Index of drugs

Rheumatoid arthritis (RA) (in combination with methotrexate): to reduce the signs and symptoms and improve physical fitness in adult patients with an active form of disease inadequately responding to treatment with antirheumatic disease-modifying drugs (DMARDs), including Methotrexate or in adult patients with severe, an active and progressive form of the disease who had not previously been treated with methotrexate or other disease-modifying drugs (DMARDs). In these groups of patients, radiological studies showed a reduction in the progression of joint damage.Crohn's disease in adults: treatment of moderate to severe active form of Crohn's disease in adult patients who did not respond to a full and appropriate corticosteroid and / or immunosuppressive regimen or treatment was poorly tolerated or contraindicated; treatment of the active form of Crohn's disease with fistulas in adult patients who have not responded to properly conducted standard treatment (including antibiotics, drainage and immunosuppressive therapy).Crohn's disease in children and adolescents: treatment of severe active form of Crohn's disease in children and adolescents aged 6 to 17 who have not responded to conventional treatment, including treatment with corticosteroids, immunomodulatory treatment and basic dietary treatment or who have had intolerance or contraindications to such treatments . The drug has been studied only in combination with standard immunosuppressive therapy.Ulcerative colitis: treatment of moderate or severe active ulcerative colitis in adult patients who have not responded adequately to standard therapy, including treatment with corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or have been tolerated or contraindicated treatment.Ulcerative colitis in children and adolescents: treatment of severe active ulcerative colitis in children and adolescents aged 6 to 17 years who have not responded adequately to standard therapy, including treatment with corticosteroids and 6-MP or AZA, or treatment was poorly tolerated or contraindicated.Ankylosing spondylitis: treatment of severe, active forms of ankylosing spondylitis in adult patients who have not responded adequately to conventional treatment.Psoriatic arthritis: treatment of active and progressive psoriatic arthritis in adults when the response to previous treatment with disease-modifying antirheumatic drugs (DMARDs) was insufficient. Infliximab should be given in combination with methotrexate alone or in patients who have been poorly tolerated or contraindicated in methotrexate therapy. In radiological studies, patients with polyarticular symmetrical forms of psoriatic arthritis have demonstrated that treatment with infliximab improves physical activity and reduces the rate of progression of peripheral joint damage.Psoriasis: treatment of moderate to severe plaque psoriasis in adult patients who have stopped responding to treatment, have contraindications or do not tolerate other general treatment regimens, including treatment with cyclosporine, methotrexate or PUVA.

1 vial contains 100 mg of infliximab. After reconstitution, 1 ml contains 10 mg of infliximab.

An immunosuppressant, an inhibitor of tumor necrosis factor alpha (TNF_α). Infliximab is a chimeric human-mouse monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of human tumor necrosis factor alpha (TNF_α) but not binding to lymphotoxin (TNF_β). It inhibits the functional activity of TNF_α in various biological testsin vitro. In vivo, infliximab rapidly forms stable complexes with human TNF_α, which is synonymous with the loss of biological activity by TNF_α. In RA, infliximab treatment reduced infiltration of inflammatory cells to inflamed joints, as well as the expression of molecules responsible for cell adhesion, chemotacticity and tissue degradation. After treatment with infliximab, there was a decrease in interleukin-6 (IL-6) and serum c-reactive protein (CRP) in serum, and increased hemoglobin in RA patients with initially reduced hemoglobin levels, compared to baseline results. In patients with psoriasis, treatment with infliximab resulted in decreased epidermal inflammation and normalization of keratinocyte differentiation in psoriasis plaques. In psoriatic arthritis, short-term treatment with infliximab reduces the number of T-cells and blood vessels in the synovium and cutaneous psoriatic lesions. Treatment with infliximab for patients with Crohn's disease was associated with a significant reduction in the usually elevated levels of the inflammatory indicator - C-reactive protein (CRP) in the serum. One-time intravenous infusion at a dose of 1, 5, 10 or 20 mg / kg infliximab caused a dose-proportional increase in C_max and AUC. Inflictimab elimination routes have not been determined. Infliximab was not detected unchanged in urine. Median of the final T_0,5 in the dose range of 3, 5 or 10 mg / kg ranges from 8 to 9.5 days. No drug accumulation was observed in the serum that would have clinical significance.

