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Ilamod tablets (adesin)

Active rheumatoid arthritis. More role
App download minus 10 yuan
Common name:
Eilamod tablets
Product No.:
Approval No.:
Gyzz h20110084 (inquired by the State Drug Administration)
Jianke price:
Product specification:
25mg * 28 tablets 25mg*14s
Xiansheng Pharmaceutical Co., Ltd
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Product name Ilamod tablets (adesin)
Main raw materials The active ingredient of this product is: eilamod.
Main role Active rheumatoid arthritis.
Product specification 25mg*14s
Usage and dosage Oral. Take 25mg (1 tablet) once after meals, twice a day, once in the morning and once in the evening.
manufacturing enterprise Xiansheng Pharmaceutical Co., Ltd
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[drug name] Ilamod tablets (adesin)

[common name] Eilamod tablets

[specification and model] 25mg*14s

[manufacturer] Xiansheng Pharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20110084

[validity period] 24 months

[functional indications] Active rheumatoid arthritis.

[usage and dosage] Oral. Take 25mg (1 tablet) once after meals, twice a day, once in the morning and once in the evening.

[adverse reactions] 1. In phase II and III clinical trials in China, 518 patients with active rheumatoid arthritis used this product. In phase II clinical trial, 192 patients with active rheumatoid arthritis used this product. In phase II clinical trials: Common adverse drug reactions (> 1 / 100, < 1 / 10) mainly include epigastric discomfort, elevated aminotransferase, nausea, anorexia, rash or skin pruritus, headache, dizziness, leucopenia, tinnitus or hearing loss, fatigue, abdominal distension, lower limb edema, palpitation, decreased hemoglobin, insomnia, hyperhidrosis, vomiting, chest tightness, elevated platelet, decreased platelet, abnormal ECG Chills, sleepiness, poor spirit, swollen hands, menstrual disorders, gum bleeding, facial edema. In phase III clinical trial, 326 patients with active rheumatoid arthritis used this product. In phase III clinical trials: The most common adverse drug reactions (> 1 / 10) were the increase of aminotransferase; Common adverse drug reactions (> 1 / 100, < 1 / 10) mainly include leucopenia, stomach discomfort, anorexia, rash, upper abdominal discomfort, nausea, abdominal distension, stomach pain, thrombocytopenia, acid reflux, abdominal pain, stomach distention, blurred vision, skin pruritus, duodenitis, gastritis, fecal occult blood, hair loss, insomnia, abnormal ECG, menstrual disorders and decreased hemoglobin; Rare adverse drug reactions (> 1 / 1000, < 1 / 100) mainly include diarrhea, dyspepsia, Qi, gastric ulcer, reflux esophagitis, duodenal ulcer, antral bleeding, vomiting, fever, cough, dry mouth, oral ulcer, facial edema, skin edema, fatigue, chest tightness, chest pain, positive urinary protein, elevated total bilirubin, influenza like symptoms, upper respiratory tract infection Pox like gastritis. Most of the above adverse reactions were relieved or disappeared after drug withdrawal. 2. According to the literature, 376 cases of rheumatoid arthritis were carried out in 81 medical institutions in Japan for 28 weeks In a randomized, double-blind, parallel controlled clinical trial in which patients with rheumatoid arthritis participated, the efficacy and safety of ilamod tablets, placebo and sulfasalazine in the treatment of rheumatoid arthritis were investigated (dosage: 25 mg / day for ilamod tablets for the first 4 weeks, 50 mg / day for later; 1000 mg / day for sulfasalazine). The common adverse drug reactions (> 1 / 10) in this test were mainly the increase of aminotransferase; The common adverse drug reactions (> 1 / 100, < 1 / 10) were epigastric pain, stomatitis and skin diseases; The rare adverse drug reactions (> 1 / 1000, < 1 / 100) were mainly melena, interstitial pneumonia, fever and gastric ulcer. According to the literature, in a 52 week single group, long-term drug safety clinical trial carried out in 90 medical institutions in Japan, 394 patients with rheumatoid arthritis were treated with ilamod. During the first four weeks, they took orally 25 mg of ilamod every day and 50 mg of ilamod every day for the following 48 weeks. Among them, 57 patients continued to take this product for 100 weeks. The common adverse drug reactions (> 1 / 10) in this test mainly include the increase of aminotransferase γ- Glutamyltranspeptidase and alkaline phosphatase increased; Common adverse drug reactions (> 1 / 100, < 1 / 10) were mainly β- N-acetylglucosaminase increased, bilirubin increased, abnormal liver function test, cholinesterase decreased, fecal occult blood, blood β Elevated 2-microglobulin and urine β 2-microglobulin increased, blood eosinophils increased, hematocrit decreased, hemoglobin decreased, lymphocyte count decreased, erythrocyte decreased, leukocyte increased, urea nitrogen increased, hematuria, proteinuria, urinary leukocyte positive, tubular urine, urinary sediment positive, blood iron decreased, anorexia, abdominal distension, abdominal pain, epigastric pain, diarrhea, loose stool, nausea Retching, vomiting, stomatitis, dermatitis, eczema, hair loss, pruritus, nasopharyngitis, dizziness (except vertigo), taste disorder; The rare adverse drug reactions (> 1 / 1000, < 1 / 100) were mainly gastric ulcer, empyema, interstitial pneumonia and sepsis.

