detailed description Description: White or off-white, oblong, film-coated tablets with a score line. Composition: 0.5 g tablet contains active substance (mg): Oclacitinib (oclacitinib maleate) – 18.0. Excipients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate. Apokvel tablets for dogs are available in three doses: 100 mg tablet (contains oclacitinib (oclacitinib maleate) – 3.6 mg); 150 mg tablet (contains oclacitinib (oclacitinib maleate) – 5.4 mg); 450 mg tablet (contains oclacitinib (oclacitinib maleate) – 16 mg). Pharmacological properties: Oclacitinib is a Janus-kinase inhibitor (ЈАК involved in intracellular signal transduction from cytokine receptors). It inhibits the function of various cytokines depending on the activity of JAK1 or ЈАК3 enzymes. The target cytokines for oclacitinib are pro-inflammatory cytokines and those that play a role in allergic reactions or itch. However, oclacitinib may also affect other cytokines (for example, those involved in immune responses or hemocytopoiesis) with the potential for adverse effects. After oral administration in dogs, oclacitinib maleate is rapidly and well absorbed, reaching peak plasma levels in less than one hour. The absolute bioavailability of oclacitinib maleate reaches 89%. Food does not affect the rate and extent of absorption of oclacitinib. It is excreted from the body unchanged, mainly with urine, the half-life is 3-4 hours. No accumulation of the drug was observed in dogs treated with oclacitinib for 6 months. Method of use and dosage: treatment of dogs suffering from allergic dermatitis (itching control), as well as with clinical manifestations of atopic dermatitis. Orally with an initial dose of 0.4-0.6 mg oclacitinib per 1 kg of animal weight twice a day for 14 days. For maintenance therapy, the same dose (0.4-0.6 mg oclacitinib per 1 kg of body weight) is prescribed once a day. The need for long-term maintenance therapy should be based on an individual assessment of benefits and risks. The drug is taken with or without food. Tablets are divided by a score line in the middle of the tablet. Doses of Apokvel according to dog's body weight and dosage are given in the table below: Body weight of the dog, kg Apoquel single dose – number of tablets per dose – oclacitinib, mg/tablet below target above target3.6 mg5.6 mg16 mg3.04.41/2––4.55.9–1/2–6.08.91––9.013, 4–1–13,519.9––1/220,026.9–2–27,039.9––140,054.9––1 ½55,080.0––2 Side effects The table shows the side effects that were detected during the clinical trials on the 16th day of using Apoquel and placebo: Adverse events observed after day 16 of atopic dermatitis treatment Adverse events observed after day 7 of atopic dermatitis treatment (n=152) Placebo (n=147) Apokvel (n=216) Placebo (n=220) Diarrhea4.6%3.4%2.3%0.9%Vomiting3.9%4.1%2.3%1.8%Anorexia2.6%0%1.4%0%New skin or subcutaneous edema2.6%2.7%1.0%0% Apathy2.0%1.4%1.8%1.4%Polydipsia0.7%1.4%1.4%0% Contraindication: Do not use in case of hypersensitivity to the active substance or any of the fillers in the composition of the drug. Do not use in dogs under 12 months of age or weighing less than 3 kg. Do not use in dogs with signs of immunosuppression, such as hyperadrenocorticism, or signs of progressive malignant neoplasia, as the effect of the active substance in such cases has not been studied. Warning: Oclacitinib modulates the immune system and may increase susceptibility to infection. Before starting the treatment of allergic dermatitis with the drug Apoquel, it is necessary to investigate and treat other possible causes of the disease (for example, flea dermatitis, contact dermatitis, or hypersensitivity to food, etc.). In addition, investigation and treatment of complicating factors such as bacterial, fungal or parasitic infections/infestations (eg fleas or scabies) is recommended in the treatment of allergic dermatitis and atopic dermatitis. When a dog receives Apoquel for a long time, it is necessary to monitor the condition of the body by controlling the norms of blood parameters (general and biochemical analysis of blood). Use during pregnancy, lactation and influence on fertility: During pregnancy and lactation, the safety of use of Apokvel in cattle, as well as in sows, has not been studied, therefore its use in the above groups of animals is not recommended. Storage conditions: in a dry, dark place out of the reach of children at a temperature between 15°C and 25°C. Shelf life: 3 years. Release form: white plastic bottle