Hypersensitivity to infliximab in a history, other murine proteins or to any of the excipients. Tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections. Moderate or severe heart failure (NYHA class III / IV).

Acute infusion-related reactions, including anaphylactic shock, may develop during the infusion (within a few seconds) or within hours of the infusion; if such reactions occur, the infusion should be stopped immediately (a resuscitation kit must be available). To prevent mild and transient infusion reactions, the patient may receive, for example, antihistamines, Hydrocortisone and / or paracetamol. Antibodies against infliximab may be associated with an increase in the frequency of infusion-related reactions. A small part of the infusion-related reactions was a serious allergic reaction. There was a relationship between the development of antibodies to infliximab and the shortened duration of response to treatment. Concomitant administration of immunomodulators was associated with a reduction in the incidence of antibodies to infliximab and the incidence of infusion-related reactions. The effect of simultaneous immunomodulatory treatment was better expressed in episodically treated patients than in patients receiving maintenance treatment. Patients who discontinue immunosuppressive therapy before or during treatment with infliximab, have an increased risk of developing these antibodies. Antibodies to infliximab are not always detectable in serum samples. If severe reactions occur, symptomatic treatment should be given and no further infusions should be given. The risk of late type hypersensitivity reactions increases with prolonged intervals between consecutive administrations. Patients being treated again after a long break, must be very carefully observed because of the possibility of late type hypersensitivity symptoms. Patients must be closely monitored due to the possibility of infections, including tuberculous infections both before, during and after treatment with the preparation. Elimination of infliximab may last up to 6 months, which is why it is very important to observe patients during this period. Treatment with the preparation should be discontinued if the patient develops symptoms of serious infection or sepsis. In patients with a history of chronic infection or recurrent infections, including those undergoing immunosuppressive therapy, special care should be taken when administering the preparation. Patients should be advised to avoid exposure to factors potentially increasing the risk of infection if possible. In some patients treated with infliximab, the defense of the host against infections is reduced. TNFα suppression may mask the symptoms of infection, e.g. fever. Early diagnosis of atypical clinical symptoms of serious infections and rare, typical clinical symptoms and atypical infections has the greatest impact on reducing the time to make a diagnosis and start treatment.Patients with a new infection should be closely monitored and the overall diagnostic process should be performed. If a patient develops a serious infection or sepsis, discontinue the preparation and start the appropriate antibacterial or antifungal treatment until the infection is controlled. Before starting treatment, each patient must be examined for the presence of active or latent tuberculosis. This study should include a detailed history of tuberculosis or any possible contact with people with tuberculosis and prior and / or current immunosuppressive therapy. It should also be performed in all patients (local recommendations can be used) appropriate screening (chest x-ray, tuberculin test). It is recommended that these tests be recorded in the Patient Special Warning Card. It should be remembered that a false negative tuberculin test may occur, especially in severely ill patients or immunocompromised patients. In case of diagnosing active tuberculosis, treatment with the preparation can not be started. If there is a suspicion of latent tuberculosis, it should be consulted with a doctor who has experience in the treatment of tuberculosis. In all situations described below, the benefits and risks of treatment with the product should be carefully considered. If latent tuberculosis is diagnosed, treatment with latent tuberculosis against local tuberculosis must be initiated in accordance with local recommendations before treatment begins. In patients with several risk factors for tuberculosis or a serious risk factor for tuberculosis and a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before initiation of treatment with the preparation. The use of anti-tuberculosis therapy before starting prepratematic treatment should also be considered in patients with history of latent or active tuberculosis in the past when it can not be confirmed whether they have received appropriate treatment. In patients treated with the preparation, an invasive fungal infection should be suspected, such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis, in