Mektix Chewable 12.5 mg/125 mg Film-coated Tablets for Dogs Weighing at Least 5 kg

routes and dosage)
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 3.5 Special precautions for use.
3.4 Special warnings
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.
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.
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 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, tapeworm 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:
Accidental ingestion of a tablet by a child may be harmful. In order to prevent children
from accessing the veterinary medicinal product, tablets should be administered and
stored out of sight and reach of children.
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.
Special precautions for the protection of the environment:
See also, section 5.5.
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).
3.6 Adverse events
Dogs:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Systemic disorders (e.g. lethargy)
Neurological disorders (e.g. ataxia, muscle
tremor)
Digestive tract disorders (e.g. anorexia,
diarrhoea, drooling, emesis)
Hypersensitivity reaction
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:
Can be used during pregnancy and lactation.
Fertility:
Can be used in breeding dogs.
3.8 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.
3.9 Administration routes and dosage
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.
The veterinary medicinal product is palatable i. e. it is usually taken voluntarily by
dogs (voluntary consumption on > 80% of occasions in animals studied). If the dog
does not voluntarily accept the tablet, it can also be administered into the mouth.
Depending on the bodyweight of the dog, the practical dosing is as follows:
Body
weight
Film-coated
tablets
5 – 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
monosubstance 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.
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 monosubstance
veterinary medicinal product containing milbemycin oxime alone.