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

The veterinary medicinal product can also be used in the prevention of heartworm
disease (Dirofilaria immitis), if concomitant treatment against cestodes is indicated.
3.3 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 "Special precautions for use".
3.4 Special warnings
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
3.5 Special precautions for use
Special precautions for safe use in the target species:
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 (see also section 3.10).
To ensure a correct dosage, body weight should be determined as accurately as
possible.
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
infestation of . 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 the 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.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out
of reach of the 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.
Do not handle this veterinary medicinal product in case of known hypersensitivity to
the active substances or to any of the excipients.
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.
3.6 Adverse events
Dogs
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypersensitivity reaction
Systemic disorder (e.g. Lethargy and Anorexia)
Neurological disorder (e.g. Muscle tremors, Ataxia
and Convulsions)
Digestive tract disorder (e.g. Emesis, Diarrhoea,
and 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 the package
leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
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 veterinary medicinal product has not been performed,
use during pregnancy and lactation only according to the benefit-risk assessment by
the responsible veterinarian.
3.8 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 veterinary medicinal product and
other macrocyclic lactones. Also no such studies have been performed with
reproducing animals.
3.9 Administration routes and dosage
Oral use.
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.
The tablets are meat flavoured and easy to administer (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 veterinary medicinal 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 veterinary medicinal product and
continue with the monovalent product containing milbemycin oxime alone, for the
remaining three weekly treatments.
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 , milbemycin oxime should be given in 2
treatments, seven days apart. Where concomitant treatment against cestodes is
indicated, the veterinary medicinal product can replace the monovalent product
containing milbemycin oxime alone.