case of severe systemic disease. You should also consult a physician specializing in the diagnosis and treatment of invasive fungal infections at an early stage while testing these patients. Invasive fungal infections may occur in a disseminated, rather than localized, disease, and in some patients with active infection, tests for antigens and antibodies may be negative. Appropriate antifungal empiric therapy should be implemented while conducting diagnostic tests, taking into account both the risk of severe fungal infection and the risk of antifungal treatment. In patients who have lived or traveled in endemic areas with invasive fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis, the benefit-risk ratio of the preparation should be carefully evaluated prior to treatment initiation. In patients with Crohn's disease with fistulas with acute purulent fistulas, treatment with the preparation must not be started until the source of a possible infection, in particular an abscess, is ruled out. Patients receiving a TNF inhibitor, including infliximab who were long-term carriers of HBV, had a recurrence of hepatitis B (deaths). Before starting treatment with infliximab, tests for HBV infection should be performed. In patients with positive HBV test results, it is recommended to consult a physician experienced in the treatment of hepatitis B. Hepatitis carriers who require treatment with the preparation should be closely monitored to detect the symptoms of active HBV infection during treatment with the preparation and several months after the therapy. Appropriate data regarding the treatment of patients who carry HBV, antiviral drugs in combination with treatment with TNF inhibitors to suppress HBV recurrence are not available. In patients who have had hepatitis B recurrence, discontinue therapy and initiate effective antiviral therapy and appropriate supportive care. Patients with signs and symptoms of liver dysfunction should be examined for liver damage.If jaundice and / or ALT activity is ≥5 times greater than ULN, discontinue the preparation and perform accurate examinations of the disorders. Combination of the preparation with anakinra and abatacept is not recommended. Infliximab is not recommended at the same time as biological medicines used to treat the same conditions that are treated with infliximab. When changing one biological drug to another biological medicine, care should be taken and patients should be monitored further, due to the increased risk of side effects, including infection. Due to the risk of developing clinical infections (including spreading infections), it is not recommended to use vaccines containing live microorganisms together with the preparation. Administration of other infectious agents with therapeutic use, such as attenuated bacteria (eg BCG vaccine administered intravesically as part of anti-cancer immunotherapy), may cause the development of clinical infections, including disseminated infections. It is not recommended to administer infectious agents with therapeutic use simultaneously with the preparation. If the patient being treated with the preparation develops symptoms suggestive of a lupus-like syndrome and double-stranded DNA antibodies are found, treatment with the preparation should be discontinued. Due to the risk of demyelinating diseases o.u.n. It is recommended to carefully consider the benefits and risks of anti-TNF administration in patients with pre-existing or recent symptoms of demyelinating disorders prior to initiation of treatment with the preparation; if these disorders develop, cessation of treatment should be considered. The risk of developing lymphomas or other malignancies in patients treated with TNF-blocking agents can not be ruled out. In patients with a history of malignancy or considering continuing treatment in patients who have a malignancy, caution should be used when considering treatment with agents that suppress TNF activity. Patients with an increased risk of malignant tumors due to heavy smoking should be cautious when considering treatment. Caution should also be exercised in patients with psoriasis who have received extensive immunosuppressive therapy or long-term PUVA therapy. The risk of developing liver and spleen T-cell lymphoma in patients treated with the preparation can not be ruled out. All cases of this disease during treatment with infliximab have occurred in patients with Crohn's disease or ulcerative colitis and for the most part were in adolescents and young adult males; all patients received AZA or 6-MP together with infliximab or immediately before its adoption - the potential risk of combination therapy of AZA or 6-MP with infliximab should be considered. Due to the risk of melanoma and carcinoma from Merkel cells, it is recommended to perform periodic skin examinations, especially in patients who have risk factors for developing skin cancer. All patients with ulcerative colitis who have