Elanco Milbemycin - Praziquantel 12.5 mg/125 mg Tablets for Dogs

Thelazia callipaeda
administered and administration route”)

Issued: December 2022
AN: 00869/2022
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 section 4.5 "Special precautions for use"
4.4 Special warnings for each target species
It is recommended to treat all the animals living in the same household concomitantly.
When infection with the cestode has been confirmed, concomitant
treatment against intermediate hosts, such as fleas and lice, should be discussed with
a veterinarian to prevent re-infection.
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 Elanco Milbemycin - Praziquantel 12.5 mg/125 mg tablets for dogs 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).
4.5 Special precautions for use
Special precautions for use in animals
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 Elanco Milbemycin - Praziquantel 12.5
mg/125 mg tablets for dogs, 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 Elanco Milbemycin -
Praziquantel 12.5 mg/125 mg tablets for dogs.
Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific
guidelines on the treatment and follow up and on the safeguard of persons have to
be followed. Experts or institutes of parasitology should be consulted.

Issued: December 2022
AN: 00869/2022
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, 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 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.
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) have been observed in dogs after
administration of the veterinary medicinal product”.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
The product may be used in breeding dogs including pregnant and lactating bitches.
4.8 Interaction with other medicinal products and other forms of interaction
The concurrent use of Elanco Milbemycin - Praziquantel 12.5 mg/125 mg tablets for
dogs with selamectin is well tolerated. No interactions were observed when the
recommended dose of the macrocyclic lactone selamectin was administered during
treatment with Elanco Milbemycin - Praziquantel 12.5 mg/125 mg tablets for dogs at
the recommended dose. In the absence of further studies, caution should be taken in
the case of concurrent use of Elanco Milbemycin - Praziquantel 12.5 mg/125 mg
tablets for dogs and other macrocyclic lactones. Also, no such studies have been
performed with reproducing animals.

Issued: December 2022
AN: 00869/2022
4.9 Amounts to be administered and administration route
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.
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, Elanco Milbemycin - Praziquantel 12.5 mg/125 mg
tablets for dogs 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 Elanco Milbemycin -
12.5 mg/125 mg tablets for dogs 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 Thelazia callipaeda
treatments, seven days apart. Where concomitant treatment against cestodes is
indicated, Elanco Milbemycin - Praziquantel 12.5 mg/125 mg tablets for dogs can
replace the monovalent product containing milbemycin oxime alone.