals less than 4 weeks old with a combination veterinary medicinal product
may therefore not be necessary.
As the tablets are flavoured, they should be stored in a safe place out of the
reach of 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 veterinary medicinal product
should be stored out of sight and reach of children.
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.
This veterinary medicinal product may cause hypersensitivity reactions. People
with known hypersensitivity to the active substances or to the excipients,
butylhydroxyanisole (E320) and propyl gallate (E310), should avoid contact with
the veterinary medicinal product. If contact occurs, wash hands and seek
medical advice in case of hypersensitivity reactions.
Wash hands after use.
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).