an increased risk of dysplasia or colorectal cancer (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis) and patients who have previously had dysplasia or colon cancer should be treated before starting treatment and duration of the disease should be examined at regular intervals for dysplasia (the study should include a colonoscopy and biopsies in accordance with local recommendations). Based on currently available data, it is not known whether infliximab influences the risk of developing dysplasia and colorectal cancer. Since the likelihood of an increased risk of developing cancer in patients with newly diagnosed dysplasia treated with infliximab has not been determined, the risks and benefits for each patient must be carefully assessed and cessation of treatment should be considered. The preparation should be administered with caution to patients with mild heart failure (NYHA class I / II). Patients should be monitored very carefully, and if new symptoms of heart failure or worsening of existing symptoms occur, the treatment should not be continued. All patients should be instructed to seek medical advice if they show signs or symptoms that may indicate a disorder (eg persistent fever, bruising, bleeding, paleness); in patients with confirmed significant hematological disorders, discontinuation of treatment with the preparation should be considered.There is limited experience in the safety of infliximab in patients after surgery, including arthroplasty. When planning surgery, the long half-life of infliximab should be taken into account. Patients requiring surgery during treatment with infliximab must be closely monitored for possible infections and appropriate measures should be taken. In the case of Crohn's disease, a lack of response to treatment may indicate the presence of a fixed intestinal stenosis that may require surgical treatment. Available data suggest that infliximab does not worsen or cause bowel obstruction. In patients aged 65 years and older, the incidence of serious infections was higher - special care should be taken in this group of patients because of the risk of infection. Infections were reported more often in children and adolescents compared to adult patients. It is recommended that children and adolescents receive, as far as possible, all vaccines that should be taken at a given age according to current guidelines before starting treatment. The safety and efficacy of the preparation in children with Crohn's disease or ulcerative colitis of under 6 years of age have not been established. The safety and efficacy of the preparation in children and adolescents under 18 years of age in the treatment of psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile rheumatoid arthritis have not been established.

Limited data on the use of infliximab during pregnancy does not indicate an unexpected effect on the outcome of pregnancy. Due to inhibition of TNF_α, infliximab administered during pregnancy may impair normal immune response in newborns. The available clinical experience is too limited to exclude the risk, and therefore the use is not recommended during pregnancy. Infliximab crosses the placenta and has been detected up to 6 months in the serum of infants born to women treated with infliximab during pregnancy. As a consequence, these infants may be at greater risk of infection. It is not recommended to give vaccines containing live microbes to infants if less than 6 months have passed since the last infusion of infliximab during pregnancy. Women of childbearing potential must use appropriate contraception during treatment and for at least 6 months after the last treatment with the preparation. Women must not breastfeed for at least 6 months after treatment with the preparation.

Very common: viral infections (eg influenza, virus infectionherpes), headache, upper respiratory tract infections, sinusitis, abdominal pain, nausea, infusion-related reactions, pain. Common: bacterial infections (eg sepsis, cellulitis, abscess), neutropenia, leukopenia, anemia, generalized enlargement of the lymph nodes, allergic reactions from the respiratory system, depression, insomnia, diarrheal and extralorative vertigo, hypoesthesia, paresthesia, inflammation conjunctivitis, tachycardia, palpitations, hypotension, hypertension, bruising, flushing, facial flushing, lower respiratory tract infections (eg bronchitis, pneumonia), dyspnoea, epistaxis, gastrointestinal haemorrhage, diarrhea, dyspepsia, reflux gastro-oesophageal, constipation, liver dysfunction, increased transaminases, new onset or exacerbation of psoriasis, including pustular psoriasis (primarily hand and feet), urticaria, rash, pruritus, excessive sweating, dry skin, skin mycosis, eczema, alopecia, joint pain, muscle pain, back pain, urinary tract infection, chest pain, fatigue, fever, injection site reactions, chills, swelling. Uncommon: tuberculosis, fungal infections (eg candidiasis), thrombocytopenia, lymphopenia, lymphocytosis, anaphylactic