Wormit Plus 2.5 mg/25 mg Flavoured Tablets for Small Dogs and Puppies (Milbemycin / Praziquantel)

“Amounts to be administered and administration route”)
The veterinary medicinal product can also be used in the prevention of
heartworm disease (Dirofilaria immitis) if concomitant treatment against
cestodes is indicated.
3.3 Contraindications
Do not use in in puppies of less than 2 weeks of age and/or weighing less than
0.5 kg.
Do not use in case of hypersensitivity to the active substances or to any of the
excipients.
See also point 3.5 "Special precautions for use".
3.4 Special warnings
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 in point 3.10).
3.5 Special precautions for use
Special precautions for safe use in the target species
As per good veterinary practice, animals should be weighed to ensure accurate
dosing
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 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
Wash hands after use.
In the event of accidental ingestion of the tablets, particularly by a child, seek
medical advice immediately and show the package leaflet or the label to the
doctor.
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).
3.6 Adverse events
Dogs:
Very rare
(<1 animal / 10,000 animals
treated, including isolated reports):
Digestive tract disorders (such as
Diarrhoea, Drooling, Emesis)
Hypersensitivity reaction
Neurological disorders (such as Ataxia,
Convulsions, Muscle tremors)
Systemic disorders (such as Anorexia,
Lethargy)
Reporting adverse events is important. It allows continuous safety monitoring of
a veterinary medicinal product. Reports should be sent, preferably via a
veterinarian, to either the marketing authorisation holder or its local
representative or the national competent authority via the national reporting
system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
The veterinary medicinal product may be used in breeding dogs including
pregnant and lactating bitches.
3.8 Interaction with other medicinal products and other forms of interaction
The concurrent use of the veterinary medicinal product with selamectin is well
tolerated. No interactions were observed when the recommended dose of the
macrocyclic lactone selamectin was administered during treatment with the
veterinary medicinal product at the recommended dose. In the absence of
further studies, caution should be taken in the case of concurrent use of the
veterinary medicinal product and other macrocyclic lactones. Also, no such
studies have been performed with reproducing animals.
3.9 Administration routes and dosage
Oral use.
Minimum recommended dose rate: 0.5 mg of milbemycin oxime and 5 mg of
praziquantel per kg are given once orally.
The veterinary medicinal product should be administered with or after some
food.
Depending on the bodyweight of the dog, the practical dosing is as follows:
WeightTablets0.5 - 1 kg½ tablet> 1 – 5 kg1 tablet> 5 – 10 kg2 tablets
In cases when heartworm disease prevention is used and at the same time
treatment against tapeworm is required, the veterinary medicinal product can
replace the monovalent product for the prevention of heartworm disease.
For treatment of Angiostrongylus vasorum infections, milbemycin oxime should
be given four times at weekly intervals. It is recommended, where concomitant
treatment against cestodes is indicated, to treat once with the veterinary
medicinal product and continue with the monovalent product containing
milbemycin oxime alone, for the remaining three weekly treatments.

In endemic areas administration of the veterinary medicinal product every four
weeks will prevent angiostrongylosis by reducing immature adult (L5) and adult
parasite burden, where concomitant treatment against cestodes is indicated.
For the treatment of Thelazia callipaeda
treatments, seven days apart. Where concomitant treatment against cestodes is
indicated, the veterinary medicinal product can replace the monovalent product
containing milbemycin oxime alone.