Milteforan is the new oral treatment for leishmaniasis that respects the kidneys.
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Composition: Miltefosine 20 mg/ml. Hidroxipropilcelulosa.Propilenglicol. Purified water.
Target species: Dogs.
Indications: Control of canine leishmaniasis. Immediately after the start of treatment the clinical signs of the disease begin to decrease markedly, and two weeks later are significantly reduced. The continued improvement in the signs at least 4 weeks after completing treatment.
Contraindications: Do not use in case of hypersensitivity to the active substance or to any of the excipients. It has not been demonstrated safety of the product during pregnancy, lactation or breeding animals. Do not use the drug during pregnancy, lactation or breeding animals. Laboratory studies in rats and rabbits have shown teratogenic effects (rats), toxic toxic to the fetus and the mother.
Special warnings species each target: Underdosing should be avoided to reduce the risk of resistance development that may ultimately lead to ineffective therapies.
Special precautions for use in animals: Before and during treatment must accurately determine the weight of the dog. It is recommended to administer the product in the animal feed to reduce the gastrointestinal side effects. In case of occurrence of side effects (like eg. Vomiting, diarrhea) immediately inform the veterinarian. Therapy can be combined with an antiemetic agent in order to reduce the risk of these adverse effects.
In dogs with severe hepatic and cardiac veterinarian should evaluate the benefit / risk of the product. If you suspect your dog is pregnant before using this medicine, consult your veterinarian.
Special precautions to be taken by the person administering the medicinal product to animals: In case of accidental ingestion or spillage onto skin, seek medical advice immediately and show the container or the label. People with known hypersensitivity to miltefosine should avoid contact with the veterinary medicinal product or any type of animal excretion (fecal elements, urine, saliva, etc.) and should administer the product with caution. The product can cause skin irritations and eye and awareness: Failure to wear gloves and goggles when handling. In case of contact with eyes or skin rinse immediately with plenty of water and consult a doctor. The product should not be used by pregnant women, women intending to become pregnant and those who do not know they are pregnant. Do not allow recently treated dogs lick people immediately after taking the medication. Do not eat or drink or smoke when the product is administered. Do not shake the vial to avoid foaming.
Adverse reactions (frequency and seriousness): In clinical studies, were very common mild and transient episodes of vomiting (16% of treated dogs), and common diarrhea episodes (12% of treated dogs). These effects occurred on average within 5 to 7 days after starting treatment and for a period of 1-2 days in most cases, but can be extended to more than 7 days in some animals. They did not affect the efficacy of the product and therefore it was not necessary to discontinue treatment or change the dosage regimen. These effects were reversible at the end of treatment and all dogs recovered without specific therapy.
Dosage and administration: The product should be administered at 2 mg / kg body weight, poured over the feed, the whole food or component of food, once a day for 28 days orally (corresponding to 1 ml of oral solution per 10 kg bodyweight per day). Because the parasite is also located in deep tissues (bone marrow, lymph nodes, spleen, liver), it is essential to respect the duration of treatment (28 days) to ensure effectiveness. Determine the exact weight of the dog before and during treatment.
Overdose: A study of overdose (up to twice the recommended dose for 28 days) showed undesirable effects such as uncontrolled vomiting.
Pharmacodynamic Properties: Canine leishmaniasis is a deadly disease caused by Leishmania infantum transmitted by the bite of an insect (Phlebotomus spp.) Miltefosine has a strong direct antileishmanica activity in vitro and in animal models against L. donovani (promastigotes and amastigotes) and L. infantum. Miltefosine is believed that inhibits penetration of Leishmania species in macrophages through interaction with the glycosylphosphatidylinositol anchors and glycosomes (essential for intracellular survival of Leishmania) and interfering with signal transduction in membrane of Leishmania by inhibiting phospholipase C.
Pharmacokinetic data: Following oral administration to dogs, miltefosine is absorbed almost completely, with an absolute bioavailability of 94%. After administration of a therapeutic dose of 2 mg / kg / day, the maximum plasma concentration (Cmax) is about 32582 ng.ml -1 in dogs that have been fed. In rats, repeated oral administration generate drug levels are decreasing in the following order: kidneys, skin, adrenal gland, spleen, small intestine, adipose tissue, stomach, liver, lung, serum, colon, brain, heart and muscle: the most of these bodies location serves amastigote forms. In the mouse, miltefosine equivalently distributed between plasma and erythrocytes. 24 h after intravenous injection of miltefosine in female mice, 63% of the extractable liver radioactivity was recovered as unchanged compound. Miltefosine is characterized by a slow elimination half-life (t ½ 160 h) and a low plasma clearance (Cl = 0.04 ml / kg / min) after repeated administration of the therapeutic dose Milteforan 2 mg / kg / day for 28 days in fed dogs, the maximum plasma concentration (Cmax) was close to 32582 ± 4030 ng.ml ng.ml-1-1 with a mean Tmax of 5.0 ± 2.0 h and AUC0-t of 649617. 94478 ng.h.ml-1 after the last administration. The elimination half-life obtained after the last administration is a long t ½ = 153 ± 13.7h. Accordingly, repeated administrations of Milteforan for 28 days in an accumulation by a factor of 7.65 1.99. Miltefosine is eliminated primarily via faeces and about 10% of the administered dose is excreted unmetabolized in feces. The elimination of miltefosine in the urine is negligible.
List of excipients
Hydroxypropylcellulose, propylene glycol, purified water.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging medicine: 1 month.
Special precautions for storage: Not required
Nature and composition of immediate packaging
Unbreakable polyethylene terephthalate bottles 30 ml, 60 ml and 90 ml, sealed with a rubber stopper and aluminum cap sealed. Carton bottle includes 1 dispenser cap 1 measuring syringe, gloves. Not all pack sizes may be marketed.
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