reactions, lupus-like syndrome, serum sickness, serum sickness-like symptoms, amnesia, agitation, confusion, drowsiness, nervousness, epileptic seizure, neuropathy, keratitis periorbital edema, barley, heart failure (new onset or worsening), arrhythmia, syncope, bradycardia, peripheral ischemia, thrombophlebitis, hematomas, pulmonary edema, bronchospasm, pleurisy,pleural effusion, intestinal perforation, intestinal obstruction, diverticulitis, pancreatitis, inflammation of the lips, hepatitis, hepatocellular damage, cholecystitis, bullous rash, onychomycosis, seborrhea, rosacea, dermal papilla, hyperkeratosis, abnormal pigmentation of the skin, pyelonephritis nephritis, vaginitis, impaired healing processes, positive autoantibodies. Rarely: meningitis, opportunistic infections (such as invasive fungal infections - pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis, bacterial infections - atypical mycobacteria, listeriosis, salmonellosis, viral infections - cytomegalovirus), parasitic infections, reactivation of hepatitis B virus infection, lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukemia, melanoma, agranulocytosis, thrombocytopenic purpura, pancytopenia, hemolytic anemia, idiopathic thrombocytopenic purpura, anaphylactic shock, vasculitis, sarcoid-like reaction, apathy, transverse myelitis , CNS demyelinating diseases (a disease similar to multiple sclerosis and optic neuritis), demyelinating diseases of the peripheral nervous system (such as Guillain-Barre syndrome, chronic demyelinating inflammatory polyneuropathy and multifocal motor neuropathy), internal inflammation of the eye, cyanosis, pericardial effusion, circulatory insufficiency, ecchymosis, vasoconstriction, interstitial lung disease (including rapidly progressing disease, pulmonary fibrosis and pneumonia), autoimmune hepatitis, jaundice, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, irritability, granulomatous lesions, abnormal complement system. Not known: T-cell lymphoma of the liver and spleen (especially in adolescents and young adult patients with Crohn's disease and ulcerative colitis), Merkel cell carcinoma, transient loss of vision during the infusion or within 2 hours after infusion, muscle ischemia cardiac infarction / myocardial infarction occurring during infusion or within 2 hours after infusion, hepatic failure, worsening of symptoms of dermatomyositis. In clinical trials, late type hypersensitivity reactions have been observed uncommonly. They occurred when the interruption in the use of infliximab was shorter than 1 year. In psoriasis, late type hypersensitivity reactions occurred early in treatment. Signs and symptoms included muscle pain and / or joint pain, fever and / or rash. Some patients had pruritus, swelling of the face, hands or lips, difficulty swallowing, urticaria, sore throat and headaches. The risk of late type hypersensitivity reactions increases with prolonged intervals between consecutive administrations of infliximab. Patients with antibodies to infliximab were more likely to develop infusion-related reactions than those who did not have antibodies (about 2-3 times). The simultaneous use of immunosuppressive therapy seems to reduce the frequency of infusion-related reactions. Following the observation of patients in clinical trials, approximately half of patients treated with infliximab who did not have antinuclear antibodies (ANA) detected at the beginning of treatment were found to be present during treatment. Antibodies against double-stranded DNA (dsDNA) were found in approximately 17% of patients treated with infliximab. 57% of patients treated with infliximab remained positive anti-ds at the time of the last determination. However, reports of the occurrence of lupus and lupus-like syndrome are not frequent. In children and adolescents with Crohn's disease, the following adverse events were more frequent than in adults: anemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), facial flushing (8.7%) %), viral infection (7.8%), neutropenia (6.8%), bone fracture (6.8%), bacterial infection (5.8%) and respiratory allergic reaction (5.8%). 17.5% of patients had one or more infusion-related reactions. In 2.9% of children examined, antibodies against infliximab were found. 56.3% of the patients who were randomized were found to be infected (more frequently in patients receiving infusions at an interval of 8 weeks than in those receiving infusions 12 weeks apart).The most frequently reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess. In children and adolescents with ulcerative colitis, the side effects were generally the same as in adults. The most common adverse reactions were upper respiratory tract infections, pharyngitis, abdominal pain, fever and headache. The most frequent adverse event was exacerbation of ulcerative colitis, with the incidence of this adverse event being higher in the treatment group every 12 weeks than in the group receiving treatment every 8 weeks.

