Milbemax Tablets for Cats and Kittens Species: Cats Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats Active ingredient: Milbemycin Oxime, Praziquantel Product:Milbemax film-coated Tablets for Cats Milbemax film-coated Tablets for Small Cats and Kittens Product index: Milbemax Tablets for Cats and Kittens Qualitative and quantitative composition One tablet contains: Active substances: Milbemax tablets for Cats: Milbemycin oxime 16 mg, Praziquantel 40 mg . Milbemax tablets for Small Cats and Kittens: Milbemycin oxime 4 mg, Praziquantel 10 mg. Excipients: Iron oxide (E172) 0.288 mg - Milbemax tablets for Cats Only. For a full list of excipients, see Pharmaceutical Particulars. Pharmaceutical form Film-coated tablets. Milbemax tablets for Cats: Oblong shaped, reddish to reddish brown, artificial beef flavoured tablet with a score on both sides. One side bears the imprint “KK”, the other side “NA”. Milbemax tablets for Small Cats and Kittens: Oblong shaped, beige to brown, artificial beef flavoured tablet with a score on both sides. One side bears the imprint “BC”, the other side “NA”. Clinical particulars Target species Cats. Indications for use, specifying the target species In cats: treatment of mixed infections by immature and adult cestodes and nematodes of the following species : - Cestodes: Dipylidium caninum Taenia spp. Echinococcus multilocularis - Nematodes: Ancylostoma tubaeforme Toxocara cati 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. Special warnings In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the cat should be taken into account. 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. Special precautions for use Special precautions for use in animals As per good veterinary practice, animals should be weighed to ensure accurate dosing. 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 (1/2 or 1 tablet) for the corresponding weight band (1/2 tablet for cats weighing 0.5 to 1 kg ; 1 tablet for cats weighing >1 to 2 kg – 1 tablet). Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific guidelines on the treatment and follow up and on the safeguard of persons have to be followed. Experts or institutes of parasitology should be consulted. No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The 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 the event 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. Adverse reactions (frequency and seriousness) In very rare occasions, especially in young cats, systemic signs (such as lethargy), neurological signs (such as ataxia and muscle tremors) and/or gastrointestinal signs (such as emesis and diarrhoea) have been observed after administration of the veterinary medicinal product. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). Use during pregnancy, lactation or lay MILBEMAX can be used in breeding cats including pregnant and lactating queens. Interaction with other medicinal products and other forms of interaction The concurrent use of MILBEMAX with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with MILBEMAX at the recommended dose. Although not recommended, the concomitant use of MILBEMAX 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 of the product with any other macrocyclic lactone. Also, no such studies have been performed with reproducing animals. Amounts to be administered and administration route Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of praziquantel per kg are given orally as a single dose. The 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 tablets for Small Cats and Kittens: Weight Tablets 0.5 - 1 kg 0.5 tablet >1 - 2 kg 1 tablet Milbemax tablets for Cats: Weight Tablets 2 - 4 kg ½ tablet >4 - 8 kg 1 tablet >8 - 12 kg 1½ tablets MILBEMAX can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. MILBEMAX has a duration of heartworm prevention of 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 "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 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 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 Available pack sizes: Box with 2 tablets in blister Box with 4 tablets in blister Box with 10 tablets in blister Box with 20 tablets in blister Box with 50 tablets in blister Box with 100 tablets in blister 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 Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. MILBEMAX should not enter water courses as this may be dangerous for fish and other aquatic organisms