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Entecavir dispersible tablets (Runzhong)

This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum transaminase ALT or active liver histology. More role
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Common name:
Entecavir dispersible tablets
Product No.:
S14200011369
Approval No.:
Gyzz h20100019 (inquired by the State Drug Administration)
Jianke price:
¥156.00
Product specification:
0.5mg*7s 0.5mg * 14s * 2 plate
Manufacturer:
Zhengda Tianqing Pharmaceutical Group Co., Ltd
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Product name Entecavir dispersible tablets (Runzhong)
Main raw materials The main ingredients of this product are: entecavir chemical name: 2-amino-9 - [(1s, 3R, 4S) - 4-hydroxy-3-hydroxymethyl-2-methylene cyclopentyl] - 1,9-dihydro-6h-purine-6-one monohydrate chemical structure formula: molecular formula: c12h15n5o3 & middot; Molecular weight of H2O: 295.3
Main role This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum transaminase ALT or active liver histology.
Product specification 0.5mg*7s
Usage and dosage Patients should take this product under the guidance of an experienced doctor. Recommended dose: Adults and adolescents aged 16 and over take this product orally, once a day, 0.5mg each time. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1mg (0.5mg two tablets) once a day. This product should be taken on an empty stomach (at least 2 hours before or after meals). Renal insufficiency In patients with renal insufficiency, the apparent oral clearance of entecavir decreases with the decrease of creatinine clearance (see pharmacokinetics, special population). Creatinine clearance & lt; The dosage should be adjusted for patients with 50ml / min (including patients treated with hemodialysis or CAPD). See Table 1. Table 1: recommended interval adjustment of entecavir in patients with renal insufficiency Creatinine clearance (ml / min) Usual dose (0.5mg) Lamivudine treatment failure (1mg) &su
manufacturing enterprise Zhengda Tianqing Pharmaceutical Group Co., Ltd
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[drug name] Entecavir dispersible tablets (Runzhong)

[common name] Entecavir dispersible tablets

[specification and model] 0.5mg*7s

[manufacturer] Zhengda Tianqing Pharmaceutical Group Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20100019

[validity period] 36 months

[functional indications] This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum transaminase ALT or active liver histology.

[usage and dosage] Patients should take this product under the guidance of an experienced doctor. Recommended dose: Adults and adolescents aged 16 and over take this product orally, once a day, 0.5mg each time. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1mg (0.5mg two tablets) once a day. This product should be taken on an empty stomach (at least 2 hours before or after meals). Renal insufficiency In patients with renal insufficiency, the apparent oral clearance of entecavir decreases with the decrease of creatinine clearance (see pharmacokinetics, special population). Creatinine clearance & lt; The dosage should be adjusted for patients with 50ml / min (including patients treated with hemodialysis or CAPD). See Table 1. Table 1: recommended interval adjustment of entecavir in patients with renal insufficiency Creatinine clearance (ml / min) Usual dose (0.5mg) Lamivudine treatment failure (1mg) &su

[adverse reactions] The evaluation of adverse reactions was based on four global clinical trials: ai463014, ai463022, ai463026, ai463027 and three clinical trials in China (ai463012, ai463023, ai463056). In these 7 studies, 2596 chronic hepatitis B patients were enrolled. In the study compared with lamivudine, the adverse events and laboratory abnormalities of entecavir and lamivudine were similar. In studies conducted abroad, the most common adverse events of this product are headache, fatigue, dizziness and nausea. The common adverse events of patients treated with lamivudine were headache, fatigue and vertigo. In these four studies, 1% of patients treated with entecavir and 4% of patients treated with lamivudine withdrew from the study due to adverse events and abnormal laboratory test indicators, respectively. Clinical adverse events abroad Table 2 compares the differences between entecavir and lamivudine in four clinical studies. Moderate to severe adverse events and clinical adverse events that may at least be related to treatment during treatment were selected as the indicators for comparison. Table 2: clinical adverse events from moderate to severe (grade 2 to 4) in four two-year clinical studies of entecavir a

[precautions] Patients with renal insufficiency For patients with creatinine clearance < 50ml / min, including hemodialysis or CAPD, it is recommended to adjust the dosage of entecavir (see usage and dosage). Recipients of liver transplantation The safety and efficacy of entecavir in liver transplant recipients are unclear. If it is considered that the liver transplant recipient needs to be treated with entecavir and has received or is receiving immunosuppression that may affect renal function, such as cyclosporin or tacrolimus, renal function should be closely monitored before and during the administration of entecavir. (see pharmacokinetics) Patient information The patient should take entecavir under the guidance of the doctor, and inform the doctor of any new symptoms and drug combination. The patient should be informed that if the drug is stopped, sometimes the liver condition will worsen, so the treatment method should be changed under the guidance of the doctor. Patients need to be tested for HIV antibody before starting entecavir treatment. Patients should be informed that if they are infected with HIV and do not receive effective HIV drug treatment, entecavir may increase the chance of resistance to HIV drug treatment (see warning 3. Co infection with HIV). Entecavir treatment does not reduce the risk of HBV transmission through sexual contact or contaminated blood sources. Therefore, appropriate protective measures need to be taken. Please read the instructions carefully and follow the doctor's advice.

[taboo] It is prohibited for those allergic to entecavir or any ingredient in the preparation.

[listing Permit Holder] Zhengda Tianqing Pharmaceutical Group Co., Ltd

[packaging unit] box

[main ingredients] The main ingredients of this product are: entecavir chemical name: 2-amino-9 - [(1s, 3R, 4S) - 4-hydroxy-3-hydroxymethyl-2-methylene cyclopentyl] - 1,9-dihydro-6h-purine-6-one monohydrate chemical structure formula: molecular formula: c12h15n5o3 & middot; H2O molecular weight: 295.3

[character] This product is white or off white.

[applicable population] unlimited

[medication for pregnant and lactating women] The study on the effect of entecavir on pregnant women is not sufficient. This product can only be used when the potential risks and benefits of fetus are fully weighed. At present, there is no data suggesting that this product can affect the mother to child transmission of HBV. Therefore, appropriate intervention measures should be taken to prevent neonatal infection with HBV. Entecavir can be secreted from rat milk, but it is still unclear whether it is secreted in human milk, so mothers taking this product are not recommended to breastfeed.

[medication for children] Data on the safety and efficacy of this product for children under the age of 16 have not been established.

[medication for elderly patients] Since there are not enough elderly patients aged 65 and over to participate in the clinical study of this product, it is unclear how the response of elderly patients and young patients to this product is different. Other clinical trial reports have not found the difference between elderly patients and young patients. Entecavir is mainly excreted by the kidney, and the risk of toxic reaction may be higher in patients with renal function injury Because most of the elderly patients have decreased renal function, we should pay attention to the choice of drug dose and monitor renal function.

[storage] Sealed, dry below 25 ℃

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    Entecavir dispersible tablets (Runzhong)

    ¥156.00

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