Pramilon 2.5 mg/25 mg Film-coated Tablets for Small Dogs and Puppies

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 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.
It is recommended to treat all the animals in the same household concomitantly.
When 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
4.5 i 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.

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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.
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.
As the tablets are flavoured, they should be stored in a safe place out of the reach of
animals.
4.5 ii Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Wash hands after use.
Part tablets should be returned to the open blister and inserted into the outer carton.
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.
4.5 iii 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.
4.6 Adverse reactions (frequency and seriousness)
Hypersensitivity reactions,
(such as muscle tremors, ataxia and convulsions) and/or gastrointestinal signs (such
as emesis, diarrhoea, anorexia and drooling) may be observed, in very rare
occasions, 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).

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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.
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. Also no such studies have been performed with reproducing animals.
4.9 Amounts to be administered and administration route
Oral use.
Minimum recommended dose rate: 0.5 mg of milbemycin oxime and 5 mg of
praziquantel per kg are given once orally.
Animals should be weighed to ensure accurate dosing.
The product should be administered with or after some food.
The tablets are meat flavoured and easy to administer (usually dogs and puppies will
accept them voluntarily even without any food).
The tablets can be divided into halves.
Depending on the bodyweight of the dog, the practical dosing is as follows:
WeightTablets 0.5 - 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 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.

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For the treatment of , milbemycin oxime should be given in 2
treatments, seven days apart. Where concomitant treatment against cestodes is
indicated, the product can replace the monovalent product containing milbemycin
oxime alone.