Target species
Cats.
Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens: Cats. (≥ 0.5 - 2 kg).
Milbemax 16 mg/40 mg film-coated tablets for cats: Cats (≥ 2 kg).
Indications for use, specifying the target species
For cats with, or at risk from mixed infections of cestodes, gastrointestinal nematodes, and/or heartworm. This veterinary medicinal product is only indicated when use against cestodes and nematodes or prevention of heartworm disease is indicated at the same time.
Cestodes
Treatment of tapeworm:
Dipylidium caninum
Taenia spp.
Echinococcus multilocularis
Gastrointestinal nematodes
Treatment of: Hookworm: Ancylostoma tubaeforme
Roundworm: Toxocara cati
Heartworm
Prevention of heartworm disease (Dirofilaria immitis) if concomitant treatment against cestodes is indicated.
Contraindications
Milbemax tablets for Small Cats and Kittens: Do not use in cats of less than 6 weeks of age and/or weighing less than 0.5 kg.
Milbemax tablets for Cat: Do not use in cats weighing less than 2 kg.
Do not use in cases of hypersensitivity to the active substances or to any of excipients.
Special warnings
The possibility that other animals in the same household can be a source of reinfection should be considered, and these should be treated as necessary with an appropriate veterinary medicinal product.
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.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each individual animal.
In the absence of risk of co-infection with nematodes or cestodes, a narrow spectrum veterinary medicinal product should be used when available.
The use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available.
Special precautions for use
Special precautions for use in animals
Ensure cats and kittens weighing between 0.5 kg and ≤2 kg receive the appropriate tablet strength (4 mg MBO/10 mg praziquantel) and the appropriate dose. See also section Amount(s) to be administered and administration route.
No studies have been performed with severely debilitated cats 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.
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.
Special precautions for the protection of the environment
See section Pharmaceutical Particulars
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 (e.g. experts or institutes of parasitology).
Adverse reactions (frequency and seriousness)
| |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Digestive tract disorders (such as Diarrhoea, Emesis) Hypersensitivity reaction Neurological disorders (such as Ataxia and Muscle tremor) Systemic disorders (such as Lethargy) |
| |
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 also the package leaflet for contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Fertility:
Can be used in breeding animals.
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.
Although not recommended, the concomitant use of the veterinary medicinal product with a spot on containing moxidectin and imidacloprid at recommended dose rates following a single application was well tolerated in one laboratory study in 10 kittens.
The safety and efficacy of the concurrent use have not been investigated in field studies. In the absence of further studies, caution should be taken in the case of concurrent use with any other macrocyclic lactone. Also, no such studies have been performed with breeding animals.
Amounts to be administered and administration route
Oral use. Underdosing could result in ineffective use and may favour resistance development.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of praziquantel per kg are given as a single dose. The veterinary medicinal product should be administered with or after some food. Doing so ensures optimum protection against heartworm disease.
Depending on the bodyweight of the cat, the practical dosing is as follows:
Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens
Weight | Tablets |
0.5 - 1 kg | 0.5 tablet |
>1 - 2 kg | 1 tablet |
Milbemax 16 mg/40 mg film-coated tablets for cats
Weight | Tablets |
2 - 4 kg | ½ tablet |
>4 - 8 kg | 1 tablet |
>8 - 12 kg | 1½ tablets |
The veterinary medicinal product can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. The duration of heartworm prevention is one month. For regular prevention of heartworm disease the use of a monosubstance is preferred.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, in addition to signs observed at the recommended dose (see section "Adverse reactions"), drooling was observed. This sign will usually disappear spontaneously within a day.
Withdrawal period(s)
Not applicable.