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

Thelazia callipaeda (see specific treatment schedule under section “4.9 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.
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 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
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 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 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.
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

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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
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.
Part tablets should be returned to the open blister pocket and inserted into the outer
carton.
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.
4.6 Adverse reactions (frequency and seriousness)
Dogs:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypersensitivity reaction
Systemic disorders (e.g. lethargy, anorexia)
Neurological disorders (e.g. muscle tremor, ataxia)
Digestive tract disorders (e.g. emesis, diarrhoea,
drooling)
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 also section 16
of the package leaflet for contact details.>

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4.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Fertility:
Can be used in breeding animals.
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
veterinary medicinal 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.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
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:
Body weightTablets 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 veterinary medicinal product can replace
the monovalent veterinary medicinal 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 veterinary medicinal product containing
milbemycin oxime alone, for the remaining three weekly treatments.

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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 veterinary
medicinal product containing milbemycin oxime alone.