Intravenously. Treatment should be initiated and maintained by a qualified physician experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis, psoriatic arthritis or psoriasis. Infusions should be performed by experienced medical personnel trained to detect any infusion problems. During treatment with the preparation, doses of concomitant medications, eg corticosteroids or immunosuppressants, should be optimized.Adults (≥ 18 years old). Rheumatoid arthritis (RA). 3 mg / kg administered by intravenous infusion. Subsequent infusions at a dose of 3 mg / kg they are given 2 and 6 weeks after the first infusion and then every 8 weeks. Treatment with the preparation requires the simultaneous administration of methotrexate. Clinical response is achieved within 12 weeks of treatment. If the patient's response is not adequate or the response disappears after this period, a gradual dose increase of approximately 1.5 mg / kg should be considered, up to a maximum dose of 7.5 mg / kg every 8 weeks. Alternatively, a dose of 3 mg may be considered. kg, every 4 weeks. If an adequate response is obtained in patients, the treatment should be continued with the selected dose or with the chosen frequency of administration. Continuation of treatment should be considered carefully in patients who have not had any therapeutic benefit during the first 12 weeks of treatment or after adjusting the dose.Moderate to severe, active form of Crohn's disease. 5 mg / kg administered intravenously, followed by an additional 5 mg / kg 2 weeks after the first administration of the drug. If the patient does not respond to treatment after 2 doses, no additional treatment with infliximab should be used. The available data do not justify continuing treatment with infliximab for patients who did not respond within 6 weeks to the first infusion. For patients responding to treatment, the following alternative treatments are recommended: maintenance: subsequent infusions of 5 mg / kg. after 6 weeks after the first dose, followed by infusion every 8 weeks or re-administration: infusion at a dose of 5 mg / kg if the disease symptoms recur. Despite the lack of comparative reports, there are limited data showing that patients who initially responded to treatment at a dose of 5 mg / kg but who subsequently lost their response can be restored by increasing the dose. Careful consideration should be given to continuing treatment in patients who have not received any therapeutic benefit after adjusting the dose.The active form of Crohn's disease with fistulas. 5 mg / kg administered in intravenous infusion, and then 2 and 6 weeks after the first administration should be given additional infusions of 5 mg / kg. If the patient does not respond to treatment after 3 doses, infliximab should not be continued. For patients responding to treatment, the following alternative treatments are recommended: maintenance: subsequent infusions of 5 mg / kg. every 8 weeks or re-administration: infusion at a dose of 5 mg / kg if the signs or symptoms of the disease recur, followed by infusions of 5 mg / kg. every 8 weeks. Despite the lack of comparative reports, there are limited data showing that patients who initially responded to treatment at a dose of 5 mg / kg but who subsequently lost their response can be restored by increasing the dose the drug. Careful consideration should be given to continuing treatment in patients who have not received any therapeutic benefit after adjusting the dose. Experience with re-administration in case of relapse of signs or symptoms of Crohn's disease is limited. There are no comparative results on the benefit-risk balance with other alternative methods of continuous treatment.Ulcerative colitis. 5 mg / kg administered by intravenous infusion. Then, 2 and 6 weeks after the first administration, additional infusions should be given at a dose of 5 mg / kg and then every 8 weeks. Available data suggest that clinical response is achieved within 14 weeks of treatment, i.e. three doses. The continuation of treatment should be carefully considered in patients who have not had any therapeutic benefit during this period.Ankylosing spondylitis. 5 mg / kg administered by intravenous infusion. Then, 2 and 6 weeks after the first administration, additional infusions should be given at a dose of 5 mg / kg, and then every 6 to 8 weeks. If the patient does not respond to treatment for 6 weeks (ie after administration of 2 doses), do not give further doses of infliximab.Psoriatic arthritis. 5 mg / kg administered by intravenous infusion. Then, 2 and 6 weeks after the first administration, additional infusions should be given at a dose of 5 mg / kg, and then every 8 weeks.Psoriasis. 