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Entecavir dispersible tablets (Leide)

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.:
S14200073440
Approval No.:
Gyzz h20100129 (inquired by the State Drug Administration)
Jianke price:
¥140.00
Product specification:
0.5mg*14s 1mg*7s 0.5mg*7s 0.5mg*28s
Manufacturer:
Suzhou Dongrui Pharmaceutical Co., Ltd
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Product name Entecavir dispersible tablets (Leide)
Main raw materials Entecavir.
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). (see the inner packaging manual for details)
manufacturing enterprise Suzhou Dongrui Pharmaceutical Co., Ltd
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[drug name] Entecavir dispersible tablets (Leide)

[common name] Entecavir dispersible tablets

[specification and model] 0.5mg*7s

[manufacturer] Suzhou Dongrui Pharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20100129

[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). (see the inner packaging manual for details)

[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. (see the inner packaging manual for details)

[precautions] Creatinine clearance in patients with renal insufficiency<;50ml/min,包括血透析或CAPD的患者,建议调整恩替卡韦的给药剂量。肝移植受体患者恩替卡韦治疗肝移植受体的安全性和有效性尚不清楚。如果认为肝移植受体需要接受恩替卡韦治疗,其曾经或正在接受可能影响肾功能的免疫抑制,如:环孢菌素或他克莫司的治疗,应在恩替卡韦给药前及给药过程中严密监测肾功能。患者须知患者应在医生的指导下服用恩替卡韦,并告知医生任何新出现的症状及合并用药情况。应告知患者如果停药有时会出现肝脏病情加重,所以应在医生的指导下改变治疗方法。患者在开始恩替卡韦治疗前,需要进行HIV抗体的检测。应告知患者如果感染了HIV而未接受有效的HIV药物治疗,恩替卡韦可能会增加对HIV药物治疗耐药的机会。使用恩替卡韦治疗并不能降低经性接触或污染血源传播HBV的危险性。因此,需要采取适当的防护措施。请仔细阅读说明书并遵医嘱使用。

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

[listing Permit Holder] Suzhou Dongrui Pharmaceutical Co., Ltd

[packaging unit] box

[main ingredients] Entecavir.

[character] This product is white or off white.

[applicable population] unlimited

[medication for pregnant and lactating women] 1. The study on the effect of entecavir on pregnant women is insufficient. This product can only be used after fully weighing the potential risks and benefits of the fetus. 2. 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. 3. Entecavir can be secreted from rat milk. However, it is still unclear whether there is secretion 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 also did not find the difference between elderly patients and young patients. Entecavir is mainly excreted by the kidney. In patients with renal function injury, the risk of toxic reaction may be higher. 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] Seal and store in a dry place.

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    Entecavir dispersible tablets (Leide)

    ¥140.00

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