MILBMAX

MILBEMAX CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substances:

Milbemycin oxime 2,5 mg
Praziquantel 25,0 mg
Excipients:
Glycerol (E 422) 92,12 mg
Propylene glycol (E 1520) 0,91 mg
Iron oxide, brown (E 172) 0,66 mg
Butylated hydroxyanisole (E 320) 0,26 mg

Propyl gallate (E 310) 0,9 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable tablet.
Oval shape, dark brown.
4. CLINICAL DATA

4.1 Target species

Dogs

MILBMAX

4.2 Indications for use, specifying the target species
In dogs: treatment of mixed infections by adult cestodes and nematodes of the
following species:
– Cestodes:
Canine dipylidium
Taenia spp.
Echinococcus spp.
Mesocestoides spp.
– Nematodes:
Ancylostoma caninum
toxocara canis
Toxascaris leonina
Trichuris vulpis
Crenosome vulpis (Reduction of the level of infection).

Angiostrongylus vasorum (Reduction of the level of infection) (see the specific treatment scheme in section 4.9 “Posology and route of administration”).
The drug can also be used in the prevention of heartworm (Unforgiving heartworms), if concomitant treatment against cestodes is indicated.

MILBMAX

4.3 Contraindications
Do not use in dogs weighing less than 5 kg.
Do not use in case 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
Studies with milbemycin oxime indicate that the margin of safety in some dogs of
Collie or related breed is inferior to that of other breeds. In these dogs, one should observe
strictly the recommended dosage.
The tolerance of the drug in puppies of these breeds has not been studied.
Clinical symptoms in Collies are similar to those seen in the general population of
overdosed dogs (see section 4.10 “Overdose”).
4.5 Special precautions for use
Special precautions for use in animals
Treatment of dogs with high numbers of circulating microfilariae may sometimes cause hypersensitivity reactions, such as pale mucous membranes, vomiting, tremors, respiratory distress or excessive salivation. Are
reactions are associated with protein release from dead or dying microfilariae and are not a direct toxic effect of the drug. Therefore, its use in dogs suffering from microfilaraemia is not recommended.
In heartworm risk areas, or if the dog is known to have traveled to or from a heartworm risk area, prior to using the product, a visit to the veterinarian is recommended to rule out concurrent heartworm infestation. Unforgiving heartworms. In
In case of a positive diagnosis, an adulticide treatment is indicated before administering the drug.
Echinococcosis poses a risk to people. In the case of echinococcosis, specific guidelines for treatment and monitoring, and for the safety of people must be followed. Experts or parasitology institutes should be consulted.
No studies have been done in severely debilitated dogs or in individuals with severely compromised liver or kidney function. The drug is not recommended in these animals, or only after a benefit/risk assessment by the veterinarian.
responsible. In dogs less than 4 weeks old, tapeworm infection is rare. Therefore, treatment of animals less than 4 weeks old with a combination drug may not be necessary.

After frequent and repeated use of an anthelmintic of a particular class, resistance against that specific class may develop.

Special precautions to be taken by the person administering the medicinal product to animals
Wash hands after use. In case of accidental ingestion of the tablets, especially in the case of children, consult a doctor and show him the label and/or the package leaflet.
4.6 Adverse reactions (frequency and seriousness)
In very rare cases, systemic (such as lethargy), neurological (such as muscle tremors and ataxia) and/or gastrointestinal (such as emesis, drooling, diarrhea and anorexia) signs have been observed in dogs following administration of the veterinary medicinal product.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has been established during pregnancy and lactation. It can be used in pregnant and lactating bitches.
It can be used in breeding animals.
4.8 Interaction with other medicinal products and other forms of interaction
The concomitant use of the drug with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the drug at the recommended dose. In the absence of other studies, caution should be taken in the case of concomitant use of the drug and other macrocyclic lactoses. No such studies have been performed in breeding animals.
4.9 Amounts to be administered and administration route
Minimum recommended dose: 0,5 mg milbemycin oxime and 5 mg praziquantel per kg in a single oral dose. The medicine should be administered with or after some food.
Depending on the weight of the dog, the practical dose is as follows:

In cases where heartworm prevention is being carried out and at the same time
need treatment against cestodes, MILBEMAX can replace the medicine
monovalent in the prevention of filariasis.
For infections of Angiostrongylus vasorum, milbemycin oxime four should be administered
times at weekly intervals. Recommended, where treatment is indicated

concomitant cestodes, treat once with the drug and continue with the
monovalent drug containing milbemycin oxime only, during the three
remaining weekly treatments.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
The adverse reactions observed are the same as those observed at the dose
recommended (see section 4.6 “Adverse reactions (frequency and seriousness)”), but more
pronounced.
4.11 Timeout
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: antiparasitic drugs, insecticides and repellents –
endocicides.
ATCvet code: QP54AB51 (combinations with milbemycin)

6. PHARMACEUTICAL DATA
6.1 List of excipients
Glycerol (E 422)
Propylene glycol (E 1520)
Iron oxide, brown (E 172)
Butylated hydroxyanisole (E320)
Propyl gallate (E 310)
Pregelatinized starch.
natural chicken flavor
confectioners sugar
Purified water
Sodium chloride
Citric acid monohydrate
6.2 Incompatibilities
Not applicable.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
6.4. Special storage precautions
Do not store at temperatures above 25°C.
6.5 Nature and composition of immediate packaging
Aluminium/aluminium (OPA/AL/PE//Al/PE) blister or aluminum strip (polyester/Al/PE).
Available formats:

MILBMAX

See technical sheet