Milbeworm 12.5 mg/125 mg Film-coated Tablets for Dogs

The product can also be used in the prevention of heartworm disease (Dirofilaria
immitis), if concomitant treatment against cestodes is indicated.
4.3 Contraindications
Do not use in dogs weighing less than 5 kg
Do not use in cases of hypersensitivity to the active substances or to any of the
excipients.
See also point "Special precautions for use".
4.4 Special warnings for each target species
In order to develop an effective worm control programme, local epidemiological
information and the living conditions of the dog should be taken into account, and
therefore it is recommended to seek professional advice.
Parasite resistance to any particular class of anthelmintic may develop following
frequent, repeated use of an anthelmintic of that class.
4.5 Special precautions for use
Special precautions for use in animals
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 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 also section 4.10).
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 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 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.

Revised: December 2021
AN: 01705/2021
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.
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.
Other precautions
Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable
disease to the World Organisation for Animal Health (OIE), 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) If the dog
has visited areas where
consulted.
4.6 Adverse reactions (frequency and seriousness)
In very rare occasions, hypersensitivity reactions, systemic signs (such as lethargy),
neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs
(such as emesis, diarrhea, anorexia and drooling) may be observed in dogs after
administration of the veterinary medicinal product.
4.7 Use during pregnancy, lactation or lay
In a study, this combination of active substances was demonstrated to be well
tolerated in breeding bitches, including during pregnancy and lactation. As a specific
study with this product has not been performed, use during pregnancy and lactation
only according to a benefit/risk assessment by the responsible veterinarian. Also no
such studies have been performed with reproducing animals.
4.8 Interaction with other medicinal products and other forms of interaction
The concurrent use of the combination praziquantel/milbemycin oxime with
selamectin is well tolerated. No interactions were observed when the recommended
dose of the macrocyclic lactone selamectin was administered during treatment with
the combination at the recommended dose. In the absence of further studies, caution
should be taken in the case of concurrent use of the product and other macrocyclic
lactones.
4.9 Amounts to be administered and administration route
Oral use.

Revised: December 2021
AN: 01705/2021
Minimum recommended dose rate: 0.5 mg of milbemycin oxime and 5 mg of
praziquantel per kg are given once orally.
The product should be administered with or after some food.
The tablets are meat flavoured and easy to administer tablets (usually dogs and
puppies will accept them voluntarily even without any food).
Depending on the bodyweight of the dog, the practical dosing is as follows:
WeightTablets5 – 25 kg1 tablet>25 – 50 kg2 tablets>50 – 75 kg3 tablets
In cases when heartworm disease prevention is used and at the same time treatment
against tapeworm is required, the product can replace the monovalent product for the
prevention of heartworm disease.
For treatment of 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 product and continue with the
monovalent product containing milbemycin oxime alone, for the remaining three
weekly treatments.
In endemic areas administration of the 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
treatments, seven days apart. Where concomitant treatment against cestodes is
indicated, the product can replace the monovalent product containing milbemycin
oxime alone.