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Date: Thursday, December 12, 2024 11:03

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 5.81
Milbemax Tablets for Cats and Kittens
 
Species: Cats
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats
Active ingredient: Milbemycin Oxime, Praziquantel
Product:Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens
Milbemax 16 mg/40 mg film-coated tablets for cats
Product index: Milbemax Tablets for Cats and Kittens
Incorporating:Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens
Milbemax 16 mg/40 mg film-coated tablets for cats
Qualitative and quantitative composition
One tablet contains:
Active substances:
Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens: Milbemycin oxime 4 mg, Praziquantel 10 mg
Milbemax 16 mg/40 mg film-coated tablets for cats: Milbemycin oxime 16 mg, Praziquantel 40 mg
Excipients:
For a full list of excipients, see Pharmaceutical Particulars.
Pharmaceutical form
Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens: Oblong shaped, beige to brown, artificial beef flavoured film-coated tablet with a score on both sides. One side bears the imprint “BC”, the other side “NA”.
Milbemax 16 mg/40 mg film-coated tablets for cats: Oblong shaped, reddish to reddish brown, artificial beef flavoured film-coated tablet with a score on both sides. One side bears the imprint “KK”, the other side “NA”
Clinical particulars
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.
Pharmacological particulars
Pharmacotherapeutic group: Antiparasitic products, insecticides and repellants - endectocides
ATCvet Code: QP54AB51 (milbemycin oxime, combinations)
Pharmacodynamic properties
Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis.
The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite.
Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.
Pharmacokinetic particulars
In the cat, praziquantel reaches peak plasma concentrations within an hour after oral administration.
The half life of elimination is around 3 hours.
In the dog, there is rapid hepatic biotransformation, prinicipally to monohydroxylated derivatives.
The principal route of elimination in the dog is renal.
After oral administration in the cat, milbemycin oxime reaches peak plasma concentrations within 2 hours. The half life of elimination is around 13 hours (± 9 hours).
In the rat, metabolism appears to be complete although slow, since unchanged milbemycin oxime has not been found in urine or feces. Main metabolites in the rat are monohydroxylated derivatives, attributable to hepatic biotransformation. In addition to relatively high liver concentrations, there is some concentration in fat, reflecting its lipophilicity.
Pharmaceutical particulars
List of excipients
Core:
Cellulose, microcristalline
Croscarmellose sodium
Povidone
Lactose monohydrate
Silica, colloidal anhydrous
Magnesium stearate
Coat:
Hypromellose
Macrogol
Talc
Iron oxide red (Milbemax Tablets for Cats only)
Artificial beef flavour
Major incompatibilities
Not applicable.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life after first opening of the immediate packaging: 6 months (half tablet)
Special precautions for storage
Do not store above 25°C.
Keep blister in the outer carton to protect from light.
Nature and composition of immediate packaging
PVC/PE/PVdC/aluminium blister in an outer cardboard box
Cardboard box with 1 blister of 2 or 4 film-coated tablets.
Cardboard box with 1, 2, 5 or 10 blisters of 10 film-coated tablets. Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
The veterinary medicinal product should not enter water courses as this may be dangerous for fish and other aquatic organisms
Marketing Authorisation Holder (if different from distributor)
NA
Marketing Authorisation Number
Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens UK (Great Britain): Vm 00879/5025
Milbemax 16 mg/40 mg film-coated tablets for cats UK (Great Britain): Vm 00879/5026
Milbemax 4 mg/10 mg film-coated tablets for small cats and kittens UK (Northern Ireland): Vm 00879/3021
Milbemax 16 mg/40 mg film-coated tablets for cats UK (Northern Ireland): Vm 00879/3022
Significant changes
Date of the first authorisation or date of renewal
17 April 2003
Date of revision of the text
April 2024
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:MILBEMAX film-coated tablets for Cats 100 tablets
GTIN:05037694165291
GTIN description:MILBEMAX film-coated tablets for Cats 50 tablets
GTIN:05037694024031
GTIN description:MILBEMAX film-coated tablets for Cats 4 tablets
GTIN:05037694024048
GTIN description:MILBEMAX film-coated tablets for Small Cats and Kittens 50 tablets
GTIN:05037694024017
GTIN description:MILBEMAX film-coated tablets for Small Cats and Kittens 4 tablets
GTIN:05037694024024