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Entecavir capsule (ngandine)

This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum alanine aminotransferase (ALT) or active lesions in liver histology. It is also suitable for the treatment of nucleoside untreated children with chronic HBV infection compensated liver disease from 2 years old to < 18 years old. There is evidence of active virus replication and continuous increase of serum ALT level or histological evidence of moderate to severe inflammation and / or fibrosis. See usage and dosage for specific usage More role
App download minus 10 yuan
Common name:
Entecavir capsule
Product No.:
S14201014978
Approval No.:
Gyzz h20110172 (inquired by the State Drug Administration)
Jianke price:
¥120.00
Product specification:
0.5mg*14s 0.5mg*7s
Manufacturer:
Fujian guangshengtang Pharmaceutical Co., Ltd
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Product name Entecavir capsule (ngandine)
Main raw materials The main component is entecavir.
Main role This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum alanine aminotransferase (ALT) or active lesions in liver histology. It is also suitable for the treatment of nucleoside untreated children with chronic HBV infection compensated liver disease from 2 years old to < 18 years old. There is evidence of active virus replication and continuous increase of serum ALT level or histological evidence of moderate to severe inflammation and / or fibrosis. See usage and dosage for specific usage
Product specification 0.5mg*7s
Usage and dosage Patients should take this product under the guidance of an experienced doctor. 1. Recommended dose: adults and adolescents aged 16 and over take this product orally, once a day, 0.5mg each time. 2. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1mg once a day. This product should be taken on an empty stomach (at least 2 hours before or after meals). 3. Renal insufficiency: in patients with renal insufficiency, the apparent oral clearance of entecavir decreased with the decrease of creatinine clearance. 4. Creatinine clearance rate & lt; Patients with 50ml / min [including patients treated with hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)] should adjust the dosage. 5. Liver insufficiency: Patients with liver insufficiency do not need to adjust the dosage. 6. Treatment period: the best treatment time of this product and its relationship with long-term treatment results, such as liver cirrhosis and liver cancer, are not clear at present.
manufacturing enterprise Fujian guangshengtang Pharmaceutical Co., Ltd
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[drug name] Entecavir capsule (ngandine)

[common name] Entecavir capsule

[specification and model] 0.5mg*7s

[manufacturer] Fujian guangshengtang Pharmaceutical Co., Ltd

[drug type] Western medicine

[approval No.] Gyzz h20110172

[validity period] 24 months

[functional indications] This product is suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase of serum alanine aminotransferase (ALT) or active lesions in liver histology. It is also suitable for the treatment of nucleoside untreated children with chronic HBV infection compensated liver disease from 2 years old to < 18 years old. There is evidence of active virus replication and continuous increase of serum ALT level or histological evidence of moderate to severe inflammation and / or fibrosis. See usage and dosage for specific usage

[usage and dosage] Patients should take this product under the guidance of an experienced doctor. 1. Recommended dose: adults and adolescents aged 16 and over take this product orally, once a day, 0.5mg each time. 2. Patients with viremia or lamivudine resistant mutation during lamivudine treatment were 1mg once a day. This product should be taken on an empty stomach (at least 2 hours before or after meals). 3. Renal insufficiency: in patients with renal insufficiency, the apparent oral clearance of entecavir decreased with the decrease of creatinine clearance. 4. Creatinine clearance rate & lt; Patients with 50ml / min [including patients treated with hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)] should adjust the dosage. 5. Liver insufficiency: Patients with liver insufficiency do not need to adjust the dosage. 6. Treatment period: the best treatment time of this product and its relationship with long-term treatment results, such as liver cirrhosis and liver cancer, are not clear at present.

[adverse reactions] 1. In studies conducted abroad, the most common adverse events of this product are headache, fatigue, dizziness and nausea. 2. The common adverse events of patients treated with lamivudine are 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 instructions for details.

[precautions] The creatinine clearance rate of patients with renal insufficiency is less than 50ml / min, including patients with hemodialysis or CAPD. It is recommended to adjust the dosage of entecavir. The safety and efficacy of entecavir in liver transplant recipients is unclear. If it is considered that the liver transplant recipient needs to be treated with entecavir, and he has received or is receiving immunosuppressive agents that may affect renal function, such as cyclosporine or tacrolimus, renal function should be closely monitored before and during the administration of entecavir. Special precautions for patients with drug resistance and failure of lamivudine treatment: mutations in lamivudine resistance sites in HBV polymerase region may lead to secondary mutations, including mutations in entecavir resistance related sites. A few patients who failed lamivudine treatment had mutations in entecavir resistance related sites rtt184, rts202 and rtm250 at baseline. Patients with lamivudine resistance had a higher risk of subsequent entecavir resistance than patients without lamivudine resistance. In the lamivudine treatment failure study, the cumulative incidence of entecavir genotype resistance after 1, 2, 3, 4 and 5 years of entecavir treatment was 6%, 15%, 36%, 47% and 51%, respectively. Patients should be informed that patients should take entecavir under the guidance of doctors, and inform doctors of any new symptoms and drug combinations. 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 antibodies before starting entecavir treatment. Patients should be informed to read the instructions carefully and follow the doctor's instructions if necessary.

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

[listing Permit Holder] Fujian guangshengtang Pharmaceutical Co., Ltd

[packaging unit] box

[main ingredients] The main component is entecavir.

[character] The content of this product is white or off white particles or powder.

[applicable population] Adult, female, male

[medication for pregnant and lactating women] The effect of entecavir on pregnant women has not been fully studied. This product can only be used after making a full balance between the potential risks and benefits of the fetus. 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. 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 18 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 16: different. Other clinical trial reports also did not find the difference between elderly patients and young patients. Entecavir is mainly excreted from 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] Shading and sealing, at 25 ℃

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    Entecavir capsule (ngandine)

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