5 mg / kg administered by intravenous infusion. Then, 2 and 6 weeks after the first administration, additional infusions should be given at a dose of 5 mg / kg, and then every 8 weeks. If the patient does not respond to treatment after 14 weeks (ie after administering 4 doses), administer Next doses of infliximab.Re-administration in Crohn's disease and rheumatoid arthritis (RA). If the signs and symptoms of the disease recur, infliximab can be given again within 16 weeks of the last infusion. In clinical trials, late type hypersensitivity reactions have been observed uncommonly. They occurred when the interruption in the use of infliximab was shorter than 1 year. The efficacy and safety of re-infliximab after a break longer than 16 weeks has not been evaluated. This applies to both patients with Crohn's disease and rheumatoid arthritis.Re-administration in ulcerative colitis and psoriatic arthritis. The safety and efficacy of re-administration were not established differently than every 8 weeks.Re-administration in ankylosing spondylitis. The safety and efficacy of re-administration were not established differently than every 6 to 8 weeks.Re-administration in psoriasis. Limited experience with repeated administration of one dose of infliximab after 20 weeks in psoriasis. the interval indicates a reduction in efficacy and an increase in cases of mild or moderate infusion-related reactions compared to the first course of treatment. The limited experience of re-treatment after the next rejection of the disease by means of reinduction patterns suggests a higher rate of infusion reactions, including severe infusion reactions, compared to 8 weeks. maintenance treatment.Re-administration of the drug in individual indications. If the maintenance treatment is discontinued and the patient needs to be re-enrolled, the reinduction pattern is not recommended. In this situation, the preparation should be re-administered in a single dose followed by a maintenance dose in accordance with the above recommendations. No dose adjustment is required for elderly patients (≥ 65 years). Due to the lack of tests, no dose recommendations can be given to patients with impaired renal function and / or liver function.Children and youth. Crohn's disease (6 to 17 years). 5 mg / kg administered by intravenous infusion, followed by infusions of 5 mg / kg 2 and 6 weeks after the first infusion and then every 8 weeks. Available data do not justify continuing treatment with infliximab for children and adolescents who have not responded to the first 10 weeks of treatment. Some patients may require shorter intervals between individual doses to maintain clinical benefit, while others may have to take longer breaks. In patients who have been shortened to less than 8 weeks between dosages, the risk of side effects may be greater. In the case of people who have not shown any signs of additional therapeutic benefits after changing the interval between doses, the possibility of continuing the therapy according to the schedule with a shortened interval should be carefully considered. There are no dose recommendations for children under the age of 6 years.Ulcerative colitis (6 to 17 years). 5 mg / kg administered by intravenous infusion, followed by infusions of 5 mg / kg 2 and 6 weeks after the first infusion and then every 8 weeks. Available data do not justify continuing treatment with infliximab in children and adolescents who have not responded during the first 8 weeks of treatment. There are no dose recommendations for children under the age of 6 years.There are no dose recommendations for children and adolescents under 18 years of age for the treatment of psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis. The preparation should be administered as an intravenous infusion over 2 hours. All patients given the product should be monitored for at least 1-2 hours after the infusion to notice the acute reactions associated with the infusion of the drug. A resuscitation kit must be available, such as adrenaline, antihistamines, corticosteroids and artificial respiration equipment. Patients may receive, for example, an antihistamine, hydrocortisone and / or paracetamol; the rate of infusion can also be reduced to reduce the risk of infusion-related reactions, especially in cases where infusion-related reactions have occurred in the past. In carefully selected adult patients who tolerated at least 3 initial 2-h infusions (induction phase) and receive maintenance treatment, the administration of subsequent infusions may be considered in not less than 1 hour. If a patient develops a shorter infusion, an infusion reaction occurs, and treatment is to be continued, a slower rate of infusion may be considered. No studies on shorter infusion times at doses ≥6 mg / kg have been performed.