[precautions] 1.肝毒性:临床试验发现本品可引起可逆性的肝脏酶升高,大多数氨基转移酶升高为轻度[≤ 2倍 正常值上限(Upper Limit of Normal,简称ULN)],且通常在继续治疗过程中缓解;显著升高(>3-fold ULN) is infrequent and can be alleviated by reducing the dose or stopping the drug. The increase of aminotransferase in most patients occurs within 3 months of medication. In the initial stage of medication, blood alanine aminotransferase (ALT) and glutamate aminotransferase (AST) should be checked regularly, and the inspection interval depends on the patient's situation. Patients with liver damage and positive serological indicators of hepatitis B or hepatitis C should be used with caution. ALT was checked every month before and after medication, and the time interval depends on the specific situation of the patient. If ALT rises during medication, the principle of adjusting dose or interrupting treatment: ① if ALT rises to 2 ~ 3 times of the upper limit of normal value, elamod can be given continuously under close monitoring, and the dose can be reduced to 25mg / day. ② ALT increases by 2 ~ 3 times the upper limit of normal value. If ALT remains at 2 ~ 3 times the upper limit of normal value and more than 3 times after dose reduction, stop the drug, strengthen liver protection treatment and observe closely. 2. Active gastrointestinal diseases: Patients with active gastrointestinal diseases should be used with caution. In case of black stool, anemia, abnormal stomach / abdominal pain and other symptoms, inform the doctor in time and go to the hospital as soon as possible. Once gastric ulcer or duodenal ulcer is diagnosed, the drug should be stopped immediately and symptomatic treatment should be carried out. 3. Live immune vaccine: there is no clinical data on the effect and safety of live immune vaccine during treatment, so live immune vaccine should not be used during medication. 4. Use with caution in patients with immune deficiency, uncontrolled infection, renal insufficiency and bone marrow dysplasia. 5. No systematic carcinogenicity test has been conducted for adexin (elamod tablets), so the cumulative medication time is temporarily limited to 24 weeks (including 24 weeks). Please read the instructions carefully and follow the doctor's advice.

[taboo] 1. It is forbidden for those who are allergic to any ingredient of this product. 2. It is forbidden for those with serious liver function damage. 3. It is forbidden for pregnant women, lactating women and women who have fertility requirements during treatment. 4. It is forbidden for patients with asthma, urticaria or allergic reaction induced by aspirin or other non steroidal anti-inflammatory drugs. 5. It is forbidden for patients with a history of gastrointestinal bleeding or perforation after the application of non steroidal anti-inflammatory drugs. 6. It is forbidden for patients with active peptic ulcer / bleeding or previous recurrent ulcer / bleeding. (see the inner package manual for details)

[listing Permit Holder] Xiansheng Pharmaceutical Co., Ltd

[packaging unit] box

[main ingredients] The active ingredient of this product is: eilamod.

[character] This product is white or off white.

[applicable population] adult

[medication for pregnant and lactating women] There is no relevant clinical trial data. Based on the results of rat animal reproductive toxicity test, it is forbidden for pregnant women, lactating women and women with fertility requirements during treatment.

[medication for children] The efficacy and safety of adexin have not been adequately and well controlled in children and adolescents, and there is no reliable reference. Children and adolescents should avoid using adexin.

[medication for elderly patients] There is no systematic study on the drug safety of elderly patients. If it is used, it should be used with caution under the guidance of doctors.

[storage] Shading and sealing.

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