Alpramil 12.5 mg/125 mg Tablets for Dogs Weighing at Least 5 kg

“Administration 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
The use of the veterinary medicinal product should follow the implementation of
appropriate diagnostic measures towards mixed infections by nematodes and
cestodes with consideration of animal history and characteristics (e.g. age, health
status), environment (e.g. kennelled dogs, hunting dogs), feeding (e.g. access to raw
meat), geographical location and travel. Judgement of the administration of the
veterinary medicinal product in dogs at risk from mixed re-infections or in specific at
risk situations (such as zoonotic risks), should be made by the veterinarian
responsible.
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.
It is recommended to treat all the animals living in the same household
concomitantly.
When infection with the cestode D. caninum has been confirmed, concomitant
treatment against intermediate hosts, such as fleas and lice, should be discussed
with a veterinarian to prevent re-infection.
Parasite resistance to any particular class of anthelmintic may develop following
frequent, repeated use of an anthelmintic of that class. Unnecessary use of
antiparasitics or use deviating from the instructions may increase the resistance
selection pressure and lead to reduced efficacy. In third countries (USA), resistance
of Dipylidium caninum to praziquantel as well as cases of multiple-drug resistance of
Ancylostoma caninum to milbemycin oxime have already been reported.
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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 MDR1 mutant (-/-)
dogs of Collie or related breeds is lower compared to the normal population.
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 these dogs are similar to those seen in the general dog
population (see section 3.6 “Adverse events”).
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:
This veterinary medicinal product may be harmful when ingested, particularly for
children.
Avoid accidental ingestion.
The veterinary medicinal product should be stored in a safe place.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
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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 disorders (e.g. lethargy, anorexia);
Neurological disorders (e.g. muscle tremor and
ataxia);
Digestive tract disorders (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:
Can be used during pregnancy and lactation.
Fertility:
Can be used in breeding animals.
3.8 Interaction with other medicinal products and other forms of interaction
The concurrent use of the veterinary medicinal product with selamectin is well
tolerated. No interactions were observed when the recommended dose of the
macrocyclic lactone selamectin was administered during treatment with the veterinary
medicinal product 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.
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Depending on the bodyweight of the dog and the availability of tablet strengths,
practical dosing examples are as follows:
Weight
(kg)
12.5 mg/125 mg tablet
> 5 – 25 1 tablet> 25 – 50 2 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.
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.