Aderexa 2.5 mg/25 mg Chewable Tablets for Small Dogs and Puppies Weighing at Least 0.5 kg

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AN: 02981/2023 & 03345/2023Page 2 of 7
Thelazia callipaeda (see specific treatment schedule under section 4.9 Amounts to
be administered and administration route).
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 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 section 4.5 Special precautions for use.
4.4 Special warnings for each target species
Parasite resistance to any particular class of anthelmintic may develop following
frequent, repeated use of an anthelmintic of that class.
It is recommended to treat all the animals in the same household concomitantly.
In order to develop an effective worm control programme local epidemiological
information and the risk of exposure of the dog should be taken into account, and it is
recommended to seek professional (e. g. veterinary) advice.
When D. caninum infection is present, concomitant treatment against intermediate
hosts, such as fleas and lice, should be considered to prevent re-infection.
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.
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 Dirofilaria immitis.
In the case of a positive diagnosis, adulticidal therapy is indicated before
administering the product.
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.

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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
Accidental ingestion of a tablet by a child may be harmful. In order to prevent children
from accessing the product, tablets should be administered and stored out of sight
and reach of children.
Part tablets should be returned to the open blister pocket and inserted into the outer
carton.
In the event of accidental ingestion of one or more tablets, seek medical advice
immediately and show the package leaflet or the label to the doctor.
Wash hands after use.
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).
4.6 Adverse reactions (frequency and seriousness)
On very rare occasions, hypersensitivity reaction, systemic signs (such as lethargy),
neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs
(such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after
administration of the combination of milbemycin oxime and praziquantel.
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 and lactation
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
No interactions were observed when the recommended dose of the macrocyclic
lactone selamectin was administered during treatment with the combination of
milbemycin oxime and praziquantel 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. Also, no such studies have been performed with
reproducing animals.
4.9 Amounts to be administered and administration route
Oral use.
Dogs should be weighed to ensure accurate dosing.

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AN: 02981/2023 & 03345/2023Page 4 of 7
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:
Body weight
Chewable
tablets
0.5 – 1 kg1/2 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 product can replace the monosubstance 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 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 Thelazia callipaeda
treatments, seven days apart. Where concomitant treatment against cestodes is
indicated, the product can replace the monosubstance product containing milbemycin
oxime alone.